HAHM

Unit-1
INTRODUCTION TO LEGAL ASPECTS IN HOSPITAL AND HEALTH
CARE MANAGEMENT

Learning Objectives
After going through this Unit, you will be able to:

∑ enumerate the changes taking place in modern medical practice;

∑ understand the context of medical legislation;
∑ Understand the basic functioning of Medical Council of India.

Structure
1.1. Introduction
1.2 Changes in Health Care
1.3 Basic Terminologies
1.4 Legislation in Health Care
1.5 Medical Council of India
1.6 Summary
1.7 Key Words

1.1 INTRODUCTION

Healthcare is an essential commodity. Rapidly changing demographic trends, spiralling population

base, increasing affordability with rising income, have further contributed to the escalation in the
need, for “good quality” healthcare. Reports suggest that private sector dominates the healthcare
delivery market due to their ubiquitous presence and growing inadequacies in the public sector. The
Ernst and Young Report projects a need for 10 lakh hospital beds in the next five years, and
anticipates that 88% of this will come from the private sector.
Understanding Law and Legal framework of the constitution is imperative for any form of business or
activity, including healthcare. Though seemingly unrelated, medicine and law have a long association.
Law enforcements agencies seek medical assistance all the time. Like every human activity, health
care also needs to be regulated. Some kind of guidelines to practice medicine existed for thousands of
years. Hippocrates oath and the ethical principles in Ayurveda are some examples.
In modern times, legal provisions related to health care can be found in different statutes. Indian Penal
Code, Environmental Protection Act, Epidemic Disease Control Act are more than centuries old.
Laws are dynamic. They reflect the societal attitude at a particular period. It is worth noting that laws
are enacted to control the behavior and practice of certain section of the society. Recent examples are
enactment of Human Organ Transplant Act to prevent commercialization in Kidney Transplants,
PCPNDT Act to curb Female Feticide and Biomedical Waste Rules to stop spread of diseases due to
infectious waste.
Till mid-eighties, though laws existed, medical and health care professionals, paid little attention to
them. Application of Consumer Protection Act, 1984, to the doctors and health care institutions
suddenly changed the perspective. Practically, every stake holder realized the importance of laws. The
next two decades saw umpteen number of cases filed against health care providers and institutions. It
resulted in enormous financial loss and damage to the reputation of individuals and institutions. It
became imperative to know the laws to prevent complaints and legal cases. Everyone realized that it
was prudent to remain on the right side of law.

1.2 CHANGES IN HEALTH CARE

The last few decades have witnessed a few revolutionary changes are underway in the health field in
India.

Firstly, in the last four decades, as a result of planned attempts by the Central and State Governments
and with the support of international bodies, significant improvements have been made in the
strengthening of the health and medical care systems, training of manpower and infrastructure
development. Excellent modern medical facilities of international standards have been developed in
the public, private and voluntary sector. At the beginning of the 21st century, India is poised to take a
lead in healthcare services globally.

Secondly, majority of the Indian people, who were less educated, ignorant, passive - dependent and
fatalistic, are now demanding quality care, are aggressive, informed, and ready to fight for justice.

Thirdly huge Inroads have made by commercialism in the health care industry. The spirit of
privatization now pervades India. Whilst the benefits have been widely publicized, the drawbacks
have been little discussed. Hitherto, poor patients had free access to the best that the medical sciences
had to offer at the public hospitals run by governments (central and state) and municipal corporations.
These hospitals were created for the poor patient and the costs were wholly subsidized.

Rising costs and the wave of privatization have combined to throw these hospitals to the winds.
Administrators and bureaucrats now seek ways to raise income from the abjectly poor patients who
throng their institutions. When such funds cannot be raised, the hospitals are allowed to decay and
disintegrate. In my own city, Mumbai, we are now witnesses to a public hospital being auctioned to
the highest bidder.

Commercialism has had other ill consequences. Here are some examples:

∑ Smelling fast bucks, several individuals (some of them medical consultants

themselves) or groups, have set up Computerized Tomography and Magnetic
Resonance scanners in most major cities. The intense competition between these
centers has engendered the pernicious system of fee splitting. The doctor referring a
patient for a scan is paid a handsome fee for `pre-scan clinical workup'!

∑ Unscrupulous clinicians - and there are plenty of them - have been quick to seize this
opportunity and refer every patient with a headache or a backache for such scans,
often without a detailed clinical examination.

The advent of corporate hospitals set up purely with a motive to make huge profits and offer
dividends to their shareholders has aggravated the sharp departure from ethical practice. Chains of
hospitals are being set up with a holding company, a subsidiary for making centralized purchases for
the entire chain, and individual companies for each hospital. The holding company often ensures that
equipment is purchased from predetermined firms, often for considerations other than merit.
Channelling all purchases through a centralized subsidiary ensures fat returns on each item purchased
for the entire chain. In the process, the patient pays hugely inflated costs.

Zero priority for medical ethics in the minds of administrators, teachers and students and a general
lack of character amongst care providers.

With the increased demand in healthcare, application of modern technology, costs escalation in
healthcare, commercialization of medical education, fake doctors in every city and establishment of
large number of nursing homes by many fake doctors and quick-rich entrepreneurs, there have been
increasingly reported cases of professional misconduct, negligence, malpractice and consumer
exploitation.

1.3 BASIC TERMINOLOGIES

The terms "legislation" and "law" are used to refer generically to statutes, regulation and other legal
instruments (e.g. ministerial decrees) that may be the forms of law used in a particular country.
In general, there are a wide range of regulatory strategies that might be used to ensure
people's health and safety. Increasingly, regulators are taking an approach of "responsive regulation".
This involves using mechanisms that are responsive to the context, conduct and culture of those being
regulated, providing for a range of regulatory mechanisms to achieve the behaviour desired. Where
appropriate, the aim is to use incentives before sanctions. However, when those being regulated do
not respond accordingly, escalating sanctions can be invoked. These strategies may be broadly
classified into five groups.

Voluntarism: voluntary compliance undertaken by an individual organization without any coercion.

Self-regulation: for example, an unorganized group that regulates the behaviour of its own members
through a voluntary code of practice.

Economic instruments: for example, supply funding sanctions or incentives for health care providers,
and/or demand-side measures that give more power to consumers

Meta-regulation: involving an external regulatory body to ensure that health care providers implement
safety and quality practices and programmes.

Command and control mechanisms: involving enforcement by government.

Health law is the federal, state, and local law, rules, regulations and other jurisprudence affecting the
health care industry and their application to health care patients, providers and payers, and vendors to
the health care industry, including without limitation the relationships among providers, payers and
vendors to the health care industry and its patients; and (2) delivery of health care services; all with an
emphasis on operations, regulatory and transactional legal issues. Some areas of law it includes are:

∑ Contract law
∑ Medical malpractice
∑ Medical law
∑ Administrative law
∑ Public health law
∑ Consent

Medical law

∑ Not to be confused with Health law or Medical jurisprudence.

∑ Medical law is the branch of law which concerns the prerogatives and responsibilities
of medical professionals and the rights of the patient. It should not be confused with medical
jurisprudence, which is a branch of medicine, rather than a branch of law.

∑ The main branches of medical law are the law on confidentiality, negligence and torts in
relation to medical treatment (most notably medical malpractice), and criminal law in the
field of medical practice and treatment. Ethics and medical practice is a growing field.

1.4 LEGISLATION IN HEALTH CARE

As a result, and in order to ensure safe and quality health care and also to protect the interests of the
patient against unethical and nefarious malpractice many acts, legislations have been enacted and
promulgated. This includes the law under which health services are organized, the laws which impose
liabilities on medical personnel, and the laws which give special rights to particular categories of
patients like women, mentally ill persons, other handicapped persons, children, etc.

Types of Law in Health Care

The various laws pertaining to Hospitals and Health care can be categorized as under:
∑ Laws Related To Governing The Commissioning Of Hospitals.
∑ Laws Related To Governing Of qualifications /Practice and Conduct of Professionals.
∑ Laws Governing Storage / Sale of Drugs and Safe Medication
∑ Laws Governing Biomedical Research
∑ Laws Related to Governing of management Of Patients.
∑ Laws Related To Governing of Medico Legal Aspects.
∑ Law Governing the Safety of Patients, Public and Staff within the Hospital Premises and
Environmental Protection.
∑ Law Governing The Safety of Patients, Public and Staff within the Hospital Premises
∑ Laws Governing The Employment Of Manpower
∑ Laws Governing Professional Training And Research
 ∑ Laws Governing The Business Aspects Of Hospital

Law Related to Governing the Commissioning of Hospital

Sl. No. Name of Act / Rule Year
1. Society registration Act 1960
2. Companies Act 1956
3. Delhi Fire Service Act 2007
4. Delhi Fire Prevention and Fire Safety Act 1986
5. Fire safety rules 1987
6. Electricity rules 1956
7. Delhi lift Act 1942
8. Bombay Lifts Act 1939
9. Delhi Nursing Home Registration Act 1953
10. Bombay Nursing Homes Registration (Amendment) Act 2005
11. Bombay Nursing Homes Registration (Extension and 1959
Amendment) Act
12. Bombay Nursing Homes Registration Act 1949
13. Radiation Protection Certificate for Radiology Dept. from Provision
BARC

14. Atomic Energy Regulatory Body Approval For Radiology / 1962

Nuclear Medicine Services Under The Atomic Energy Act
15. Atomic Energy ( safe disposal of radioactive waste) rules 1987
16. Indian Telegraph Act 1885
17. Clinical Establishments Bill 2010
18. Building And Other Construction Workers (Regulation Of 1908
Employment And Conditions Of Service) Act.
19. The Registration Act. 1908
20. The National Capital Territory of Delhi Laws (Special 2007
Provisions) Second Bill
21. Government Buildings Act 1899
22. Karnataka Medical Registration (Amendment) Act 2003
23. Red Cross Society (Allocation of Property) Act 1936
24. St. John Ambulance Association (India) Transfer of Funds 1956
Act,

Laws Governing the Qualifications / Practice and Conduct of Professionals

Sl. Name of Act / Rule Year
No.
1. Indian Medical Council Act 1956
2. Indian Medical Council (professional conduct, etiquette and ethics) 2002
Regulations
3. Indian Medical Degrees Act 1916
4. Registration Of Medical Practitioners With State Medical Councils
Provision
5. Indian Nursing Council Act 1947
6. Delhi Nursing Council Act 1997
7. The ICN Code of Ethics For Nurses 1953
8. The Dentists Act 1948
9. The Dentists ( code of ethics regulation) 1976
10. Dental Council of India Regulations 2006
11. All India Council for Technical Education ACT 1987
12. The Apprenticeship Act 1961
13. Rehabilitation Council of India Act 1992
14. Rehabilitation Council of India (Amendment) Act 2000
15. Kerala Anatomy Act 1957
16. Kerala Co-operative Hospital Complex and the Academy of Medical 1997
Sciences (Taking over the Management) Act
17. Kerala Professional Colleges or Institutions (Prohibition of Capitation Fee, 2007
Regulation of Admission, Fixation of Non-exploitative Fee and Other
Measures to Ensure Equity and Excellence in Professional Education)
Amendment Act
18. Karnataka Anatomy Act 1957

Laws Governing Storage/Sale of Drugs and Safe Medication

Sl. Name of Act / Rule Year

No.
1. Drugs And Cosmetic Act 1940
2. Drug And Cosmetic Act Amendment 1982
3. The Drug And Cosmetics Rules (Amendment 2005) 1945
4. The Drugs Control Act 1950
5. Pharmacy Act 1948
6. License for Possession and Use of Rectified/Denatured Provisions of the Bombay
Spirit Prohibition Act, 1949 (Boom.
XXV of 1949)
7. Narcotics and Psychotropic Substances Act 1985
8. Central Excise Act ( for permit to use and store sprit ) 1944
9. Retail Drug License Provisions of Drugs Cosmetics
Act-1940.
10. VAT Act 2005
11. Central Sales Tax Act 1956
12. Sales of Good Act 1930
13. Adulteration of Drugs (IPC Sec 274)
14. Sales of Adulterated Drugs ( IPC Sec 275 )
15. Sales of Drug as Different Drug or Preparation ( IPC Sec 276 )
16. Negligent Conduct With Regard To Poisonous (IPC Sec 284)
 Substances
17. Blood Bank Regulations Under Drugs And Cosmetic ( 1999
2nd amendment ) Rules
18. Homoeopathy Central Council (Amendment) Act 2002
19. Homoeopathy Central Council Act 1973

Laws Governing Biomedical Research

Sl. Name of Act / Rule Year

No.
1. Breeding of and Experiments on Animals (Control and 2005
Supervision )Amendment Rules
2. Reconstitution of Committee for the Purpose of Control and Chapter 4, Section 15(1) of
Supervision of Experiments on Animals (CPCSEA). the Prevention of Cruelty
to Animals Act 1960.

Law Governing to Management of Patients

Sl. No. Name of Act / Rule Year

1. Drugs And Magic Remedies ( objectionable ) Advertisements Act 1954
1954
2. PNDT Act 1994
3. Pre Conception And Prenatal Diagnostic Techniques ( prohibition of 1996
sex selection ) Rules,
4. MTP Act 1997
5. MTP Rules 1971
6. Transplantation of Human Organ Act 1994
7. Transplantation of Human Organ Rule 1995
8. Birth And Death And Marriage Registration Act 1886
9. Delhi Registration of Birth And Deaths Act 1969
10. Indian Lunacy Act 1912
11. The Epidemic Disease Act 1897
12. Delhi Municipal Corporation ( Malaria and other mosquito Borne 1975
disease ) Bye Law
13. Lepers Act 1975
14. Guardians And Wards Act 1890
15. National Guidelines For Clinical Management Of HIV / AIDS , Guidelines of
NACO, Govt of India ministry of
family welfare
and department
of AIDS control.
16. Manual For Control Of Hospital Associated Infections : SOPs, Guidelines for
NACO , Govt of India control of
hospital
associated
infections.
17. The Mental Health Act 1987
18. Ear Drums and Ear Bones (Authority for Use for Therapeutic 1982 La
Purposes) Act w
Go
19. Eyes (Authority for Use for Therapeutic Purposes) Act 1982
ver
ning Medico Legal Aspects
Name of Act / Rule Year
1. Law Of Privileged Communications Provision
2. Indian Evidence Act (disclosure of privileged / confidential patient 1872
related information before a court of law – under protest)
3. Law of Torts Concept in Law
4. Consumer Protection Act 1986
5. Protection of Human Rights Act 1993

Law Governing the Safety of Patients, Public and Staff within the Hospital Premises and
Environmental Protection

Sl. Name of Act / Rule Year/Amendment

No.
1. Biomedical Medical Waste Management Handling 1998/2000
Rules
2. Water ( prevention and control of pollution) Act 1974
3. The Water (Prevention and Control of Pollution) 2003
Cess (Amendment) Act
4. The Water (Prevention and Control of Pollution) 1974/1988
Act
5. The Water (Prevention and Control of Pollution) 1978
Cess Rules
6. The Water (Prevention and Control of Pollution) 1975
Rules
7. The Noise Pollution (Regulation and Control) 2010
(Amendment) Rules
8. The Noise Pollution (Regulation and 2006
Control)(Amendment) Rules
9. The Noise Pollution (Regulation and Control) 2006
(Amendment) Rules
10. The Noise Pollution (Regulation and Control) 2002
(Amendment) Rules
11. The Noise Pollution (Regulation and Control) 2000
(Amendment) Rules
12. Business) Rules 1975/1976
13. Rules Regarding The Safe Discharge of Effluents In
The Public Sewers / Drains
14. DMC Sanitation and Public Health Bye Laws 1959
15. Air ( prevention and control of pollution ) act 1981/1987
16. The Air (Prevention and Control of Pollution) 1983
(Union Territories) Rules,
17. The Air (Prevention and Control of Pollution) Rules 1982
18. Environment Protection Act 1986
19. Environment Protection Rule 1986
20. Environment Protection Act 1996
21. Noise Pollution Control Rules 2000
22. IPC sec 269 ( negligent act likely to spread Provision of Water
infection or disease dangerous to life , unlawfully or (Prevention and Control of
negligently Pollution) Act, 1974

Law Governing the Safety of Patients, Public and Staff within the Hospital Premises
S. no Name of Act / Rule Year
1. Indian Boilers Act 1923
2. Explosive Act 1884 (for diesel storage) 1884
3. Petroleum Act + storage Rules 2002
4. Gas cylinder Rules 2004
5. Rules for provision of safe drinking water 1974
7. Prevention of food adulteration Act 1954
8. The radiation surveillance procedures for the medical 1989
application of radiation
9. Radiation protection Rules 1971
10. AERB safety code no. AERB/SC/Med -2 ( REV -1) 2001
11. Insecticide Act 1968
12. Arms Act, 1950
16. The Indian Fatal Accidents Act 1955
17. The Cigarettes and Other Tobacco Products ( prohibition of 2003
advertisement and Regulation of trade and commerce ,
production , supply and distribution ) bill
18. Prohibition of Smoking In Public Places Rules 2008
19. Prohibition of Smoking In Public Places Rules 2008
20. The Tamil Nadu Medicare Service Persons And Medicare 2008
Service Institutions( prevention of violence and damage or
loss to property ) Act
21. The Tamil Nadu Medicare Service Persons and Medicare 2008
Service Institutions( prevention of violence and damage or
loss to property ) Act
22. Vaccination Act 1880
23. Vaccination (Repeal) Act 2001
24. Disaster Management Act 2005
25. Protection of Human Rights Act 1993

Laws Governing the Employment of Manpower

Sl. No. Name of Act / Rule Year
1. Child Labour Act 1986
2. Citizenship Act 1955
3. Employees Provident Fund and Misc. Provision Act 1952
4. ESI Act 1948
5. ESI ( central ) Rules 1950
6. Employment Exchange ( compulsory notification of 1959
vacancies ) Act
7. Equal Remuneration Act 1976
8. Minimum Wedge Act 1948
9. Payment of Bonus Act 1965
10. Payment of Gratuity Act 1972
11. Payment of Wages Act 1936
12. PPF Act 1968
13. TDS Act Provision of Income
Tax Act, 1961.
14. Maternity Benefit (Amendment) Act 2008
15. Workmen’s Compensation Act 1923
16. Workmen's Compensation (Amendment) Act 2009
17. Indian Trade Union Act 1926
18. Industrial Disputes Act 1947
19. Shops and Factories Act (for national holidays) 1948
20. Negotiable Instrument Act 1881
21. Persons with Disabilities Act 1995
22. SC and ST Act 1989
23. Weekly Holidays Act 1942
24. Official Secrets Act 1923
25. Persons With Disabilities (Equal Opportunities, Protection of 1995
Rights and Full Participation) Act
26. Karnataka Prohibition of Violence against Medicare Service 2009
Personnel and Damage to Property in Medicare Service
Institutions Act
27. Information Technology (Amendment) Act 2008
28. Information Technology Act 2000

Law Governing to Professional Training and Research

Sl. No. Name of Act / Rule Year

1. MCI Rules for Internship Training Rules of Medical

council of India
2. National Board Of Examinations Rules for DNB Training Rules of national board
of examination
3. Nursing Council of India Rules for Staring School / College Guidelines by Indian
 of Nursing nursing council to start
nursing council.
4. ICMR rules Governing Medical Research Guidelines by ICMR

Regulations Governing the Business Aspects of Hospital

Sl. No. Name of Act / Rule Year/Amendment
1. Charitable and Religious trust Act 1920
2. Contract Act 1982
3. Income Tax Act 1961
4. Customs Act 1962
5. Foreign Exchange Management Act 1999
6. Insurance Act 1938
7. Rules for Display of Red Cross Guidelines by international
Insignia committee of red cross.
8. Sales of Good Act 1930
9. Cable Television Network ACT 1995
10. Gift Tax Act 1958
11. Copyright Act 1982
12. The Public Liability Insurance Act 1991/1992
13. The Public Liability Insurance Rules 1991/1993

1.5 MEDICAL COUNCIL OF INDIA

Before 1930, medical profession was regulated by General Medical Council of UK. Medical Council
of India (MCI), bill was proposed in 1030 and the same was passed in 1933, accordingly MCI was
established in 1934. MCI Act was revised in 1956, 1964, 1993, 1999 and 2002. The schedules of MCI
include the list of medical degrees recognized by MCI:

∑ Schedule 1 – includes list of recognized degrees awarded by Indian Universities and

also DNB (Diplomate of National Board) awarded by National Board of
Examination, New Delhi.
∑
∑ Schedule 2 – Includes list of recognized medical degrees other than MBBS awarded
by Indian Societies and Boards e.g. LMP and diplomas of CPS (College of Physicians
& Surgeons, Bombay).
∑
∑ Schedule 3 – Part II – includes list of recognized medical degrees other than MBBS
awarded by Foreign Societies and Boards.

Formation of MCI: The Central Government shall cause to be constituted council consisting
of the following members, namely:
 ∑ One member (possessing qualification as per schedule 1 or 2) from each state,
nominated by Central Government in consultation with respective State
Governments.
∑
∑ One member (possessing qualification as per schedule 1 or 2) from each Union
Territory, nominated by Central Government in consultation with union territory
administration.
∑
∑ One member from each University in India from amongst the members of the medical
faculty, elected by members of Senate of University.
∑
∑ One member from each state, possessing qualifications as per Schedule 1, 2, or part II
or 3rd Schedule, elected from amongst themselves by the persons registered with State
Medical Council.
∑
∑ A total of 7 members from all states taken together, possessing qualifications as per
part 1 of 3rd schedule.
∑
∑ Total 8 members nominated by Central Government
∑
∑ Director General Health Services of India
∑
∑ Director General Armed Forces Medical Services

Term of Office and Executive Committee

The term of office of a MCI member is 5 years. The executive committee of MCI besides the
President and Vice President has 7 – 10 members. From amongst the members are elected the
president, the vice president and Registrar (secretary). An executive member holds office till he
remains a member of MCI. (Dr B C Roy was the first president of MCI).

FUNCTIONS OF MCI

∑ Medical education
∑ Medical qualifications
∑ Medical register
∑ Medical ethics
∑ CME
∑ Issuing certificate of good standard
∑ Maintenance of Indian Pharmacopoeia
∑ Disciplinary control

Medical Education

∑ MCI lays down standards and curriculum of under graduate medical education.

∑ MCI lays down standards and curriculum of post graduate medical education.
 ∑ MCI has laid down requirements of accommodation, equipment, teaching and non-
teaching staff – with their qualifications and experience and other facilities required for a
medical college.

∑ MCI appoints inspectors to inspect the facilities in a medical college or to attend to the
examinations held by the University and based on their report grants or withdraws
recognition of medical college.

∑ Without MCI approval no new medical college can be started, no new course can be
started in an existing medical college and no course number of seats can be increased.

∑ MCI has laid down guidelines for transfer of students to other medical colleges. (A
maximum of 5% students can be transferred in first term of Ian MBBS course from a
recognized medical college to another recognized medical college, only after prior
approval of MCI).

Medical Qualifications

∑ All recognized medical qualifications are listed in schedule 1, 2, and 3 [only the medical
graduates possessing recognized medical degrees from recognized medical institutions are
registered with the medical council and hence are eligible for the rights of a RMP – registered
medical practitioner.

∑ With some countries there is a system of reciprocal recognition of qualifications.

∑ Certain foreign qualifications are recognized by MCI even without reciprocity.

Medical Register

The register maintained by the MCI is known Indian Medical Register and includes names and
addresses of doctors possessing recognized medical qualifications. After passing MBBS the medical
graduate is granted temporary registration which is made permanent after successful completion of
compulsory rotating internship of one year duration. Any additional qualification obtained later can
also be entered. The registrar keeps the register up to date by:

∑ Deleting names of those dead

∑ Deleting names of those given penal erasure for professional misconduct
∑ Deleting names of those convicted by court in cases involving moral turpitude
∑ Adding names of fresh medical graduates registered with State Medical Council
∑ Adding names of those whose term of temporary erasure expires
Medical Ethics

The earliest code of medical ethics was the Hippocrates oath. It was modified by the World Medical
Association, and was named as ‘Declaration of Geneva.’ The oath of Hippocrates is followed by MCI
as a code of medical ethics. Every doctor while applying for registration with medical council has to
sign a pledge that he will obey medical this throughout his professional life.

Continuing Medical Education (CME)

MCI organizes and sponsors CME programs that doctors can know of latest developments in medical
science.

Issuing Certificates of Good Conduct

To those who want to go abroad and need a certificate of good conduct and character may seek this
certificate which is issued by MCI.

Maintenance of Indian Pharmacopeia

MCI advises central government in maintenance of Indian Pharmacopoeia.

Disciplinary Control

The MCI has prescribed standards of professional conduct and etiquettes. Primarily control over cases
of professional misconduct is maintained by State Medical Council, but MCI can also directly issue a
warning notice in cases of professional misconduct. In case of a doctor punished for professional
misconduct by the state medical council, appeals to the central health ministry, the central health
ministry can modify the punishment in consultation with the MCI.

State Medical Council

In majority of the states, there is a state medical council, which is constituted by following members:

∑ Total 9 members elected from among themselves by registered medical

practitioners of the state.

∑ One member from each university of the state

∑ Five members nominated by state government (maximum one can be a non-

medical member)

∑ Director Medical Education and Research (DMER)

 ∑ Director health services of the state

Functions of State Medical Council

Medical education: State Medical Council supervises medical education in that state as per
guidelines of MCI.

Medical register: The registrar is required to maintain the state medical register. He should:

Keep it up to date

Inform MCI of new registrations

In some states there is a system of renewal of registration every 5 – 10 years.

Medical etiquettes: It refers to existing customs of brotherhood among people of medical

profession e.g. it is a custom not to charge other doctors or his close relatives (though it is not a
law).

Medical ethics: It refers to values and guidelines that govern decision in medicine and dealings
with patient and other colleagues.

Professional misconduct: enquires on occurrence of professional misconduct and decide on

suitable penalty.

1.6 SUMMARY

The shocking news pertaining to the hospital deaths of six infants spread from the land of cricketing
geniuses, South Africa, leaving the rest of the world in a state of disbelief. This is particularly so
because South Africa is known to have the most developed health care facilities compared to the rest
of Africa. The shocking incident took place on May 18, 2010, at the neonatal ward of Charlotte
Maxeke Johannesburg Academic Hospital; and the cause for the hospital deaths was diarrhoea, which
the infants contracted over the weekend due to negligent practices in the hospital. Similarly,
incidences of wrong site surgery, items left inside surgical sites, Hospital acquired Infections and
many other cases of malpractice and negligence are on the rise. In the course of practicing medicine,
a range of issues may arise that lead to consultation with a medical ethicist, a lawyer, and/or a risk
manager. The following discussion will outline key distinctions between these roles.

Clinical ethics may be defined as a discipline or methodology for considering the ethical implications
of medical technologies, policies, and treatments, with special attention to determining what ought to
be done (or not done) in the delivery of health care.
Law may be defined as established and enforceable social rules for conduct or non-conduct; a
violation of a legal standard may create criminal or civil liability.

Risk Management may be defined as a method of reducing risk of liability through institutional
policies/practices.

In today’s scenario, it has become the moral, ethical and legal obligation of the care
providers/hospitals to ensure safe and quality health care to the patients. Therefore, a hospital
administrator and care providers must have an in depth knowledge about the various aspects medical
codes, ethics, risk management and applicable of laws in these fields.

1.7 KEY WORDS

Medical law is the branch of law which concerns the prerogatives and responsibilities of medical
professionals and the rights of the patient. It should not be confused with medical jurisprudence,
which is a branch of medicine, rather than a branch of law.
The main branches of medical law are the law on confidentiality, negligence and torts in relation to
medical treatment (most notably medical malpractice), and criminal law in the field of medical
practice and treatment. Ethics and medical practice is a growing field.
Health law is the federal, state, and local law, rules, regulations and other jurisprudence affecting the
health care industry and their application to health care patients, providers and payers, and vendors to
the health care industry, including without limitation the relationships among providers, payers and
vendors to the health care industry and its patients; and (2) delivery of health care services; all with an
emphasis on operations, regulatory and transactional legal issues.
Some areas of law it includes are:

∑ Contract law
∑ Medical malpractice
∑ Medical law
∑ Administrative law
∑ Public health law
∑ Consent
 UNIT 2 CODES OF MEDICAL PRACTICE

Learning Objectives:

After going through this Unit, you will be able to:

∑ the importance of code of medical practice;

∑ Know about important codes of medical practice.

Structure

2.1 Declaration of Geneva

2.2 Hippocratic Oath
2.3 The Declaration of Helsinki
2.4 The Nuremberg Code (1947)
2.5 Ethical Principles for Medical Research Involving Human Subjects-WMA
2.6 Summary
2.7 Key words

2.1 DECLARATION OF GENEVA

The Declaration of Geneva was adopted by the General Assembly of the World Medical
Association at Geneva in 1948 and amended in 1968, 1984, 1994, 2005 and 2006. It is a declaration
of physicians' dedication to the humanitarian goals of medicine, a declaration that was especially
important in view of the medical crimes which had just been committed in Nazi Germany. The
Declaration of Geneva was intended as a revision of the Oath of Hippocrates to a formulation of that
oath's moral truths that could be comprehended and acknowledged in a modern way.

The Original Declaration of Geneva reads:

At the time of being admitted as a Member of the medical profession a doctor must take the following
pledges:

∑ I solemnly pledge to consecrate my life to the service of humanity.

∑ I will give to my teachers the respect and gratitude which is their due.
∑ I will practice my profession with conscience and dignity.
∑ The health and life of my patient will be my first consideration.
∑ I will respect the secrets which are confided in me.
∑ I will maintain by all means in my power, the honor and the noble traditions of the
medical profession.
∑ My colleagues will be my brothers.
 ∑ I will not permit considerations of religion, nationality, race, party politics or social
standing to intervene between my duty and my patient.
∑
∑ I will maintain the utmost respect for human life, from the time of its conception, even
under threat; I will not use my medical knowledge contrary to the laws of humanity.
∑ I make these promises solemnly, freely and upon my honor.

Amended Declaration of Geneva reads:

AT THE TIME OF BEING ADMITTED AS A MEMBER OF THE MEDICAL

PROFESSION:

∑ I SOLEMNLY PLEDGE to consecrate my life to the service of humanity.

∑ I WILL GIVE to my teachers the respect and gratitude that is their due.
∑ I WILL PRACTICE my profession with conscience and dignity.
∑ THE HEALTH OF MY PATIENT will be my first consideration.
∑ I WILL RESPECT the secrets that are confided in me, even after the patient has died.
∑ I WILL MAINTAIN by all the means in my power, the honor and the noble traditions of
the medical profession.
∑ MY COLLEAGUES will be my sisters and brothers.
∑
∑ I WILL NOT PERMIT considerations of age, disease or disability, creed, ethnic origin,
gender, nationality, political affiliation, race, sexual orientation, social standing or any
other factor to intervene between my duty and my patient.
∑ I WILL MAINTAIN the utmost respect for human life.
∑ I WILL NOT USE my medical knowledge to violate human rights and civil liberties,
even under threat.
∑ I MAKE THESE PROMISES solemnly, freely and upon my honor.

2.2 HIPPOCRATIC OATH

The Hippocratic Oath is an oath historically taken by physicians and other healthcare professionals
swearing to practice medicine ethically and honestly. It is widely believed to have been written either
by Hippocrates, often regarded as the father of western medicine, or by one of his students.[1] The oath
is written in Ionic Greek (late 5th century BC) and is usually included in the Hippocratic Corpus.
Classical scholar Ludwig Edelstein proposed that the oath was written by Pythagoreans, a theory that
has been questioned due to the lack of evidence for a school of Pythagorean medicine. Of historic and
traditional value, the oath is considered a rite of passage for practitioners of medicine in many
countries, although nowadays the modernized version of the text varies among them. The Hippocratic
Oath (orkos) is one of the most widely known of Greek medical texts. It requires a new physician to
swear upon a number of healing gods that he will uphold a number of professional ethical standards.

Modern Use and Relevance

The Oath has been modified multiple times, in several different countries. One of the most significant
revisions is the Declaration of Geneva, first drafted in 1948 by the World Medical Association; it has
since been revised several times. While there is currently no legal obligation for medical students to
swear an oath upon graduating, 98% of American medical students swear some form of oath, while
only 50% of British medical students do.

Hippocratic Oath-English Translation, Version 1

I do solemnly vow, to that which I value and hold most dear;

That I will honor the Profession of Medicine, be just and generous to its members, and
Help sustain them in their service to humanity;

That just as I have learned from those who preceded me, so will I instruct those?
Who follow me in the science and the art of medicine?

That I will recognize the limits of my knowledge and pursue lifelong learning to
Better care for the sick and to prevent illness;

That I will seek the counsel of others when they are more expert so as to fulfill my
Obligation to those who are entrusted to my care;

That I will not withdraw from my patients in their time of need;

That I will lead my life and practice my art with integrity and honor, using my
Power wisely;

That whatsoever I shall see or hear of the lives of my patients that are not fitting to
Be spoken, I will keep in confidence;

That into whatever house I shall enter, it shall be for the good of the sick;
That I will maintain this sacred trust, holding myself far aloof from wrong, from
Corrupting, from the tempting of others to vice;

That above all else I will serve the highest interests of my patients through the
Practice of my science and my art;

That I will be an advocate for patients in need and strive for justice in the
Care of the sick.

I now turn to my calling, promising to preserve its finest traditions, with the reward of a long
Experience the joy of healing.

I make this vow freely and upon my honor

English Translation, Version 2

I swear by Apollo, the healer, Asclepius, Hygeia, and Panacea, and I take to witness all the gods, all
the goddesses, to keep according to my ability and my judgment, the following Oath and agreement:

To consider dear to me, as my parents, him who taught me this art; to live in common with him and, if
necessary, to share my goods with him; To look upon his children as my own brothers, to teach them
this art; and that by my teaching, I will impart a knowledge of this art to my own sons, and to my
teacher's sons, and to disciples bound by an indenture and oath according to the medical laws, and no
others.

I will prescribe regimens for the good of my patients according to my ability and my judgment
and never do harm to anyone.

I will give no deadly medicine to any one if asked, nor suggest any such counsel; and similarly I will
not give a woman a pessary to cause an abortion.

But I will preserve the purity of my life and my arts.

I will not cut for stone, even for patients in whom the disease is manifest; I will leave this operation to
be performed by practitioners, specialists in this art.

In every house where I come I will enter only for the good of my patients, keeping myself far from all
intentional ill-doing and all seduction and especially from the pleasures of love with women or men,
be they free or slaves.

All that may come to my knowledge in the exercise of my profession or in daily commerce with men,
whom ought not to be spread abroad, I will keep secret and will never reveal.

If I keep this oath faithfully, may I enjoy my life and practice my art, respected by all humanity and in
all times; but if I swerve from it or violate it, may the reverse be my life.

Hippocratic Oath – Modern Version

Written in 1964 by Louis Lasagna, Academic Dean of the School of Medicine at Tufts University,
and used in many medical schools today.

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won scientific gains of those physicians in whose steps I walk, and gladly share
such knowledge as is mine with those who are to follow.

I will apply, for the benefit of the sick, all measures [that] are required, avoiding those twin traps of
over treatment and therapeutic nihilism.

I will remember that there is art to medicine as well as science, and that warmth, sympathy, and
understanding may outweigh the surgeon's knife or the chemist's drug.

I will not be ashamed to say "I know not," nor will I fail to call in my colleagues when the skills of
another are needed for a patient's recovery.
I will respect the privacy of my patients, for their problems are not disclosed to me that the world may
know.

Most especially must I tread with care in matters of life and death? If it is given me to save a life, all
thanks. But it may also be within my power to take a life; this awesome responsibility must be faced
with great humbleness and awareness of my own frailty. Above all, I must not play at God.

I will remember that I do not treat a fever chart, a cancerous growth, but a sick human being, whose
illness may affect the person's family and economic stability. My responsibility includes these related
problems,

I will prevent disease whenever I can, for prevention is preferable to cure.

I will remember that I remain a member of society, with special obligations to all my fellow human
beings that sound of mind and body as well as the infirm.

If I do not violate this oath, may I enjoy life and art, respected while I live and remembered with
affection thereafter.

May I always act so as to preserve the finest traditions of my calling and may I long experience the
joy of healing those who seek my help.

2.3 THE DECLARATION OF HELSINKI (DOH)

The Declaration of Helsinki (DoH) is, indisputably, a remarkable document. In less than 2000 words,
the World Medical Association (WMA) spells out a set of ethical guidelines for physicians and other
participants in medical research. At the recent Scientific Session held in association with the WMA's
annual assembly, various independent experts on research ethics confirmed the central role of this
document. At this meeting the DoH was described as the ‘cornerstone’ document pertaining to
medical research ethics and as ‘the most widely recognized source of ethical guidance for biomedical
research’. Yet the DoH's guideline statements are not without controversy; and even more so since the
most recent revision at the 16th Annual Assembly of the WMA in Edinburgh in October 2000.

One of the darkest episodes in the history of medical research – the horrific experiments carried out
by doctors on concentration camp victims in Nazi Germany – was exposed at the Nuremberg trials of
1947. Emerging from the Nuremberg trials was a code of ethics setting out ‘standards to which
physicians must conform when carrying out experiments on human subjects’. The original DoH is
seen as having its roots in the Nuremberg Code

The original DoH also states ‘In the field of clinical research a fundamental distinction must be
recognized between clinical research in which the aim is essentially therapeutic for a patient, and
clinical research the essential object of which is purely scientific and without therapeutic value to the
person subjected to the research’. This led to the fundamental structure of the document. The
paragraphs of the original and the first four revisions of the DoH are grouped under the headings
‘Introductory statements’, ‘I. Basic principles’, ‘II. Clinical research combined with professional care’
and ‘III. Non-therapeutic clinical research’. This structure persisted until the Edinburgh (2000)
revision when it was substantially revised.

The World Medical Association (WMA)

This is the largest global grouping of doctors and as such there may be legitimacy in the claim that it
is an authoritative body for making statements about the collective views of the medical profession
and has a vital role in drafting and amending DoH.

First revision: Tokyo (1975)

The first revision to the DoH was adopted by the WMA at its 29th annual assembly in Tokyo (1975).
This document was drafted by three Scandinavian professors of medicine. The document was
extensively revised from the 1964 version. Arguably the single most important addition in terms of
the ensuing conduct of medical research was the requirement that independent committees review
research protocols. Another major development was a significant elaboration of the requirements for
informed consent.

Second Revision: Venice (1983)

Given the extensive nature of the revision in 1975, it could be argued that the very minor changes of
1983 hardly warrant the term revision.

In 1983 there were four fairly minor changes to the text of the DoH.
∑ The word ‘doctor(s)’ was changed to ‘physician(s)’ in the 16 instances where the word
occurred in the 1975 version.
∑
∑ In the ‘Introduction’, the quotation from the Introduction from the International Code of
Medical Ethics changed slightly as the wording of this code had changed. Also in the
‘Introduction’, the Latin phrase a forteriori was changed to ‘especially’ in the statement
∑
∑ ‘In current medical practice most diagnostic, therapeutic or prophylactic procedures involve
hazards. This applies especially to biomedical research’.
∑
∑ Finally, in the ‘Basic Principles’ section, the requirement that where a minor is able to give ‘a
consent’ that such consent should be sought was added to paragraph I.11 dealing with
situations of legal incapacity for consent.

Third revision: Hong Kong (1989)

This revision requires a fairly careful reading to see where any difference at all occurs. The only
change in wording which occurs is in paragraph I.2 under the section ‘Basic Principles’. Previously
the Declaration required that experimental protocols ‘should be transmitted to a specially appointed
independent committee for consideration, comment and guidance’. This was considerably elaborated
in 1989. Protocols were now to be ‘transmitted for consideration, comment and guidance to a
specially appointed committee independent of the investigator and the sponsor provided that this
independent committee is in conformity with the laws and regulations of the country in which the
research experiment is performed’

Fourth Revision: Somerset West, South Africa (1996)

As in 1983 and 1989, the actual changes to the text were minimal. However, the nature of the small
textual change provided a seed out of which grew a much larger debate. In 1996, at the 48th General
Assembly, the WMA adopted the following addition (shown in italics) to paragraph II.3 in the section
pertaining to ‘Medical Research Combined with Clinical Care (Clinical Research)’:
‘II.3 In any medical study, every patient – including those of a control group, if any – should be
assured of the best proven diagnostic and therapeutic method. This does not exclude the use of inert
placebo in studies where no proven diagnostic or therapeutic method exists’. [Italics ours]
This occurred in the context of rising disquiet about the use of placebo controls in studies of
maternal–fetal HIV transmission. It is the first time the DoH makes reference to any specific type of
research methodology, i.e. the placebo-controlled trial. A careful reading of paragraph II.3 without the
addition would appear to have the same requirement on researchers, but for the first time the DoH
refers specifically to placebo. It is the addition of this specific requirement that meant that the Food
and Drug Administration of the USA chose to continue to refer to the 1989 version of the DoH in its
regulations]. This brings us neatly to the present version of the DoH with its attendant controversies.

The 2000 version of the DoH is completely restructured. There is now a section headed ‘Introduction’
comprising paragraphs 1–9 which sets out the scope of the document and some of the underlying
principles. Although many of the statements in the ‘Introduction’ were present in previous versions of
the Declaration, they have been re-ordered to present a more logical sequence of reasoning. Arguably
one of the most important statements is the requirement in paragraph 5 that ‘In medical research on
human subjects, considerations related to the well-being of the human subject should take preference
over the interests of science and society’. By the end of the ‘Introduction’ the document has very
clearly set up the dilemma that gives rise to the need for clear thinking about research ethics. On the
one hand, it would be unethical not to challenge current methods in medical practice (paragraph 6)
through research. On the other hand, it is wrong to simply use people as a means to an end (paragraph
5); particularly vulnerable people (paragraph 8). Having described this ethical tension in the
‘Introduction’, the DoH then seeks in the next two sections to articulate the guiding principles for
deciding what research meets the ethical standards required and what does not.

2.4 The Nuremberg Code (1947)

The judgement by the war crimes tribunal at Nuremberg laid down 10 standards to which physicians
must conform when carrying out experiments on human subjects.
∑ The voluntary consent of the human subject is absolutely essential. This means that
the
- person involved should have legal capacity to give consent, should be so
situated as to be able to exercise free power of choice, without the
intervention of any element of force, fraud, deceit, duress, overreaching, or
other ulterior form of constraint or coercion;

- And should have sufficient knowledge and comprehension of the elements

of the subject matter as to enable him to make an understanding and
enlightened decision.

- This latter element requires that before the acceptance of an affirmative

decision by the experimental subject there should be made known to him :

ß the nature, duration, and purpose of the experiment;

ß the method and means by which it is to be conducted;

 ß All inconveniences and hazards reasonably to be expected; and the effects
upon his health or person which may possibly come from his participation
in the experiment.

ß The duty and responsibility for ascertaining the quality of the consent rests
upon each individual who initiates, directs, or engages in the experiment. It
is a personal duty and responsibility which may not be delegated to another
with impunity.

∑ The experiment should be such as to yield fruitful results for the good of society,
unprocurable by other methods or means of study, and not random and unnecessary in
nature.

∑ The experiment should be so designed and based on the results of animal

experimentation and knowledge of the natural history of the disease or other problem
under study that the anticipated results justify the performance of the experiment.

∑ The experiment should be conducted as to avoid all unnecessary physical and mental
suffering and injury.

∑ No experiment should be conducted where there is an a priori reason to believe that

death or disabling injury will occur; except, perhaps, in those experiments where the
experimental physicians also serve as subjects.

∑ The degree of risk to be taken should never exceed that determined by humanitarian
importance of the problem to be solved by the experiment.
∑ Proper preparations should be made and adequate facilities provided to protect the
experimental subject against even remote possibilities of injury, disability or death.
∑ The experiment should be conducted only by scientifically qualified persons. The
highest degree of skill and care should be required through all stages of the
experiment of those who conduct and engage in the experiment.

∑ During the course of the experiment the human subject should be at liberty to bring
the experiment to an end if he has reached the physical or mental state where
continuation of the experiment seems to him to be impossible.

∑ During the course of the experiment the scientist in charge must be prepared to
terminate the experiment at any stage, if he has probable cause to believe, in the
exercise of good faith, superior skill and careful judgement required of him, that a
continuation of the experiment is likely to result in injury, disability, or death to the
experimental subject.

2.5 ETHICAL PRINCIPLES FOR MEDICAL RESEARCH INVOLVING HUMAN

SUBJECTS-WMA

Adopted by the 18th WMA General Assembly Helsinki, Finland, June 1964 and amended from time
to time.

Introduction
∑ The World Medical Association has developed the Declaration of Helsinki as a statement
of ethical principles to provide guidance to physicians and other participants in medical
research involving human subjects. Medical research involving human subjects includes
research on identifiable human material or identifiable data.

∑ It is the duty of the physician to promote and safeguard the health of the people. The
physician's knowledge and conscience are dedicated to the fulfillment of this duty.

∑ The Declaration of Geneva of the World Medical Association binds the physician with
the words, ‘The health of my patient will be my first consideration’, and the International
Code of Medical Ethics declares that ‘A physician shall act only in the patient's interest
when providing medical care which might have the effect of weakening the physical and
mental condition of the patient’.

∑ Medical progress is based on research which ultimately must rest in part on

experimentation involving human subjects.

∑ In medical research on human subjects, considerations related to the well-being of the

human subject should take preference over the interests of science and society.

∑ The primary purpose of medical research involving human subjects is to improve

prophylactic, diagnostic and therapeutic procedures and the understanding of the etiology
and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and
therapeutic methods must continuously be challenged through research for their
effectiveness, efficiency, accessibility and quality.

∑ In current medical practice and in medical research, most prophylactic, diagnostic and
therapeutic procedures involve risks and burdens.

∑ Medical research is subject to ethical standards that promote respect for all human beings
and protect their health and rights. Some research populations are vulnerable and need
special protection. The particular needs of the economically and medically disadvantaged
must be recognized. Special attention is also required for those who cannot give or refuse
consent for themselves, for those who may be subject to giving consent under duress, for
those who will not benefit personally from the research, and for those for whom the
research is combined with care.

∑ Research investigators should be aware of the ethical, legal and regulatory requirements
for research on human subjects in their own countries as well as applicable international
requirements. No national ethical, legal or regulatory requirement should be allowed to
reduce or eliminate any of the protections for human subjects set forth in this document.

Basic Principles for All Medical Research

∑ It is the duty of the physician in medical research to protect the life, health,
privacy, and dignity of the human subject.

∑ Medical research involving human subjects must conform to generally accepted

scientific principles, be based on a thorough knowledge of the scientific literature,
other relevant sources of information, and on adequate laboratory and, where
appropriate, animal experimentation.
∑ Appropriate caution must be exercised in the conduct of research which may affect
the environment, and the welfare of animals used for research must be respected.

∑ The design and performance of each experimental procedure involving human

subjects should be clearly formulated in an experimental protocol.

- This protocol should be submitted for consideration, comment, guidance, and

where appropriate, approval to a specially appointed ethical review committee,
which must be independent of the investigator, the sponsor or any other kind
of undue influence.
-
- This independent committee should be in conformity with the laws and
regulations of the country in which the research experiment is performed. The
committee has the right to monitor ongoing trials.
-
- The researcher has the obligation to provide monitoring information to the
committee, especially any serious adverse events. The researcher should also
submit to the committee, for review, information regarding funding, sponsors,
institutional affiliations, other potential conflicts of interest and incentives for
subjects.

∑ The research protocol should always contain a statement of the ethical

considerations involved and should indicate that there is compliance with the
principles enunciated in this Declaration.

∑ Medical research involving human subjects should be conducted only by

scientifically qualified persons and under the supervision of a clinically competent
medical person. The responsibility for the human subject must always rest with a
medically qualified person and never rest on the subject of the research, even
though the subject has given consent.

∑ Every medical research project involving human subjects should be preceded by

careful assessment of predictable risks and burdens in comparison with foreseeable
benefits to the subject or to others. This does not preclude the participation of
healthy volunteers in medical research. The design of all studies should be publicly
available.

∑ Physicians should abstain from engaging in research projects involving human

subjects unless they are confident that the risks involved have been adequately
assessed and can be satisfactorily managed. Physicians should cease any
investigation if the risks are found to outweigh the potential benefits or if there is
conclusive proof of positive and beneficial results.

∑ Medical research involving human subjects should only be conducted if the

importance of the objective outweighs the inherent risks and burdens to the subject.
This is especially important when the human subjects are healthy volunteers.

∑ Medical research is only justified if there is a reasonable likelihood that the

populations in which the research is carried out stand to benefit from the results of
the research.
∑
∑ The subjects must be volunteers and informed participants in the research project.
∑
∑ The right of research subjects to safeguard their integrity must always be respected.
Every precaution should be taken to respect the privacy of the subject, the
confidentiality of the patient's information and to minimize the impact of the study
on the subject's physical and mental integrity and on the personality of the subject.
∑
∑ In any research on human beings,
- each potential subject must be adequately informed of the aims, methods,
sources of funding, any possible conflicts of interest, institutional
affiliations of the researcher
-
- The anticipated benefits and potential risks of the study and the discomfort
it may entail.
-
- The subject should be informed of the right to abstain from participation in
the study or to withdraw consent to participate at any time without reprisal.
-
- After ensuring that the subject has understood the information, the
physician should then obtain the subject's freely given informed consent,
preferably in writing. If the consent cannot be obtained in writing, the no
written consent must be formally documented and witnessed.
∑
∑ When obtaining informed consent for the research project the physician should be
particularly cautious if the subject is in a dependent relationship with the physician
or may consent under duress. In that case the informed consent should be obtained
by a well-informed physician who is not engaged in the investigation and who is
completely independent of this relationship.
∑
∑ For a research subject who is legally incompetent, physically or mentally incapable
of giving consent or is a legally incompetent minor, the investigator must obtain
informed consent from the legally authorized representative in accordance with
applicable law. These groups should not be included in research unless the research
is necessary to promote the health of the population represented and this research
cannot instead be performed on legally competent persons.

∑ When a subject deemed legally incompetent, such as a minor child, is able to give
assent to decisions about participation in research, the investigator must obtain that
assent in addition to the consent of the legally authorized representative.

∑ Research on individuals from whom it is not possible to obtain consent, including

proxy or advance consent, should be done only if the physical/mental condition
that prevents obtaining informed consent is a necessary characteristic of the
research population. The specific reasons for involving research subjects with a
condition that renders them unable to give informed consent should be stated in the
experimental protocol for consideration and approval of the review committee. The
protocol should state that consent to remain in the research should be obtained as
soon as possible from the individual or a legally authorized surrogate.

∑ Both authors and publishers have ethical obligations. In publication of the results
of research, the investigators are obliged to preserve the accuracy of the results.
Negative as well as positive results should be published or otherwise publicly
available. Sources of funding, institutional affiliations and any possible conflicts of
 interest should be declared in the publication. Reports of experimentation not in
accordance with the principles laid down in this Declaration should not be accepted
for publication.

Additional Principles for Medical Research Combined With Medical Care

∑ The physician may combine medical research with medical care, only to the extent that
the research is justified by its potential prophylactic, diagnostic or therapeutic value.
When medical research is combined with medical care, additional standards apply to
protect the patients who are research subjects.

∑ The benefits, risks, burdens and effectiveness of a new method should be tested against
those of the best current prophylactic, diagnostic, and therapeutic methods. This does not
exclude the use of placebo, or no treatment, in studies where no proven prophylactic,
diagnostic or therapeutic method exists.

To clarify further the WMA position on the use of placebo-controlled trials, the WMA Council issued,
during October 2001, a note of clarification on article 29.
∑ At the conclusion of the study, every patient entered into the study should be assured
of access to the best proven prophylactic, diagnostic and therapeutic methods
identified by the study.

∑ The physician should fully inform the patient which aspects of the care are related to
the research. The refusal of a patient to participate in a study must never interfere
with the patient–physician relationship.

∑ In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic

methods do not exist or have been ineffective, the physician, with informed consent
from the patient, must be free to use unproven or new prophylactic, diagnostic and
therapeutic measures, if in the physician's judgment it offers hope of saving life, re-
establishing health or alleviating suffering. Where possible, these measures should
be made the object of research, designed to evaluate their safety and efficacy. In all
cases, new information should be recorded and, where appropriate, published. The
other relevant guidelines of this Declaration should be followed.

Note of clarification on paragraph 29 of the WMA Declaration of Helsinki

The WMA is concerned that paragraph 29 of the revised Declaration of Helsinki (October 2000) has
led to diverse interpretations and possible confusion. It hereby reaffirms its position that extreme care
must be taken in making use of a placebo-controlled trial and that in general this methodology should
only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be
ethically acceptable, even if proven therapy is available, under the following circumstances:
∑ Where for compelling and scientifically sound methodological reasons it is necessary
to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic
method; or
∑
∑ Where a prophylactic, diagnostic or therapeutic method is being investigated for a
minor condition and the patients who receive placebo will not be subject to any
additional risk of serious or irreversible harm.
All other provisions of the Declaration of Helsinki must be adhered to, especially the need for
appropriate ethical and scientific review.
All other provisions of the Declaration of Helsinki must be adhered to, especially the need for
appropriate ethical and scientific review.

2.6 SUMMARY

Various International as well as National bodies have recognized the importance of having
standardized ethical codes of conduct which are to be observed by Doctors and also other categories
of care providers. These codes have been amended from time to time to address relevant and current
ethical issues. Therefore, to ensure safe and quality patient care it is imperative that everyone working
in Hospital and Health care industry must be made aware of these codes and abide by them.

2.7 KEY WORDS

Consent means that the

∑ person involved should have legal capacity to give consent, should be so situated as to be
able to exercise free power of choice, without the intervention of any element of force,
fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion;

∑ And should have sufficient knowledge and comprehension of the elements of the subject
matter as to enable him to make an understanding and enlightened decision.
 UNIT 3: INDIAN COUNCIL OF MEDICAL RESEARCH - ETHICAL GUIDELINES FOR
BIOMEDICAL RESEARCH ON HUMAN PARTICIPANTS-2006

Learning Objectives:

After going through this Unit you will be able to:

• enumerate the changes taking place in modern medical research;

• understand the context of ethical guidelines in biomedical research;
• appreciate the ethical issues which are emerging in biomedical research involving human beings;
• Know about the principles of biomedical research.

Structure
3.1 Introduction
3.2 Statement of General Principles In Biomedical Research Involving human participants
3.3 Ethical Review Procedures
3.4 Monitoring
3.5 Record Keeping
3.6 Administration and Management
3.7 General Ethical Issues
3.8 Selection of Special Groups as Research Participants
3.9 Drug Trials: Specific Principles
3.10 Statement of Specific Principles for human Genetics and Genomics Research
3.11 Statement of Specific Principles for Research in Transplantation
3.12 Stem Cell Research and Therapy
3.13 Statement of Specific Principles for Assisted Reproductive Technologies
3.14 Summary
3.15 Key Words

3.1 INTRODUCTION

The Indian Council of Medical research brought out the 'Policy Statement on Ethical Considerations involved in
Research on Human Subjects' in 1980 and revised these guidelines in 2000 as the 'Ethical guidelines for
Biomedical Research on Human Subjects'. Due to further rapid developments in science and technology in India
after the release of the second version, it became necessary to update these guidelines to make adequate specific
provision to meet ethical challenges posed by these advances.

Some of the points in the international guidelines for biomedical research on human participants, which have
relevance to international collaborative research initiatives, have been included in this version. Detailed
description of vaccine trials, herbal products, bio banking, and stem cell research etc. has been provided to make
the document reflect current ethical requirements, which can be applied to Indian circumstances from ethical,
legal and social angle. The intention is to update this document at frequent intervals to keep the scientific
community knowledgeable about the current concepts in bioethics, which is a dynamic process. Such an
exercise is in keeping with similar trends seen in many countries and worked out by international agencies.

3.2 STATEMENT OF GENERAL PRINCIPLES IN BIOMEDICAL RESEARCH INVOLVING

HUMAN PARTICIPANTS

This statement of Ethical Guidelines for Biomedical Research on Human Participants shall be known as the
ICMR Code and shall consist of the following:

• Statement of General Principles on Research using Human Participants in Biomedical Research

• Statement of Specific Principles on Research using Human Participants in specific areas of Biomedical
Research

• Statement of General Principles

Any research using the human beings as participants shall follow the principles given below:
Principles of essentiality: whereby the research entailing the use of human participants is considered to be
absolutely essential after a due consideration of all alternatives in the light of the existing knowledge in the
proposed area of research and after the proposed research has been duly vetted and considered by an appropriate
and responsible body of persons who are external to the particular research and who, after careful consideration,
come to the conclusion
That the said research is necessary for the advancement of knowledge and for the benefit of all members of the
human species and for the ecological and environmental well-being of the planet.

Principles of voluntariness: informed consent and community agreement whereby research participants are fully
apprised of the research and the impact and risk of such research on the research participant and others; and
whereby the research participants retain the right to abstain from further participation in the research irrespective
of any legal or other obligation that may have been entered into by such human participants or someone on their
behalf, subject to only minimal recitative obligations of any advance consideration received and outstanding.
Where any such research entails treating any community or group of persons as a research participant, these
principles of voluntariness and informed consent shall apply, mutatis mutandis, to the community as a whole
and to each individual member who is the participant of the research or experiment.
Principles of compliance: whereby, there is a general and positive duty on all persons, conducting, associated or
connected with any research entailing the use of a human participant to ensure that both the letter and the spirit
of these guidelines, as well as any other norms, directions and guidelines which have been specifically laid
down or prescribed and which are applicable for that area of research or experimentation, are scrupulously
observed and duly complied with.

These 12 principles laid down under Statement on General Principles are common to all areas of biomedical
research. The specific issues are mentioned under relevant topics.

3.3 ETHICAL REVIEW PROCEDURES

It is mandatory that all proposals on biomedical research involving human participants should be cleared by an
appropriately constituted Institutional Ethics Committee (IEC), also referred to as Institutional Review Board
(IRB), Ethics Review Board (ERB) and Research Ethics Board (REB) in other countries, to safeguard the
welfare and the rights of the participants. There are also independent ethics committees [IEC (In)] functioning
outside institutions for those researchers who have no institutional attachments or work in institutions with no
ethics committee. The Ethics Committees are entrusted not only with the initial review of the proposed research
protocols prior to initiation of the projects but also have a continuing responsibility of regular monitoring of the
approved programmers to foresee the compliance of the ethics during the period of the project. Such an ongoing
review shall be in accordance with the international guidelines wherever applicable and the Standard Operating
Procedures (SOP) of the WHO available at www.who.int

Basic Responsibilities
The basic responsibility of an Institutional Ethics Committee (IEC) is to ensure a competent review of all ethical
aspects of the project proposals received by it in an objective manner. IECs should provide advice to the
researchers on all aspects of the welfare and safety of the research participants after ensuring the scientific
soundness of the proposed research through appropriate Scientific Review Committee

The responsibilities of an IEC can be defined as follows:

• To protect the dignity, rights and well-being of the potential research participants.
• To ensure that universal ethical values and international scientific standards are
Expressed in terms of local community values and customs.
• To assist in the development and the education of a research community
• Composition
The IECs should be multidisciplinary and multisectorial in composition. Independence and competence are the
two hallmarks of an IEC. The number of persons in an ethics committee should be kept fairly small (8 - 12
members). It is generally accepted that a minimum of five persons is required to form the quorum without which
a decision regarding the research should not be taken. The IEC should appoint from among its members a
Chairman who should be from outside the Institution and not head of the same Institution to maintain the
independence of the Committee. The Member Secretary should be from the same Institution and should conduct
the business of the Committee. Other members should be a mix of medical/ non-medical, scientific and non-
scientific persons including lay persons to represent the differed points of view.

The composition may be as follows:

• Chairperson
• One - two persons from basic medical science area
• One - two clinicians from various Institutes
• One legal expert or retired judge
• One social scientist/ representative of non-governmental voluntary agency
• One philosopher/ ethicist/ theologian
• One lay person from the community
• Member Secretary

As per revised Schedule Y of Drugs & Cosmetics Act, 1940, amended in 2005, the ethics committee approving
drug trials should have in the quorum at least one representative from the following groups:

• One basic medical scientist (preferably one pharmacologist).

• One clinician
• One legal expert or retired judge Ethical Review Procedures
• One social scientist/ representative of non-governmental organization/
• philosopher/ ethicist/ theologian or a similar person
• One lay person from the community.
Training
The IEC members should be encouraged to keep abreast of all national and international developments in ethics
through orientation courses on related topics by its own members or regular training organized by constituted
body (is), so that they become aware of their role and responsibilities. For drug trial review it is preferable to
train the IEC members in Good Clinical Practice. Any change in the regulatory requirements should be brought
to their attention and they should be aware of local, social and cultural norms, as this is the most important
social control mechanism.
Review Procedures
The IEC should review every research proposal on human participants before the research is initiated. It should
ensure that a scientific evaluation has been completed before ethical review is taken up. The Committee should
evaluate the possible risks to the participants with proper justification, the expected benefits and adequacy of
documentation for ensuring privacy, confidentiality and the justice issues.
All proposals will be scrutinized to decide under which of the following three categories it will be considered:
Exemption from review
Proposals which present less than minimal risk fall under this category as may be seen in following situations:
Research on educational practices such as instructional strategies or effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods.
Exceptions
When research on use of educational tests, survey or interview procedures, or observation of public behavior
can identify the human participant directly or through identifiers, and the disclosure of information outside
research could subject the participant to the risk of civil or criminal or financial liability official Procedures
psychosocial harm.
Expedited Review
The proposals presenting no more than minimal risk to research participants may be subjected to expedited
review. The Member- Secretary and the Chairperson of the IEC or designated member of the Committee or
Subcommittee of the IEC may do expedited review only if the protocols involve:

• Minor deviations from originally approved research during the period of approval (usually of one year
duration).

• Revised proposal previously approved through full review by the IEC or continuing review of
approved proposals where there is no additional risk or activity is limited to data analysis.

• Research activities that involve only procedures listed in one or more of the following categories :
 - Clinical studies of drugs and medical devices only when research is on already approved
drugs except when studying drug interaction or conducting trial on vulnerable population or
adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is
reported.

• Research involving clinical materials (data, documents, records, or specimens) that have been collected
for non-research (clinical) purposes.

• When in emergency situations like serious outbreaks or disasters a full review of the research is not
possible, prior written permission of IEC may be taken before use of the test intervention.
Research on Disaster Management
A disaster is the sudden occurrence of a calamitous event at any time resulting in substantial material damage,
affecting persons, society, community or state(s). It may be periodic, caused by both nature and humans and
creates an imbalance between the capacity and resources of the society and the needs of the survivors or the
people whose lives are threatened, over a given period of time. It may also be unethical sometimes not to do
research in such circumstances. Disasters create vulnerable persons and groups in society, particularly so in
disadvantaged communities, and therefore, the following points need to be considered when reviewing such
research:

Ethical Review Procedures

All research presenting with more than minimal risk, proposals/ protocols which do not qualify for exempted or
expedited review and projects that involve vulnerable population and special groups shall be subjected to full
review by all the members. While reviewing the proposals, the following situations may be carefully assessed
against the existing facilities at the research site for risk/benefit analysis:

- Collection of blood samples by finger prick, heel prick, ear prick, or vein puncture.

- Removal of skin appendages like hair and nail clippings in a non-disfiguring manner

- Dental procedures - deciduous teeth at time of exfoliation or if routine

- patient care indicates a need for extraction of permanent teeth; supra and

- sub gingival dental plaque and calculus, provided the collection procedure is not more invasive than
routine prophylactic scaling of the teeth;

- Excreta and external secretions (including sweat)

- Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gum or by

applying a dilute citric solution to the tongue

- Placenta removed at delivery

- Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor

- Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

- Sputum collected after saline mist nebulization and bronchial lavages.

- Collection of data through noninvasive procedures routinely employed in clinical practice. Where medical
devices are employed, they must be cleared/approved for marketing.

Submission of Application
The researcher should submit an application in a prescribed format along with the study protocol as prescribed
in SOP of IEC concerned. The protocol should include the following:

• The title with signature of Principal Investigator (PI) and Coinvestigators as attestation for conducting
the study.
• Clear research objectives and rationale for undertaking the investigation in human participants in the
light of existing knowledge.

• Ethical Review Procedures

• Recent curriculum vitae of the Investigators indicating qualification and experience.

• Participant recruitment procedures and brochures, if any.

• Inclusion and exclusion criteria for entry of participants.

• Precise description of methodology of the proposed research, including sample size (with justification),
type of study design (observational, experimental, pilot, randomized, blinded et c.), intended
intervention, dosages of drugs, route of administration, duration of treatment and details of invasive
procedures if any.

• Plan to withdraw or withhold standard therapies in the course of research.

• Plan for statistical analysis of the study.

• Procedure for seeking and obtaining informed consent with sample of patient information sheet and
informed consent forms in English and local languages.

• Safety of proposed intervention and any drug or vaccine to be tested, including results of relevant
laboratory, animal and human research.

• For research involving more than minimal risk, an account of management of such risk or injury.

• Proposed compensation and reimbursement of incidental expenses and management of research related
and unrelated injury/ illness during and after research period.

• An account of storage and maintenance of all data collected during the trial.

• Plans for publication of results - positive or negative - while maintaining the privacy and
confidentiality of the study participants.

• A statement on probable ethical issues and steps taken to tackle the same like justification for washout
of standard drug, or the use of placebo control.

• All other relevant documents related to the study protocol like investigator's brochure for trial on drugs/
devices/ vaccines/ herbal remedies and statement of relevant regulatory clearances.

• Agreement to comply with national and international Good Clinical Practices (GCP) protocols for
clinical trials.

• Details of Funding agency/ Sponsors and fund allocation.

• Ethical Review Procedures

• For international collaborative study details about foreign collaborators and documents for review of
Health Ministry's Screening

• Committee(HMSC) or appropriate Committees under other agencies/ authority like Drug Controller
General of India (DCGI)

• For exchange of biological material in international collaborative study a MoU/ Material Transfer
Agreement between the collaborating partners.

• A statement on conflict-of-interest (COI), if any.

Decision Making Process
The IEC should be able to provide complete and adequate review of the research proposals submitted to them. It
should meet periodically at frequent intervals to review new proposals, evaluate annual progress of ongoing
ones, review Serious Adverse Event (SAE) reports and assess final reports of all research activities involving
human beings through a previously scheduled agenda, amended wherever appropriate. The following points
should be considered while doing so:

• The decision must be taken by a broad consensus after the quorum requirements are fulfilled to
recommend / reject / suggest modification for a repeat review or advice appropriate steps. The Member
Secretary should communicate the decision in writing to the PI.

• If a member has conflict-of-interest (COI) involving a project then She /he should submit this in
writing to the chairperson before the review meeting, and it should also be recorded in the minutes.

• If one of the members has her/his own proposal for review or has any COI then s/he should withdraw
from the IEC while the project is being discussed.

• A negative decision should always be supported by clearly defined reason.

• An IEC may decide to reverse its positive decision on a study if it receives information that may
adversely affect the risk/ benefit ratio.

• The discontinuation of a trial should be ordered if the IEC finds that the goals of the trial have already
been achieved midway or unequivocal results are obtained.

• In case of premature termination of study, notification should include the reasons for termination along
with the summary of results conducted till date.

The following circumstances require the matter to be brought to the attention of IEC: Ethical Review
Procedures

- any amendment to the protocol from the originally approved protocol with proper justification;

- serious and unexpected adverse events and remedial steps taken to tackle them;

- Any new information that may influence the conduct of the study.

• If necessary, the applicant/investigator may be invited to present the protocol or offer clarifications in
the meeting. Representative of the patient groups or interest groups can be invited during deliberations
to offer their viewpoint.

• Subject experts may be invited to offer their views, but should not take part in the decision making
process. However, her / his opinion must be recorded.

• Meetings are to be minute which should be approved and signed by the Chairperson/ alternate
Chairperson/ designated member of the committee.

3.4 MONITORING

Once IEC gives a certificate of approval it is the duty of the IEC to monitor the approved studies, therefore an
oversight mechanism should be in place. Actual site visits can be made especially in the event of reporting of
adverse events or violations of human rights. Additionally, periodic status reports must be asked for appropriate
intervals based on the safety concerns and this should be specified in the SOP of the IEC. SAE reports from the
site as well as other sites are reviewed by EC and appropriate action taken when required. In case the IEC
desires so, reports of monitoring done by the sponsor and the recommendations of the DSMB may also be
sought.

3.5 RECORD KEEPING

All documentation and communication of an IEC are to be dated, filed and preserved according to written
procedures. Strict confidentiality is to be maintained during access and retrieval procedures. The following
records should be maintained for the following:

• the Constitution and composition of the IEC

• signed and dated copies of the latest the curriculum vitae of all IEC members with records of training if
any
• standing operating procedures of the IEC
• national and International guidelines
• copies of protocols submitted for review
• all correspondence with IEC members and investigators regarding application, decision and follow up
• agenda of all IEC meetings
• minutes of all IEC meetings with signature of the Chairperson
• copies of decisions communicated to the applicants
• record of all notification issued for premature termination of a study with a summary of the reasons
• final report of the study including microfilms, CDs and Video recordings

It is recommended that all records must be safely maintained after the completion/termination of the study for a
period of 3 years if it is not possible to maintain the same for more than that due to resource crunch and lack of
infrastructure.

3.6 ADMINISTRATION AND MANAGEMENT

A full time secretariat and space for keeping records is required for a well-functioning IEC. The members could
be given a reasonable compensation for the time spared for reviewing the proposals. Reasonable fees can be
charged to cover the expenses related to review and administrative processes. Every institution should allocate
reasonable amount of funds for smooth functioning of the IEC..
3.7 GENERAL ETHICAL ISSUES

All the research involving human participants should be conducted in accordance with the four basic ethical
principles, namely autonomy (respect for person / participant) beneficence, non-maleficence (do no harm) and
justice. The guidelines laid down are directed at application of these basic principles to research involving
human participants. The Principal Investigator is the person responsible for not only undertaking research but
also for observance of the rights, health and welfare of the participants recruited for the study. S/he should have
qualification and
Competence in biomedical research methodology for proper conducts of the study and should be aware of and
comply with the scientific, legal and ethical requirements of the study protocol.

Informed Consent Process

Informed Consent of Participants: For all biomedical research involving human participants, the investigator
must obtain the informed consent of the prospective participant or in the case of an individual who is not
capable of giving informed consent, the consent of a legal guardian. Informed consent protects the individual’s
freedom of choice and respect for individual’s autonomy and is given voluntarily to participate in research or
not. Adequate information about the research is given in a simple and easily understandable unambiguous
language in a document known as the Informed Consent Form with Participant/ Patient Information Sheet.

The latter should have following components as may be applicable:

 • Nature and purpose of study stating it as research
• Duration of participation with number of participants
• Procedures to be followed
• Investigations, if any, to be performed
• Foreseeable risks and discomforts adequately described and whether project
Involves more than minimal risk
• Benefits to participant, community or medical profession as may be applicable
• Policy on compensation
• Availability of medical treatment for such injuries or risk management
• Alternative treatments if available
• Steps taken for ensuring confidentiality
• No loss of benefits on withdrawal
• Benefit sharing in the event of commercialization
• Contact details of PI or local PI/Co-PI in metacentric studies for asking more
Information related to the research or in case of injury
• Contact details of Chairman of the IEC for appeal against violation of rights
• Voluntary participation
• If test for genetics and HIV is to be done, counseling for consent for testing must be given as per
national guidelines
• Storage period of biological sample and related data with choice offered to participant regarding future
use of sample, refusal for storage and receipt of its results
Fresh or re-consent is taken in following conditions:
• Availability of new information which would necessitate deviation of protocol.

• When a research participant regains consciousness from unconscious state or is mentally competent to
understand the study. If such an event is expected then procedures to address it should be spelt out in
the informed consent form.

• When long term follow-up or study extension is planned later.

• When there is change in treatment modality, procedures, site visits.

• Before publication if there is possibility of disclosure of identity through data presentation or

photographs (which should be camouflaged adequately)?

Waiver of Consent: Voluntary informed consent is always a requirement for every research proposal. However,
this can be waived if it is justified that the research involves not more than minimal risk or when the participant
and the researcher do not come into contact or when it is necessitated in emergency situations If such studies
have protections in place for both privacy and confidentiality, and do not violate the rights of the participants
then IECs may waive off the requirement for informed consent in following instances:

• When it is impractical to conduct research since confidentiality of personally identifiable information

has to be maintained throughout research as may be required by the sensitivity of the research
objective, e.g. Study on disease burden of HIV/AIDS.

• Research on publicly available information, documents, records, works, performances, reviews, quality
assurance studies, archival materials or third party interviews, service programs for benefit of public
having a bearing on public health programs, and consumer acceptance studies.

• Research on anonymised biological samples from deceased individuals, left over samples after clinical
investigation, cell lines or cell free derivatives like viral isolates, DNA or RNA from recognized
institutions or qualified investigators, samples or data from repositories or registries etc.

• In emergency situations when no surrogate consents can be taken.

3.8 SELECTION OF SPECIAL GROUPS AS RESEARCH PARTICIPANTS

Pregnant or Nursing Women

Pregnant or nursing women should in no circumstances be the participant of any research unless the research
carries no more than minimal risk to the fetus or nursing infant and the object of the research is to obtain new
knowledge about the foetus, pregnancy and lactation. As a general rule, pregnant or nursing women should not
be participants of any clinical trial except such trials as are designed to protect or advance the health of pregnant
or nursing women or foetuses or nursing infants, and for which women who are not pregnant or nursing would
not be suitable participants.

• The justification of participation of these women in clinical trials would be that they should not be
deprived arbitrarily of the opportunity to benefit from investigations, drugs, vaccines or other agents
that promise therapeutic or preventive benefits. Example of such trials are, to test the efficacy and
safety of a drug for reducing perinatal transmission of HIV infection from mother to child, trials for
detecting foetal abnormalities and for conditions associated with or aggravated by pregnancy etc.

• Research related to termination of pregnancy: Pregnant women who desire to undergo Medical
Termination of Pregnancy (MTP) could be made participants for such research as per The Medical
Termination of Pregnancy Act, GOI, 1971.

• Research related to pre-natal diagnostic techniques: In pregnant women such research should be limited
to detect the foetal abnormalities or genetic disorders as per the Prenatal Diagnostic Techniques
(Regulation and Prevention of Misuse) Act, GOI, 1994 and not for sex determination of the General
Ethical Issues foetus.

Children
Before undertaking trial in children the investigator must ensure that:

• children will not be involved in research that could be carried out equally well with adults

• the purpose of the research is to obtain knowledge relevant to health needs

Of children

• a parent or legal guardian of each child has given proxy consent

• the assent of the child should be obtained to the extent of the child’s capabilities such as in the case of
mature minors from the age of seven years up to the age of 18 years

• research should be conducted in settings in which the child and parent can obtain adequate medical and
psychological support

• interventions intended to provide direct diagnostic, therapeutic or preventive benefit for the individual child
participant must be justified in relation to anticipated risks involved in the study and anticipated benefits to
society

• the child’s refusal to participate in research must always be respected

• interventions that are intended to provide therapeutic benefit are likely to be at least as advantageous to the
individual child participant as any available alternative interventions

• The risk presented by interventions not intended to benefit the individual child participant is low when
compared to the importance of the knowledge that is to be gained.

Vulnerable Groups
Effort may be made to ensure that individuals or communities invited for research be selected in such a way that
the burdens and benefits of the research are equally distributed.
 • research on genetics should not lead to racial inequalities;

• persons who are economically or socially disadvantaged should not be used to benefit those who are
better off than them;

• Rights and welfare of mentally challenged and mentally differently able persons who are
incapable of giving informed consent or those with behavioral disorders must be protected.
Appropriate proxy consent from the legal guardian should be taken after the person is well informed
about the study, need for participation, risks and benefits involved and the privacy and
confidentiality procedures. The entire consent process should be properly documented

3.9 DRUG TRIALS - SPECIFIC PRINCIPLES

As per the revised Schedule ‘Y’ of the Drugs & Cosmetic Act (2005), “a clinical trial is a systematic study of
new drug(s) in human subject to generate data for discovering and/or verifying the clinical, pharmacological
(including pharmacodynamics, and pharmacokinetics), and/or adverse effects with the objective of determining
the safety and/or efficacy of the new drugs”. Clinical trial of drugs is a randomized single or double blind
controlled study in human participants, designed to evaluate prospectively the safety and effectiveness of new
drugs/ new formulations. The new drug as defined under the Drugs and Cosmetic Rules 1945 (DCR), and
subsequent amendments include:

• a new chemical entity (NCE)

• a drug which has been approved for a certain indication, by a certain route, in a certain dosage
regimen, but which is now proposed to be used for another indication, by another route, or in another
dosage regimen
• A combination of two or more drugs which, although approved individually, are proposed to be
combined for the first time in a fixed dose combination (FDC).
Special Considerations for Clinical Evaluation of Drugs/ Vaccines/ Devices

Statement of Specific Principles:

Use of a placebo in drug trials and sham surgery has been intensely debated and even the fifth version of
Helsinki Declaration has not been helpful in providing clarity in this matter. Each such protocol using
placebo requires careful consideration before approval. Denial of the available treatment to control (placebo)
group of patients is unethical.

3.10 STATEMENT OF SPECIFIC PRINCIPLES FOR HUMAN GENETICS AND GENOMICS

RESEARCH

Termination of pregnancy or selection of embryos to avert birth of a genetically abnormal child, possible
discrimination by insurers and employers because of genetic trait, tailored development of stem cells from
embryos created by conception, in vitro fertilization or nuclear transfer for regenerative therapy or organ
transplantation, and potential for producing designer babies as per whims and fancies of parents or even society
have been subject of fierce public debate. Serious issues are raised by genetic research because it can potentially
create conflict between the rights and freedoms of the individual versus that of the family and the society at
large particularly when it involves human embryo and vulnerable population not competent to give informed
consent. Besides the Human Rights issues of dignity, autonomy, and justice, the Human Genome Project (HGP)
has also precipitated an unprecedented concern for Intellectual Property Rights.

General Guidelines
Clinical research in the area of human genetics and human genome, including gene therapy, is subject to general
ethical considerations of protection from harm and voluntariness of participation. It concerns not only the
individual but also the family, community or society from which s/he has been drawn. Therefore, the additional
considerations are:
3.11 STATEMENT OF SPECIFIC PRINCIPLES FOR RESEARCH IN TRANSPLANTATION

The practice of transplantation is in its infancy in India. The exceedingly high cost restricts its application, and
also reduces the interest in research into this field. The same reason makes it imperative that Indian scientists
should devise means of reducing the cost and improving the success rate, to make it feasible to increase the
number of Indians who can benefit by this treatment. At present the protocols devised in the West are followed
which are not necessarily ideal. Transplantation raises some specific ethical aspects, and these will have to be
weighed in the light of ethical guidelines as applicable to Indian ethos. The problem has been considered with
special reference to the following points:

• Transplants from live or cadaver donors

• Embryonic and foetal tissue and organ transplantation
• Xenon-transplantation
• Transplantation for cosmetic purposes

Guidelines on Live Donor Transplants

Donation from a live donor should be restricted to renewable tissues like bone marrow, or to a paired organ,
which on removal will not greatly alter, physiological functions, as in the case of the kidney. Since the removal
of an eye will compromise binocular vision and produce disfigurement, it should not be permitted in a live
donor.
The donor should be at liberty to withdraw from the experiment and to abrogate the consent given earlier, with
no requirement to offer any explanation of the reasons for his or her doing so.

Statement of Specific Principles for Research in Transplantation

If at any time during the course of the experiment the investigator comes to know that there is risk to the
donor or to the recipient as a result of the procedure, it is her/ his responsibility to terminate the experiment
forthwith.

This does not preclude any treatment or procedure done on the organ or tissue after removal from the
donor’s body, aimed at reducing its antigenicity and improving graft survival.

Creation of human beings for transplantation purposes should be banned.

Guidelines on Cadaver Donor Transplants

Everyone should give a thought to the need for organ donation after death. In such an event one should make a
decision and inform the next of kin, and register oneself with an appropriately constituted authority. Where one
is opposed to donating her/ his organs, this too, should be made known to the next of kin, so that this wish of the
deceased may be respected after death. Such a “Living Will” is in vogue in a number of countries in the world.

If consent for organ donation is given prior to death in the presence of two or more witnesses, consent for
transplantation of organs should be presumed and permissible without seeking further consent from relatives

In the absence of such prior directions from the deceased, the person in lawful possession of the body will make
the decision to use the organs or not, as he may think fit, after consultation with the family.

It is important that the medical team uses the body only for the purpose for which consent has been given.

Remaining tissue and organs should be treated with the respect due to a human body, and will not be used for
any purpose to which explicit consent had not been given unless anonymised.

Under no circumstances should financial gain be made from any such procedure.

There shall be no coercion and no monetary inducements offered to the family of the prospective cadaver donor.
Confidentiality of the donation must be maintained on both sides: the recipient and her/ his family will not be
informed of the identity of the donor, and the family of the donor will equally be kept unaware of who receives
the donated organ. This is essential to avoid any form of exploitation by the donor’s family.

Guidelines on Recipients of Transplants

The patient with failure of a vital organ is at a particular disadvantage in developing countries due to the
enormous cost involved for the available interventions. If the organs involved are the kidneys, most Indians
cannot afford to maintain themselves on dialysis. Similarly ventilators are available at very few centers. There
are no artificial supports for other organs like the heart, the
Lungs and the liver, so death is imminent and no means is available to keep the individual alive short of
replacing the organ concerned. Thus a measure of urgency is introduced into the search for a donor organ.
Under no circumstances should there be a conflict between scientific content of a study and the best interests of
the patient. Should there be need to choose, the experiment should be abandoned and the patient should receive
the best treatment possible.

3.12 STEM CELL RESEARCH AND THERAPY

The stem cell research hold s great promise of improving human health by control of degenerative diseases and
restoration of damage to organs by various injuries; but at the same time it also raises several ethical and social
issues such as destruction of human embryos to create human embryonic stem (he’s) cell lines, potential for
introducing commodification in human tissues and organs with inherent barriers of access to socioeconomically
deprived and possible use of technology for germline engineering and reproductive cloning. The research in this
field, therefore, needs to be regulated to strike a balance.

3.13 STATEMENT OF SPECIFIC PRINCIPLES FOR ASSISTED REPRODUCTIVE

TECHNOLOGIES

The special programmer by WHO on human reproduction has estimated that there are 60 to 80 million infertile
couples worldwide. It has also been variously estimated that between 6-10% of the couple are infertile. The
advent of Assisted Reproductive Technologies (ART) from the late ‘70s has not only enhanced the possibility of
pregnancy but has also made women conceive in situations which would not have been possible decades ago.
However many of these technologies require enormous technical expertise and infrastructure, carry a success
rate below 30% even in the best of hands, are expensive, and tax the couple’s endurance physically, emotionally
and economically. In order to ensure quality of care it is imperative that a proper accreditation procedure is
followed in establishment of ART Centers, which should follow standardized protocols and guidelines.

National guidelines for Accreditation, Supervision and Regulation of ART Clinics have been formulated by
ICMR in 2005 to provide optimum benefit of these newer technologies to appropriate persons by skilled team of
experts, at affordable health and economic cost, in all public and private facilities in our country. A national
registry pertaining to all centers that are accredited by the licensing authority shall be maintained at ICMR and
shall contain records of treatment cycles and outcome. Equally important are issues related to the conduct of
research with material obtained as byproducts from the clinical activity. These include the follicular fluid,
oocytes, and spare embryos, semen samples which can be used by researchers in basic or molecular science.

General Principles
There is a certain element of risk associated with all AR procedures. It is, therefore, necessary to ascertain the
therapeutic and research value of the AR procedure in each case.

Informed Consent: After duly counseling the couple / oocyte/semen donor, an informed and written consent
should be taken from both the spouses as well as the donor, as the case may be. They should be explained the
various risk factors associated with the procedures in simple language and the words that they can understand.
They should also be explained that:

- there is no guarantee on the success / failure of the procedure and the need to reduce the number of viable
foetuses, in order to ensure the survival of at least two fetuses
 - there may be possible disruption of the patient’s domestic life which the treatment may cause

- about the possible deterioration of gametes or embryos associated with storage, and possible pain and
discomfort

- about the cost (with suitable break-up) to the patient of the treatment proposed and of an alternative
treatment, if any (there must be no other “hidden costs”)

- about the importance of informing the clinic of the result of the pregnancy in a pre-paid envelope; and

- About the advantages and disadvantages of continuing treatment after a certain number of attempts.

Informed consent should include information regarding use of spare embryos. It should be made clear
whether embryos that are not used for transfer could or could not be used for research purposes or
implanted in another woman’s womb, or “preserved “ for use at a later date or destroyed. Investigators
should ensure that participants are informed and consent is taken afresh in writing on the above issues at
every stage.

- Consent may be withdrawn at any time before implantation.

- Specific consent must be obtained from couples who have their gametes or embryos frozen, with
regard to what should be done with them in case of death, or if any of the parties becomes incapable of
varying or revoking her or his consent.

- Investigators should clarify the ownership of the embryos that they belong to the genetic mother or the
laboratory. Abortions should never be encouraged for research purposes.

- No AR procedure will be done without the consent of the spouse or partner.

- There is no ethical objection at the moment for IVF or any other related procedure for research or for
clinical application.

Specific Principles

Legitimacy of the Child born through ART

A child born through AR is presumed to be the legitimate child of the couple having been born within the
wedlock and with consent of both the spouses with all the attendant rights of parentage, support and inheritance.
Sperm/Oocyte donor should have no parental right or duties in relation to the child and their anonymity should
be protected.

IVF-ET (in-vitro fertilization and embryo-transfer) and Surrogate Motherhood

There are no medico-legal problems posed by IVF-ET with egg and sperm of married couple. Donation of either
egg or sperm is governed on the same lines as those for Artificial Insemination Donor with the married partner
as the natural or biological mother. IVF-ET with donated egg or sperm or womb leasing will create two to three
sets of parents, genetic/ biological and natural.

Following consensus has emerged universally with respect to surrogate motherhood:

Surrogacy is an arrangement in which a woman agrees to carry a pregnancy that is genetically unrelated to her
and her husband, with the intention to carry it to term and hand over the child to the genetic parents with whom
she enters into a contract for surrogacy.

• It should be resorted to only when it is coupled with authorized adoption wherever applicable.

• The intending parents should have a preferential right to adopt the child subject to six week’s postpartum
delay for necessary maternal consent.
• Genetic parent’s claim for the custody of the child in it’s the best interest through adoption would be, to
establish that the child is theirs through genetic (DNA) fingerprinting, of which the records will be
maintained in the clinic.

• Surrogacy should be resorted to only if medically certified as the only solution to infertility or any other
medical bar on pregnancy by the intending mother.

Right of Children / Parents

A child born through ART shall be presumed to be the legitimate child of the couple, having been born in
wedlock and with the consent of both the spouses. Therefore, the child shall have a legal right to parental
support, inheritance, and all other privileges of a child born to a couple through sexual intercourse.

• Children born through use of donor gametes and their social/adopted parents have the right to know
the medical or genetic information about the genetic parents that may be relevant to the child’s health.

• The child’s has a right to seek information on genetic parent(s) or surrogate mother (including a copy
of the DNA fingerprint, if available) on reaching 18 years, except for information on the personal
identity of the gamete donor or the surrogate mother unless when required in threatening medical
conditions.

• The couple is not obliged to provide the information to the child on their own when s/he reaches the
age of 18, but no attempt must be made by the couple to hide this information from the child should an
occasion arise when this issue becomes important for the child.
Pre-conceptnal or pre-implantation sex selection is prohibited except for detecting
specific sex- linked genetic disorders
3.14 SUMMARY
Given the magnitude and severity of the health problems in different countries, capacity building to address
ethical issues that arise out of collaborative research must be promoted on a priority basis. Strategies should be
implemented so that various countries and communities can practise meaningful self-determination in health
development and can ensure the scientific and ethical conduct of research. Careful consideration should be
given to protect the dignity, safety and welfare of the participants when the social contexts of the proposed
research can create foreseeable conditions for exploitation of the participants or increase their vulnerability to
harm. The steps to be taken to overcome these should be described and approval taken from concerned
IEC/IndEC.

3.15 KEY WORDS

Cadaver: A dead body. For purposes of this document, the term refers to a dead
human body.

Death: This was originally defined as entire and continuous cessation of respiration
and circulation. It has since been recognized that the heart could continue beating
for a time, even for days, though the brain may have lost the ability to maintain
respiration and sustain life. Death of the brain stem, also called brain death, has
since been recognized internationally, and in the ‘Indian Transplantation of Human
Organs Act’, 1994.

Brain death: Specified in ‘Transplantation of Human Organs Act, 1994’ with ‘Transplantation of Human
Organs’ Rules, 1995’ the salient features are as described below:

Entire, Permanent, And Irreversible Cessation Of Functions Of The Brain Stem –

this is synonymous with brain-stem death, since the centers for the control of essential body functions such as
consciousness, respiration, and blood pressure are situated within the brain stem.

When testing the brain-stem reflexes, the following normal responses must be
looked for:
- constriction of the pupils in response to light,
- blinking in response to stimulation of the cornea,
- grimacing in response to firm pressure applied just above the eye socket,
- movements of the eyes in response to the ears being flushed with ice water,
- coughing or gagging in response to a suction catheter being passed down the airway. All responses
have to be absent on at least two occasions with an interval of six hours between them.
 UNIT 4. MEDICAL ETHICS

Learning Objectives
After going through this Unit you will be able to:
Enumerate the principles of medical ethics;
Understand the context of medical ethics;
Appreciate the ethical issues which are emerging in modern medical practice;
Importance of Ethics Committee.

Structure
4.1 Introduction
4.2 History
4.3 Principles of Medical Ethics
4.4 Criticisms of Orthodox Medical Ethics
4.5 Ethics Committees
4.6 Issues in Medical Ethics
4.7 Futility of Medical Care
4.8 Golden rules
4.9 Indian medical council (professional conduct, etiquette and ethics) regulations, 2002
4.10 Summary
4.11 Key words

4.1 INTRODUCTION
Medical ethics is a system of moral principles that apply values and judgments to the practice
of medicine. As a scholarly discipline, medical ethics encompasses its practical application in
clinical settings as well as work on its history, philosophy, theology, and sociology.

4.2 HISTORY
Historically, Western medical ethics may be traced to guidelines on the duty of physicians in
antiquity, such as the Hippocratic Oath, and early rabbinic and Christian teachings. The first
code of medical ethics, Formula Comities Archiatrorum, was published in the 5th century;
during the reign of the Ostrogothic king Theodoric the Great. In the medieval and early
modern period, the field is indebted to Muslim medicine such as Ishaq bin Ali Rahawi (who
wrote the Conduct of a Physician, the first book dedicated to medical ethics) and Muhammad
ibn Zakariya ar-Razi (known as Rhazes in the West), Jewish thinkers such
as Maimonides, Roman Catholic scholastic thinkers such as Thomas Aquinas, and the case-
oriented analysis (casuistry) of Catholic moral theology. These intellectual traditions continue
in Catholic, Islamic and Jewish medical ethics.
By the 18th and 19th centuries, medical ethics emerged as a more self-conscious discourse. In
England, Thomas Percival, a physician and author, crafted the first modern code of medical
ethics. He drew up a pamphlet with the code in 1794 and wrote an expanded version in 1803,
in which he coined the expressions "medical ethics" and "medical jurisprudence". However,
there are some who see Percival's guidelines that relate to physician consultations as being
excessively protective of the home physician's reputation. Jeffrey Berlant is one such critic
who considers Percival's codes of physician consultations as being an early example of the
anti-competitive, "guild"-like nature of the physician community.
In 1815, the Apothecaries Act was passed by the Parliament of the United Kingdom. It
introduced compulsory apprenticeship and formal qualifications for the apothecaries of the
day under the license of the Society of Apothecaries. This was the beginning of regulation of
the medical profession in the UK.
In 1847, the American Medical Association adopted its first code of ethics, with this being
based in large part upon Percival's work. While the secularized field borrowed largely from
Catholic medical ethics, in the 20th century a distinctively liberal Protestant approach was
articulated by thinkers such as Joseph Fletcher. In the 1960s and 1970s, building upon liberal
theory and procedural, much of the discourse of medical ethics went through a dramatic shift
and largely reconfigured itself into bioethics.
(Professional Conduct, Etiquette and Ethics) Regulations, 2002 is the code of ethics
which is to be followed in India.

4.3 PRINCIPLES OF MEDICAL ETHICS

A common framework used in the analysis of medical ethics is the "four principles" approach
postulated by Tom Beauchamp and James Childress in their textbook Principles of
biomedical ethics. It recognizes four basic moral principles, which are to be judged and
weighed against each other, with attention given to the scope of their application. The four
principles are:
Respect for autonomy - the patient has the right to refuse or choose their treatment. (Voluntas
aegroti suprema lex.)
Beneficence - a practitioner should act in the best interest of the patient. (salus aegroti
suprema lex.)
Non-maleficence - "first, do no harm" (primum non nocere).
Justice - concerns the distribution of scarce health resources, and the decision of who gets
what treatment (fairness and equality).
Other values which are sometimes discussed include:
Respect for persons - the patient (and the person treating the patient) have the right to be
treated with dignity.
Truthfulness and honesty - the concept of informed consent has increased in importance since
the historical events of the doctors' trial of the Nuremberg trials and Tuskegee syphilis
experiment.

The principle of autonomy recognizes the rights of individuals to self-determination. This is

rooted in society's respect for individuals' ability to make informed decisions about personal
matters. Autonomy has become more important as social values have shifted to define
medical quality in terms of outcomes that are important to the patient rather than medical
professionals. The increasing importance of autonomy can be seen as a social reaction to a
"paternalistic" tradition within healthcare. Some have questioned whether the backlash
against historically excessive paternalism in favor of patient autonomy has inhibited the
proper use of soft paternalism to the detriment of outcomes for some patients. Respect for
autonomy is the basis for informed consent and advance directives.
Autonomy is a general indicator of health. Many diseases are characterised by loss of
autonomy, in various manners. This makes autonomy an indicator for both personal well-
being, and for the well-being of the profession. This has implications for the consideration of
medical ethics: "is the aim of health care to do well, and benefit from it?” or "is the aim of
health care to do well to others, and have them, and society, benefit from this?". (Ethics - by
definition - tries to find a beneficial balance between the activities of the individual and its
effects on a collective.)
By considering autonomy as a gauge parameter for (self) health care, the medical and ethical
perspective both benefit from the implied reference to health.
Psychiatrists and clinical psychologists are often asked to evaluate a patient's capacity for
making life-and-death decisions at the end of life. Persons with a psychiatric condition such
as delirium or clinical depression may not have the capacity to make end-of-life decisions.
Therefore, for these persons, a request to refuse treatment may be taken in consideration of
their condition and not followed. Unless there is a clear advance directive to the contrary,
persons who lack mental capacity are generally treated according to their best interests. On
the other hand, persons who have the mental capacity to make end-of-life decisions have the
right to refuse treatment and choose an early death if that is what they truly want. In such
cases, psychiatrists and psychologists are typically part of protecting that right.
In practice, however, many treatments carry some risk of harm. In some circumstances, e.g.
in desperate situations where the outcome without treatment will be grave, risky treatments
that stand a high chance of harming the patient will be justified, as the risk of not treating is
also very likely to do harm. So the principle of non-maleficence is not absolute, and balances
against the principle of beneficence (doing well), as the effects of the two principles together
often give rise to a double effect (further described in next section).
Depending on the cultural consensus conditioning (expressed by its religious, political and
legal social system) the legal definition of non-maleficence differs. Violation of non-
maleficence is the subject of medical malpractice litigation. Regulations therefore differ over
time, per nation.
Double Effect
Double effect refers to two types of consequences which may be produced by a single
action, and in medical ethics it is usually regarded as the combined effect of beneficence and
non-malfeasance.
A commonly cited example of this phenomenon is the use of morphine or other analgesic in
the dying patient. Such use of morphine can have the beneficial effect of easing the pain and
suffering of the patient, while simultaneously having the maleficent effect of hastening the
death of the patient through suppression of the respiratory system.
Conflicts Between Autonomy and Beneficence/Non-Malfeasance
Autonomy can come into conflict with beneficence when patients disagree with
recommendations that health care professionals believe are in the patient's best interest. When
the patient's interests conflict with the patient's welfare, different societies settle the conflict
in a wide range of manners. Western medicine generally defers to the wishes of a mentally
competent patient to make his own decisions, even in cases where the medical team believes
that he is not acting in his own best interests. However, many other societies prioritize
beneficence over autonomy.
Examples include when a patient does not want a treatment because of, for example, religious
or cultural views. In the case of euthanasia, the patient, or relatives of a patient, may want to
end the life of the patient. Also, the patient may want an unnecessary treatment, as can be the
case in hypochondria or with cosmetic surgery; here, the practitioner may be required to
balance the desires of the patient for medically unnecessary potential risks against the
patient's informed autonomy in the issue. A doctor may want to prefer autonomy because
refusal to please the patient's will would harm the doctor-patient relationship.
Individuals' capacity for informed decision making may come into question during resolution
of conflicts between autonomy and beneficence. The role of surrogate medical decision
makers is an extension of the principle of autonomy.
On the other hand, autonomy and beneficence/non-malfeasance may also overlap
For example, a breach of patients' autonomy may cause decreased confidence for medical
services in the population and subsequently less willingness to seek help, which in turn may
cause inability to perform beneficence. Beneficence is a task worthy of many to complete due
to its difficulty to perform under extreme circumstances that are not correlated directly with
individuals seeking euthanasia.
The principles of autonomy and beneficence/non-maleficence may also be expanded to
include effects on the relatives of patients or even the medical practitioners, the overall
population and economic issues when making medical decisions.

Euthanasia
Some American physicians [interpret the non-maleficence principle to exclude the practice
of euthanasia, though not all concur. Probably the most extreme example in recent history of
the violation of the non-maleficence dictum was Dr. Jack Kevorkian, who was convicted of
second-degree homicide in Michigan in 1998 after demonstrating active euthanasia on the TV
news show 60 Minutes.
In some countries such as the Netherlands, euthanasia is accepted as standard medical
practice. Legal regulations assign this to the medical profession. In such nations, the aim is to
alleviate the suffering of patients from diseases known to be incurable by the methods known
in that culture. In that sense, the "Primum no Nocere" is based on the belief that the inability
of the medical expert to offer help, creates a known great and ongoing suffering in the
patient. Euthanasia has been discussed in detail later on.
Informed consent: in ethics usually refers to the idea that a person must be fully informed
about and understand the potential benefits and risks of their choice of treatment. An
uninformed person is at risk of mistakenly making a choice not reflective of his or her values
or wishes. It does not specifically mean the process of obtaining consent, nor the specific
legal requirements, which vary from place to place, for capacity to consent. Patients can elect
to make their own medical decisions, or can delegate decision-making authority to another
party. If the patient is incapacitated, laws around the world designate different processes for
obtaining informed consent, typically by having a person appointed by the patient or
their next of kin make decisions for them. The value of informed consent is closely related to
the values of autonomy and truth telling.

Confidentiality: is commonly applied to conversations between doctors and patients. This

concept is commonly known as patient-physician privilege.
Legal protections prevent physicians from revealing their discussions with patients, even
under oath in court.
Confidentiality is mandated in America by HIPAA laws, specifically the Privacy Rule, and
various state laws, some more rigorous than HIPAA. However, numerous exceptions to the
rules have been carved out over the years. For example, many states require physicians to
report gunshot wounds to the police and impaired drivers to the Department of Motor
Vehicles. Confidentiality is also challenged in cases involving the diagnosis of a sexually
transmitted disease in a patient who refuses to reveal the diagnosis to a spouse, and in the
termination of a pregnancy in an underage patient, without the knowledge of the patient's
parents. Many states in the U.S. have laws governing parental notification in underage
abortion.
Traditionally, medical ethics has viewed the duty of confidentiality as a relatively non-
negotiable tenet of medical practice. More recently, critics like Jacob Appel have argued for a
more nuanced approach to the duty that acknowledges the need for flexibility in many cases.
Confidentiality is an important issue in primary care ethics, where physicians care for many
patients from the same family and community, and where third parties often request
information from the considerable medical database typically gathered in primary health care
4.4 CRITICISMS OF ORTHODOX MEDICAL ETHICS
It has been argued that mainstream medical ethics is biased by the assumption of a
framework in which individuals are not simply free to contract with one another to provide
whatever medical treatment is demanded, subject to the ability to pay. Because a high
proportion of medical care is typically provided via the welfare state, and because there are
legal restrictions on what treatment may be provided and by whom, an automatic divergence
may exist between the wishes of patients and the preferences of medical practitioners and
other parties. Tassano [15] has questioned the idea that Beneficence might in some cases have
priority over Autonomy. He argues that violations of Autonomy more often reflect the
interests of the state or of the supplier group than those of the patient.
Routine regulatory professional bodies or the courts of law are valid social recourses.
Importance of Communication
Many so-called "ethical conflicts" in medical ethics are traceable back to a lack
of communication. Communication breakdowns between patients and their healthcare team,
between family members, or between members of the medical community, can all lead to
disagreements and strong feelings. These breakdowns should be remedied, and many
apparently insurmountable "ethics" problems can be solved with open lines of
communication.
Control and Resolution
To ensure that appropriate ethical values are being applied within hospitals, effective hospital
accreditation requires that ethical considerations are taken into account, for example with
respect to physician integrity, conflicts of interest, research ethics and organ
transplantation ethics.
Guidelines
There are various ethical guidelines. For example, the Declaration of Helsinki is regarded as
authoritative in human research ethics.
In the United Kingdom, General Medical Council provides clear overall modern guidance in
the form of its 'Good Medical Practice' statement. Other organisations, such as the Medical
Protection Society and a number of university departments, are often consulted by British
doctors regarding issues relating to ethics. In India we have ethical guidelines by IMC, ICMR

4.5 ETHICS COMMITTEES

Often, simple communication is not enough to resolve a conflict, and a hospital ethics
committee must convene to decide a complex matter.
These bodies are composed primarily of health care professionals, but may also
include philosophers, lay people, and clergy - indeed, in many parts of the world their
presence is considered mandatory in order to provide balance.
U.S. recommendations suggest that Research and Ethical Boards (REBs) should have five or
more members, including at least one scientist, one non-scientist and one person not affiliated
with the institution. The REB should include people knowledgeable in the law and standards
of practice and professional conduct. Special memberships are advocated for handicapped or
disabled concerns, if required by the protocol under review. The European Forum for Good
Clinical Practice (EFGCP) suggests that REBs include two practicing physicians who share
experience in biomedical research and are independent from the institution where the
research is conducted; one lay person; one lawyer; and one paramedical professional, e.g.
nurse or pharmacist. They recommend that a quorum include both sexes from a wide age
range and reflect the cultural make-up of the local community. The 1996 Australian Health
Ethics Committee recommendations were entitled, "Membership Generally of Institutional
Ethics Committees". They suggest a chairperson be preferably someone not employed or
otherwise connected with the institution. Members should include a person with knowledge
and experience in professional care, counselling or treatment of humans; a minister of
religion or equivalent, e.g. Aboriginal elder; a layman; a laywoman; a lawyer and, in the case
of a hospital-based ethics committee, a nurse.
The assignment of philosophers or religious clerics will reflect the importance attached by
the society to the basic values involved. An example from Sweden with Torbjörn Tännsjö on
a couple of such committees indicates secular trends gaining influence.

4.6 ISSUES IN MEDICAL ETHICS

Medical Ethics in an Online World
Increasingly, medical researchers are researching activities in online environments such as
discussion boards and bulletin boards, and there is concern that the requirements of informed
consent and privacy are not as stringently applied as they should be, although some
guidelines do exist.
One issue that has arisen, however, is the disclosure of information. While researchers wish
to quote from the original source in order to argue a point, this can have repercussions. The
quotations and other information about the site can be used to identify the site, and
researchers have reported cases where members of the site, bloggers and others have used
this information as 'clues' in a game in an attempt to identify the site. Some researchers have
employed various methods of "heavy disguise," including discussing a different condition
from that under study, or even setting up bogus sites (called 'Maryut sites') to ensure that the
researched site is not discovered.
Online Business Practices
The delivery of diagnosis online leads patients to believe that doctors in some parts of the
country are at the direct service of drug companies. Finding diagnosis as convenient as what
drug still has patent rights on it. Physicians and drug companies are found to be competing
for top ten search engine ranks to lower costs of selling these drugs with little to no patient
involvement.
Cultural Concerns
Culture differences can create difficult medical ethics problems. Some cultures have spiritual
or magical theories about the origins of disease, for example, and reconciling these beliefs
with the tenets of Western medicine can be difficult.
Truth-Telling
Some cultures do not place a great emphasis on informing the patient of the diagnosis,
especially when cancer is the diagnosis. American culture rarely used truth-telling especially
in medical cases, up until the 1970s. In American medicine, the principle of informed
consent now takes precedence over other ethical values, and patients are usually at least
asked whether they want to know the diagnosis.
Conflicts of Interest
Physicians should not allow a conflict of interest to influence medical judgment. In some
cases, conflicts are hard to avoid, and doctors have a responsibility to avoid entering such
situations. Unfortunately, research has shown that conflicts of interests are very common
among both academic physicians [23] and physicians in practice.
Referral
For example, doctors who receive income from referring patients for medical tests have been
shown to refer more patients for medical tests. This practice is proscribed by the American
College of Physicians Ethics Manual.
Fee Splitting and the payments of commissions to attract referrals of patients are considered
unethical and unacceptable in most parts of the world.
Vendor Relationships
Studies show that doctors can be influenced by drug company inducements, including gifts
and food. Industry-sponsored Continuing Medical Education (CME) programs influence
prescribing patterns. Many patients surveyed in one study agreed that physician gifts from
drug companies influence prescribing practices. A growing movement among physicians is
attempting to diminish the influence of pharmaceutical industry marketing upon medical
practice, as evidenced by Stanford University's ban on drug company-sponsored lunches and
gifts. Other academic institutions that have banned pharmaceutical industry-sponsored gifts
and food include the Johns Hopkins Medical Institutions, University of Michigan, University
of Pennsylvania, and Yale University.
Treatment Of Family Members
Many doctors treat their family members. Doctors who do so must be vigilant not to create
conflicts of interest or treat inappropriately.
Sexual Relationships
Sexual relationships between doctors and patients can create ethical conflicts, since sexual
consent may conflict with the fiduciary responsibility of the physician. Doctors who enter
into sexual relationships with patients face the threats of deregistration and prosecution. In
the early 1990s, it was estimated that 2-9% of doctors had violated this rule. Sexual
relationships between physicians and patients' relatives may also be prohibited in some
jurisdictions, although this prohibition is highly controversial.

4.7 FUTILITY OF MEDICAL CARED

The concept of medical futility has been an important topic in discussions of medical ethics.
What should be done if there is no chance that a patient will survive but the family members
insist on advanced care? Previously, some articles defined futility as the patient having less
than a one percent chance of surviving. Some of these cases wind up in the courts.
Advanced directives include living wills and durable powers of attorney for health care. In
many cases, the "expressed wishes" of the patient are documented in these directives, and this
provides a framework to guide family members and health care professionals in the decision
making process when the patient is incapacitated. Undocumented expressed wishes can also
help guide decisions in the absence of advanced directives, as in the Quinlan case in
Missouri.
"Substituted judgment" is the concept that a family member can give consent for treatment if
the patient is unable (or unwilling) to give consent themselves. The key question for the
decision making surrogate is not, "What would you like to do?", but instead, "What do you
think the patient would want in this situation?”
Courts have supported family's arbitrary definitions of futility to include simple biological
survival, as in the Baby K case (in which the courts ordered a child born with only a brain
stem instead of a complete brain to be kept on a ventilator based on the religious belief that
all life must be preserved).
In some hospitals, medical futility is referred to as "non-beneficial care."
Baby Doe Law establishes state protection for a disabled child's right to life, ensuring that
this right is protected even over the wishes of parents or guardians in cases where they want
to withhold treatment

4.8 GOLDEN RULES

Do unto others, as you would have others do unto you. Ask ‘Were I the patient, what
course of action would I have wished the doctor to follow?’

The Patient Comes First: The raison d’êtreof our profession is the patient. We are here to
serve him. The sick patient, often in physical pain and always in mental distress, deserves our
fullest attention and calls for the best qualities of our mind and heart. His interests and
decisions must prevail above all else except when the patient is non compos mentis. In the
latter instance, the decisions of his family must prevail.

The Poor Patient Deserves Special Consideration: He has nowhere else to go. He does not
possess the means to command or demand. In our milieu he is often reduced to seeking help
with bowed head and hands folded together. And he is ill. Medical malpractice against this
group is particularly abhorrent.

Act Without Fear Or Favour — Ensure that your decisions and actions are scientific,
humane,
effective and in the best interests of the patient and his family. Record them. Once this is
done,
you need fear no individual, administrator or tribunal.

4.9 INDIAN MEDICAL COUNCIL (PROFESSIONAL CONDUCT, ETIQUETTE

AND ETHICS) REGULATIONS, 2002

(Published in Part III, Section 4 of the Gazette of India, dated 6th April, 2002) MEDICAL
COUNCIL OF INDIA NOTIFICATION New Delhi dated 11th March, 2002 No. MCI-
211(2)/2001/Registration. In exercise of the powers conferred under section 20A read with
section 33(m) of the Indian Medical Council Act, 1956 (102 of 1956), the Medical Council of
India, with the previous approval of the Central Government, hereby makes the following
regulations relating to the Professional Conduct, Etiquette and Ethics for registered medical
practitioners, namely:- Short Title and Commencement: (1) These Regulations may be called
the Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002.
(2)They shall come into force on the date of their publication in the Official Gazette.

Declaration: Each applicant, at the time of making an application for registration under the
provisions of the Act, shall be provided a copy of the declaration and shall submit a duly
signed Declaration as provided in Appendix 1. The applicant shall also certify that he/she had
read and agreed to abide by the same.

Duties and responsibilities of the Physician in general

Character of Physician: (Doctors with qualification of MBBS or MBBS with post graduate
degree/ diploma or with equivalent qualification in any medical discipline):

A physician shall uphold the dignity and honour of his profession.

The prime object of the medical profession is to render service to humanity; reward or
financial gain is a subordinate consideration.
Who- so-ever chooses his profession, assumes the obligation to conduct him in accordance
with its ideals.

Maintenance of Medical Records

Every physician shall maintain the medical records pertaining to his / her indoor patients for a
period of 3 years from the date of commencement of the treatment in a standard preform laid
down by the Medical Council of India and attached as Appendix 3.

If any request is made for medical records either by the patients / authorised attendant or legal
authorities involved, the same may be duly acknowledged and documents shall be issued
within the period of 72 hours

A Registered medical practitioner shall maintain a Register of Medical Certificates giving full
details of certificates issued. When issuing a medical certificate he / she shall always enter the
identification marks of the patient and keep a copy of the certificate. He / She shall not omit
to record the signature and/or thumb mark, address and at least one identification mark of the
patient on the medical certificates or report. The medical certificate shall be prepared as in
Appendix 2.

Efforts shall be made to computerize medical records for quick retrieval.

Every physician shall display the registration number accorded to him by the State Medical
Council / Medical Council of India in his clinic and in all his prescriptions, certificates,
money receipts given to his patients

Physicians shall display as suffix to their names only recognized medical degrees or such
certificates/diplomas and memberships/honours which confer professional knowledge or
recognizes any exemplary qualification/achievements.

Every physician should, as far as possible, prescribe drugs with generic names and he / she
shall ensure that there is a rational prescription and use of drugs.
Highest Quality Assurance in patient care
Every physician should aid in safeguarding the profession against admission to it of those
who are deficient in moral character or education. Physician shall not employ in connection
with his professional practice any attendant who is neither registered nor enlisted under the
Medical Acts in force and shall not permit such persons to attend, treat or perform operations
upon patients wherever professional discretion or skill is required.
Exposure of Unethical Conduct
A Physician should expose, without fear or favour, incompetent or corrupt, dishonest or
unethical conduct on the part of members of the profession.
Payment of Professional Services
The physician, engaged in the practice of medicine shall give priority to the interests of
patients. The personal financial interests of a physician should not conflict with the medical
interests of patients. A physician should announce his fees before rendering service and not
after the operation or treatment is under way. Remuneration received for such services should
be in the form and amount specifically announced to the patient at the time the service is
rendered. It is unethical to enter into a contract of "no cure no payment". Physician rendering
service on behalf of the state shall refrain from anticipating or accepting any consideration.
Legal Responsibility
The physician shall observe the laws of the country in regulating the practice of medicine and
shall also not assist others to evade such laws. He should be cooperative in observance and
enforcement of sanitary laws and regulations in the interest of public health. A physician
should observe the provisions of the State Acts like Drugs and Cosmetics Act, 1940;
Pharmacy Act, 1948; Narcotic Drugs and Psychotropic substances Act, 1985; Medical
Termination of Pregnancy Act, 1971; Transplantation of Human Organ Act, 1994; Mental
Health Act, 1987; Environmental Protection Act, 1986; Pre–natal Sex Determination Test
Act, 1994; Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954; Persons
with Disabilities (Equal Opportunities and Full Participation) Act, 1995 and Bio-Medical
Waste (Management and Handling) Rules, 1998 and such other Acts, Rules, Regulations
made by the Central/State Governments or local Administrative Bodies or any other relevant
Act.

Duties of Physicians to Their Patients

Obligations to the Sick

Though a physician is not bound to treat each and every person asking his services, he should
not only be ever ready to respond to the calls of the sick and the injured, but should be
mindful of the high character of his mission and the responsibility he discharges in the course
of his professional duties. In his treatment, he should never forget that the health and the lives
of those entrusted to his care depend on his skill and attention. A physician should endeavour
to add to the comfort of the sick by making his visits at the hour indicated to the patients. A
physician advising a patient to seek service of another physician is acceptable; however, in
case of emergency a physician must treat the patient. No physician shall arbitrarily refuse
treatment to a patient. However for good reason, when a patient is suffering from an ailment
which is not within the range of experience of the treating physician, the physician may
refuse treatment and refer the patient to another physician. Medical practitioner having any
incapacity detrimental to the patient or which can affect his performance vis-à-vis the patient
is not permitted to practice his profession.

Patience, Delicacy and Secrecy

Patience and delicacy should characterize the physician. Confidences concerning individual
or domestic life entrusted by patients to a physician and defects in the disposition or character
of patients observed during medical attendance should never be revealed unless their
revelation is required by the laws of the State. Sometimes, however, a physician must
determine whether his duty to society requires him to employ knowledge, obtained through
confidence as a physician, to protect a healthy person against a communicable disease to
which he is about to be exposed. In such instance, the physician should act as he would wish
another to act toward one of his own family in like circumstances.

Prognosis
The physician should neither exaggerate nor minimize the gravity of a patient’s condition. He
should ensure himself that the patient, his relatives or his responsible friends have such
knowledge of the patient’s condition as will serve the best interests of the patient and the
family.

The Patient Must Not Be Neglected

A physician is free to choose whom he will serve. He should, however, respond to any
request for his assistance in an emergency. Once having undertaken a case, the physician
should not neglect the patient, nor should he withdraw from the case without giving adequate
notice to the patient and his family. Provisionally or fully registered medical practitioner shall
not willfully commit an act of negligence that may deprive his patient or patients from
necessary medical care.

Engagement for an Obstetric case

When a physician who has been engaged to attend an obstetric case is absent and another is
sent for and delivery accomplished, the acting physician is entitled to his professional fees,
but should secure the patient’s consent to resign on the arrival of the physician engaged.

Duties of Physician in Consultation

Unnecessary consultations should be avoided

However in case of serious illness and in doubtful or difficult conditions, the physician
should request consultation, but under any circumstances such consultation should be
justifiable and in the interest of the patient only and not for any other consideration.
Consulting pathologists /radiologists or asking for any other diagnostic Lab
investigation should be done judiciously and not in a routine manner.

Consultation for Patient’s Benefit: In every consultation, the benefit to the patient is of
foremost importance. All physicians engaged in the case should be frank with the patient and
his attendants.

Punctuality in Consultation
Utmost punctuality should be observed by a physician in making themselves available for
consultations.

Statement to Patient after Consultation

All statements to the patient or his representatives should take place in the presence of the
consulting physicians, except as otherwise agreed. The disclosure of the opinion to the patient
or his relatives or friends shall rest with the medical attendant. Differences of opinion
should not be divulged unnecessarily but when there is irreconcilable difference of opinion
the circumstances should be frankly and impartially explained to the patient or his relatives or
friends. It would be opened to them to seek further advice as they so desire.

Treatment after Consultation

No decision should restrain the attending physician from making such subsequent variations
in the treatment if any unexpected change occurs, but at the next consultation, reasons for the
variations should be discussed/ explained. The same privilege, with its obligations, belongs to
the consultant when sent for in an emergency during the absence of attending physician. The
attending physician may prescribe medicine at any time for the patient, whereas the
consultant may prescribe only in case of emergency or as an expert when called for.
Patients Referred to Specialists
When a patient is referred to a specialist by the attending physician, a case summary of the
patient should be given to the specialist, who should communicate his opinion in writing to
the attending physician.

Fees and other charges

A physician shall clearly display his fees and other charges on the board of his chamber
and/or the hospitals he is visiting. Prescription should also make clear if the Physician
himself dispensed any medicine. A physician shall write his name and designation in full
along with registration particulars in his prescription letter head. Note: In Government
hospital where the patient–load is heavy, the name of the prescribing doctor must be written
below his/her signature.

Responsibilities of Physicians to Each Other

Dependence of Physicians on each other

A physician should consider it as a pleasure and privilege to render gratuitous service to all
physicians and their immediate family dependants.

Conduct in consultation
In consultations, no insincerity, rivalry or envy should be indulged in. All due respect should
be observed towards the physician in-charge of the case and no statement or remark be made,
which would impair the confidence reposed in him. For this purpose no discussion should be
carried on in the presence of the patient or his representatives.

Consultant not to take charge of the case: When a physician has been called for consultation,
the Consultant should normally not take charge of the case, especially on the solicitation of
the patient or friends. The Consultant shall not criticize the referring physician. He / she shall
discuss the diagnosis treatment plan with the referring physician.
Appointment of Substitute: Whenever a physician requests another physician to attend his
patients during his temporary absence from his practice, professional courtesy requires the
acceptance of such appointment only when he has the capacity to discharge the additional
responsibility along with his / her other duties. The physician acting under such an
appointment should give the utmost consideration to the interests and reputation of the absent
physician and all such patients should be restored to the care of the latter upon his/her return.
The medical officer/ physician occupying an official position should avoid remarks upon the
diagnosis or the treatment that has been adopted.
Duties of Physician to The Public and to the Paramedical Profession: Physicians, as good
citizens, possessed of special training should disseminate advice on public health issues. They
should play their part in enforcing the laws of the community and in sustaining the
institutions that advance the interests of humanity. They should particularly co-operate with
the authorities in the administration of sanitary/public health laws and regulations.
Public and Community Health: Physicians, especially those engaged in public health work,
should enlighten the public concerning quarantine regulations and measures for the
prevention of epidemic and communicable diseases. At all times the physician should notify
the constituted public health authorities of every case of communicable disease under his
care, in accordance with the laws, rules and regulations of the health authorities. When an
epidemic occurs a physician should not abandon his duty for fear of contracting the disease
himself.
Pharmacists / Nurses: Physicians should recognize and promote the practice of different
paramedical services such as, pharmacy and nursing as professions and should seek their
cooperation wherever required.
Unethical Acts
A physician shall not aid or abet or commit any of the following acts which shall be
construed as unethical:
A physician shall not make use of him / her (or his / her name) as subject of any form or
manner of advertising or publicity through any mode either alone or in conjunction with
others which is of such a character as to invite attention to him or to his professional position,
skill, qualification, achievements, attainments, specialities, appointments, associations,
affiliations or honours and/or of such character as would ordinarily result in his self-
aggrandizement. A physician shall not give to any person, whether for compensation or
otherwise, any approval, recommendation, endorsement, certificate, report or statement with
respect of any drug, medicine, nostrum remedy, surgical, or therapeutic article, apparatus or
appliance or any commercial product or article with respect of any property, quality or use
thereof or any test, demonstration or trial thereof, for use in connection with his name,
signature, or photograph in any form or manner of advertising through any mode nor shall he
boast of cases, operations, cures or remedies or permit the publication of report thereof
through any mode.

A medical practitioner is however permitted to make a formal announcement in press

regarding the starting practice, change of type of practice, changing address, temporary
absence from duty, resumption of another practice, succeeding to another practice, and Public
declaration of charges.
Printing of self-photograph or any such material of publicity in the letter head or on sign
board of the consulting room or any such clinical establishment shall be regarded as acts of
self-advertisement and unethical conduct on the part of the physician. However, printing of
sketches, diagrams, picture of human system shall not be treated as unethical.
Patent and Copy rights: A physician may patent surgical instruments, appliances and
medicine or Copyright applications, methods and procedures. However, it shall be unethical
if the benefits of such patents or copyrights are not made available in situations where the
interest of large population is involved.
It is not unethical for a physician to prescribe or supply drugs, remedies or appliances as long
as there is no exploitation of the patient. Drugs prescribed by a physician or brought from the
market for a patient should explicitly state the proprietary formulae as well as generic name
of the drug.
Rebates and Commission: A physician shall not give, solicit, or receive nor shall he offer to
give solicit or receive, any gift, gratuity, commission or bonus in consideration of or return
for the referring, recommending or procuring of any patient for medical, surgical or other
treatment. A physician shall not directly or indirectly, participate in or be a party to act of
division, transference, assignment, subordination, rebating, splitting or refunding of any fee
for medical, surgical or other treatment
Secret Remedies: The prescribing or dispensing by a physician of secret remedial agents of
which he does not know the composition, or the manufacture or promotion of their use is
unethical and as such prohibited. All the drugs prescribed by a physician should always carry
a proprietary formula and clear name.
Human Rights: The physician shall not aid or abet torture nor shall he be a party to either
infliction of mental or physical trauma or concealment of torture inflicted by some other
person or agency in clear violation of human rights.
Euthanasia: Practicing euthanasia shall constitute unethical conduct. However on specific
occasion, the question of withdrawing supporting devices to sustain cardio-pulmonary
function even after brain death, shall be decided only by a team of doctors and not merely by
the treating physician alone. A team of doctors shall declare withdrawal of support system.
Such team shall consist of the doctor in charge of the patient, Chief Medical Officer /
Medical Officer in charge of the hospital and a doctor nominated by the in-charge of the
hospital from the hospital staff or in accordance with the provisions of the Transplantation of
Human Organ Act, 1994.
Dealing with Pharmaceutical and allied health sector industry, a medical practitioner shall
follow and adhere to the stipulations given below:
Gifts: A medical practitioner shall not receive any gift from any pharmaceutical or allied
health care industry and their sales people or representatives.
Travel facilities: A medical practitioner shall not accept any travel facility inside the country
or outside, including rail, air, ship, cruise tickets, paid vacations etc. from any pharmaceutical
or allied healthcare industry or their representatives for self and family members for vacation
or for attending conferences, seminars, workshops, CME programme etc. as a delegate.
Hospitality: A medical practitioner shall not accept individually any hospitality like hotel
accommodation for self and family members under any pretext.
Cash or monetary grants: A medical practitioner shall not receive any cash or monetary
grants from any pharmaceutical and allied healthcare industry for individual purpose in
individual capacity under any pretext. Funding for medical research, study etc. can only be
received through approved institutions by modalities laid down by law / rules / guidelines
adopted by such approved institutions, in a transparent manner. It shall always be fully
disclosed.
Medical Research: A medical practitioner may carry out, participate in, and work in research
projects funded by pharmaceutical and allied healthcare industries. A medical practitioner is
obliged to know that the fulfillment of the following items will be an imperative for
undertaking any research assignment/project funded by industry for being proper and ethical.
Thus, in accepting such a position a medical practitioner shall:
Ensure that the particular research proposal(s) has the due permission from the competent
concerned authorities.

Ensure that such a research project(s) has the clearance of national/state/ institutional ethics
committees/bodies.

Ensure that it fulfils all the legal requirements prescribed for medical research.

Ensure that the source and amount of funding is publicly disclosed at the beginning itself.

Ensure that proper care and facilities are provided to human volunteers, if they are necessary
for the research project(s).

Ensure that undue animal experimentations are not done and when these are necessary they
are done in a scientific and a humane way.

Ensure that while accepting such an assignment a medical practitioner shall have the
freedom to publish the results of the research in the greater interest of the society by inserting
such a clause in the MoU or any other document / agreement for any such assignment.

Maintaining Professional Autonomy: In dealing with pharmaceutical and allied healthcare

industry a medical practitioner shall always ensure that there shall never be any compromise
either with his / her own professional autonomy and / or with the autonomy and freedom of
the medical institution.
Affiliation: A medical practitioner may work for pharmaceutical and allied healthcare
industries in advisory capacities, as consultants, as researchers, as treating doctors or in any
other professional capacity. In doing so, a medical practitioner shall always:

Ensure that his professional integrity and freedom are maintained.

Ensure that patient’s interest is not compromised in any way.
Ensure that such affiliations are within the law.
Ensure that such affiliations/employments are fully transparent and disclosed.

Endorsement: A medical practitioner shall not endorse any drug or product of the industry
publically. Any study conducted on the efficacy or otherwise of such products shall be
presented to and / or through appropriate scientific bodies or published in appropriate
scientific journals in a proper way”

Misconduct
The following acts of commission or omission on the part of a physician shall constitute
professional misconduct rendering him/her liable for disciplinary action:
Violation of the Regulations:
If he/she commits any violation of these Regulations.
If he/she does not maintain the medical records of his/her indoor patients for a period of
three years as per regulation and refuses to provide the same within 72 hours when the patient
or his/her authorised representative makes a request for it as per the regulation
If he/she does not display the registration number accorded to him/her by the State Medical
Council or the Medical Council of India in his clinic, prescriptions and certificates etc. issued
by him or violates the provisions of regulation.
Adultery or Improper Conduct: Abuse of professional position by committing adultery or
improper conduct with a patient or by maintaining an improper association with a patient will
render a Physician liable for disciplinary action as provided under the Indian Medical Council
Act, 1956 or the concerned State Medical Council Act.
Conviction by Court of Law: Conviction by a Court of Law for offences involving moral
turpitude / Criminal acts.
Sex Determination Tests: On no account sex determination test shall be undertaken with the
intent to terminate the life of a female foetus developing in her mother’s womb, unless there
are other absolute indications for termination of pregnancy as specified in the Medical
Termination of Pregnancy Act, 1971. Any act of termination of pregnancy of normal female
foetus amounting to female foeticide shall be regarded as professional misconduct on the part
of the physician leading to penal erasure besides rendering him liable to criminal proceedings
as per the provisions of this Act.
Signing Professional Certificates, Reports and other Documents: Registered medical
practitioners are in certain cases bound by law to give, or may from time to time be called
upon or requested to give certificates, notification, reports and other documents of similar
character signed by them in their professional capacity for subsequent use in the courts or for
administrative purposes etc. Such documents, among others, include the ones given at
Appendix –4. Any registered practitioner who is shown to have signed or given under his
name and authority any such certificate, notification, report or document of a similar
character which is untrue, misleading or improper, is liable to have his name deleted from the
Register.
A registered medical practitioner shall not contravene the provisions of the Drugs and
Cosmetics Act and regulations made there under. Accordingly, a) Prescribing steroids/
psychotropic drugs when there is no absolute medical indication; b) Selling Schedule “H &
L” drugs and poisons to the public except to his patient in contravention of the above
provisions shall constitute gross professional misconduct on the part of the physician.

Performing or enabling unqualified person to perform an abortion or any illegal operation for
which there is no medical, surgical or psychological indication.

A registered medical practitioner shall not issue certificates of efficiency in modern medicine
to unqualified or non-medical person. (Note: The foregoing does not restrict the proper
training and instruction of eligible students, midwives, dispensers, surgical attendants, or
skilled mechanical and technical assistants and therapy assistants under the personal
supervision of physicians.)

A physician should not contribute to the lay press articles and give interviews regarding
diseases and treatments which may have the effect of advertising himself or soliciting
practices; but is open to write to the lay press under his own name on matters of public
health, hygienic living or to deliver public lectures, give talks on the radio/TV/internet chat
for the same purpose and send announcement of the same to lay press. An institution run by
a physician for a particular purpose such as a maternity home, nursing home, private hospital,
rehabilitation centre or any type of training institution etc. may be advertised in the lay press,
but such advertisements should not contain anything more than the name of the institution,
type of patients admitted, type of training and other facilities offered and the fees.

It is improper for a physician to use an unusually large sign board and write on it anything
other than his name, qualifications obtained from a University or a statutory body, titles and
name of his speciality, registration number including the name of the State Medical Council
under which registered. The same should be the contents of his prescription papers. It is
improper to affix a sign-board on a chemist’s shop or in places where he does not reside or
work.

The registered medical practitioner shall not disclose the secrets of a patient that have been
learnt in the exercise of his / her profession except – i) in a court of law under orders of the
Presiding Judge; ii) in circumstances where there is a serious and identified risk to a specific
person and / or community; and iii) notifiable diseases. In case of communicable / notifiable
diseases, concerned public health authorities should be informed immediately

The registered medical practitioner shall not refuse on religious grounds alone to give
assistance in or conduct of sterility, birth control, circumcision and medical termination of
Pregnancy when there is medical indication, unless the medical practitioner feels
himself/herself incompetent to do so.

Before performing an operation the physician should obtain in writing the consent from the
husband or wife, parent or guardian in the case of minor, or the patient himself as the case
may be. In an operation which may result in sterility the consent of both husband and wife is
needed.

A registered medical practitioner shall not publish photographs or case reports of his / her
patients without their permission, in any medical or other journal in a manner by which their
identity could be made out. If the identity is not to be disclosed, the consent is not needed.
In the case of running of a nursing home by a physician and employing assistants to help him
/ her, the ultimate responsibility rests on the physician. A Physician shall not use touts or
agents for procuring patients. A Physician shall not claim to be specialist unless he has a
special qualification in that branch. No act of investor (new Point) fertilization or artificial
insemination shall be undertaken without the informed consent of the female patient and her
spouse as well as the donor. Such consent shall be obtained in writing only after the patient is
provided, at her own level of comprehension, with sufficient information about the purpose,
methods, risks, inconveniences, disappointments of the procedure and possible risks and
hazards. Research: (new Point) Clinical drug trials or other research involving patients or
volunteers as per the guidelines of ICMR can be undertaken, provided ethical considerations
are borne in mind. Violation of existing ICMR guidelines in this regard shall constitute
misconduct. Consent taken from the patient for trial of drug or therapy which is not as per the
guidelines shall also be construed as misconduct.
4.10 SUMMARY
A Nobel profession like medicine needs to be governed by strict ethical guidelines. However
medical colleges which are the fountainheads of medical education all over India and are the
ideal places to sow the seeds of ethical practices in the minds of medical students .They must
set the pace and led the way in teaching, ethical patient-care and research. However most of
these colleges have been found wanting on this aspect.
All guidelines are openly flouted. Senior teachers are seen in private hospitals in the
mornings and afternoons, attend several private hospitals, and divert patients from their
teaching hospitals for personal profit. Therefore MCI must take bold initiatives to ensure the
doctors follow ethical practices. Like similar institutions in other countries (the General
Medical Council in Britain is an example), they must take up active measures to prevent
unethical practices.

4.11 KEY WORDS

Confidentiality is commonly applied to conversations between doctors and patients. This

concept is commonly known as patient-physician privilege.
Double Effect
Double effect refers to two types of consequences which may be produced by a single
action, and in medical ethics it is usually regarded as the combined effect of beneficence and
non-maleficence

Character of Physician (Doctors with qualification of MBBS or MBBS with post graduate
degree/ diploma or with equivalent qualification in any medical discipline):
A physician shall uphold the dignity and honour of his profession.
The prime object of the medical profession is to render service to humanity; reward or
financial gain is a subordinate consideration.
Who- so-ever chooses his profession, assumes the obligation to conduct him in accordance
with its ideals.
A physician should be an upright man, instructed in the art of healings. He shall keep himself
pure in character and be diligent in caring for the sick; he should be modest, sober, patient,
prompt in discharging his duty without anxiety; conducting himself with propriety in his
profession and in all the actions of his life.
No person other than a doctor having qualification recognised by Medical Council of India
and registered with Medical Council of India/State Medical Council (s) is allowed to practice
Modern system of Medicine or Surgery. A person obtaining qualification in any other system
of Medicine is not allowed to practice Modern system of Medicine in any form.
UNIT 5 DOCTOR PATIENT RELATIONSHIP
.

Learning Objectives

After going through this Unit you will be able to:

• understand the importance of Doctor and Patient relationship;

• understand the concept of Boundary Violation;
• understand the duties of RMP;
• understand the Rights Of a Patient;
• know What Constitutes Professional Misconduct;
• Understand the concept of Privileged Communication.

Structure

5.1 Introduction
5.2 History
5.3 Definition
5.4 Importance
5.5 Boundary Violations (BVS)
5.6 Some Concepts in Boundary Issues
5.7 Suggestions to Prevent Bvs
5.8 Duties of R.M.P (Registered Medical Practitioner
5.9 Rights Of A Patient
5.10 Issues
5.11 Professional Misconduct (Infamous Conduct
5.12 Action Taken By SMC for Professional Misconduct.
5.13 Professional Secrecy and Privileged Communication
5.14 Summary
5.15 Key words

5.1 INTRODUCTION
The doctor-patient relationship is central to the practice of healthcare and is essential for the
delivery of high-quality health care in the diagnosis and treatment of disease. The doctor–
patient relationship forms one of the foundations of contemporary medical ethics. A doctor
must maintain professional secrecy, uphold patient’s dignity and pay due respect to their
privacy.

5.2 HISTORY
Michael Belint pioneered the study of the physician patient relationship in the UK with his
wife Enid Balint resulting in the publication of the seminal book "The Doctor, His Patient
and the Illness." Balint's work is continued by The American Balint Society in the United
States, The International Balint Federation and other national Balint societies in other
countries.

5.3 DEFINITION

Whenever a patient comes in contact with doctor for treatment, there is a contract established
between the doctor and the patient. This is called doctor-Patient Relationship.

5.4 IMPORTANCE

A patient must have confidence in the competence of their physician and must feel that they
can confide in him or her. For most physicians, the establishment of good rapport with a
patient is important. Some medical specialties, such as psychiatry and family medicine,
emphasize the physician-patient relationship more than others, such as pathology and
radiology.

The quality of the patient-physician relationship is important to both parties. The better the
relationship in terms of mutual respect, knowledge, trust, shared values and perspectives
about disease and life, and time available, the better will be the amount and quality of
information about the patient's disease transferred in both directions, enhancing accuracy of
diagnosis and increasing the patient's knowledge about the disease. Where such a relationship
is poor the physician's ability to make a full assessment is compromised and the patient is
more likely to distrust the diagnosis and proposed treatment, causing decreased compliance to
actually follow the medical advice. In these circumstances and also in cases where there is
genuine divergence of medical opinions, a second opinion from another physician may be
sought or the patient may choose to go to another physician.

5.5 BOUNDARY VIOLATIONS (BVs)

Boundary violations (BVs) in doctor–patient relationships are an important concern in India,

as indeed in the rest of the world. While some countries have recognized this unfortunate
facet of
Medical practice, it has received scant attention in India. Both sexual and non-sexual BVs
occur in India. As BVs damage the doctor–patient relationship and invariably harm both the
patient and the doctor, it is the ethical responsibility of the healthcare providers that medical
students, doctors and other concerned staff should be made aware of the term ‘boundaries’
and how boundary issues may arise in different contexts when practicing medicine in order to
reinforce these concepts and enable them to understand the practical implications. All
practicing doctors should also be aware of boundary issues. This can prevent, or at least
reduce, the occurrence of BVs. In addition, improving awareness will ensure that if one
healthcare professional comes across a BV by another health professional, he or she will be
able to more easily recognize, acknowledge and address it. This can prevent the
compounding of harm that occurs when BVs are ignored. Improved awareness among
doctors will also reduce their vulnerability to false allegations, which can be personally and
professionally devastating. All this would require the MCI to have clearer guidelines on
boundary issues than the existing one line under ‘adultery or improper conduct’ .relationships
with patients, can be discussed when students are posted in or taught subjects such as general
medicine and psychiatry.

Future Action on Other Related Issues

Once the topic has been introduced into the curriculum and guidelines framed pathways for
redressal need to be established / clarified. Institutional heads must take the lead in
facilitating the establishment of clear pathways for the redressal of complaints of BVs.
These would include:
• complaint procedures
• investigative processes
• disciplinary consequences of BVs
• and provision of compassionate support to the patient and his family
It would also be necessary to find means of handling false allegations, as well as establish
mechanisms for the doctor(s) concerned to be able to defend themselves. Lawyers and patient
support groups would have to be involved. An important area in prevention is the provision
of non-sensationalized education to patients and their caregivers. The assistance of
responsible media might be useful in this context. We also hope that the MCI will consider
amending the Code of Medical Ethics and specifically mention the importance of being
cognizant of BVs in healthcare and preventing their occurrence.

5.6 SOME CONCEPTS IN BOUNDARY ISSUES IN THE DOCTOR–PATIENT

RELATIONSHIP

Boundaries
These define the limits of the doctor–patient relationship in certain conditions, as this is a
fiduciary relationship, wherein the patient entrusts his or her well-being to the doctor.

Problem conditions
These include the establishment of a dual relationship between the doctor and the patient,
involving areas such as active socialization, the exchange of gifts, business transactions, and
romantic or sexual involvement.

Boundary crossings
These are minor ‘departures’ in some of the above areas that are neither harmful, nor
exploitative. Indeed, in certain contexts they might even be appropriate. Following a
boundary crossing there is a return to the usual doctor–patient relationship. An example is the
doctor occasionally accepting a box of sweets on behalf of the entire treating team from a
patient who can afford it.
Boundary violations
In these transgressions, the doctor exploits the doctor–patient relationship for his personal or
sexual gain. Boundary violations are invariably harmful. The inherent power differential in
the doctor–patient relationship makes the patient vulnerable to abuse and ethically speaking,
any ‘consent’ from the patient would be invalid.

5.7 SUGGESTIONS TO PREVENT BVs

As of now, boundary issues are not adequately discussed in standard medical undergraduate
textbooks. Though this issue is being recognized and addressed, it might take a few more
years to make an appearance in these textbooks. The teaching material on boundaries that is
used here can be made freely available online. There is a need to ensure that what constitutes
an improper conduct?

Statement in the MCI’s Current Code of Ethics Which Deals with ‘Improper Conduct’

Adultery or Improper Conduct

Abuse of professional position by committing adultery or improper conduct with a patient or
by maintaining an improper association with a patient will render a Physician liable for
disciplinary action as provided under the Indian Medical Council Act, 1956 or the concerned
State Medical Council Act.

What Do Medical Students And Doctors Need To Know?

They need to understand concepts such as boundaries, boundary crossings versus BVs and
the importance of context. As it is impossible to prepare guidelines for every eventuality,
students (by the end of internship) and practicing medical doctors should be clear on what is
unacceptable or acceptable behavior, as well as be able to recognize and handle grey areas
through their own informed judgment. BVs are traditionally described as occurring in the
context of the ‘relationship’ between the doctor and the patient. However, as BVs are
sometimes recognized by actions and not intent, there is a need to address other issues,
including inappropriate physical examination.

When, How And By Whom Do Students Need To Be Taught?

The issues pertaining to boundaries should be taught to medical students in a graded manner,
i.e. in a way that is appropriate to the stage of training right through their course. The concept
is simple and should be incorporated into the existing subject-specific methodologies. This
will ensure that incorporation into the curriculum is simplified and not burdensome to the
undergraduate student. Subsequently, when they enter the clinical years, it can be discussed
in detail (2 hours of sessions, theory with case vignettes), as part of their medical ethics
curriculum. To ensure that students do not see this topic as being of ‘fringe relevance’,
certain types of student interactions with patients should also be discussed in the light of the
boundaries, even if only for a couple of minutes. This helps to establish an awareness of and
respect for boundaries. The importance of maintaining boundaries can be briefly emphasized
when students first deal with ‘live subjects’ during physiology practicals. Certain general
issues, such as accepting gifts, self-disclosure can be discussed.

5.8 DUTIES OF R.M.P (REGISTERED MEDICAL PRACTITIONER)

The duties of a R.M.P can be categorized in to the following:

• Compulsory Duties
• Fundamental Duties
• Miscellaneous duties

Compulsory Duties

• To report immediately cases of Birth, Death, Infectious diseases

• To report all cases of food poisoning and also other types of poisoning irrespective of
whether suicidal, homicidal or accidental.
• To report to police all types of medico legal cases.
• To carry out professional duties when called by the state/nation(in cases of
war/national emergencies)
• To attend all cases of emergencies and life threatening conditions.
Fundamental Duties

• Maintain good character.

• Maintain good ethical behavior and practice.
• Treat the patient with utmost skill, care and knowledge till his recovery.
• To prevent professional negligence by all means.
Miscellaneous Duties

• Not to involve in professional misconduct and unethical practices

• Keep the patient well informed about his condition/prognosis /details of treatment
given and other available modalities of treatment
• Attend to patient whenever required
• Maintain professional secrecy
• Practice evidence based medicine
• Should maintain proper medical records and preserve them as per legal procedures
• All medico-legal as well as medical records to be based on facts
• Should undertake any form of treatment, investigations/procedure after proper
informed consent
• Should not carryout illegal operations or prenatal sex determination
• Should practice path wise
 • Should not criticize professional colleagues
• Use standard, clean instruments, equipment’s
• Should be courteous to patients, peers, colleagues
• Constantly update his knowledge and skills
• Keep trained staff only
• Should not solicit commission
• Should refer timely whenever in doubt
• Must not perform adultery
• Should not undertake unnecessary advertisement
• Should not charge excessively
• Should not associate with drug manufacturing firms
Second Opinion

The R.M.P must solicit second opinion under the following conditions:

• When he is not sure of the diagnosis

• When the patient does not respond to treatment
• When the condition gets serious
• In mutilating operations(amputation)
• Homicidal injury
• All cases of Rape, burns, poisoning
• MTP beyond 12 weeks of pregnancy
• Declaring a patient brain dead
• Any operation which can interfere with potency/reproductive capacity
• Any operation which can interfere with intellectual ability
• Declaring a person insane
• All cases of medico legal post mortem
• Treatment in emergency without consent
• Any operation which is dangerous to life

5.9 RIGHTS OF A PATIENT

• Humane and ethical behavior and treatment by the doctor.

• Courteous behavior.
• Detailed information regarding the following:
- Diagnosis
- Prognosis
- Investigations undertaken and their results
- Details of treatment /procedures advocated by the doctor
 - Other available modalities of treatment
- Side effects
• To refuse treatment/investigation
• Right to ask for a second opinion
• To approach courts for negligent treatment
• To be explained in detail on how to prevent recurrences
• To ask for a female attendant if the patient is a female
• Maintenance of professional secrecy

Since the doctor–patient relationship is unequal and weighted in favor of the doctor,
boundaries have been demarcated by ethicists with the intention of discouraging doctors from
transgressing them while treating patients. The most obvious boundaries relate to the
examination and treatment of women by men doctors. Other boundaries are intended to
prevent material exploitation of vulnerable patients by rapacious doctors. In enlightened
countries, these boundaries are discussed modified over time, taught to medical students and
doctors under training, and reinforced by local and national agencies. An example of a means
of reinforcement is the periodic publications sent out to all registered medical practitioners in
the UK by the General Medical Council.
5.10 ISSUES

The following issues may complicate or negatively affect the doctor-patient relationship if
not taken properly into consideration.

Physician Superiority

The physician may be viewed as superior to the patient, because the physician has the
knowledge and credentials, and is most often the one that is on home ground. The physician-
patient relationship is also complicated by the patient's suffering and limited ability to relieve
it on his/her own, potentially resulting in a state of desperation and dependency on the
physician.

A physician should at least be aware of these disparities in order to establish rapport and
optimize communication with the patient. It may be further beneficial for the doctor-patient
relationship to have a form of shared care with patient empowerment to take a major degree
of responsibility for her or his care.

Benefiting or Pleasing
A dilemma may arise in situations where determining the most efficient treatment, or
encountering avoidance of treatment, creates a disagreement between the physician and the
patient, for any number of reasons. In such cases, the physician needs strategies for
presenting unfavorable treatment options or unwelcome information in such a way that
minimizes strain on the doctor-patient relationship while benefiting the patient's overall
physical health and best interests.

Truth and Informed Consent

How doctors should present information about a patient's condition to the patient has changed
over time. There has been a shift from paternalism or "doctor knows best" to the idea that
patients must have a choice in the provision of their care, and be given the right to
make informed consent to medical procedures.[1] There can be issues with how to handle
informed consent in a doctor-patient relationship. For instance, with patients who don't want
to know the truth about their condition?

Secondly, there are ethical concerns regarding the use of placebo and whether or not giving a
placebo leads to an undermining of trust between doctor and patient and whether deceiving a
patient for their own good is compatible with a respectful and consent-based doctor-patient
relationship

Formal or Casual
There may be differences in opinion between the doctors and patient in how formal or casual
the doctor-patient relationship should be.

For instance, according to a Scottish study,] patients want to be addressed by their first name
more often than is currently the case. In this study, most of the patients either liked (223) or
did not mind (175) being called by their first names. Only 77 disliked it, most of who were
aged over 65. On the other hand, most patients don't want to call the doctor by his or her first
name.

In Indian Scenario, the communication is more formal.

Some familiarity with the doctor generally makes it easier for patients to talk about intimate
issues such as sexual subjects, but for some patients, a very high degree of familiarity may
make the patient reluctant to reveal such intimate issues.

Transitional Care

Transitions of patients between health care practitioners may decrease the quality of care in
the time it takes to reestablish proper doctor-patient relationships. Generally, the doctor-
patient relationship is facilitated by continuity of care in regard to attending personnel.
Special strategies of integrated care may be required where multiple health care providers are
involved, including horizontal integration (linking similar levels of care, e.g. multi-
professional teams) and vertical integration (linking different levels of care, e.g. primary,
secondary and tertiary care).
Other People Present
 An example of where other people present in a doctor-patient encounter may influence their
communication is one or more parents present at a minor's visit to a doctor. These may
provide psychological support for the patient, but in some cases it may compromise
the doctor-patient confidentiality and inhibit the patient from disclosing uncomfortable or
intimate subjects.

When visiting a health provider about sexual issues, having both partners of a couple present
is often necessary, and is typically a good thing, but may also prevent the disclosure of
certain subjects, and, according to one report, increases the stress level.

5.11PROFESSIONAL MISCONDUCT(INFAMOUS CONDUCT)

If a doctor while discharging his/her professional duties does something which is
regarded by his/her professional colleagues of good repute and competency as
disgraceful, dishonorable and infamous for medical profession than the State Medical
Council after due investigation and enquiry can hold the professional guilty of
Professional Misconduct.

Examples

• Treating a patient while under the influence of alcohol

• A doctor who is a drug addict
• Criminal operations/abortions
• Unethical advertisement and marketing
• Association with drug manufacturers
• Receiving commission
• Appointing unqualified staff
• Appointing touts/agents for getting patients
• Selling drugs/equipment’s
• Neglecting patients

5.12 ACTION TAKEN BY SMC FOR PROFESSIONAL MISCONDUCT

• Issue Of Warning Notice

• Temporary Erasure of name from the state medical register(penal erasure)
• Permanent Erasure of name from the state medical register(professional death
sentence)

5.13 PROFESSIONAL SECRECY AND PRIVILEGED COMMUNICATION

Hospitals and health systems are responsible for protecting the privacy and confidentiality of their
patients and patient information. Hospitals also have a responsibility to work with law enforcement
to help keep their communities safe.
The federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandated
regulations that govern privacy standards for health care information. HIPAA’s privacy regulation,
effective April 2003, specifies the circumstances under which protected health information may
and may not be released. In general under HIPAA, either a patient or a patient’s representative
must authorize disclosure of protected health information or the disclosure must fit a specific
exception in order for protected health information to be disclosed to law enforcement. If a patient
(or the patient’s representative) authorizes the disclosure, the authorization must meet the
regulatory requirements for a valid authorization.

Both law and ethics recognize the confidential nature of communication between physician and
patient. Public policy recognizes the need for a patient to be free to communicate openly with
his/her physician in order to promote effective treatment. This protection is typically extended to
any treating medical provider. Under this requirement for confidentiality certain professionals,
including physicians, cannot reveal confidential information without patient consent. Certain
exceptions apply however, such as when a physician suspects child abuse and is mandated to
report. It will be discussed in detail later on.

Evidentiary privileges are not absolute and many exceptions apply. Statutory exceptions include
mandated child abuse reporting requirements. The Family Court Act states that no privilege applies
in child abuse and neglect proceedings. According to New York Social Services Law, physicians
may also inform child protection and law enforcement authorities that, in the opinion of the
physician, a child he or she is treating faces imminent danger if the child remains in the care and
custody of the parent or guardian. They are also required to disclose reports, X-rays, and
photographs with regard to a report.

Thus the concept of privileged communication and the right of an individual to preserve
confidentiality of communication is a fundamental human right which is recognized by law. The
rationale is that a patient should be able to consult a doctor in confidentiality without the fear of
having to disclose communication between them at a later date.

Requirement of Privileged Communication

Privilege can only be claimed if the communication in question is confidential. Once it cases to be
confidential, it is no longer privileged. Thus, confidentiality is an essential ingredient of privileged
communication. However, just because a document is confidential it does not have to be
necessarily privileged.

Important Definitions

Physician–patient privilege communication is a legal concept, related to medical confidentiality

that protects communications between a patient and his or her doctor from being used against the
patient or revealed to others without the consent of the patient.
Privileged communications exist because society values the privacy or purpose of certain
relationships. A communication is not confidential and therefore not privileged, if it is overheard
by a third party who is not an agent of the listener. Agents include secretaries and other employees
of the listener. For example, a communication between a psychotherapist and patient would be
privileged even if the psychotherapist's secretary happened to overhear it. In such a case, the
secretary could not be forced to testify about the communication. However, a communication
between a psychotherapist and a patient on a public elevator occupied by third parties would not be
privileged and could be used in court.

Privileged communications are not always absolute. For instance, a criminal defendant may be able
to access communications between an accuser and the accuser's doctor if the defendant's interest in
the disclosure, in the opinion of the court, outweighs the interest in confidentiality. The court will
consider such a request only if the defendant can establish a reasonable probability that important
information exists in the communication that will be relevant to the case.

Directory information: Directory information means the following information maintained

regarding individuals in a facility: the individual’s name, location in the facility, and a description
of the individual’s condition that does not communicate specific medical information. Where an
admitted patient is listed in the facility directory and is asked for by name, an one‐word condition
and general location may be released unless the patient has opted out of the directory. The
disclosure of directory information is made in response to a call or inquiry to the facility. The
following conditions and locations that may be provided when a patient is listed in the facility
directory and is asked for by name:
Undetermined: The patient is awaiting a physician and assessment.

Treated and Released: The patient has been treated by the hospital, and has been released.
In this instance, “treated” is the condition and “released” is the location. Generally, this
indicates the patient’s condition was satisfactory upon release.

Stabilized and Transferred: The patient was stabilized at the hospital, and has been
transferred to another facility for further care. In this instance, “stabilized” is the condition
and “transferred” is the location. Hospitals should not release where the patient was
transferred. This classification does not imply a patient condition, but simply that the
patient is at another facility.

Satisfactory: Vital signs (heartbeat, breathing, blood pressure, temperature) are stable and
within normal limits. The patient is conscious and comfortable. Indicators are good.

Serious: Vital signs may be unstable and not within normal limits. Patient is acutely ill.
Indicators are questionable.

Critical: Vital signs are unstable or not within normal limits. The patient may be
unconscious. There is some doubt the patient will recover. Death could be imminent.
 Deceased: The death of a patient may be reported to the authorities by the hospital, as
required by law. Typically, a report will be made after efforts have been made to notify the
next‐of‐kin. The death of a patient may also be reported to the media after the next‐of‐kin
has been notified, as long as the patient’s body is still in the hospital.

Released: If a patient has been released, and the hospital receives an inquiry about the
patient by name, the hospital may confirm that the patient is no longer in the hospital, but
cannot give the release date, admission date, length of stay, or any other information.

Patient: Under Washington State law and for purposes of this Guide, patient is defined as
“an individual who receives or has received health care.” The term includes a deceased
individual who has received health care.

Differences Between Confidentiality & Privileged Communication

Confidential and privileged communication are two different things.
1.
2. Privileged
o When one is discussing one’s medical history with one’s doctor, the patient and the doctor are
engaged in privileged communication. By law, doctor cannot disclose patient’s personal, private
medical information to a third party without the consent of the patient. This privileged
communication depends on the relationship the patient has with the person to whom he is
disclosing information. If he decides to share your medical information with a friend, legally that
disclosure is not considered privileged and could be relayed to a third party.

Confidential
o Confidential communication exists usually by agreement where privileged communication does not
inherently exist. When you go to work for a company and they ask you to sign a non-disclosure
agreement, you are agreeing to keep any information about internal company affairs confidential.

Characteristics of Privileged Communication

• It cannot be revealed to the parents if a patient is a major under normal circumstances.
However, if the patient is unconscious, insane, under the influence of drugs/drinks it can be
revealed to parents.
• If the patient is minor, it can be revealed to the parents/guardian.
• It cannot be revealed to spouse.
• It cannot be revealed to the insurance company unless the doctor is the appointed Medical
Officer of an insurance company.
• To the employer or the master if he is a major.
• Even after death, privileged communication cannot be revealed without the permission of
legal heir/NOK.
• In case of a under trial person, the privileged communication cannot be revealed even to the
jailor/police.
• However the privileged communication (health status) of a convict can be revealed to
police/jailor.

As Compulsory Duty: Every doctor has to give details of the following:

• All cases of birth
• All cases of death
• All cases of communicable diseases
• All medicolegal cases including rape

As Citizen of India: He is duty bound to report any case of crime.

As A Social Duty: If the health of a patient can cause danger to others, the doctor is duty bound
to communicate such too concerned authorities.
• Railway engine driver /pilot being color blind.
• Automobile driver suffering from epilepsy, drug/alcohol addiction/severe mental
disease.
• Waiters being typhoid carrier.
• Swimming pool user suffering from communicable diseases including sexually
transmitted diseases.
• Cases of food poisoning.

In The Interest Of Patient: If the patient is not taking due care of his illness, in his interest the
details of his disease can be communicated to his NOK.

In The Doctor’s Own Interest: The doctor can reveal information about patients under the
following conditions:

• The doctor sues the patient for recovery of his fees.

• In an alleged case of professional negligence/professional misconduct.

To Insurance Company: If he is a designated Medical Officer for the company, he should

report the result of medical examination to the company.

Government Employees: The medical Officer may be asked to report on health of employees
or those who are entering Government Service.

Medical Malpractice Actions: In a case of alleged negligence by a physician, written

summaries of the case by physicians provided to the insurance carrier or other parties can be the
subject of a subpoena duces tecum, if, in the opinion of the court, they are relevant to
the plaintiff's case. Claims that these statements are "work product" will generally fail.

Experts and Opinion Evidence: In tort actions for recovery of damages, it is necessary for
 the introduction of medical records to establish a basis for the claimed loss. An injured plaintiff
is entitled to recover the expenses necessary to cure or treat injuries. Courts frequently call
upon expert testimony to interpret and advise, after examining medical records concerning the
nature of injuries, future medical, disability and other issues before the court.

Worker's Compensation Actions: Medical records introduced as evidence are crucial in

determining both causation and impairment in worker's compensation cases. In cases where the
evidence is contested, medical evidence in the form of records, opinions, affidavits and
testimony concerning both fact and opinion is necessary. When oral testimony is taken from
physicians, the usual standard is to state an opinion "within a reasonable degree of medical
certainty".
Action For Divulging Privileged Communication
• Professional Misconduct
• Professional Negligence
• Breach of trust and confidence

5.14 Summary
Since the doctor–patient relationship is unequal and weighted in favor of the doctor, boundaries
have been demarcated by ethicists with the intention of discouraging doctors from transgressing
them while treating patients. The most obvious boundaries relate to the examination and treatment
of women by men doctors. Other boundaries are intended to prevent material exploitation of
vulnerable patients by rapacious doctors. In enlightened countries, these boundaries are discussed,
modified over time, taught to medical students and doctors under training, and reinforced by local
and national agencies. Once there is a general acceptance by ethicists and bodies of medical
professionals in India of the boundaries demarcating harmful or exploitative behavior on the part of
the physician, the consensus should come into force. While logically, the MCI is the agency to take
the process forward, past experience with its enthusiasm about correcting unethical medical
practices by doctors suggests that medical colleges and different associations of medical doctors
might make faster progress in the implementation of the Declaration.

5.15 Key words

Doctor Patient Relationship
Whenever a patient comes in contact with doctor for treatment, there is a contract established
between the doctor and the patient. This is called doctor-Patient Relationship.

Boundaries: These define the limits of the doctor–patient relationship in certain conditions, as this
is a fiduciary relationship, wherein the patient entrusts his or her well-being to the doctor.

Problem conditions: These include the establishment of a dual relationship between the doctor and
the patient, involving areas such as active socialization, the exchange of gifts, business
Transactions and romantic or sexual involvement.
Boundary crossings: These are minor ‘departures’ in some of the above areas that are neither
harmful, nor exploitative. Indeed, in certain contexts they might even be appropriate. Following a
boundary crossing there is a return to the usual doctor–patient relationship. An example is the
doctor occasionally accepting a box of sweets on behalf of the entire treating team from a
Patient who can afford it.

Boundary violations: In these transgressions, the doctor exploits the doctor–patient relationship
for his personal or sexual gain. Boundary violations are invariably harmful. The inherent power
differential in the doctor–patient relationship makes the patient vulnerable to abuse and ethically
speaking, any ‘consent’ from the patient would be invalid.

Professional Misconduct
If a doctor while discharging his/her professional duties does something which is regarded by
his/her professional colleagues of good repute and competency as disgraceful, dishonorable and
infamous for medical profession than the State Medical Council after due investigation and enquiry
can hold the professional guilty of Professional Misconduct.

Physician–patient privilege communication is a legal concept, related to medical confidentiality

that protects communications between a patient and his or her doctor from being used against the
patient or revealed to others without the consent of the patient.
UNIT 6 CONSENT

Learning Objectives

After going through this unit, you will be able to:

∑ understand the concept of consent;

∑ understand the context of consent and Indian law;
∑ appreciate the ethical issues which are emerging in modern medical practice;
∑ know what constitutes medical negligence;
∑ know the action to be taken for medical negligence;
∑ Know the precautions the doctor can take to avoid medical negligence.

Structure

6.1 Introduction
6.2 History
6.3 Nuremberg Code
6.4 Legal Basis of Consent
6.5 Consent and Indian Law
6.6 Types of Consent
6.7 Case Study
6.8 How informed Consent should be obtained?
6.9 Emergency Situation and Consent
6.10 Euthanasia
6.11 Summary
6.12 Key Words

6.1 INTRODUCTION

Consent of the patient has an immense practical importance to the clinicians. Doctors may do
nothing to or for a patient without valid consent. This principle is applicable not only to surgical
operations but also to all forms of medical treatment and to diagnostic procedures that involve
intentional interference with the person. The doctrine of informed consent is the cornerstone of
modern medical jurisprudence. Although the need for bare consent to treatment is old, informed
consent arose after World War II, driven by the Nuremberg Doctrine and the rise of technological
medicine. It has been one of the most misunderstood principles in medical law, sometimes driving a
wedge between patients and physicians. Now it is returning to its roots in the physician’s fiduciary
duty to the patient, as consent issues shift from concerns about unnecessary or inappropriate
treatments to denial of treatment driven by managed care organizations’ cost cutting.

6.2 HISTORY
The legal precedent for informed consent in the United States arises from a court case in 1914 in
New York State in which a patient with a tumor underwent an operation to which he had not
agreed. Then New York Justice Benjamin Cardoza wrote in his opinion “Every human being of adult
years and sound mind has a right to determine what shall be done with his own body and the
surgeon who performs operation without his (patient’s) consent commits assault for which he is
liable in damages.” This landmark opinion established the concept of consent as an integral part of
the most fundamental precept for respect of a person’s bodily integrity.

The actual phrase “informed consent “entered American jurisprudence in 1957 in a California
medical malpractice case. In Salgo V Stanford University, patient’s legs were paralyzed when his
physician performed aortography to locate an obstruction in his abdominal aorta. Apparently, the
treating physician had not counseled the patient at the risk inherent in the procedure. In its decision,
the court held that “a physician violates his duty to his patient and subjects himself to liability if he
holds any facts which are necessary to form the basis of an intelligent consent by the patient to the
proposed treatment.”

6.3 THE NUREMBERG CODE

The element of consent is one of the critical issues in the area of medical treatment today. It is well
known that the patient must give valid consent to medical treatment; and it is his prerogative to
refuse treatment even if the said treatment will save his or her life. No doubt this raises many ethical
debates and falls at the heart of medical law today. The earliest expression of this fundamental
principle, based on autonomy, is found in the Nuremberg Code of 1947. The Nuremberg Code was
adopted immediately after World War II in response to medical and experimental atrocities
committed by the German Nazi regime. The code makes it mandatory to obtain voluntary and
informed consent of human subjects. Similarly, the Declaration of Helsinki adopted by the World
Medical Association in 1964 emphasizes the importance of obtaining freely given informed consent
for medical research by adequately informing the subjects of the aims, methods, anticipated
benefits, potential hazards, and discomforts that the study may entail. Several international
conventions and declarations have similarly ratified the importance of obtaining consent from
patients before testing and treatment. The present paper examines the entire gamut of issues
pertaining to consent from the point of view of the legal environment as it exists in India today. The
circle of legal development in the area (i.e., consent) appears to be almost complete when the apex
court in India recently ruled that, it is not just the ‘consent’ or ‘informed consent’ (as it is known
worldwide) but it shall also be ‘prior informed consent’ generally barring some specific cases of
emergency. This places a medical professional in a tremendous dilemma. Hence, it is time to revisit
the area of ‘consent and medical treatment’ to understand the sensitive and underpinning elements.

6.4 THE LEGAL BASIS OF CONSENT

Consent is perhaps the only principle that runs through all aspects of health care provisions today. It
also represents the legal and ethical expression of the basic right to have one's autonomy and self-
determination. If a medical practitioner attempts to treat a person without valid consent, then he
will be liable under both tort and criminal law.
 Tort is a civil wrong for which the aggrieved party may seek compensation from the wrong doer.
The consequences would be payment of compensation (in civil) and imprisonment (in criminal). To
commence, the patient may sue:

∑ the medical practitioner in tort for trespass to person

∑ Alternatively, the health professional may be sued for negligence

∑ In certain extreme cases, there is a theoretical possibility of criminal prosecution for assault
or battery

∑ In tort law, usage of force against any human body, without proper justification, is
actionable irrespective of the quantum of force. If the medical practitioner attempts to treat
a patient without obtaining proper consent, he will be held guilty under tort law.

The traditional definition of battery is an act that directly and either intentionally or negligently
causes some physical contact with another person without that person's consent. If a person has
consented to contact expressed or by implication, then there is no battery. It is a rare case in which a
doctor would be held liable for criminal breach, unless there is gross disrespect to the patient's
bodily autonomy, for instance, if a patient's organs are taken without his consent.

Often medical practitioners ask for precise prescriptions for the situations when written consent is
needed. It is interesting to note that what law demands is mere consent and not written consent
and does not prescribe such requirement on a mandatory basis. In fact, the medical practice itself
determines the need for written consent. Ideally, where the patient is subjected to anesthesia
(either local or general) or where the patient is subjected to severe pain during administration of the
treatment, a written consent would be helpful. There is no mandate that a doctor should always
obtain written consent and failure of which would hold him liable. However, if there is written
consent, the medical practitioner would have greater ease in proving consent in case of litigation.

To standardize the practice, the Medical Council of India (MCI) has laid down guidelines that are
issued as regulations in which consent is required to be taken in writing before performing an
operation. The MCI guidelines are applicable to operations and do not cover other treatments.

For other treatments, the following may be noted as general guidelines:

∑ For routine types of treatment, implied consent would suffice
∑ For detailed types of treatment, ideally express oral consent may be needed

For complex types of treatment, written express consent is required.

6.5 CONSENT AND INDIAN LAW

Consent is fundamental and established principle in the Indian law. Every person has the right to
determine what shall be done to his body. Self-defense of body (IPC sections 96 to 102, 104, 106)
provides right to the protection of bodily integrity against invasion by other. All medical procedures,
including examinations, diagnostic procedures and medical research on patients potentially acts of
bodily trespass or assault (IPC 351), in the absence of consent or statutory sanction. Treatment and
diagnosis cannot be forced upon anyone who does not wish to receive them except in statutory
sanction.

In India at present legal cases concerning absence of consent are rare. Such cases will increase in the
coming years as medical techniques become more advanced, complicated, medical care becomes
more widespread and level of awareness and education of population increases.

What consent means?

Consent means free, voluntary agreement or compliance. Sec.13 of Indian contract act lays down
that two or more persons are said to be in consent with each other when they agree upon the same
thing in same manner.

In consent there are three separate but correlated elements. These three elements must be present
in the consent, only then it is legally valid. These are:

∑ Voluntariness: This suggests willingness of patient to undergo treatment.

∑ Capacity: Capacity means a degree of ability of the patient to understand the nature and
consequences of treatment offered.

∑ Knowledge: Knowledge means that sufficient amount of information about the nature and
consequence of treatment has been disclosed to patient.

Section 90 of IPC and Consent

Section 90 of IPC defines consent in negative terms. As per this section, any consent given under the
following five circumstances will not be true consent. Analysis of this section shows that consent is
not true consent if it is given:

∑ By a person under fear of injury

∑ By a person who is under misconception of the facts and person who obtain consent knows
or has reason to believe that or consent was given in consequence of such fear/
misconception
∑ By intoxicated person
∑ By a person who is of unsound mind or, unable to understand the nature and consequences
of that to which he gives consent.
∑ By a person who is below the age of 12 yrs.

Who Can Give Consent?

Adulthood is achieved at the age of 18 yrs. in India but person above the age of 12 yrs. can give
consent for medical treatment. In Western countries like UK a person below the age of 16 yrs.
cannot give consent for medical treatment without the prior permission of parent or guardian unless
the child is sufficiently mature of understanding. Thus in UK a girl below the age of 16 yrs. cannot
give consent to take contraceptive pills. The Indian penal code and other law reforms are silent on
this aspect. For a person under 12 years of age, or of unsound mind, his/ her guardians /person in
whose lawful custody he / she is, can give consent (89 IPC)4.

loco parentis: In an emergency involving children, when their parent or guardian are not available
consent is taken from the person in charge of the child for example school teacher can give consent
for treating child, who become sick during picnic away from the home town or the consent of the
principal of a residential school.

The age for consent for medical treatment is not officially laid down. There are obscure provisions
made in Indian penal code section (IPC87 and 88), which refers to the validity of consent, which may
occur from any act done in good faith and for individual benefit. Perhaps, these provisions are not
specifically directed at medical treatment. When both the IPC (Sections 87 & 88) are combined, one
can conclude that there is an implication that parental consent is necessary for medical treatment or
surgical procedures on the minor.

No one can give consent for any treatment on behalf of adult, but it is advisable to be on the safer
side that the doctor should take the consent of the next of kin of the patient. Local guardian can give
consent on behalf of a person only if the treatment is an emergency one.

Unconscious / Unknown patient when admitted in hospital, the medical superintendent / In charge
of hospital can give consent for treatment.

Pathological autopsy should not be carried out without the consent of next of kin of the deceased. In
case of consent for donation of organ after death the will of the deceased is enough. Not taking
consent is considered as deficiency in medical services under the section 2(1) of the Consumer
Protection Act. Consent of one’s spouse is not necessary for the treatment of other. Husband or wife
has no right to refuse consent to any operation, which is required to safeguard the health of the
partner.

Provisions for Consent under Law

Sections 87 to 91 of Indian penal code deals with consent. Section 88 of IPC lays down that an act is
not offence if it is not intended or not known to be likely to cause death, which causes any harm to a
person from whose benefit it is done in good faith with his consent to suffer it. Thus after a valid
consent if surgeon operates on patient and patient dies on the operation table, then the surgeon
cannot be held guilty of murder. Persons who are non-qualified in medical profession are not
allowed to take the plea of this section, as they are not said to do the act in good faith.

IPC 52 says that an act is only done in good faith if it is done with due care and attention.

Section 91 of IPC serves as a corollary to sections 87 to 89. It states that the exceptions contained in
sect 87 to 89 do not extend to acts, which are offences independently of any harm, which they may
cause to the person, giving consent.

Ex-Thus causing miscarriage (unless caused in good faith for the purpose of saving the life of the
women) is an offence independently of any harm which it may cause or be intended to cause to the
women and the consent of the women or of her guardian for causing such miscarriage does not
justify the act ( 91 IPC ) . Barring physical examination, any medical procedure requires written
consent.
Written consent should refer to one specific procedure and not blanket permission on admission to
hospital. It is on the safest side to take the consent of a spouse if the operation destroys or limits
sexual function.

While not legally necessary it is good medical practice to consult with relatives of patient in patient’s
best interest and ones this has been established then doctor can continue to give treatment in good
faith. Consultation, consent and clinical confidence will never put the doctor in any tort cases.

Prisoners and persons released on bail can be treated without their consent in the interest of justice
of society. A registered medical practitioner can examine an accused by using reasonable force if the
examination is requested by the investigating police officer not below the rank of police sub
inspector (CrPC 53).(Force should be applied by police.) Under subsection 2 of CrPC 53 which lays
down that, whenever the person to be examined is female the examination shall be made only by or
under the supervision of female registered medical practitioner.

Consent of the patient cannot be defense to medical practitioner in negligence. Whole law of
negligence assumes the principle of consent6. Not to be applicable when the act is not done with
reasonable care and competence. If found under the influence of alcohol, then consent of such
person will not be valid, so it is always better to obtain consent from guardian/parents.(Exception-
Section 53 CrPc and Bombay prohibition act.)

6.6 TYPES OF CONSENTS

Medical profession in India practices following types of consents.

Implied Consent: Implied consent is one, which is not written but legally effective. Ex-When patient
comes to doctor’s consulting room or hospital and waits for the doctor, implied consent is
presumed. Such implied consent only goes to history taking and ordinary medical examination like
inspection, palpation and auscultation; it does not cover the consent for examination of private parts
of the patient or matters such as vein punctures or injections or any major intervention. If any
material risk is involved the specific or expressed consent must be obtained. The above discussion,
thus, shows that in certain circumstances an implied consent may not be considered as sufficient.

Expressed or Specific Consent: This may be oral or written. An oral consent is legally valid, but it is
preferred to obtain written consent for major procedures because there is risk involved that the
patient, in the case of oral consent, may at later stage deny that any oral consent was given by him.
If, for whatever reason, only oral consent is possible, it is appropriate to make an entry in the
patient’s clinical record which may be of use in future if any action is brought on this count and this
entry in the clinical record may afford corroborative evidence to support the defense taken by the
medical practitioner concerned. A written consent would afford documentary evidence that the
consent was actually obtained.

Informed consent is an ongoing process that includes the exchange of information and development
of choices. Emphasis on informed consent has been laid in Dr. Janki S. Kumar v. Mrs.
Sarafunnisa where the sterilization was done without consent. It was observed that when one
speaks of consent, that should be informed consent. The person who should give consent must be
aware of the risks involved and on that awareness the patient should give consent. When, as
 indicated, the patient was in general anesthesia neither could she understand the risks involved nor
could she give consent. It may be understood that it is only in emergency that the consent may be
done away. Otherwise, the consent is necessary and that to in writing.

6.7 CASE STUDY

In a case Aplarain Jayanand Rathod v. Dr. Shailesh Shah the operation of appendicitis was performed
without written consent under the guise of removal of stitches and no explanation was given for the
second operation. The State commission found that the Doctor was deficient in service and was
liable for compensation.

In patients who are more prone for anxiety / full disclosure in presence of malignancy or
unavoidable total results the doctor should use therapeutic privilege in the interest of patient,
disclose the fact to the kin rather than to the patient.

Presently in India, doctrine of informed consent is not in routine practice. This type of consent may
take routes in the Indian medical practice soon, since advancement in technology and information is
taking place very fast and increase consumer awareness.

6.8 HOW INFORMED CONSENT SHOULD BE OBTAINED

The elements that a physician must discuss with his / her patient to fully obtain informed consent
are the following:

∑ The diagnosis and the nature of the condition or illness calling for medical intervention.
∑ The nature and purpose of the treatment or procedure recommended.
∑ The material risks and potential complications associated with the recommended Treatment/
procedure.
∑ All feasible alternative treatments or procedures, including the option of taking no action, with
description of material risks and potential complications associated with the alternatives.
∑ The relative probability of success for the treatment or procedure in understandable terms.
∑ The expected chances of success and failure, the risk and benefit of procedure, the hazards and
complications of the particular surgery, should be explained to the patient before obtaining his
written consent for the operation.

Presence of a Third Party

In the following situations, even after consent, a female attendant/nurse must be present, if the
doctor is a male:

∑ If examination of female private parts are involved

∑ Examination of a victim of rape
∑ Administration of a general anesthesia to a patient

Format

“I Vasanthakumari Hosp. No. —— in my full senses hereby give my complete consent for flap cover
and SSG or any other procedure deemed fit, which is a diagnostic
procedure/biopsy/transfusion/operation to be performed on me/my son /my daughter/my ward —
— age — — under any anesthesia deemed fit. The nature and the risks involved in the procedures
have been explained to me to my satisfaction.’

It should also be borne in mind that merely singing the consent form does not exclude doctor’s
responsibility if he is negligent in carrying on his duties.

Right to refuse consent- Jehovah’s Witness

A competent adult has a right to refuse treatment even if others, including the medical practitioners,
believe that the refusal is neither in his/her best interest nor reasonable.

Case Study: In a Canadian case, the lady patient/plaintiff who was seriously injured in a road accident
was taken to the hospital where the defendant treated her. As her condition worsened and she
lapsed into unconsciousness, the need to treat her as an emergency arose. It became necessary to
give her blood transfusion. A Jehovah’s Witness card was found among her belongings. The card
when translated read as under:

As one of the Jehovah’s Witness with firm religious convictions, I request that no blood products be
administered to me under any circumstances. I fully realize the implications of the position but have
absolutely decided to obey the Bible command —”

The defendant doctor was made aware of both the card and its contents but, as the patient’s
condition deteriorated, he decided to administer blood. The patient’s daughter on arrival at the
hospital confirmed her mother’s wish not to be given a blood transfusion and actually signed a
consent to treatment and release of liability for’. Despite this the defendant continued to administer
the blood. The Ontario Court of Appeal held that the defendant was liable in trespass. As Robin JA
said, the instructions imposed a valid restriction on emergency treatment that could be provided—
and precluded blood transfusion.”

6.9 EMERGENCY SITUATION AND CONSENT

Can Consent be done away?

The consent can be done away if there is emergency and there is no advance directive or refusal to
take treatment. The most sacred duty of the medical practitioner is to save the life of his patient. If
the patient needs emergent and immediate surgery and the waiting for the consent may prove fatal
for the patient, the surgeon may go ahead with the operation without waiting for the consent of the
patient because it is an attempt to save the life of the patient.

In such cases, the Supreme Court laid down some important guidelines such as:

(i) The doctor when approached by an injured person, shall render all such help which is
possible for him at that time, including referring him to the proper experts

(ii) The doctor treating such persons shall be protected by law, as they are not
contravening any procedural laws of the land (regarding jurisdictions etc.)

(iii) All legal bars (either real or perceived by the doctors) are deemed to have been
eliminated by the verdict. This is in consonance with the Hippocratic Oath, which a
 doctor takes when entering the profession. Hence, a doctor is duty-bound to treat a
patient in the case of an emergency, without waiting for any formalities. There are
several statutes (like medical institutions regulation acts in various states) imposing this
duty upon medical establishments to treat emergency patients, especially accident
victims.

Case Study:
In Dr. T.T. Thomas vs. Elisa, the patient was admitted into the hospital on March 11, 1974. Upon
admission, the patient was diagnosed as a case of perforated appendix with peritonitis requiring an
operation. But, unfortunately no operation was done until his death on March 13, 1974. The
contention of the doctor was that no surgery could be adhered to, albeit the suggestion, because the
patient did not consent for the surgery. Therefore, other measures were taken to ameliorate the
condition of the patient, which grew worse by the next day. Although the patient was then willing to
undergo the operation, his condition did not permit it. On the other hand, the version of the
respondent (i.e., the Plaintiff) was that the doctor demanded money for performing the surgery.
Furthermore, the doctor was attending to some chores in an outside private nursing home to
conduct operations on the other patients and that the appellant doctor came back only after the
death of the patient. The two versions before the court were: 1) the plaintiff (the deceased patient's
wife) said that the doctors concerned demanded a bribe, hence the operation was delayed until it
proved fatal and 2) the version of denial for consent. Finally, the court delivered a verdict in favor of
the plaintiffs stating that consent under such an emergent situation is not mandatory. It is
interesting to note the following observations:

When a surgeon or medical man advances a plea that the patient did not give his consent for the
surgery or the course of treatment advised by him, the burden is on him to prove that the non-
performance of the surgery or the non-administration of the treatment was on account of the
refusal of the patient to give consent thereto. This is especially so in a case where the patient is not
alive to give evidence. Consent is implicit in the case of a patient who submits to the doctor and the
absence of consent must be made out by the patient alleging it.

Case Study: One case came up before Gujarat State Commission1 where the complainant, a lady,
having the son and the daughter, both minors, contacted the doctor while she was carrying 13
weeks pregnancy. She was advised Medical Termination of Pregnancy (MTP) and consent in writing
was taken. After the operation the husband of the complainant was informed that the uterus was
removed. The complainant filed a case alleging that no consent for the removal of uterus was
obtained either from the patient or from her husband. It was found the eminent gynecologist had
participated in order to save life of the patient and they all were unanimous for removal of the
uterus, as there was continuous bleeding and the condition of the patient was deteriorating. Thus,
no negligence regarding removal of uterus was found on the part of doctors.

Consent of Maternity Patients

Consent to obstetric procedure should be discussed during the antenatal period. If the medical
practitioner finds that the wishes of the pregnant woman are unusual, these should be noted
carefully in the antenatal record. It is necessary because the practitioner who discussed the matter
with the lady may not be on duty when that lady is admitted in labor. If the pregnant woman insists
on restrictions that were unsafe in view of the doctor attending her, or the woman places such
restrictions which make the doctor reluctant to accept the responsibility, he (the doctor) should
frankly say so.

Case Study

The plaintiff, aged 29, had 4 children and longed for more. Her religious belief precluded sterilization
and contraception. She was admitted to the hospital for a minor operation on her womb. Without
her consent and knowledge the surgeons decided to sterilize her because they feared that if she
becomes pregnant again her womb would rupture. Although acting in the patient’s interest, there
was no immediate urgency to perform the operation without permission. The defendants admitted
the liability, and damages to the tune of 4000 pounds were awarded.

Case Study

In a Canadian case the doctor tied the patient’s fallopian tubes during a caesarian operation, as he
was concerned about the consequences of a second pregnancy. No consent for it had been
obtained. It was held that there was no immediate danger and therefore, the liability existed. But in
another Canadian case the patient’s diseased testicle was removed in the course of an operation of
hernia. It was observed that there was no liability, as it was an emergency.

6.10 EUTHANASIA

Euthanasia (from the Greek: meaning "good death": (death)) refers to the practice of intentionally
ending a life in order to relieve pain and suffering.
History

Like other terms borrowed from history, "euthanasia" has had different meanings depending on
usage. The first apparent usage of the term "euthanasia" belongs to the historian Suetonius who
described how the Emperor Augustus, "dying quickly and without suffering in the arms of his wife,
Livia, experienced the 'euthanasia' he had wished for. The word "euthanasia" was first used in a
medical context by Francis Bacon in the 17th century, to refer to an easy, painless, happy death,
during which it was a "physician's responsibility to alleviate the 'physical sufferings' of the body."
Bacon referred to an "outward euthanasia"—the term "outward" he used to distinguish from a
spiritual concept—the euthanasia "which regards the preparation of the soul."
In current usage, one approach to defining euthanasia has been to mirror Suetonius, regarding it as
the "painless inducement of a quick death" However, it is argued that this approach fails to properly
define euthanasia, as it leaves open a number of possible actions which would meet the
requirements of the definition, but would not be seen as euthanasia. In particular, these include
situations where a person kills another, painlessly, but for no reason beyond that of personal gain; or
accidental deaths which are quick and painless, but not intentional.

Definition
Thus another approach is to incorporate the notion of suffering into the definition. The definition
offered by the Oxford English Dictionary incorporates suffering as a necessary condition, with "the
painless killing of a patient suffering from an incurable and painful disease or in an irreversible
coma" and this approach can be seen as a part of other works, such as Marvin Kohl and Paul Kurtz's
"a mode or act of inducing or permitting death painlessly as a relief from suffering". However,
focusing on this approach to defining euthanasia may also lead to counterexamples: such definitions
may encompass killing a person suffering from an incurable disease for personal gain (such as to
claim an inheritance), and commentators such as Tom Beauchamp & Arnold Davidson have argued
that doing such would constitute "murder simpliciter" rather than euthanasia.
The third element incorporated into many definitions is that of intentionality – the death must be
intended, rather than being accidental, and the intent of the action must be a "merciful death".
Michael Wreen argued that "the principal thing that distinguishes euthanasia from intentional killing
simpliciter is the agent's motive: it must be a good motive insofar as the good of the person killed is
concerned",

"In summary, we have argued ... that the death of a human being, A, is an instance of euthanasia if
and only if
∑ A's death is intended by at least one other human being, B, where B is either the cause of
death or a causally relevant feature of the event resulting in death (whether by action or by
omission)

∑ there is either sufficient current evidence for B to believe that A is acutely suffering or
irreversibly comatose, or there is sufficient current evidence related to A's present condition
such that one or more known causal laws supports B's belief that A will be in a condition of
acute suffering or irreversible comatoseness

∑ (a)B's primary reason for intending A's death is cessation of A's (actual or predicted future)
suffering or irreversible comatoseness, where B does not intend A's death for a different
primary reason, though there may be other relevant reasons, and (b) there is sufficient
current evidence for either A or B that causal means to A's death will not produce any more
suffering than would be produced for A if B were not to intervene

∑ the causal means to the event of A's death are chosen by A or B to be as painless as possible,
unless either A or B has an overriding reason for a more painful causal means, where the
reason for choosing the latter causal means does not conflict with the evidence in 3b
∑ A is a nonfatal organism

Wreen, in part responding to Beauchamp & Davidson, offered a six part definition:
"Person A committed an act of euthanasia if and only if
(1) A killed B or let her die
(2) An intended to kill B
(3) The intention specified in (2) was at least partial cause of the action specified in (1)
(4) The causal journey from the intention specified in (2) to the action specified in (1) is more or less
in accordance with A's plan of action
(5) A's killing of B is a voluntary action
(6) The motive for the action specified in (1), the motive standing behind the intention specified in
(2), is the good of the person killed."
Wreen also considered a seventh requirement: "(7) the good specified in (6) is, or at least includes, the
avoidance of evil", although as Wreen noted in the paper, he was not convinced that the restriction was
required. In discussing his definition, Wreen noted the difficulty of justifying euthanasia when faced with
the notion of the subject's "right to life". In response, Wreen argued that euthanasia has to be voluntary,
and that "involuntary euthanasia is, as such, a great wrong". Other commentators incorporate consent
more directly into their definitions. For example, in a discussion of euthanasia presented in 2003 by the
European Association of Palliative Care (EPAC) Ethics Task Force, the authors offered: "Medicalized killing
of a person without the person's consent, whether no voluntary (where the person in unable to consent)
or involuntary (against the person's will) is not euthanasia: it is murder. Hence, euthanasia can be
voluntary only. Although the EPAC Ethics Task Force argued that both non-voluntary and involuntary
euthanasia could not be included in the definition of euthanasia, there is discussion in the literature about
excluding one but not the other.

Classification of Euthanasia

Euthanasia may be classified according to whether a person gives informed consent into three types:

∑ Voluntary
∑ Non-voluntary
∑ involuntary
There is a debate within the medical and bioethics literature about whether or not the non-
voluntary (and by extension, involuntary) killing of patients can be regarded as euthanasia,
irrespective of intent or the patient's circumstances. In the definitions offered by Beauchamp &
Davidson and, later, by Wreen, consent on the part of the patient was not considered to be one of
their criteria, although it may have been required to justify euthanasia. However, others see consent
as essential.

Voluntary Euthanasia
Euthanasia conducted with the consent of the patient is termed voluntary euthanasia. Active
voluntary euthanasia is legal in Belgium, Luxembourg and the Netherlands. Passive voluntary
euthanasia is legal throughout the U.S. per Cruzan v. Director, Missouri Department of Health. When
the patient brings about his or her own death with the assistance of a physician, the term assisted
suicide is often used instead. Assisted suicide is legal in Switzerland and the U.S. states of Oregon,
Washington and Montana.

Non-Voluntary Euthanasia
Euthanasia conducted where the consent of the patient is unavailable is termed non-voluntary
euthanasia. Examples include child euthanasia, which is illegal worldwide but decriminalized under
certain specific circumstances in the Netherlands under the Groningen Protocol.

Involuntary Euthanasia

Euthanasia conducted against the will of the patient is termed involuntary euthanasia.

Passive and Active Euthanasia

Voluntary, non-voluntary and involuntary euthanasia can all be further divided into passive or active
variants.

Passive euthanasia entails the withholding of common treatments, such as antibiotics, necessary for
the continuance of life.

Active euthanasia entails the use of lethal substances or forces, such as administering a lethal
injection, to kill and is the most controversial means. A number of authors consider these terms to
be misleading and unhelpful.

Euthanasia Debate

Historically, the euthanasia debate has tended to focus on a number of key concerns. According to
euthanasia opponent Ezekiel Emanuel, proponents of euthanasia have presented four main
arguments:

a) That people have a right to self-determination, and thus should be allowed to choose their own
fate

b) Assisting a subject to die might be a better choice than requiring that they continue to suffer

c) The distinction between passive euthanasia, which is often permitted, and active euthanasia,
which is not, is not substantive (or that the underlying principle–the doctrine of double effect–is
unreasonable or unsound)

d) Permitting euthanasia will not necessarily lead to unacceptable consequences. Pro-euthanasia

activists often point to countries like the Netherlands and Belgium, and states like Oregon, where it
has been made legal to argue that it is mostly unproblematic.

Similarly, Emanuel argues that there are four major arguments presented by opponents of
euthanasia:

∑ not all deaths are painful

∑ alternatives, such as cessation of active treatment, combined with the use of effective pain
relief, are available
∑ the distinction between active and passive euthanasia is morally significant
∑ legalizing euthanasia will place society on a slippery slope, which will lead to unacceptable
consequences

Legal Status
West's Encyclopedia of American Law states that "a 'mercy killing' or euthanasia is generally
considered to be a criminal homicide"] and is normally used as a synonym of homicide committed at
a request made by the patient.
The judicial sense of the term "homicide" includes any intervention undertaken with the express
intention of ending a life, even to relieve intractable suffering. Not all homicide is unlawful .Two
designations of homicide that carry no criminal punishment are justifiable and excusable
homicide. In most countries this is not the status of euthanasia. The term "euthanasia" is usually
confined to the active variety; the University of Washington website states that "euthanasia
generally means that the physician would act directly, for instance by giving a lethal injection, to end
the patient's life"
Physician-assisted suicide is thus not classified as euthanasia by the US State of Oregon, where it is
legal under the Oregon Death with Dignity Act, and despite its name, it is not legally classified as
suicide either.
Unlike physician-assisted suicide, withholding or withdrawing life-sustaining treatments with patient
consent (voluntary) is almost unanimously considered, at least in the United States, to be legal. The
use of pain medication in order to relieve suffering, even if it hastens death, has been held as legal in
several court decisions.
Some governments around the world have legalized voluntary euthanasia but generally it remains as
a criminal homicide. In the Netherlands and Belgium, where euthanasia has been legalized, it still
remains homicide although it is not prosecuted and not punishable if the perpetrator (the doctor)
meets certain legal exceptions.

Physician Sentiment

A survey in the United States of more than 10,000 physicians came to the result that approximately
16% of physicians would ever consider halting life-sustaining therapy because the family demands it,
even if believed that it was premature. Approximately 55% would not, and for the remaining 29%, it
would depend on circumstances.

This study also stated that approximately 46% of physicians agree that physician-assisted suicide
should be allowed in some cases; 41% do not, and the remaining 14% think it depends.

In the United Kingdom, the pro-assisted dying group Dignity in Dying cite conflicting research on
attitudes by doctors to assisted dying: with a 2009 Palliative Medicine-published survey showing 64%
support (to 34% oppose) for assisted dying in cases where a patient has an incurable and painful
disease, while 49% of doctors in a study published in BMC Medical Ethics oppose changing the law
on assisted dying to 39% in favor.

.
Model Format of Informed Consent

I------------------------------------son/daughter/wife of------------------------------------------aged--------------------
--------resident of-----------------------------------------being under the treatment of-------------------------------
-----------------------do hereby give consent to the performance of
medical/surgical/anesthesia/diagnostic procedure of -------------------------------------------(name of
procedure/operation/type of anesthesia)------------------------------being done on myself on----------------
-------------

I declare that I am ------------------------------------------------------years of age.

I have been informed that there are inherent risks involved in the treatment/procedure to be
performed on me. My questions about the procedures/operations and the risks involved have been
answered satisfactorily. I have signed this consent voluntarily, out of my free will, without any
pressure and in my full senses, as I accept the risk of likely harm, if any, in hope of obtaining the
desired benefits from the procedure. The doctor has explained to me the following information
which I have fully understood.

∑ Nature of my illness.
∑ Necessity and nature of operation /procedure and also the alternative treatments.
∑ Effects, unwanted side effects, likely complications during and after operations /procedure,
including serious harm leading to death and my prognosis.
∑ Nature and risks including likely death, involved in anesthesia.
∑ Risks, side effects related to various drugs, injections, blood and blood products etc. that will
be given to me during and after operation/procedure.
∑ No guarantee has been promised to me from this procedure.

Signature----------------------------

Signature of Doctor----------------

Name and Signature of Witness

1.

2. -----------------------------------------------------------------------------------------------------------------------------

6.11 SUMMARY

In medical practice, the role of informed consent cannot be undermined. It should not be taken for
granted. Free, voluntary, informed consent is most essential in medical practice Consent is necessary
for every medical examination, which should be obtained in or in the presence of disinterested
party. Barring physical examination, any medical procedure requires written consent. Written
consent should refer to one specific procedure and not blanket permission on admission to hospital.
It is on the safer side to take the consent of spouse if the operation destroys or limits sexual
functions. While it is not legally necessary it is good medical practice to consult with relatives of
patient in patient’s best interest and ones this has been established then doctor can continue to give
treatment in good faith. Consultation, consent and clinical confidence will never put the doctor in
tort cases. In the era of advancement of knowledge and technique the belief that as long as the
patient signs everything will be, well misguided, if the doctor is not having reasonable care and skill.
The consent of women concerned is useless in cases of criminal abortion since the act itself is crime.
During emergency, a doctor can treat a patient without the consent of the patient to preserve his
health, wellbeing or life of the patient (IPC 92).

1.12 KEY WORDS

Consent means free, voluntary agreement or compliance. Sec.13 of Indian contract act lays down
that two or more persons are said to be in consent with each other when they agree upon the same
thing in same manner. In consent there are three separate but correlated elements.

Euthanasia: Person A committed an act of euthanasia if and only if

(1) A killed B or let her die;

(2) An intended to kill B;

(3) The intention specified in (2) was at least partial cause of the action specified in (1);

(4) The causal journey from the intention specified in (2) to the action specified in (1) is more or less
in accordance with A's plan of action;

(5) A's killing of B is a voluntary action;

(6) The motive for the action specified in (1), the motive standing behind the intention specified in
(2), is the good of the person killed."
UNIT 7 TORT LAW IN INDIA
Learning Objectives

After going through this Unit you will be able to:

∑ understand the concept of Law Of Torts;

∑ understand the context of law of Torts and Medical Legislation;
∑ understand the concept of medical negligence;
∑ understand the different types of medical negligence and the legal implications;
∑ How to avoid medical negligence?
Structure

7.1 Introduction
7.2 Categories of Tort
7.3 Defamation
7.4 Economic Torts
7.5 Land Torts
7.6 Trespass to Land
7.7 Nuisance
7.8 Rule In Ryland’s V Fletcher
7.9 Constitutional Torts
7.10 Damages
7.11 Punitive Damages
7.12 Tortuous Litigation
7.13 Professional Negligence
7.14 Summary
7.15 Key Words

7.1 INTRODUCTION
Tort law in India is a relatively new common law development supplemented by codifying statutes including statutes
governing damages. While India generally follows the UK approach, there are certain differences which may indicate
judicial activism, hence creating controversy. However, attention is given to local socio-cultural practices and
conditions in applying foreign legal principles. The legislature have also created statutes to provide for certain social
conditions.

7.2 CATEGORIES OF TORTS

Assault

Indian Courts have that in order to constitute assault it is not necessary that there should be some actual hurt
caused. A threat constitutes assault. The ingredients are set out below:
 ∑ Making of any gesture or preparation by a person in the presence of another.
∑ Intention or knowledge of likelihood that such gesture or preparation will cause the person present to
apprehend that the person making it is about to use criminal force on him.
Battery
Battery is encapsulated in a statutory form under s350 of the Indian Penal Code

The criteria for battery is equivalent to that of criminal force defined in Section 350 of the Indian Penal Code.

False Imprisonment

False imprisonment "is the complete deprivation of his liberty for any time, however short, without lawful cause ...
There need not be any actual imprisonment in the ordinary sense.

The ingredients of this tort are listed below:

∑ Restraint must be complete

∑ There must be no reasonable condition imposed by occupiers of premises
∑ There must be no reasonable and honest belief which would justify the confinement

Negligence

Indian Jurisprudence has approved the approach stated in Ratanlal & Dhirajlal: The Law of Torts, laying down three
elements:

∑ A legal duty to exercise "ordinary care and skill"

∑ The breach of [the] duty caused by the omission to do something which a reasonable man, guided by those
considerations which ordinarily regulate the conduct of human affairs would do, or doing something which
a prudent and reasonable man would not do.
∑ Resulting in injury to the plaintiff's person or property.

Professional Negligence
The Indian approach requires that any skilled task requires a skilled professional. Such a professional would be
expected to be exercising his skill with reasonable competence.

Professionals may be held liable for negligence on one of two findings:

∑ He was not possessed of the requisite skill which he professed to have possessed.
∑ He did not exercise, with reasonable competence in the given case, the skill which he did possess.
The standard to be applied for judging negligence would be that of an ordinary competent person exercising
ordinary skill in that profession. It is not necessary for every professional to possess the highest level of expertise in
that branch which he practices. Professional opinion is generally accepted, but courts may rule otherwise if they feel
that the opinion is "not reasonable or responsible"

Contributory Negligence
Indian Courts recognize the concept of contributory negligence. Contributory negligence means the failure by a
person to use reasonable care for the safety of either of himself or his property, so that he becomes blameworthy in
part as an "author of his own wrong".

In the absence of reasonable care on the part of the claimant, courts are likely to reduce the liability of the injurer.
"The rule of negligence with the defense of contributory negligence holds an injured liable if and only if he was
negligent and the victim was not. In India, this rule requires proportional sharing of liability when both parties were
negligent. That is, the compensation that the victim receives gets reduced in proportion to his or her negligence."

7.3 DEFAMATION
The tort of defamation in India has largely followed the approach taken by the UK. Indian Courts have endorsed the
defenses of absolute and qualified privilege fair commend and justification In UK, if the defendant is only
successful in proving the truth of some of the several charges against him, the defense of justification might still be
available if the charges not proved do not materially injure the reputation. While there is no such provision in India,
the law is possibly the same.

However, in India, the weight of the authorities is for discarding between libel and slander and making both of them
actionable per se. In UK, only libel and certain types of slander is actionable per se. Criminal libel in UK was
abolished in 2010 while both slander and libel remain criminal offences in India making people liable not just to the
extent of damages but also undergoing imprisonment. An injunction may also be granted to stop further publication
of defamatory material.

7.4 ECONOMIC TORTS

Economic torts seek to protect a person in relation to his trade, business or livelihood. While Indian court has been
reluctant to award damages for the economic torts of simple and unlawful conspiracy as well as inducing breach of
contract due to the confused state of the law, the court has allowed damages for torts affecting economic interests
under the conspiracy to injure, and in doing so, referred to UK authorities on the matter. The courts have however
been more willing to adopt the law in UK in areas such as the tort of deceit, unlawful interference with
trade, intimidation and malicious falsehood.

7.5 LAND TORTS

Land Torts seek to prevent interference with land in the possession of another. Interference may take the form of
entering land or part of it, or of remaining there after the withdrawal of permission, or of dispossessing the
occupant.

7.6 TRESPASS TO LAND

Any direct interference with land in the possession of another is trespass and is actionable per se. Examples of
trespass are unauthorized entry to land, placing things on land and inducing animals to enter. Also, continuing
trespass, which is actionable from day to day, occurs when there is continuation of presence after permission is
withdrawn The position taken with regards to the elements of trespass is similar in the UK and India.

7.7 NUISANCE
Nuisance is a form of lesser interference with land. It may be private or public, and private nuisance has come to
cover the conduct of the defendants which affects the claimant's interest in the land. This could be done by:

∑ affecting materially his land

∑ affecting his use or enjoyment of it
 ∑ interfering with servitudes and similar rights over the land
While private nuisance is always actionable, public nuisance is not. A claimant of public nuisance has to establish
special loss over and above the inconvenience suffered by the public in general, as public nuisance is a crime and it
would be unreasonable for everyone inconvenienced by it to be allowed to claim. This distinction was followed in
India, along with the UK principles of nuisance.

7.8 RULE IN RYLAND’S V FLETCHER

Anyone who in the course of 'non-natural' use of his land 'accumulates' thereon for his own purposes anything likely
to do mischief if it escapes is answerable for all direct damage thereby caused It imposes strict liability on certain
areas of nuisance law .

While in the UK, this rule is strictly "a remedy for damage to land or interests in land" and "damages for personal
injuries are not recoverable under the rule", in India, the courts have developed this rule into a separate area of
absolute liability rule, where an enterprise is absolutely liable, without exceptions, to compensate everyone affected
by any accident resulting from the operation of hazardous activity. This differs greatly from the UK approach as it
includes all kinds of resulting liability other than damage to land.

7.9 CONSTITUTIONAL TORTS

Another area of tort that developed in India which differs from the UK is the availability of constitutional torts.
Creating constitutional torts is a public law remedy for violations of rights, generally by agents of the state, and is
implicitly premised on the strict liability principle The tort was further entrenched when the court allowed
compensation to be awarded as “a remedy available in public law; based on strict liability for the contravention of
fundamental rights to which the principle of sovereign immunity does not apply, even though it may be available as
a defense in private law in an action based on tort”. This approach is vastly different from the approach taken in UK
as compensation for damages is not an available public law remedy.

7.10 DAMAGES
Calculation of damages
Damages in the law of torts in India are premised on the concept of restituto in integrum. India adopts a
compensatory method and advocates "full and fair compensation" in all cases

In determining the quantum of damages, the Indian court will look to similar cases that may enable comparison.

India’s formulation of damages for tort cases is premised on the multiplier method, awarding compensation based
on the degree of compromise to the earning ability of the victim under the multiplier method, the fair and just
amount represents "the number of years' purchase on which the loss of dependency is capitalized. Then allowance
to scale down the multiplier would have to be made taking into account the uncertainties of the future. The
allowance for immediate lump sum payment the period over which the dependency is to last being shorter and the
capital feed also to be spent away over the period of dependency is to last. "

The multiplier principle is encapsulated in a statutory form for tortious cases involving personal injuries caused by
motor vehicles, under the Motor Vehicle Act However, in so calculating, the court will take into account inflation in
calculating damages.

For instances of pecuniary damages with regards to personal injury, the following heads will be
taken into account:
∑ Loss of earning
∑ Medical, hospital and nursing expenses
∑ The loss of matrimonial prospects
In instances of non-pecuniary loss, the following will be taken into consideration:

∑ Loss of expectation of life

∑ Loss of amenities or capacity for enjoying life
∑ Loss or impairment of physiological function
∑ Pain and suffering

Aggravated damages may be awarded to compensate victims for their wounded feelings in tortious cases in certain
cases. These damages are determined by examining if the defendant's conduct aggravated the plaintiff's damage by
injuring "feelings of dignity, safety and pride".

Approach towards 'pain and suffering'

Lord Scarman's ideology of compensation to victims were closely followed by the Indian courts.

In analyzing pain and suffering, several factors such as severity of injury, medical treatment required,
psychological stress and long-term physical and emotional scars, would be taken into account.
In cases of victims who were unconscious, one must award not only for the “loss of amenities and
loss of expectation of life, but also for pain and suffering such damages are awarded not as a matter
of “solace”. This view comes close to that expressed by Lord Scarman in Lim Poh Choo v Camden
and Islington Area Health Authority difference being that an award must be "made even for pain
and suffering in case of unconscious plaintiffs". The reason for so doing is that it "looks strange that
wrongdoer whose negligence makes the victim unconscious is placed in a more advantageous
position than one who inflicts a lesser injury which does not render the victim unconscious"

There are three guiding principles in measuring the quantum of compensation for pain and
suffering:

∑ Amount of compensation awarded must be reasonable and must be assessed with

moderation
∑ Regard must be had to awards made in comparable cases
∑ The sum awarded must to a considerable extent be conventional

7.11 PUNITIVE DAMAGES

Being influenced by Rookes v Barnard the India Court ruled that punitive damages can be awarded in
only three categories

∑ Cases where the plaintiff is injured by the oppressive, arbitrary or unconstitutional action by
a servant of the Government
∑ Cases in which the defendant’s conduct has been calculated by him to make a profit for
himself which may well exceed the compensation payable to the plaintiff
 ∑ Where provided by statute

However, this stand has since shifted with an expanding tort jurisdiction. The Supreme Court
accepted a Committee's suggestion to evolve a "principle of liability – punitive in nature – on
account of vandalism and rioting the reasoning given was that it "would deter people from similar
behavior in the future"

In an environmental tort case, the defendant was made to pay exemplary damages “so that it may
act as deterrent for others not to cause pollution in any manner”.

7.12 TORTUOUS LITIGATION

Despite being often cited as a litigious country the rate of litigation is low, due to problems such as
long delays, heavy expenses and meager damage awards There has apparently been an increase in
litigation over the past years, especially with cases involving the Government. This has been said to
be due to India’s socio-economic growth and the resultant sensitization regarding legal rights.

Difficulties in the Legal System

The delay in delivery of justice is a major problem plaguing India. This has been attributed to
reasons such a low judge to population ratio (1 judge per 100,000 capita, with a small number of
courts available), as well as poor administrative governance.
Outmoded procedural laws allow for delaying tactics, such as interlocutory appeals and stay
orders. The Government has also been accused of employing delay tactics whenever it is a litigant,
appealing even when the chance of success is remote. As a result, the system appears to resemble a
"sunk cost auction", where litigants invest ever-increasing amounts to stave off higher losses.

Absolute Liability
One of the controversies in Indian tort law concerns the rule on absolute liability. The extremely
strict approach, where even acts of God are not recognized as a defense is severely criticized
especially since it disregarded the “generally accepted parameter of minimum competence and
reasonable care”. The implementation of such a rule endangers the growth of science and technical
industries, as investors have to take the risk of liability given that there is no defense to the rule.

Judicial Activism
The judiciary has been criticized for being overly-activist and overstepping its jurisdiction. By creating
constitutional torts, they are accused of usurping both legislative and administrative
functions. Controversy further arose when judges began to read such obligations of the state into
Art 21 of the Indian Constitution to impose vicarious liability on the state in situations However,
such judicial activism in India has been used for “achieving social and distributive justice.

7.13 PROFESSIONAL NEGLIGENCE

There are risks inherent in most forms of medical treatment. All that one can ask is that the doctor
should keep these risks to the minimum.
Negligence usually refers to an injury or possible injury that was a result of a person neglecting to do
something. Instead of some sort of action, negligence often refers to inaction. A person can be found guilty
of negligence if he did not perform some sort of action that another average, reasonable person would. Thus,
Negligence is a failure to exercise the care that a reasonably prudent person would exercise in like
circumstances. In tort law, negligence applies to harm caused by carelessness, not intentional harm.
A good example of negligence is a driver who ran a red light. If he neglected to stop for a light and
caused an accident and injuries, he could be found guilty of negligence. To prove negligence,
however, a judge or jury must be convinced that a reasonable person most likely would have
performed some action that would have prevented the accident. If the driver ran the red light, but
did not cause an accident, he would most likely not be found guilty of negligent driving. He could,
however, be issued a traffic citation.

Definition

Professional negligence is defined as lack of reasonable care, skill or knowledge or willful negligence
on the part of the doctor during practice of medical profession so as to lead to some damage to the
patient.

According to Lord Alderson, Professional negligence is defined as an act of omission, i.e. not doing
what a reasonable man would do or an act of commission, i.e. doing what a reasonable man would
not.

According to Mc Nair, a doctor is not guilty of negligence if he acted in accordance with a practice
considered as proper by a reasonable body of medical men skilled in that particular art.

Such definitions involve the exposure of a patient to an unreasonable risk of harm, as judged by a
jury (or judge) after expert testimony has been given to establish the ever-changing standard of care.
Negligence can occur due to something we do or do not do if the act we fail to do was necessary to
prevent an injury. It cannot be proved just by the patient’s judgment unless it is very obvious but a
legal declaration has to be made by an expert of the same profession that the professional failed to
meet the basic standards while performing the act. The accused has the right to defend the
judgment in the court of law. In the US, common law and statutory law form an interlocking and
complementary set of rules and standards that define all of the forms of negligence, including
professional negligence. Negligence per se (statutory negligence) is behavior that "can be said
without hesitation or doubt that no careful person would have committed." Some states have
defined certain acts or omissions to be negligence as a matter of law (that is, per se). Committing an
act defined by such statutes effectively eliminates the plaintiff's need to prove negligence. Operating
on the wrong part of the body or leaving surgical equipment inside the body are classical examples
of negligence per se. However, a minority of states define violations of a statute to be evidence of
negligence—not negligence itself. Such evidence is still left to the jury or the judge to weigh and to
either accept or reject

Types of Professional Negligence

Professional Negligence can be of two types depending on the court by which the case is tried.

∑ Civil Professional Negligence

∑ Criminal Professional Negligence

Medical negligence differs from other litigation because the claimant must rely on expert medical
evidence to establish all the major elements of liability. Causation is particularly difficult to prove
because the effects of the allegedly negligent treatment must be distinguished from those of the
patient's underlying condition which gave rise to the need for treatment. Further, the assessment of
damages is often complicated because the court must compare the claimant's actual condition and
prognosis with the hypothetical condition and prognosis if the patient had received competent
medical treatment. The court must only compensate for the injuries caused by negligent treatment,
not for any underlying condition.
To determine whether a body of opinion is responsible, reasonable or respectable, the judge will
need to be satisfied that, in forming their views, the experts have directed their minds to the
question of comparative risks and benefits and have reached a defensible conclusion on the matter.

Civil Professional Negligence

This type of cases is tried in civil courts. Examples are as under:
∑ Failure to honor contractual obligations: As per Doctor Patient relationship the following
conditions makes the doctor liable for Civil Professional Negligence:
- The doctor refuses to treat the patient till he is all right
- Fails to exercise reasonable and accepted standards of care, skill and knowledge
- Failure to take second professional treatment when required
- Not maintaining professional secrecy
- Not ordering proper investigations
- Asking for unnecessary investigations
- Not asking for ECG in 35 years old patient complaining of chest pain/or not asking for CT
scan in a case of head injury with transient loss of consciousness
- Prolonged/unnecessary treatment
- Treatment causing further complications
- Issue of wrong certificate

Criminal Professional Negligence

It refers to those cases of gross negligence where the case is tried in criminal courts.
Prosecution for criminal negligence associated with health care is at the discretion of the public
prosecutor who often looks for:

∑ Patterns of behavior or a single behavior that

∑ Offends all public decency and is an

∑ Offense described by the criminal statutes of the state

Gross negligence is a matter of degree, defined as behavior that shows a "wanton or reckless
indifference to the safety of others."
 For example, it is certainly gross negligence and reckless behavior for a pharmacist to fill a
prescription or formulate a medication while intoxicated, but it is not necessarily negligent or
reckless to perform the same practices while sleep-deprived. If carelessness of an extreme degree
can be shown, punitive damages can be sought.

Punitive damages are difficult to obtain, because they are both defined (and limited) by statutory
law and are given for a type of behavior that is unusual among competent providers. Because the
purpose of punitive damages is to teach the responsible party a lesson they and others will not easily
forget, the court reserves such damages for the most culpable individuals.

There is no clear or bright line between ordinary negligence and gross negligence. It is usually
possible to characterize a sloppy practice as either ordinary or gross negligence. However, reckless
or wanton behavior (essential to a finding of gross negligence) has important characteristics. It is
behavior that involves a known or obvious risk of harm. It is done with a conscious indifference to
the welfare of another such that it is the close equivalent of a willingness that the harm will occur.
Such behavior does not require the proof of an actual motivation, but if a secondary motive (egg,
profit or personal fame) can be shown, recklessness is far easier to prove. Any motive other than the
general welfare of the patient can be enough to turn an inattentive error into a charge of
recklessness. Finally, and possibly most important, negligence that is both offensive and of a type
that a nonprofessional juror would consider reckless, without the help of expert testimony to
establish that it is reckless, will often be found to be gross negligence.

Examples of Criminal Professional Negligence

∑ Criminal Abortion
∑ Lack of care /skill during examination, investigation/treatment/operation and during post-
operative care resulting in grievous injury/death
∑ Operation without consent
∑ Death during anesthesia due to improper anesthesia, improper oxygenation
∑ Anesthesia by wrong route/ wrong dose
∑ Operation on wrong side
∑ Operation on wrong patient
∑ Death during operation
∑ Transfusion of wrong blood
∑ Transfusion of infected blood
∑ Tight plaster leading to gangrene
∑ Giving certain antibiotics without carrying out sensitivity test
∑ Overexposure to radiations
∑ Exposure of a pregnant women to harmful radiations
∑ Drug administration leading to deafness and blindness
∑ Leaving sponges and instruments inside the abdomen during operation

Case Study

In Thake v Maurice [1984] 2 All ER 513 a railway guard and his wife had five children living in a three-
bedroom council house and were unwilling to have further children. Thake consulted the surgeon
who made it clear that a vasectomy was final and that Thake after the operation would become
permanently sterile. Although the vasectomy was properly performed, the effect of this operation
was naturally reversed and, not unexpectedly, Mrs. Thake conceived and a daughter was born. It
was held that, applying the objective standard, the surgeon had contracted not merely to perform a
vasectomy but had contracted to make Mr. Thake irreversibly sterile. The judge relied on the
consent forms which stated that the vasectomy would be final. The claim was brought in contract
and in tort. Peter Pain J. found that there was no reason why public policy prevented the recovery of
expenses arising from the birth of a healthy child. He awarded damages in respect of the expenses of
the birth and the mother's loss of wages but refused damages for the pain and distress of labour
holding that these were offset by the joy occasioned by the birth. He did, however, award damages
in an agreed sum for the child's upkeep to its seventeenth birthday. The Court of Appeal held that
damages should be awarded for pain and suffering "per the majority" in tort rather than contract.
The joy of having the child could be set off against the time, trouble and care in the upbringing of the
child but not against prenatal pain and distress. For the latter, damages should be awarded. The case
is also interesting because there was an alternative interpretation of the consent form. After
sterilization, some couples want to change their minds because their children have died or because
they are seeing better days. Instead of the surgeon giving a guarantee of irreversible sterility which
depended on the way in which human tissue healed, the warning of finality could be aimed at telling
both husband and wife that they could not change their mind later and complain if the spouse had
become permanently sterile.

Difference between Negligence and Malpractice

Negligence is a failure to exercise the care that a reasonably prudent person would exercise in like
circumstances. In tort law, negligence applies to harm caused by carelessness, not intentional harm.

Malpractice is a type of negligence; it is often called "professional negligence". It occurs when a

licensed professional (like a doctor, lawyer or accountant) fails to provide services as per the
standards set by the governing body ("standard of care"), subsequently causing harm to the plaintiff.

What constitutes Negligence?

∑ Conduct lacking due care

∑ Conduct that falls below a standard established by law
∑ Deviation from the standard of care that a reasonable person would do (or not do) in a
particular set of circumstances
∑ Duty - There must be a legal duty, requiring the defendant to conform his or her conduct
to a specific standard
∑ Breach - The failure of the defendant to conform to the specific standard
∑ Injury - The physical, financial, or emotional injury must have resulted directly from the
breach of duty. Courts have denied liability when this connection has not been
established
∑ Individual does not intend to bring about the specific results
∑ Individuals have an obligation to anticipate results and guard against them
 ∑ Lack of professional standard of care - i.e., the specialized skills, knowledge, and abilities
of a profession

∑ Failure of professionals to act within the prevailing standards of their profession

∑ Plaintiff must establish that the defendant failed to follow the standards of his or her
profession

∑ The general public has a right to expect and receive a higher standard of care from a
professional person

Comparison chart: Differences between Malpractice and Negligence

Malpractice Negligence

Definition: A type of negligence, where a Failure to exercise the care that a reasonably
licensed professional fails to prudent person would exercise in like
provide services as per standards circumstances.
set by the governing body.

Intentional? Yes Can be intentional or unintentional.

Cases filed in: Civil Courts Civil Courts

Criteria for Duty, Breach, Causation and Duty, Breach, Causation and Damages
proving the case: Damages

Example: A doctor intentionally causing A driver causing harm to the passengers due to
harm to his patients due to not his carelessness.
performing his duties as per the
medical standards.

A professional can also be sued for malpractice and negligence at the same time, since
malpractice can consist of negligence. For example, medical negligence is a form of medical
malpractice, and it occurs when a health care provider does not provide needed care. A doctor who
failed to provide the necessary care can be found guilty of both medical malpractice and negligence.
Contributory Negligence

It is defined as combined, concurrent and /or simultaneous negligence of doctor and the patient so
as to lead to damage, injury or death of the patient.

Examples:

∑ Post-operatively patient had been advised not to take anything orally but patient did not
comply and the doctor also did not check, resulting in severe intestinal complications.
∑ Patient advised not to take anything by mouth one night prior to operation but patient
consumed food and the doctor did not verify resulting in preoperative complications.

Contributory negligence can be used as defense by the doctor, but in civil cases only.

Defenses against Professional Negligence

The following conditions can be used as defense against professional negligence.

∑ That the doctor exercised reasonable care, skill and knowledge and acted as per
accepted standards of medical treatment.
∑ That the doctor had no contractual liability.
∑ That the damage occurred due to involvement of another party.
∑ Contributory Negligence.
∑ That the damage/injury/consequence which has resulted is a known common
complication.
∑ Medical mal occurrence: - Idiosyncratic/Hypersensitivity reaction, which is not
common.
∑ That the patient insisted on a particular treatment, though the doctor had a
different view.

Action for Professional Negligence

Cases for professional negligence can be tried in:

∑ Civil Court
∑ Criminal Court
∑ Consumer Court

How to Prevent Occurrences of Professional Negligence

A - Always attend to cases

B – Behavior should be courteous and ethical

C - Informed Consent, proper Care and Communication

 D - Documentation to be proper and detailed

E - Employ qualified staff, Update expertise and efficiency

F - Follow the best practice

G - Get all required investigations done

H - Hear sympathetically to patient’s/relatives complaints/requests

I - Investigate cases of previous professional negligence

J -Judiciously use medicines/investigations/procedures

K - Know your subject. Update knowledge

L - Look alert for all possible complications/adverse reactions

M - Manage your patients, staff efficiently

N - Negligence of accepted protocols, SOPs to be avoided at every cost

O - Observe the accepted norms /protocols of therapy

P - Practice ethical medicine

Q - Queries regarding diagnosis and mode of treatment to be cross consulted

R - Rapport with patients to be Establish and be rational in treatment.

S - SOPs /protocols to be developed

T - Train subordinates. Keep trained staff

U - Use accepted methods of treatment

V - Verify documents/treatment protocols

W - Watch out for complications

X - X rays to be preserved as per guidelines

Y - Do not yield to pressure from pharma companies to adopt modalities of treatment

Z - Zealous, transparent and positive approach to be adopted

Vicarious Responsibility

Vicarious responsibility is also known as Respondent Superior or let the master answer. It refers to
the fact that the Master has got the ultimate responsibility even in spite of absence of blame on his
part. Thus the medical superintendent of the hospital is responsible for the mistakes committed by
the junior staff. The vicarious responsibility is there in cases tried in civil courts and not for criminal
negligence cases.

Res Ipsa Loquitur

This phrase has been used by law to refer to situations in which the untrained layman could presume
malpractice/negligence without the testimony of expert. That is the case speaks for itself.

Examples

∑ The patient has cataract in left eye but his right eye is operated.
∑ A sponge is left inside the abdomen of a patient after the operation.

Case Study on Medical Negligence

Case Study No. 1: A pregnant lady underwent caesarean section under spinal anesthesia. The baby
was safely delivered but 5 minutes after delivery the patient became unconscious. Subsequent CT
Scan revealed edema (swelling) of the brain. The patient stayed in coma for more than 2 months and
subsequently died.

Decision: A case of criminal negligence was filed in the name of the hospital and the operating team
and the court held the Doctors and the hospital responsible based on expert opinion which opined
that fall of blood pressure is a common complication after spinal anesthesia which had caused
unconsciousness. The fall of BP should have been detected immediately and managed. Moreover no
oxygen was administered to the patient.

Case Study No. 2: A 15 years old boy came to an orthopedic specialist with fracture of left forearm
bone. His forearm was put on plaster and he was sent back. The patient on the next day developed
severe pain and swelling of left hand. When the patient went to his clinic the doctor was not
physically present. However when contacted on telephone, he advised him to take painkillers for 5
days and to come for review after 5 days. The patient continued to have severe pain and the
swelling increased. Ultimately, after 4 days of putting the plaster he was taken to a second doctor
who immediately removed the plaster and found two of his fingers to be gangrenous. Ultimately his
left hand had to be amputated.

Decision: A case of criminal negligence was filed and the district court convicted the doctor with
criminal negligence based on expert panel’s opinion.

Case Study No. 3: A 12 years old boy while bursting crackers at the hostel received severe injury to
his right eye. As the parents were located at a distant place, the eye surgeon with the consent of the
warden removed the affected eye. Later on the parents filed a case of criminal negligence as the
operation was carried out without the consent of the parents and the eyesight could have been
saved if he was referred to a better hospital.

Decision: - The court did not hold the eye surgeon responsible based on expert panel’s opinion that
the doctor was right in removing the severely affected eye and delay in this operation would have
endangered the other healthy eye also. Moreover, the warden in the absence of parents is legally
within his rights to give consent.
7.14 SUMMARY

In the present context of Consumer protection Act and many other mandatory Acts associated with
the practice of medicine, members of the medical fraternity has to be well versed with Law of torts,
types of malpractice and professional negligence.

7.15 KEY WORDS

Professional Negligence: Professional negligence is defined as lack of reasonable care, skill or

knowledge or willful negligence on the part of the doctor during practice of medical profession so as
to lead to some damage to the patient.

Civil Professional Negligence: This type of negligence cases are tried in civil courts. Examples are as
under: Ex-Failure to honor contractual obligations. As per Doctor Patient relationship the following
conditions makes the doctor liable for Civil Professional Negligence:-
Criminal Professional Negligence

It refers to those cases of gross negligence where the case is tried in criminal courts. Gross
negligence is a matter of degree, defined as behavior that shows a "wanton or reckless indifference
to the safety of others."

Malpraxis

Malpractice is a type of negligence; it is often called "professional negligence". It occurs when a

licensed professional (like a doctor, lawyer or accountant) fails to provide services as per the
standards set by the governing body ("standard of care"), subsequently causing harm to the plaintiff.

Res Ipsa Loquitur

This phrase has been used by law to refer to situations in which the untrained layman could presume
malpractice/negligence without the testimony of expert that is the case speaks for itself.

Vicarious Responsibility

Vicarious responsibility is also known as Respondent Superior or let the master answer. It refers to
the fact the Master has got the ultimate responsibility even in spite of absence of blame on his part.
Thus the medical superintendent of the hospital is responsible for the mistakes committed by the
junior staff. The vicarious responsibility is there in cases tried in civil courts and not for criminal
negligence cases.
 UNIT 8 THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994
(TOHA)

Learning Objectives

After going through this Unit you will be able to:

∑ understand the need for TOHA;

∑ appreciate the ethical issues associated with organ donation;
∑ concept of appropriate authority;
∑ concept of authorization committee;
∑ Procedure for registration under this act.

Structure

8.1 Introduction
8.2 Need
8.3 Salient Features
8.4 Amendments-2011
8.5 Types of Donor
8.6 Punishment for violation
8.7 Registration Process
8.8 Inspection Process
8.9 Renewal Process
8.10 Documentation
8.11 The Transplantation of Human Organs Act, 1994
8.12 Summary
8.13 Key Words

8.1 INTRODUCTION
This Act Provides for the regulation of removal, storage and transplantation of human organs for
therapeutic purposes and for the prevention of commercial dealings in human organs and for matters
connected therewith or incidental thereto.

8.2 NEED

A study in India reveals that 500 kidney transplants in 180 centers, 400 livers in 25 centers and 10-
15 hearts in very few centers are done annually. Around 3,000 patients die every year due to lack of
timely organ transplant surgeries. 95% kidney and liver transplants are from living donors. At present
only 1% of all donations are from cadaver. Organ donation from dead bodies is a miniscule 0.5 per
one lakh.

In India, there is a need of approximately 1, 75,000 kidneys, 50,000 livers and 50,000 hearts for
transplantation every year. There is thus a gross imbalance between the demand and supply Added to
this, new patients are being added for transplant with no significant rise in available donors.
Therefore, the list of potential recipients is mounting day by day.

Factors Contributing to Malpractice in Organ Transplantation

∑ A vast impoverished population.
∑ Lack of appropriate laws regulating organ donation.
∑ Readily available trained doctors willing to do the needful for a consideration.
∑ Good infrastructure for organ donation.
∑ Enterprising middlemen who could arrange for any and everything.
∑ Kidney donation from economically weaker sections for money.
∑ The general dictum became "when you can buy one, why donate?"
∑ Removal of organs from ‘brain-stem-dead’ cadavers is difficult.
∑ Unethical Practices
This led to an outcry from the physicians nationally and internationally at the growing numbers of
exploitative transplants being done in India.

8.3 SALIENT FEATURES

The THOA was enacted to provide for the regulation of removal, storage, and transplantation of
human organs for therapeutic purposes and for the prevention of commercial dealings in human
organs’.

Government of India, 1994: For the words human organs, the words human organs or tissues or both
shall be substituted (Transplantation of Human Organs (Amendment) Act 2011).

To regulate hospitals involved in the transplantation of human organs and to prevent

commercialization, two authorities were formed under the Act:

∑ Appropriate Authority (AA)

∑ Authorization Committee
∑
Appropriate Authority (AA) m

Constitution: The Central and State Governments shall appoint, by notification, one or more officers
as Appropriate Authorities for purposes of this Act. (AC)

Role
 - To grant registration to a hospital for the removal, storage and transplantation of any human
organ.
- To suspend or cancel such registration.
- To enforce standards for hospitals engaged in the removal/ storage or transplantation of
human organs.
- To investigate any complaint or breach of any provision of the Act or the Rules made there
under.
- Appropriate Authorities have the powers to summon any person, seek production of a
document and issue a warrant for the search of any place suspected to be indulging in
unauthorized transactions in human organs.
- License issued to a hospital for a period of 5 years.
- The application for the renewal to be forwarded within a period of 3 months prior to the
expiry of the
- Original certificate of registration.

Authorization Committee
Constitution: The composition of the AC shall be such as may be prescribed by the Central
Government from time to time. The State Government and the Union territories shall constitute, one
or more AC’s consisting of members nominated by the State Governments and the Union territories
for the purposes of this section.

Role
The AC in each state or union territory is to approve the transplants between unrelated donors and
recipients.

AC establishes that the unrelated donors are not under any coercion or unduly influenced by
monetary considerations to donate their organs. In case of transplants if the donor or recipient is a
foreign national, NOC from their respective country’s embassy is required along with prior approval
of the Authorization Committee.

Authorization committee seeks NOC from respective domicile states, if donor, recipient and place of
transplantation are in different states.

8.4 AMENDMENT-2011

Important Features in the Amendment of TOHA-2011

- Includes donation of tissues

- Organ swapping legalized
- Enhances penalties
- Includes grandparents and grandchildren in the list of near relatives
- If a neurologist or neurosurgeon is not available, RMP may nominate an independent surgeon
or physician, and an anesthetist or intensivist
- Makes it mandatory for a doctor in an ICU to ascertain if a patient wants to donate organs
- No human organs or tissues or both shall be removed from the body of a mentally challenged
- No human organs or tissues or both shall be removed from the person before his death
 - Where the donor or recipient being near relative is a foreign national, prior approval of the
AC will be required
- The AC will not approve removal or transplantation, if the recipient is a foreign national and
donor is an Indian, unless they are near relatives
- National registry of donors and recipients.
- Cornea can be inoculated by a certified eye technician because eye surgeons may not be
always available.
- NGOs registered specially to work on human organ transplantation would be allowed.
- Mandatory for all registered hospitals for organ retrieval and transplantation to appoint a
transplant coordinator.

8.5 TYPES OF DONOR Can donate

Organs and
Tissues
(2011) DONOR
ss LIVE DONOR

DECEASED
DONOR

LIVE LIVE
UNRELATED RELATED

Swapping
Grandparents
The ‘near relative’ and
2011 means ‘spouse, son, Grandchildren in
daughter, father, The list of near
mother, brother or
Sister’
∑ Who-so-
. now enhanced to 10 years and 5lacs in
Transplantation of Human Organs Bill 2011.

∑ Offending registered medical practitioner is liable to be removed from the state medical
council roll for two years for the first offence and permanently for any subsequent offence.

∑ Commercial dealings, like indulging in monetary transaction for trading in human organs and
brokering human organ trade deals, and advertising to solicit clients, are punishable with
imprisonment ranging from two to seven years, and a fine of Rs. 10,000 to Rs.20, 000. It has
been enhanced under 2011 Amendment to 5-10 years and a fine between 20 lakh to 1 crore in
Transplantation of Human Organs Bill 2011.

8.7 REGISTRATION PROCESS

Application for registration to the Appropriate Authority has to be submitted by the hospital.
Application accompanied by Form 11 furnishing the following information:
- Hospital
- Surgical Team
- Medical Team
- Anesthesia Team
- ICU/HDU Facilities
- Imaging Services
- Lab Services, Blood Bank Facility, Dialysis Facility

Fee of Rs 1000/- to be submitted for registration along with form 11.

8.8 INSPECTION PROCESS

∑ Inspection from the nominee of AA Government of India to verify data supplied is correct.

∑ The overall assessment of the institute to perform the organ transplantation.

∑ Relevant departments inspected to confirm international standards will be followed.

∑ The certificate of registration is given in (form-12). This certificate was valid for a period of 5
years from the date of issue.

8.9 RENEWAL PROCESS

∑ Every 5 yrs., an application for renewal in (Form no-13) is submitted to AA.

∑ Any transplantation done in any institute without valid registration certificate is illegal and
liable for punishment.
∑ The center must apply three months in advance for renewal of registration along with a
Renewal fee of Rs 1000.
∑ AA may decide for re-inspection before renewing the registration.

8.10 DOCUMENTATION

The following documentation is essential:

∑ Proper recording of
- Consent
- Completion of all the forms as per the Act
- Documents of joint application
∑ Maintenance of Donor registry and waiting list
∑ Formulation of quarterly report
∑ Details of all the transplants done month wise, residential details of patients, their progress
along with costs is sent to AA

Live Related Donor

 ∑ Medical practitioner certifies that the donor is in a proper state of health and is fit to donate
the organ.
∑ Donor has to give his authorization in appropriate Form 1(A) or 1(B)
∑ Donor has to submit an application in Form 10 jointly with the recipient.
∑ Necessary medical tests to determine the factum of near relationship.

Spousal Donor
∑ The donor to give a statement that they are so related by signing a certificate in Form 1(B)
and has to submit an application in Form 10 jointly with the recipient.
∑ The proposed donation has to be approved by the authorization committee under provisions of
Rule 4-A (2) by evaluating the factum and duration of marriage.

Live Unrelated Donor

∑ The authorizing committee ensures that there is no commercial transaction between the
recipient and the donor.
∑ Seeks an explanation of the link between the donor and recipient.
∑ Documentary evidence of the link, e.g. proof that they have lived together, etc.
∑ That there is no middle man / tout involved.
∑ Financial status of the donor and the recipient is probed.
∑ Donor is not a drug addict or known person with criminal record.
∑ Next of the kin of the proposed unrelated donor is interviewed regarding awareness.

Deceased Donation
Before removal of the Human organ the authorized medical board has to ensure that life is extinct.
Where it is a case of brain-stem death has to be certified by a medical board comprising of:
∑ Hospital Administrator
∑ Medical Practitioner
∑ A neurologist or neurosurgeon (an independent surgeon or physician, and an anesthetist.)
∑ And the patient’s treating doctor.

Procedure - Transplant Department

The transplant unit on receiving clearance from the authorization committee verifies Particulars of the
donor and recipient to ensure they are the same as mentioned in documents of the Authorization
committee Photographs of the donor and recipient.

Procedure Followed For Donation from Live “Unrelated Donor” To Recipient

Step 1: Submission of Application

Proposed donor ……………….X
Proposed recipient ……………….Y

Both X and Y submit a joint application on Form 10 to the state/U.T. level Authorization Committee
of the Domicile state/ U.T.
It is submitted along with the completed form 1(c).
The doctor’s advice recommending transplantation and the medical fitness of the donor to donate the
organ.

Step 2 Documentation Required

 ∑ The application form must be accompanied with documents mentioned in the form.
∑ The lab reports showing the reason for rejection for transplantation of organ from the near
relative.
∑ An affidavit duly signed by the Notary is submitted by the husband/ mother/ father /brother/
sister of X, mentioning that they have no objection for the proposed donation.
∑ Medical certificate by the treating doctor for CKD, need for transplant.

Step 3 Approvals by the Authorization Committee of the State/ U.T.

∑ Application to state /U.T authorization committee

∑ Enquiry by the AC to see the compliance to the act and rules
∑ Approval by the AC
∑ Letter of approval sent to the HOD/ Hospital where transplant is to be done with a copy to
other members of AC.

Step 4: Approval / Rejection of Application

The AC states in writing its reasons for rejecting or approving the application.

Step 5: Decision of the AC

The AC is required to take final decision within 24 hrs. Of the meeting for grant of permission or
The decision of the AC should be displayed on the notice board of the hospital immediately and on
the website of the hospital or the institution within 24 hrs. Of making the decision.

Reasons for Rejection of Application

∑ Financial disparities
∑ The committee is unable to establish the relationship/emotional attachment between
the donor and the recipient.

Step 6: Transplant center

The application is referred to the transplant center where the transplantation is to be carried.
Once again all the documents, the identity of the donor and the recipient, the reasons for rejection of
“near relative” as donors are verified.

8.11 THE TRANSPLANTATION OF HUMAN ORGANS ACT, 1994

An Act to provide for the regulation of removal, storage and transplantation of human organs for
therapeutic purposes and for the prevention of commercial dealings in human organs and for matters
connected therewith or incidental thereto.

Whereas it is expedient to provide for the regulation of removal, storage and transplantation of human
organs for therapeutic purposes and for the prevention of commercial dealings in human organs;

And whereas Parliament has no power to make laws for the States with respect to any of the matters
aforesaid except as provided in Articles 249 and 250 of the Constitution;
And whereas in pursuance of clause (1) of Article 252 of the Constitution, resolutions have been
passed by all the Houses of the Legislatures of the States of Goa, Himachal Pradesh and Maharashtra
to the effect that the matters aforesaid should be regulated in those States by Parliament by law;

Be it enacted by Parliament in the Forty-fifth Year of the Republic of India as follows:

Short title, application and commencement:

This Act may be called the Transplantation of Human Organs Act, 1994.

It applies, in the first instance, to the whole of the States of Goa, Himachal Pradesh and Maharashtra
and to all the Union territories and it shall also apply to such other States which adopts this Act by
resolution passed in that behalf under clause (1) of Article 252 of the Constitution.

It shall come into force in the States of Goa, Himachal Pradesh and Maharashtra and in all the Union
territories on such as the Central Government may, by notification, appoint and in any other State
which adopts this Act under clause (1) of Article 252 of the Constitution, on the date of such
adoption; and any reference in this Act to the commencement of this Act shall, in relation to any State
or Union territory, means the date on which this Act comes into force in such State or Union territory.

Definitions

“Advertisement” includes any form of advertising whether to the public generally or to any section of
the public or individually to selected persons;

“Appropriate Authority” means the Appropriate Authority appointed under Section 13;

“Authorization Committee” means the committee constituted under clause (a) or clause (b) of sub-
section (4) of Section 9;

“brain-stem death” means the stage at which all functions of the brain-stem have permanently and
irreversibly ceased and is so certified under sub-section (6) of Section 3;

“Deceased person” means a person in whom permanent disappearance of all evidence of life occurs,
by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken
place;

“Donor” means any person, not less than eighteen years of age, who voluntarily authorizes the
removal of any of his human organs for therapeutic purposes under sub-section (1) or sub-section (2)
of Section 3;

“Hospital” includes a nursing home, clinic, medical center, medical or teaching institution for
therapeutic purposes and other like institution;

“Human organ” means any part of a human body consisting of a structured arrangement of tissues
which, if wholly removed, cannot be replicated by the body;

“Near relative” means spouse, son, daughter, father, mother, brother or sister;

“Notification” means a notification published in the Official Gazette;

 “Payment” means payment in money or money's worth but does not include any payment for
defraying or reimbursing:

(i) The cost of removing, transporting or preserving the human organ to be supplied; or

(ii) any expenses or loss of earnings incurred by a person so far as reasonably and directly
attributable to his supplying any human organ from his body;

“Prescribed” means prescribed by rules made under this Act;

“Recipient” means a person into whom any human organ is, or is proposed to be, transplanted;

“registered medical practitioner” means a medical practitioner who possesses any recognized medical
qualification as defined in clause (h) of Section 2 of the Indian Medical Council Act, 1956 (102 of
1956), and who is enrolled on a State Medical Register as defined in clause (k) of that section;

“Therapeutic purposes” means systematic treatment of any disease or the measures to improve health
according to any particular method or modality; and

“Transplantation” means the grafting of any human organ from any living person or deceased person
to some other living person for therapeutic purposes.

Authority for Removal of Human Organs

(1) Any donor may, in such manner and subject to such conditions as may be prescribed, authorize the
removal, before his death, of any human organ of his body for therapeutic purposes.

(2) If any donor had, in writing and in the presence of two or more witnesses (at least one of whom is
a near relative of such person), unequivocally authorized at any time before his death, the removal of
any human organ of his body, after his death, for therapeutic purposes, the person lawfully in
possession of the dead body of the donor shall, unless he has any reason to believe that the donor had
subsequently revoked the authority aforesaid, grant to a registered medical practitioner all reasonable
facilities for the removal, for therapeutic purposes, of that human organ from the dead body of the
donor.

(3) Where no such authority as is referred to in sub-section (2), was made by any person before his
death but no objection was also expressed by such person to any of his human organs being used after
his death for therapeutic purposes, the person lawfully in possession of the dead body of such person
may, unless he has reason to believe that any near relative of the deceased person has objection to any
of the deceased person's human organs being used for therapeutic purposes, authorize the removal of
any human organ of the deceased person for its use for therapeutic purposes.
(4) The authority given under sub-section (1) or sub-section (2) or, as the case may be, sub-section (3)
shall be sufficient warrant for the removal, for therapeutic purposes, of the human organ; but no such
removal shall be made by any person other than the registered medical practitioner.

(5) Where any human organ is to be removed from the body of a deceased person, the registered
medical practitioner shall satisfy himself, before such removal, by a personal examination of the body
from which any human organ is to be removed, that life is extinct in such body or, where it appears to
be a case of brain-stem death, that such death has been certified under sub-section.
(6) Where any human organ is to be removed from the body of a person in the event of his brain-stem
death, no such removal shall be undertaken unless such death; is certified, in such form and in such
manner and on satisfaction of such conditions and requirements as may be prescribed, by a Board of
medical experts consisting of the following, namely:

(i) The registered medical practitioner, in charge of the hospital in which brain-stem death has
occurred;
(ii) an independent registered medical practitioner, being a specialist, to be nominated by the
registered medical practitioner specified in clause (i), from the panel of names approved by the
Appropriate Authority;
(iii) a neurologist or a neurosurgeon to be nominated by the registered medical practitioner specified
in clause (i), from the panel of names approved by the Appropriate Authority; and
(iv) The registered medical practitioner treating the person whose brain-stem death has occurred.

(7) Notwithstanding anything contained in sub-section (3), where brain-stem death of any person, less
than eighteen years of age, occurs and is certified under sub-section (6), any of the parents of the
deceased person may give authority, in such form and in such manner as may be prescribed, for the
removal of any human organ from the body of the deceased person.

Removal of Human Organs Not To Be Authorized In Certain Cases

(1) No facilities shall be granted under sub-section (2) of Section 3 and no authority shall be given
under sub-section (3) of that section for the removal of any human organ from the body of a deceased
person, if the person required to grant such facilities, or empowered to give such authority, has reason
to believe that an inquest may be required to be held in relation to such body in pursuance of the
provisions of any law for the time being in force.

(2) No authority for the removal of any human organ from the body of a deceased person shall be
given by a person to whom such body has been entrusted solely for the purpose of interment,
cremation or other disposal.

Authority for Removal of Human Organs in Case of Unclaimed Bodies in Hospital or Prison
(1) In the case of a dead body lying in a hospital or prison and not claimed by any of the near relatives
of the deceased person within forty-eight hours from the time of the death of the concerned person,
the authority for the removal of any human organ from the dead body which so remains unclaimed
may be given, in the prescribed form, by the person incahrge, for the time being, of the management
or control of the hospital or prison, or by an employee of such hospital or prison authorized in this
behalf by the person in charge of the management or control thereof.

(2) No authority shall be given under sub-section (1) if the person empowered to give such authority
has reason to believe that any near relative of the deceased person is likely to claim the dead body
even though such near relative has not come forward to claim the body of the deceased person within
the time specified in sub-section (1).

Authority for removal of human organs from bodies sent for post-mortem examination for
medico-legal or pathological purposes
 Where the body of a person has been sent for post-mortem examination: (a) for medico-legal
purposes by reason of the death of such person having been caused by accident or any other unnatural
cause; or (b) for pathological purposes, the person competent under this Act to give authority for the
removal of any human organ from such dead body may, if he has reason to believe that such human
organ will not be required for the purpose for which such body has been sent for post-mortem
examination, authorize the removal, for therapeutic purposes, of that human organ of the deceased
person provided that he is satisfied that the deceased person had not expressed, before his death, any
objection to any of his human organs being used, for therapeutic purposes after his death or, where he
had granted an authority for the use of any of his human organs for therapeutic purposes after his
death, such authority had not been revoked by him before his death.

Preservation of Human Organs: After the removal of any human organ from the body of any
person, the registered medical practitioner shall take such steps for the preservation of the human
organ so removed as may be prescribed.
Savings
(1) Nothing in the foregoing provisions of this Act shall be construed as rendering unlawful any
dealing with the body or with any part of the body of a deceased person if such dealing would have
been lawful if this Act had not been passed.

(2) Neither the grant of any facility or authority for the removal of any human organ from the body of
a deceased person in accordance with the provisions of this Act nor the removal of any human organ
from the body of a deceased person in pursuance of such authority shall be deemed to be an offence
punishable under Section 297 of the Indian Penal Code (45 of 1860).

Restrictions on removal and transplantation of human organs

(1) Save as otherwise provided in sub-section (3), no human organ removed from the body of a donor
before his death shall be transplanted into a recipient unless the donor is a near relative of the
recipient.

(2) Where any donor authorities the removal of any of his human organs after his death under sub-
section (2) of Section 3 or any person competent or empowered to give authority for the removal of
any human organ from the body of any deceased person authorizes such removal, the human organ
may be removed and transplanted into the body of any recipient who may be in need of such human
organ.

(3) If any donor authorizes the removal of any of his human organs before his death under sub-section
(1) of Section 3 of transplantation into the body of such recipient, not being a near relative, as is
specified by the donor by reason of affection or attachment towards the recipient or for any other
special reasons, such human organ shall not be removed and transplanted without the prior approval
of the Authorization Committee.

(4) (A) The Central Government shall constitute, by notification, one or more Authorization
Committee consisting of such members as may be nominated by the Central Government on such
terms and conditions as may be specified in the notification for each of the Union territories for the
purposes of this section. (b) The State Government shall constitute, by notification, one or more
Authorization Committees consisting of such members as may be nominated by the State Government
on such terms and conditions as may be specified in the notification for the purposes of this section.

(5) On an application jointly made, in such form and in such manner as may be prescribed, by the
donor and the recipient, the Authorization Committee shall, after holding an inquiry and after
satisfying itself that the applicants have complied with all the requirements of this Act and the rules
made there under, grant to the applicants approval for the removal and transplantation of the human
organ.

(6) If, after the inquiry and after giving an opportunity to the applicants of being heard, the
Authorization Committee is satisfied that the applicants have not complied with the requirements of
this Act and the rules made there under, it shall, for reasons to be recorded in writing, reject the
application for approval.

Regulation of hospitals conducting the removal, storage or transplantation of human organs

On and from the commencement of this Act,

(a) No hospital, unless registered under this Act, shall conduct, or associate with, or help in, the
removal, storage or transplantation of any human organ;

(b) no medical practitioner or any other person shall conduct, or cause to be conducted, or aid in
conducting by himself or through any other person, an activity relating to the removal, storage or
transplantation of any human organ at a place other than a place registered under this Act; and

(c) No place including a hospital registered under sub-section (1) of Section 15 shall be used or
cause to be used by any person for the removal, storage or transplantation of any human organ except
for therapeutic purposes.

(2) Notwithstanding anything contained in sub-section (1), the eyes or the ears may be removed at any
place from the dead body of any donor, for therapeutic purpose, by a registered medical practitioner.

Explanation — for the purposes of this sub-section, “ears” includes ear drums and ear bones.

Prohibition of removal or transplantation of human organs for any purpose other than
therapeutic purposes — No donor and no person empowered to give authority for the removal of
any human organ shall authorize the removal of any human organ for any purpose other than
therapeutic purposes.

Explaining effects to donor and recipient — No registered medical practitioner shall undertake
the removal or transplantation of any human organ unless he has explained, in such manner as may be
prescribed, all possible effects, complications and hazards connected with the removal and
transplantation to the donor and the recipient respectively.

Appropriate Authority

1) The Central Government shall appoint, by notification, one or more officers as appropriate
Authorities for each of the Union territories for the purposes of this Act.

(2) The State Government shall appoint, by notification, one or more officers as Appropriate
Authorities for the purposes of this Act.

(3) The Appropriate Authority shall perform the following functions, namely:

(i) To grant registration under sub-section (1) of Section 15 or renew registration under sub-section
(3) of that section;

(ii) To suspend or cancel registration under sub-section (2) of Section 16;

(iii) To enforce such standards, as may be prescribed, for hospitals engaged in the removal, storage or
transplantation of any human organ;

(iv) To investigate any complaint of breach of any of the provision of this Act or any of the rules
made there under and take appropriate action;

(v) To inspect hospitals periodically for examination of the quality of transplantation and the follow-
up medical care to persons who have undergone transplantation and persons from whom organs are
removed; and

(vi) To undertake such other measures as may be prescribed.

Registration of Hospitals Engaged in Removal, Storage or Transportation of Human Organs

(1) No hospital shall commence any activity relating to the removal, storage or transplantation of any
human organs for therapeutic after the commencement of this Act unless such hospital is duly
registered under this Act:

Provided that every hospital engaged, either partly or exclusively, in any activity relating to the
removal, storage or transplantation of any human organ for therapeutic purposes immediately before
the commencement of this Act, shall apply for registration within sixty days from the date of such
commencement: Provided further that every hospital engaged in any activity relating to the removal,
storage or transplantation of any human organ shall cease to engage in any such activity on the expiry
of three months from the date of commencement of this Act unless such hospital has applied for
registration and is so registered or till such application is disposed of, whichever is earlier.

(2) Every application for registration under sub-section (1) shall be made to the Appropriate Authority
in such form and in such manner and shall be accompanied by such fees as may be prescribed.
(3) No hospital shall be registered under this Act unless the Appropriate Authority is satisfied that
such hospital is in a position to provide such specialized services and facilities, possess such skilled
manpower and equipment’s and maintain such standards as may be prescribed.

Certificate of Registration

(1) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the
applicant has complied with all the requirements of this Act and the rules made there under, grant to
the hospital a certificate of registration in such form, for such period and subject to such conditions as
may be prescribed.

(2) If, after the inquiry and after giving an opportunity to the applicant of being heard, the Appropriate
Authority is satisfied that the applicant has not complied with the requirements of this Act and the
rules made there under, it shall, for reasons to be recorded in writing, reject the application for
registration.

(3) Every certificate of registration shall be renewed in such manner and on payment of such fees as
may be prescribed.

Suspension or Cancellation of Registration

(1) The Appropriate Authority may, so moto or on complaint, issues a notice to any hospital to show
because why its registration under this Act should not be suspended or cancelled for the reasons
mentioned in the notice.

(2) If, after giving a reasonable opportunity of being heard to the hospital, the Appropriate Authority
is satisfied that there has been a breach of any of the provisions of this Act or the rules made there
under, it may, without prejudice to any criminal action that it may take against such hospital,
suspended its registration for such period as it may think fit or cancel its registration: Provided that
where the Appropriate Authority is of the opinion that it is necessary or expedient so to do in the
public interest, it may, for reasons to be recorded in writing, suspend the registration of any hospital
without issuing any notice.

Appeals — Any person aggrieved by an order of the Authorization Committee rejecting an

application for approval under sub-section (6) of Section 9, or any hospital aggrieved by an order of
the Appropriate Authority rejecting an application for registration under sub-section (2) of Section 15
or an order of suspension or cancellation of registration under sub-section (2) of Section 16, may,
within thirty days from the date of the receipt of the order, prefer an appeal, in such manner as may be
prescribed, against such order to:
(i) the Central Government where the appeal is against the order of the Authorization Committee
constituted under clause (a) of sub-section (4) of Section 9 or against the order of the Appropriate
Authority appointed under sub-section (1) of Section 13; or

(ii) The State Government, where the appeal is against the order of the Authorization Committee
constituted under clause (b) of sub-section (4) of Section 9 or against the order of the Appropriate
Authority appointed under sub-section (2) of Section 13.

Punishment for Removal of Human Organ without Authority

(1) Any person who renders his services to or any hospital and who, for purposes of transplantation,
conducts, associates with, or help in any manner in, the removal of any human organ without
authority, shall be punishable with imprisonment for a term which may extend to five years and with
fine which may extend to ten thousand rupees.

(2) Where any person convicted under sub-section (1) is a registered medical practitioner, his name
shall be reported by the Appropriate Authority to the respective State Medical Council for taking
necessary action including the removal of his name from the register of the Council for a period of
two years for the first offence and permanently for the subsequent offence.

Punishment For Commercial Dealings In Human Organs : Whoever — Offences And Penalties

(a) makes or receives any payment for the supply of, or for an offer to supply, any human organ;

(b) seeks to find a person willing to supply for payment any human organ;

(c) offers to supply any human organ for payment;

(d) initiates or negotiates any arrangement involving the making of any payment for the supply of, or
for an offer to supply, any human organ;

(e) takes part in the management or control of a body of persons, whether a society, firm or company,
whose activities consist of or include the initiation or negotiation of any arrangement referred to in
clause (d); or

(f) publishes or distributes or causes to be published or distributed any advertisement:

(a) inviting persons to supply for payment of any human organ;
(b) offering to supply any human organ for payment; or
(c) indicating that the advertiser is willing to initiate or negotiate any arrangement referred to in clause
(d) shall be punishable with imprisonment for a term which shall not be less than two years but which
may extend to seven years and shall be liable to fine which shall not be less than ten thousand rupees
but may extend to twenty thousand rupees;

Provided that the court may, for any adequate and special reason to be mentioned in the judgment,
impose a sentence of imprisonment for a term of less than two years and a fine less than ten thousand
rupees.

Punishment for contravention of any other provision of this Act — Whoever contravenes any
provision of this Act or any rule made, or any condition of the registration granted, there under for
which no punishment is separately provided in this Act, shall be punishable with imprisonment for a
term which may extend to three years or with fine which may extend to five thousand rupees.

Offences by Companies

(1) Where any offence punishable under this Act has been committed by a company, every person
who, at the time the offence was committed was in charge of, and was responsible to, the company for
the conduct of the business of the company, as well as the company, shall be deemed to be guilty of
the offence and shall be liable to be proceeded against and punished accordingly: Provided that
nothing contained in this sub-section shall render any such person liable to any punishment, if he
proves that the offence was committed without his knowledge or that he had exercised all due
diligence to prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where any offence punishable under this
Act has been committed by a company and it is proved that the offence has been committed with the
consent or connivance of, or in attributable to any neglect on the part of, any director, manager,
secretary or other officer of the company, such director, manager, secretary or other officer shall also
be deemed to be guilty of that offence and shall be liable to be proceeded against and punished
accordingly.

Explanation. — For the purposes of this section:

(a) “company” means anybody corporate and includes a firm or other association of individuals; and
(b) “Director”, in relation to a firm, means a partner in the firm.

Cognizance of Offence:

(1) No court shall take cognizance of an offence under this Act except on a complaint made by:

(a) the Appropriate Authority concerned, or any officer authorized in this behalf by the Central
Government or the State Government or, as the case may be, the Appropriate Authority; or

(b) A person who has given notice of not less than sixty days, in such manner as may be prescribed, to
the Appropriate Authority concerned, of the alleged offence and of his intention to make a complaint
to the court.

(2) No court other than that of a Metropolitan Magistrate or a Judicial Magistrate of the first class
shall try any offence punishable under this Act.

(3) Where a complaint has been made under clause (b) of sub-section (1), the court may, on demand
by such person, direct the Appropriate Authority to make available copies of the relevant records in its
possession to such person.
Miscellaneous
Protection of Action Taken In Good Faith:

(1) No suit, prosecution or other legal proceeding shall lie against any person for anything which is in
good faith done or intended to be done in pursuance of the provisions of this Act.

(2) No suit or other legal proceeding shall lie against the Central Government or the State
Government for any damage caused or likely to be caused for anything which is in good faith done or
intended to be done in pursuance of the provisions of this Act.

Power to Make Rules

(1) The Central Government may, by notification, make rules for carrying out the purposes of this
Act.

(2) In particular, and without prejudice to the generally of the foregoing power, such rules may
provide for all or any of the following matters, namely:
(a) the manner in which and the conditions subject to which any donor may authorize
removal, before his death, of any human organ of his body under sub-section (1) of Section 3;

(b) The form and the manner in which a brain-stem death is to be certified and the conditions
and requirements which are to be satisfied for that purpose under sub-section (6) of Section 3;

(c) the form and the manner in which any of the parents may give authority, in the case of
brain-stem death of a minor, for the removal of any human organ under sub-section (7) of
Section 3;

(d) the form in which authority for the removal of any human organ from an unclaimed dead
body may be given by the person in charge of the management or control of the hospital or
prison under sub-section (1) of section 5;

(e) The steps to be taken for the preservation of the human organ removed from the body of
any person under Section 7;

(f) The form and the manner in which an application may be jointly made by the donor and
the recipient under sub-section (5) of Section 9;

(g) the manner in which all possible effects, complications and hazards connected with the
removal and transplantation is to be explained by the registered medical practitioner to the
donor and the recipient under Section 12;

(h) the standards as are to be enforced by the Appropriate Authority for hospitals engaged in
the removal, storage or transplantation of any human organ under clause (iii) of sub-section
(3) of Section 13;

(i) The other measures as the Appropriate Authority shall undertake in performing its
functions under clause (VI) of sub-section (3) of Section 13;
 (j) The form and the manner in which an application for registration shall be made and the fee
which shall be accompanied, under sub-section (2) of Section 14;

(k) the specialized services and the facilities to be provided, skilled manpower and the
equipment’s to be possessed and the standards to be maintained by a hospital for registration,
under sub-section (3) of Section 14;

(l) The form in which, the period for which and the conditions subject to which certificate of
registration is to be granted to a hospital, under sub-section (1) of Section 15;

(m) The manner in which and the fee on payment of which certificate of registration is to be
renewed under sub-section (3) of Section 15;

(n) The manner in which an appeal may be preferred under Section 17;

(o) the manner in which a person is required to give notice to the Appropriate Authority of the
alleged offence and of his intention to make a complaint to the court, under clause (b) of sub-
section (1) of Section 22; and

(p) Any other matter which is required to be, or may be, prescribed.

(3) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House
of Parliament, while it is in session, for a total period of thirty days which may be comprised in one
session or in two or more successive sessions, and if, before the expiry of the session immediately
following the session or the successive sessions aforesaid, both Houses agree in making any
modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter
have effect only in such modified form or be of no effect, as the case may be; so, however, that any
such modification or annulment shall be without prejudice to the validity of anything previously done
under that rule.

Repeal and Saving

(1) The Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act, 1982 (28 of
1982) and the Eyes (Authority for Use for Therapeutic Purposes) Act, 1982 (29 of 1982) are hereby
repealed.

(2) The repeal shall, however, not affect the previous operation of the Acts so repealed or anything
duly done or suffered hereunder.

FORM - 1
(See rule 3)

I aged....................................... S/o, D/o, W/o, Mr. ..................................... resident of

.............................................................................. hereby authorize to remove for therapeutic purposes
/ consent to donate my organ, namely.................................................................
......…………………………
(1) Mr. / Mrs..............................................
S/o, D/o, W/o, Mr. .............................……….
aged ...................... resident of........................................................ .................. Happens to be my near
relative as defined in clause (2) of section 2 of the Act.

(Or)

(2) Mr. /Mrs......................................................

S/o, D/o, W/o, Mr. ................................…
aged ................................. resident of ..................................................................towards when I
possess special affection, attachments, or for any special reason (to be specified).

I certify that the above authority/consent has been given by me out my own free will without pressure,
inducement, influence or allurement and that the purposes of the above authority/donation and of all
possible complications, side-effects, consequences and options have been explained to me giving this
authority or consent or both.

Signature of the Donor

FORM - 2
[(See rule 4(1) (b)]

I, Dr.…………………………………………........, possessing the qualification of ........……………

registered as medical practitioner at serial No. ................. By the....................................... Medical as
Medical Council, certify that I have examined Shri / Smt / Kum. ............................. S/o, D/o, w/o
......................................................... aged................................ Who is free and is near relative of the
donor and that the said donor is in proper state of health and is ........................... medically fit to be
subjected to the procedure of organ removal.

Place: ..........................

Date:
Signature

FORM -3
[(See rule 4(1) (c)]

I, Dr...............................................possessing the qualification

of ..................... …………………………………… registered as med. practitioner at Serial No.
.............................. By the.......................... ..................... Medical council, certify that Mr. /Mrs.
…………………………….S/o, D/o, W/o ............................……………aged ...............the donor, an
Mr./Mrs. …………… ……… ……… S/o, D/o, W/o ………………………………… aged
........................., the recipient of the organ donated by the said donor are related to each other as
brother/sister/mother/father/son/daughter as per their statement and the fact of this relationship has
been established by the results of the tests for Antigenic Products of the Human Major Hysto-
compability System, namely .......................................... by the Authorization Committee as per the
information contained in their letter of approval No. ..................................................
Dated.......................

Place.......................... Signature

Date..........................

FORM -4
[(See rule 4(1) (d)]

I, Dr.......................................................................... possessing qualification of

..........................……………………………………… registered as medical practitioner at Serial No.
...................................... By the .............................................., Medical council, certify that:-

(i) Mr. …………………………………………………………………….. S/o

………………………………………………….. Aged ………………. resident of
…………………………………………………….. And Mrs. ……………………………… D/o, W/o
…….…………………………………………………………
………………….. ............................................. Resident............................................... are related to
each other as spouse a according to the statement given by them and their statement has been
confirmed by means of following evidence before effecting the organ removal from body of the said
Shri / Smt / Km......................................……….……………… …………………
……………………(Applicable only in the cases where considered necessary).

(Or)

(ii) The Clinical condition of Shri/Smt............................................. ................. Mentioned above is

such that recording of his/her statement is not
practicable Signature of Regd. medical practitioner

Place.........................

Date...........................

FORM -5
[(See rule 4(2) (a)]

I.................................................................. S/o, D/o, w/o ... aged...................................... Resident

of................. In the presence of persons mentioned below hereby unequivocally authorize the removal
of my organ/organs, namely, from my body after my death for therapeutic purposes.

Dated: Signature of the Donor

(Signature)

1. Shri/Smt./Km............................................................................

S/o, D/o, W/o.......................................................................... Aged.................... Resident of

.............................. .................. ......................…... ………… ……………………… ………
………………………………

(Signature)

2. Shri/Smt./Km................................................................of ....................aged
.............................……………….. Resident of ............................................… is a near relative to the
donor as................................................................

Dated............................

FORM -6
[(See rule 4(2) (b)]

I..................................................................s/o,d/o,w/o........................................aged.................
Resident of................................................................................having lawful possession of the dead
body Sri/Smt/km........................s/o,d/o,w/o....................................................................aged...........
of........................................................................................................having} known that the deceased
has not expressed any objection to his/her organ/organs being removed for therapeutic purposes after
his/her death and also having reasons to believe that no near relative of the said deceased person has
objection to any of his/her organs being used for therapeutic purposes authorize removal of his/her
body organs, namely..............................................

Dated...............................

Signature

Place …………………... Person in lawful possession of the dead body

Address..................................................................................
...............................................................................................

FORM -7
[(See rule 4(2) (b)]

I, Mr./ Mrs./Miss.....................................................................having lawful possession of the dead

body of Mr./ Mrs./Miss............................................................son of/ daughter of / wife of
..................... ............ aged .................................. resident of ........................................after having
known that the objection was expressed by the deceased to any of his human organs being used after
his death for therapeutic purposes and having reason to believe of deceased person has objection to
any of the deceased person's organs being used for therapeutic purposes, hereby authorize the removal
of the deceased’s organ, namely, ………………………………………………. for therapeutic
purposes.

Signature........................................................
Name..............................................................
Address..........................................................
.......................................................................
Time and Date ……………………………...

FORM - 8
[(See rule 4(3) (a) and (b)]

We the following members of the Board of medical experts after careful personal examination hereby
certify that Shri/Smt/Km.......................................................................aged about.......................son
of/wife of/ daughter of...........................................................resident of
...................................................................is dead on account of permanent and irreversible cessation
of all function of the brain stem. The test carried out by us and the findings therein are recorded in the
brain stem death Certificates annexed hereto.

Dated Signature

1. R.M.P Incahrge of the Hospital in which brain-stem death has occurred.

2. R.M.P. nominated from the panel of names approved by the Appropriate Authority
3. Neurologist / Neuro Surgeon nominated. From the panel of names approved by Appropriate
Authority.
4. R.M.P. treating the aforesaid deceased person

BRAIN STEM DEATH CERTIFICATES

(A) PATIENT DETAILS:

1. Name of the Patient Mr. /Ms. ....................................…….......................... S.O. /D.O. /W.O.

Mr...................................................................... Sex................................ Age.......................

2. Home Address ......................................................................

......................................................................

3. Hospital Number ...

4. Name and Address of next of kin or .....................................................................

person responsible for the patient (if none .....................................................................
exists, this must be specified) ……………………………………………
....................................................................
....................................................................

5. Has the patient or next of kin agreed ....................................................................to any transplant?

.....................................................................

6. In this a police Case? Yes.............................No............................

(A) PRE-CONDITIONS:

1. Diagnosis: Did the patient suffer from any illness or accident that led to irreversible brain damage?
Specify details ..............................................................................................
...........................................................................................................................................
Date and time of accident/onset of illness............................................................................
Date and onset of no-responsible coma …............................................................................

2. Finding of Board of Medical Experts: (i) the following reversible causes of coma have been
excluded:

Intoxication (Alcohol)
Depressant Drugs
Relaxants (Neuromuscular blocking agents)

First Medical Examination Second Medical Examination

1st 2nd

Primary hypothermia
Hypovolemic shock
Metabolic or endocrine disorders
Tests for absent of brain stem functions

2) Coma
3) Cessation of spontaneous breathing.
4) Pupillary Size
5) Pupillary light reflexes
6) Doll's head eyes movement
7) Corneal reflexes (Both Sizes)
8) Motor response in any cranial nerve distribution, any responses to simulation of face limb of trunk
9) Gag reflex,
10) Cough (Tracheal)
11) Eye movements on caloric testing bilaterally
12) Apnea tests as specified
13) Were any respiratory movements seen?

Date and Time of first testing........................................................................

Date and Time of second testing........................................................................

This to certify that the patient has been carefully examined twice after an interval of about six hours
and on the basis of findings recorded above, Mr/Mrs................................................................. is
declared brain-stem dead.

1. Medical Administrator Incahrge of the hospital

2. Authorized Specialist
3. Neurologist/ Neuro Surgeon

4. Medical officer treating patient.

NB. I. The minimum time interval between the first testing and second testing will be six hours.
II. No.2 and No.3 will be co-opted by the administrator incahrge of the hospital from the panel of
experts approved by the appropriate authority.
Read more: Thehttp://www.medindia.net/indian_health_act/the-transplantation-of-human-organs-
rules-1995-form-8.htm#ixzz2GzUPCDLH

FORM 9
(See rule 4(3) (b))

I, Mr./Mrs....................................son of / wife of.......................resident of...........................hereby

authorize removal of the organ/organs namely..................................for therapeutic purposes from the
dead body of my son/daughter.
Mr/Ms...............................................................aged.........................whose brain stem death has been
duly certified in accordance with the law

Signature..............................

Name....................................

Place.....................................

Date........................................

Read more: The Transplantation of Human Organs Rules, 1995 - Form

9http://www.medindia.net/indian_health_act/the-transplantation-of-human-organs-rules-1995-
form_9.htm#ixzz2GzUWzyMZ

APPLICATION FOR APPROVAL FOR TRANSPLANTATION LIVE DONOR OTHER

THAN NEAR RELATIVE

Whereas I ....................................................S/O, D/O, W/O, L/O.............................aged

residing...................................................................have been informed by my doctor that I am
suffering from.......................and may be benefitted by transplantation ......................... into my body.
And whereas I ......................................................…………………………….. S.O. D.O.
W.O......................................... aged .................. residing at..........................................by reason of
affection and attachment because: ...............................................................................................
..............................................................................................................................................
(Reason to be filled in) would like to
donate my....................................to............................we................................. (Donor)
and............................................hereby apply to authorization committee for permission (Recipient)
for such transplantation to be carried out.

We solemnly affirm that the above decision has been taken without any undue pressure,
inducement, influence or allurement and that all-possible consequences and options of organ
transplantation have been explained to
us........................................................................................................................................
............................................................................................................................................
Signature and address of prospective Signature and address of
prospective donor recipient

FORM 11
APPLICATION FOR REGISTRATION OF HOSPITAL TO CARRY OUT ORGAN
TRANSPLANTATION
To
The Appropriate Authority for organ transplantation.............................. (State of Union Territory)
We hereby apply to be recognized as an institution to carry out organs transplantation. The required
data about the facilities available in the hospital are as follows:-
(A) HOSPITAL
1. Name:
2. Location:
3. Govt./pt. :
4. Teaching/Non-Teaching:
5.Approached by:
Road: Yes No
Rail : Yes No
Air : Yes No
6. Total bed strength :
7.Name of the disciplines in the hospital :
8. Annual budget :
9. Patient turn-over/year :
(B) SURGICAL TEAM :
1. No. of beds:
2. No. of permanent staff members with their designations:
3. No. of temporary staff with their designations:
4. No. of operations done per year:
5. Trained persons available for transplantation (Please
specify organ for transplantation)
(C) MEDICAL TEAM:
1. No. of beds:
2. No. of permanent staff members with their designation:
3. No. of temporary staff members with their designation:
4. Patient turnover per year:
5. No. of potential transplant candidates admitted per year:
(D) ANAESTHESIOLOGY
1. No. of permanent staff members with their designation:
2. No. of temporary staff members with their designations:
3. Name and No. of operations performed:
4. Name and No. of equipment’s available:
5. Total No. of operation theatres in the Hospital:
6. No. of emergency operation theatres:
7. No. of separate transplant operation theatres:
(E) I.C.U. / H.D.U. FACILITIES:
1. ICU/HDU facilities: Present.....................Not Present..............
2. No. of I.C.U beds.................................................................
3. Trained
Nurses.................................................
Technicians..........................................
4. Name and number of equipment’s in ICU
(F) OTHER SUPPORTIVE FACILITIES
Data about facilities available in hospital.
(G) LABORATORY FACILITIES :
No. of permanent staff with their designations
No. of temporary staff with their designations
Names of the investigations carried out in the Dept.
Name and number of equipment’s available
(H) IMAGING SERVICES
1. No. of permanent staff with their designations
2. No. of temporary staff with their designations
3. Names of the investigations carried out in the Dept.
4. Name and number of equipment’s available
(I) HAEMATOLOGY SERVICES
1. No. of permanent staff with their designations
2. No. of temporary staff with their designations
3. Names of the investigations carried out in the Dept.
4. Name and number of equipment’s available
(J) BLOOD BANK FACILITIES: Yes........................... No....................
(K) DIALYSIS FACILITIES Yes........................... No.................…
(L) OTHER PERSONNEL
Nephrologist Yes/No
Neurologist Yes/No
Neuro-Surgeon Yes/No
Urologist Yes/No
G.I. Surgeon Yes/No
Pediatrician Yes/No
Physiotherapist Yes/No
Social Worker Yes/No
Immunologists Yes/No
Cardiologist Yes/No
The above said information is true to the best of my knowledge and I have no objection to any
scrutiny of our facility by authorized personnel. A Bank Draft/Cheese of Rs. 1,000/- is being
enclosed.
ds/-
HEAD OF THE INSTITUTION

FORM-12

CERTIFICATE OF REGISTRATION

This is to certify that.....................................Hospital located at..............................…...has been

inspected by the Appropriate Authority and certificate of registration is granted for performing the
organ transplantation of the following organs

1. ...................................................
2. ....................................................
3. ...................................................
4. ....................................................

This certificate of registration is valid for a period of five years from the date of issue.

Signature Signature

FORM-13

(See sub-rule 8(2))

OFFICE OF THE APPROPRIATE AUTHORITY

This is with reference to the application, dated..................................from.................... (Name of the

hospital) for renewal of certificate of registration for performing organ transplantation under the
Act.

After having considered the facilities and standards of the above said hospital the Appropriate
Authority hereby renews the certificate of registration of the said hospital for the purpose of
performing organ transplantation for a period of five years.

Appropriate Authority..................

Place.............................................

Date..............................................

8.12 SUMMARY
The TOHA, 1994 and its subsequent amendments have definitely decreased the human organ
trafficking and unethical practices associated with organ donation and transplantation. However,
this law needs to be implemented more strictly with continuous vigilance and monitoring.

8.13 KEY WORDS

Donor” means any person, not less than eighteen years of age, who voluntarily authorizes the
removal of any of his human organs for therapeutic purposes
“Hospital” includes a nursing home, clinic, medical center, medical or teaching institution for
therapeutic purposes and other like institution;

Human organ” means any part of a human body consisting of a structured arrangement of
tissues which, if wholly removed, cannot be replicated by the body

(1) Any person who renders his services to or any hospital and who, for purposes
of transplantation, conducts, associates with, or help in any manner in, the removal of any
human organ without authority, shall be punishable with imprisonment for a term which may
extend to five years and with fine which may extend to ten thousand rupees.

(2) Where any person convicted under sub-section (1) is a registered medical practitioner, his
name shall be reported by the Appropriate Authority to the respective State Medical Council for
taking necessary action including the removal of his name from the register of the Council for a
period of two years for the first offence and permanently for the subsequent offence.

(1) Any person who renders his services to or any hospital and who, for purposes
of transplantation, conducts, associates with, or help in any manner in, the removal of any
human organ without authority, shall be punishable with imprisonment for a term which may
extend to five years and with fine which may extend to ten thousand rupees.

(2) Where any person convicted under sub-section (1) is a registered medical practitioner, his
name shall be reported by the Appropriate Authority to the respective State Medical Council for
taking necessary action including the removal of his name from the register of the Council for a
period of two years for the first offence and permanently for the subsequent offence.
 UNIT 9 MEDICAL TERMINATION OF PREGNANCY ACT (MTP) 1971
Learning Objectives

After going through this Unit you will be able to:

∑ understand the need for Medical Termination of Pregnancy Act;

∑ appreciate the ethical issues associated with MTP;
∑ requirements for carrying out MTP;
∑ the latest amendments available on MTP;
∑ understand what constitutes criminal abortion;
∑ legal implications of criminal abortion;
∑ Safeguard against criminal abortion practices.

Structure

9.1 Short Title Extent and Commencement

9.2 Definitions
9.3 When Pregnancies Can Be Terminated
9.4 Place Where Pregnancy Cab Be Terminated
9.5 Power to Make Rules
9.6 Power to Make Regulations
9.7 Protection of Action Taken In Good Faith
9.8 Amendment 2002
9.9 Indications for MTP
9.10 Requirement for Routine MTP
9.11 Doctor and Criminal Abortion
9.12 Summary
9.13 Key Words

An Act to provide for the termination of certain pregnancies by registered Medical Practitioners
and for matters connected therewith or incidental thereto. Be it enacted by Parliament in the
Twenty-second Year of the Republic of India.

9.1 SHORT TITLE, EXTENT AND COMMENCEMENT

∑ This Act may be called the Medical Termination of Pregnancy Act, 1971.
∑ It extends to the whole of India except the State of Jammu and Kashmir.
∑ It shall come into force on such date as the Central Government may, by notification
in the Official Gazette, appoint.

9.2 DEFINITIONS
In this Act, unless the context otherwise requires:

(a) “Guardian” means a person having the care of the person of a minor or a lunatic;

(b) “Lunatic” has the meaning assigned to it in section 3 of the Indian Lunatic Act, 1912 (4 of 1912);

(c) “Minor” means a person who, under the provisions of the Indian Majority Act, 1875 (9 of 1875), is
to be deemed not to have attained his majority;

(d) “registered medical practitioner” means a medical practitioner who possesses any recognized
medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 956, (102
of 1956), whose name has been entered in a State Medical Register and who has such experience or
training in gynecology and obstetrics as may be prescribed by rules made under this Act.

9.3 WHEN PREGNANCIES MAY BE TERMINATED?

(1)Notwithstanding anything contained in the Indian Penal Code (45 of 1860), a registered medical
practitioner shall not be guilty of any offence under that Code or under any other law for the time
being in force, if any pregnancy is terminated by him in accordance with the provisions of this Act.

(2)Subject to the provisions of sub-section (4), a pregnancy may be terminated by a registered

medical practitioner –

(a) here the length of the pregnancy does not exceed twelve weeks if such medical practitioner is, or
(b) Where the length of the pregnancy exceeds twelve weeks but does not exceed twenty weeks, if
not less than two registered medical practitioner are, of opinion, formed in good faith, that -

(i) The continuance of the pregnancy would involve a risk to the life of the pregnant woman or of
grave injury to her physical or mental health; or

(ii) There is a substantial risk that if the child were born, it would suffer from such physical or mental
abnormalities to be seriously handicapped.

Explanation 1- Where any pregnancy is alleged by the pregnant woman to have been caused by
rape, the anguish caused by such pregnancy shall be presumed to constitute a grave injury to the
mental health of the pregnant woman.

Explanation 2- Where any pregnancy occurs as a result of failure of any device or method used by
any married woman or her husband for the purpose of limiting the number of children, the anguish
caused by such unwanted pregnancy may be resumed to constitute a grave injury to the mental
health of the pregnant woman.

In determining whether the continuance of a pregnancy would involve such risk of injury to the
health as is mentioned in sub-section (2), account may be taken of the pregnant women’s actual or
reasonable foreseeable environment.

(a)No pregnancy of a woman, who has not attained the age of eighteen years, or, who, having
attained the age of eighteen years, is a lunatic, shall be terminated except with the consent in
writing of her guardian.

(b)Save as otherwise provided in clause (a), no pregnancy shall be terminated except with the
consent of the pregnant woman.

9.4 PLACE WHERE PREGNANCY MAY BE TERMINATED

No termination of pregnancy shall be made in accordance with this Act at any place other than:

(a) A hospital established or maintained by Government, or

(b) A place for the time being approved for the purpose of this Act by Government.

9.5 POWER TO MAKE RULES

(1) The Central Government may, by notification in the Official Gazette, make rules to carry out the
provisions of this Act.

(2) In particular, and without prejudice to the generality of the foregoing power, such rules may
provide for all or any of the following matters, namely:

(a) The experience or training, or both, which is registered medical practitioner shall have if he
intends to terminate any pregnancy under this Act; and

(b) Such other matters as are required to be or may be, provided by rules made under this Act.

(3) Every rule made by the Central Government under this Act shall be laid, as soon as may be after
it is made, before each House of Parliament while it is in session for a total period of thirty days
which may be comprised in one session or in two successive sessions, and if, before the expiry of the
session in which it is so laid or the session immediately following, both Houses agree in making any
modification in the rule or both Houses agree that the rule should not be made, the rule shall
thereafter have effect only in such modified form or be of no effect, as the case may be; so,
however, that any such modification or annulment shall be without prejudice to the validity of
anything previously done under that rule.
9.6 POWER TO MAKE REGULATIONS

(1) The State Government may, by regulations -

(a) require any such opinion as is referred to in sub-section (2) of section 3 to be certified by a
registered medical practitioner or practitioners concerned, in such form and at such time as may be
specified in such regulations, and the preservation or disposal of such certificates ;

(b) Require any registered medical practitioner, who terminates a pregnancy, to give intimation of
such termination and such other information relating to the termination as may be specified in such
regulations;

(c) Prohibit the disclosure, except to such purposes as may be specified in such regulations, of
intimations given or information furnished in pursuance of such regulations.

(2) The intimation given and the information furnished in pursuance of regulations made by virtue
of clause (b) of sub-section (1) shall be given or furnished, as the case may be, to the Chief Medical
Officer of the State.

(3) Any person who willfully contravenes or willfully fails to comply with the requirements of any
regulation made under sub-section (1) shall be liable to be punished with fine, which may extend to
one thousand rupees.

9.7 PROTECTION OF ACTION TAKEN IN GOOD FAITH

No suit or legal proceedings shall lie against any registered medical practitioner for any damage
caused or likely to be caused by anything, which is in good faith done or intended to be done under
this Act.

9.8 AMENDMENT 2002 (18th December 2002)

Be it enacted by Parliament in the Fifty-third Year of the Republic of India as follows:

Short title and commencement:

(1) This Act may be called the Medical Termination of Pregnancy (Amendment) Act, 2002.

(2) It shall come into force on such date as the Central Government may, by notification in the
Official Gazette, appoint.

Amendment of section 2

In section 2 of the Medical Termination of Pregnancy Act,-34 of 1971, (hereinafter referred to as the
principal Act),

(i) In clause (a), for the word “lunatic”, the words ‘mentally ill person” shall be substituted.
(ii) For clause (b), the following clause shall be substituted, namely:-

‘(b) “Mentally ill person” means a person who is in need of treatment by reason of any mental
disorder other than mental retardation;’

Amendment of Section 3

In section 3 of the principal Act, in sub-section (4), in clause (a), for the word “lunatic”, the words
“mentally ill person” shall be substituted.

Substitution of new section for section 4

Place where pregnancy may be terminated

For section 4 of the principal Act, the following section shall be substituted, namely:-

"No termination of pregnancy shall be made in accordance with this Act at any place other than

(a) A hospital established or maintained by Government, or

(b) a place for the time being approved for the purpose of this Act by Government or a District
Level Committee constituted by that Government with the Chief Medical Officer or District Health
Officer as the Chairperson of the said Committee:

Provided that the District Level Committee shall consist of not less than three and not more than five
members including the Chairperson, as the Government may specify from time to time:”

Amendment of section 5

In section 5 of the principal Act, for sub-section (2) and the Explanation thereto, the following shall
be substituted, namely:

‘(2) Notwithstanding anything contained in the Indian Penal Code, the termination of pregnancy by a
person who is not a registered medical practitioner shall be an offence punishable with rigorous
imprisonment for a term which shall not be less than two years but which may extend to seven years
under that Code, and that Code shall, to this extent, stand modified. (3) Whoever terminates any
pregnancy in a place other than that mentioned in section 4, shall be punishable with rigorous
imprisonment for a term which shall not be less than two years but which may extend to seven
years. (4) Any person being owner of a place which is not approved under clause (b) of section 4
shall be punishable with rigorous imprisonment for a term which shall not be less than two years but
which may extend to seven years.

Explanation 1: For the purposes of this section, the expression “owner” in relation to a place means
any person who is the administrative head or otherwise responsible for the working or maintenance
of a hospital or place, by whatever name called, where the pregnancy may be terminated under this
Act.
 Explanation 2: For the purposes of this section, so much of the provisions of clause (d) of section 2
as relate to the possession, by registered medical practitioner, of experience or training in
gynecology and obstetrics shall not apply’.

9.9 INDICATIONS FOR MTP

Therapeutic, Eugenic, Humanitarian, Social, Environmental.

Therapeutic Grounds: Pregnancy can be terminated if continuation of pregnancy is a danger to the

health or life of the mother. Some of the conditions are as under:

∑ Cancer of Vagina, cervix, breast, ovary

∑ Large fibroid of uterus
∑ Hydatidiform mole
∑ Hydramnios
∑ Insanity
∑ Severe epilepsy
∑ Preeclampsia
∑ Eclampsia
∑ Severe glomerulonephritis

Eugenic Grounds: Pregnancy can be terminated if continuation of pregnancy is likely to result in:

∑ Gross physical handicap in the baby

∑ Gross mental handicap in the baby
∑ Death of the baby

Examples

- Viral infections like rubella, chickenpox of mother

- Intake of cytotoxic drugs during pregnancy
- Exposure to radioactive radiations
- Rh incompatibility-untreated
- Parents with certain genetic disorders not compatible with life in the fetus
- Parents with certain psychiatric disorders

Humanitarian Grounds: Pregnancy can be terminated in case of pregnancy caused by rape.

Social grounds: Pregnancy can be terminated in pregnancy caused by failure of contraceptives.

Environmental: Pregnancy can be terminated if the environment around the mother is not healthy for
development of the child.

- Extreme poverty
- Small home
- Many children in a poor household
 - Earlier handicapped children

9.10 REQUIREMENT FOR ROUTINE MTP

∑ Record preliminary data

∑ Written informed consent,
∑ A RMP having experience in Obstetrics and gynecology of 6 months or have
performed/assisted in 25 MTPs can perform MTP up to 12 weeks of gestation.
∑ RMP has to be registered by civil surgeon /CMO of the district.
∑ MTP can be performed in a district hospital or in a center recognized by the Government.
∑ For MTP between 12-20 weeks of gestation, opinion of 2 doctors are required.
∑ Beyond 20 weeks MTP cannot be done.
∑ All information to be kept as secrets.

9.11 DOCTOR AND CRIMINAL ABORTION

Definition: Any abortion done with criminal intention or without the consent of the pregnant lady is
labeled as criminal abortion and is punishable.

Criminal Abortion and Law

Section 312: Criminal abortion with consent. Punishable with 3 years of imprisonment/ fine/or both.

Section 313: Criminal abortion without consent. Punishable with 10 years of imprisonment/ fine/or
both.

Section 314: During criminal abortion if the lady dies and was done with consent of the lady-
Criminal abortion with consent - Punishable with life/10years of imprisonment/ fine/or both.

Section 315: During criminal abortion the baby dies. Punishable with /10years of imprisonment/
fine/or both.

Section 511: Attempted criminal abortion.

Precautions during Medical Examination of A case of Criminal Abortion

∑ Record preliminary data

∑ Obtain written informed consent
∑ Take detailed history
∑ Examine in detail with a female attendant /nurse
∑ Inform police
∑ Initiate medico legal case
∑ Consult a specialist/colleague
∑ If patient is about to die get dying declaration
 ∑ In case patient dies, inform police, do not issue death certificate and send the body for
postmortem.

9.12 SUMMARY

Since the time Medical Termination of Pregnancy has been legalized, its contribution towards
reduction in the maternal mortality rate has been significant. Therefore, the institutions where MTP
can be carried out as well as RMPs who have been registered to carry out MTP have a responsibility
towards carrying out MTP as per guidelines given in this Act.

9.13 KEY WORDS

1. “Guardian” means a person having the care of the person of a minor or a lunatic.

2. Lunatic” has the meaning assigned to it in section 3 of the Indian Lunatic Act, 1912 (4 of 1912)

3. Minor” means a person who, under the provisions of the Indian Majority Act, 1875 (9 of 1875), is
to be deemed not to have attained his majority.

4. registered medical practitioner” means a medical practitioner who possesses any recognized
medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956,
(102 of 1956), whose name has been entered in a State Medical Register and who has such
experience or training in gynecology and obstetrics as may be prescribed by rules made under this
Act.

Criminal Abortion and Law

Section 312:- Criminal abortion with consent. Punishable with 3 years of imprisonment/ fine/or
both.

If quick with child: - Punishable with7 years of imprisonment/ fine/or both.

Section 313:- :- Criminal abortion without consent. Punishable with 10 years of imprisonment/
fine/or both.

Section 314:- During criminal abortion the lady dies and was done with consent of the lady-:-
Criminal abortion with consent. Punishable with life/10years of imprisonment/ fine/or both.

Section 315:- During criminal abortion the baby dies. Punishable with /10years of imprisonment/
fine/or both

Section 511:- Attempted criminal abortion

UNIT 10 MEDICAL RECORDS AND LAW

Learning Objectives

After going through this Unit you will be able to:

∑ understand the importance of Medical records;

∑ understand what constitutes medico legal work;
∑ understand the legal implications of all types of medical records;
∑ concept of death certificate;
∑ precautions to be taken while writing a death certificate;
∑ understand the concept of brain death;
∑ understand the Importance of dying declaration;
∑ Learn important provisions of Birth and Death Registration Act.

Structure

10.1 Introduction
10.2 Contents of The Medical Records
10.3 Medico-Legal Work

10.4 Medico-Legal Records

10.5 Property Rights
10.6 Medical Records In Court
10.7 Disposal of Medical Records
10.8 Death Certificate
10.9 Dying Declaration

10.10 Diagnosis of Death

10.11 The Registration of Births and Deaths (Amendment) Bill, 2012

10 .12 Summary
10 .13 Key Words

10.1 INTRODUCTION
It is necessary for the hospital and a general practitioner to maintain the medical records
of the patients examined both in indoor as well as outdoor basis. The medical care must
address the “who” “why” “what” “where” and “when” of the patient care.

10.2 CONTENTS OF THE MEDICAL RECORDS

The medical records must have the following data:
 ∑ Name/age/sex/address to the patient
∑ Name and address of the person who brought the patient
∑ Name of the doctor who referred the patient
∑ Date/time of arrival of the patient
∑ Date and time of examination of the patient
∑ Date and time of discharge
∑ Relevant past history
∑ Relevant family history
∑ Relevant personal history
∑ Details of examination and findings
∑ Details of investigation reports
∑ Consent form duly filled
∑ Details of treatment given and follow up advised
∑ In case of consultation with other doctors/his reports/advise/treatment
∑ Details of information given to the police
∑ In case of death, date, time, cause of death
∑ Name/designation and sign of the doctor

10 .3 MEDICO-LEGAL WORK

In hospitals, the importance of medico legal work and its record cannot be undermined. This
is a specialized work which requires knowledge and training. The quality of medico legal
work and record have its repercussions on subsequent law proceedings and since occasions
where strictures have been imposed on medical officers an hospitals due to deficient medico
legal work and records are quite common, the hospitals and doctors must accept the
importance of correct medico legal work and recordkeeping.

What Is Medico-legal work?

The doctor must be clear in his/her mind what constitutes medico legal work? Some of the
examples of medico legal work are:
∑ All cases of burns
∑ All cases of road traffic accidents
∑ All other suspicious cases
∑ Child abuse
∑ Rape
∑ Found/Brought in Dead cases
All medico-legal cases have to be informed to police in writing and receipt of the intimation
to be obtained and filed. In addition, telephonically the police should also be informed. A
register should be maintained wherein the details of telephonic intimation is to be endorsed. It
should also mention the time, date of call and the buckle number of the constable who
received the call.
Medico-Legal Register

It is also known as Emergency Police Register (EPR). The register has the following details
of all medico legal cases:
∑ Serial Number/MLC number
∑ The date and time of attendance
∑ Buckle number of the police constable to whom the medico legal case was
first informed
∑ Details of examination findings of the case
∑ Identification marks of the patient
∑ Details of the patient
∑ Details of the person who brought the case
∑ Details of dispatch letters to the police coke regarding the case

All medico legal cases/correspondences are confidential and have to be kept under lock and
key by the medical officer.

10.4 MEDICO-LEGAL RECORDS

In addition to the contents mentioned above the following details are required:

∑ All the pages of the medico legal registers to be duly numbered, stamped and
initialed by a medical officer and a certificate to this effect must be endorsed on
the first page of the register.
∑ All communication with the police must be in writing in duplicate with one copy
attached to the case papers.
∑ On all pages of case sheet, investigation requisition and reports, the word MLC to
be endorsed.
∑ All medico legal documents to be prepared in duplicate
∑ All the entries to be correct and in sequence
∑ Abbreviations not to be used
∑ All corrections to be initialed
∑ All medico legal reports to be kept under lock and key
∑ In the medico legal register, details of 2-3 identification marks, injuries to be
endorsed
∑ The medico legal report must have details of examination, findings, investigation
asked for and their reports
10.5 PROPERTY RIGHTS

The medical records, X ray/CT scan and MRI plates are the properties of the hospital.
Usually patient is given a case summary, a copy of the investigation reports, treatment
advised and the follow up schedule. In case of death of the patient his/her NOK can be given
all these detail. However, if in the opinion of the doctor, handing over such records will harm
the patient, he can exercise professional/therapeutic discretion and not issue these records.
These Records cannot be used by the doctor or the hospital for publication without the
consent of the patient or NOK.

10.6 MEDICAL RECORDS IN COURT

In case of subpoena, summon served by the court, requesting production of the case
records, these have to be produced before the court. The court normally asks for records
in the following cases:

Criminal Cases
- Murder
- Rape
- Assault
- Injury
- Poisoning
- Burns
- Suicide
- Criminal abortion
- RTA
- Dowry deaths

Civil Cases - Workmen compensation cases

- Malpractice cases
- Will cases
- Disputed paternity
- Insurance cases
- Fraud cases

Information given to the law courts regarding the health conditions of the patient is covered
under privileged communication and the plea of professional secrecy does not hold well on
such cases. Before submitting the records to the court, they should be photocopied and a
receipt is to be taken.

Medical Records Asked By Other agencies

Many times medical records are asked by LIC and other insurance agencies as per law they
are not entitled to this information without the written and informed consent of the patient.
 10.7 DISPOSAL OF MEDICAL RECORDS

NON MLC CASES: OPD records are retained for a period of 3 years. The IPD reports are
kept for a period of 5 years.

MLC CASES: There is no specified time limit after which they can be destroyed.

10.8 DEATH CERTIFICATE

Definition: It refers to the certificate, certifying death of a person.

Issuing Authority
∑ To be issued by the RMP who had attended the deceased at the time of death.
∑ Death certificate not to be issued in case of Brought in Dead/Found Dead cases. In
such cases Post Mortem has to be conducted.
∑ In case organs are to be transplanted, then 2 separate death certificates to be issued
by two independent doctors who are not a part of the transplant team.

Precautions to be taken While Issuing Death Certificates

∑ Ensure that the patient is dead. The present criteria of death is Brain Stem
Death evidenced by
- Absence of voluntary respiration
- Absence of cranial and motor responses
- Abolition of all responses

∑ Death can sometimes be wrongly diagnosed as a case of Suspended

Animation. In such a case the vital functions of the body are so low that they
cannot be diagnosed by routine examination. This is common in cases of
cholera, typhoid, drowning, electrocution etc.

∑ Ensure that the death is natural as if it is not so, then inquest has to be done
and PM has to be carried out.

∑ If death is due to natural causes, then Death certificate has to be issued

promptly without charging any fees and even If other professional fees are not
paid.

∑ DC should never be issued in Brought in Dead cases, at the request of the

relatives and without examining the patient.
 ∑ In some hospitals DC is to be countersigned by the Medical Superintendent of
the hospital. There is no legal sanction for this.

∑ Routinely death occurring within 24 hours of operation or during operation is

a medico legal case.

Contents of A Death Certificate

- Name/age/sex/address and two identification marks of the deceased
- Place, time ,date of death
- Name of the hospital and the doctor
- Exact cause of death
- Mention the immediate and contributory causes of death

Importance of Death Certificate

Death certificate is required for
- Registration of Death
- For cremation of the body
- For insurance settlement claims
- For property transfer
- For execution of the will

SAMPLE OF DEATH CERTIFICATE

Date

I hereby certify that I attended the deceased------------------------------------------------------------

--------------------aged--------------------------sex---------------------------residing at ----------------
----------------------------------------------------------------------------------------------------. /She died
at-----------------------------------------------------------------------------on (date).
To the best of my knowledge the cause of death is as stated below.
Cause of Death----------------------------------------------------------------------------------------------
------
1. Disease or condition directly leading to death------------------------------------------------
----------------------------------------------------------------------------------
2. Antecedent causes--------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------
3. Morbid conditions if any giving rise to the above cause stating the underlying
condition last---------------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------
----------------------------------------------------------------
4. Other significant conditions contributing to death but not related to the disease or
conditions causing it.------------------------------------------------------------------------------
-------------------------------------------------------------------------------------------------------
---------------
5. If deceased was a female was the death associated with pregnancy?
6. If yes to 5, was there a delivery--------------------------------------------------------------

Address of The Hospital Signature of the doctor

Name/registration no
and stamp of the hospital

10.9 DYING DECLARATION

Definition: It is the written or verbal statement made by a person likely to die because of
some unnatural act done on his/her body, narrating the circumstances and conditions
responsible for his /her present state of health or the cause or manner of likely unnatural
death.

Precaution
The precautions while recording dying declaration are as under:

- It should ideally recorded by Executive or Honorary magistrate.

- The doctor has to certify that the patient is “Compos Mentis” or in a fit state to give
statement.
- During recording no relatives are allowed to be present.
- During recording no police is allowed to be present.
- No oath is administered.
- No leading questions are allowed.
- It is recorded in the presence of two disinterested and independent witness.
- It is recorded in question and answer form.
- It is recorded in the vernacular of the patient.
- At the end it is signed by magistrate, the patient, the doctor and the two witnesses.

Procedure for Recording

Though Dying declaration refers to the written or verbal statement made by a person likely to
die because of some unnatural act done on his/her body, narrating the circumstances and
conditions responsible for his /her present state of health or the cause or manner of likely
unnatural death it is not necessary that the patient is sure to die.

Ideally it is to be recorded by Executive or Honorary magistrate. However if he is not

available and there is not enough time to wait for him, the doctor can record the Dying
Declaration.

If the patient is not at hospital dying declaration can be recorded by any adult person.

In case of dowry death, the dying declaration is to be recorded by the executive or honorary
magistrate only.
Before the dying declaration is given, the doctor has to certify that the patient s in a fit state
of mind to understand the nature of questions put to him and that he can answer them in a
logical manner.

All efforts should be made to encourage the patient to write what he\she wants to inform. If
this is not possible, the verbal statement is to be taken. During recording no police officer or
any relatives or any other person who can influence the patient are allowed to be present.

After Recording
- The doctor again examines the patient for Compos Mentis.
- The contents of the dying declaration are read to the patient and also it is to be
certified that the contents have been read over to the patient and the patient agrees to
it.
- The date, time and place of recording are endorsed.
- The declaration is signed by the doctor, patient, the two disinterested witnesses and
the Magistrate.
- If the Magistrate is not present, dying Declaration is sent to the magistrate in a sealed
envelope.

Special Circumstance
- If the patient cannot write, verbal statement can be recorded.
- If the patient cannot write or talk due to any reason, signs and gestures made by the
patient can be recorded.
- If the Magistrate or the Doctor does not understand the language /dialect of the
patient, a third party who is disinterested can be called to help.
- If the patient dies during recording and the doctor certifies death, then the incomplete
dying declaration is signed by all concerned.

Importance
- As per section 32 and 157 of Indian Evidence Act, every person during last stage of
life speaks the truth; therefore great sanctity is attached to the dying declaration and is
admitted as evidence.
- If however, the patient does not die, dying declaration loses its importance.

10.10 DIAGNOSIS OF DEATH

The Kansas Definition

A person is considered medically and legally dead, in the opinion of the of a physician, based
on the ordinary standards of medical practice when there is absence of Spontaneous
respiratory function, Cardiac function.

Because of the disease condition which caused directly or indirectly to cease or because of
the passage of time since these functions ceased, attempts at resuscitation are considered
hopeless and in event death will have occurred as these functions ceased.

The second alternative criterion is related to the absence of brain function.

The Swiss Formula: That a person must be regarded as dead if one of the following
conditions is fulfilled:
- Irreversible cardiac arrest resulting in interruption of blood circulation in the body
and also causing in interruption of blood circulation to brain(cardio circulatory
death)
- Complete and irreversible failure of cerebral function or brain death.

Harvard Formula: Brain death which is evidenced by the all of the following:

- UN receptivity and unresponsively, that is total unresponsiveness to externally

applied stimuli and complete unresponsiveness to the even most painful stimuli.
- Absence of reflexes
- Total absence of spontaneous breathing for 3 minutes
- Flat EEG and ECG

The Hungarian Formula:

- Deep COMA
- Complete ABSENCE OF ALL REFLEXES
- Both pupils fully dilated and unreactive to light
- During repeated examination during next 10 minutes period shows no
spontaneous respiration
- An absolutely linear EEG

The Australia Formula:

- Irreversible cessation of all brain functions

- Irreversible cessation of circulation of the blood in the body of the person

Brain Stem Death

∑ The patient must be comatose for at least 24 hours after the circulation has been
restored artificially.
∑ No abnormal decorticate or vertebrate posture
∑ No epileptic movements
∑ No spontaneous respiratory movements
∑ All of the brain stem reflexes are absent:
- The pupils are fixed, dilated and not reactive to light.
- Absence of occult cephalic reflex or doll’s eye movements.
- No vestibule ocular reflexes.
- No motor response within the cranial nerve distribution.
- No gag reflex and bronchial stimulation reflex.
∑ No respiratory movement when the patient is taken off the ventilators.

Under the following conditions the diagnosis of brain death should not be considered:
 ∑ In children below 5 years of age.
∑ In deeply comatose patient when there is a suspicion of coma may be due
to:
- Primary hypothermia
- Depressant drugs
- Metabolic/endocrine disorders
- Severe shock
- Respiratory insufficiency or arrest requiring use of respirator
because of the use of relaxant drugs or neuromuscular blocking
agents and other drugs

10.11 THE REGISTRATION OF BIRTHS AND DEATHS (AMENDMENT) BILL,

2012

A Statement of Objects and Reasons

The Registration of Births and Deaths (Amendment) Bill, 2012 seeks to amend the
Registration of Births and Deaths Act, 1969 (18 of 1969) so as to provide for registration of
marriages irrespective of religion professed and practiced by the parties to the marriage. At
present the Registration of Births and Deaths Act, 1969 provides only for the regulation of
registration of births and deaths and for matters connected therewith.

The Committee on Empowerment of Women (2006-2007) in its Twelfth Report (Fourteenth

Lok Sabha) on Plight of Indian Women Deserted by Non Resident Indian (NRI) Husbands
presented to Lok Sabha on the 13th August, 2007, has, inter alia, expressed the view that all
marriages, irrespective of religion should be compulsorily registered and desired that the
Government to make registration of all marriages mandatory, making the procedure simpler,
affordable and accessible.

The 18th Law Commission of India in its 205th Report titled “Proposal to Amend the
Prohibition of Child Marriage Act, 2006 and other Allied Laws”, inter alia, recommended
that “registration of marriages within a stipulated period, of all the communities, viz. Hindu,
Muslim, Christian, etc., should be made mandatory by the Government”. Further, the
18thLaw Commission in its 211th Report titled “Laws on Registration of Marriage and
Divorce — A proposal for Consolidation and Reform”, has recommended for Parliamentary
legislation on compulsory registration of marriages which will bring country-wide uniformity
in the substantive law relating to registration and will be helpful in achieving the desired goal.

The Registration of Births and Deaths Act, 1969, inter alia, provides for Registration
establishments consisting of Registrar-General, Chief Registrar and registration division,
District Registrars and Registrars. It also provides procedures for registration of births and
deaths and for maintenance of records and statistics. Further, by virtue of the powers
conferred under section 30 of the aforesaid Act, rules for compulsory registration of births
and deaths have been framed by the State Governments and Union territory Administrations.

Therefore, it is proposed to amend the aforesaid Act suitably to include registration of

marriages as well within its scope so that the existing administrative machinery would also be
able to carry out registration of marriages in accordance with the specified procedures and be
able to maintain necessary records and statistics for registration of marriages also.

Having regard to the aforesaid directions of the Supreme Court, report of the Committee on
Empowerment of Women and recommendations of the Law Commission referred to in the
foregoing paragraphs, it is proposed to amend the Registration of Births and Deaths Act,
1969 to provide for compulsory registration of marriages without affecting in any manner the
State law making provisions for compulsory registration of marriages in their respective
States. For this purpose, suitable provisions are incorporated in the Bill to avoid any
duplication of registration of marriages under the proposed Central law and the State law. It is
also proposed to provide in the Bill that the Registration of Births and Deaths Act, 1969 (after
the enactment of proposed amendments) shall not apply to any person who has registered his
marriage under any other law for the time being in force including a State Act providing for
registration of marriages or with any other authority under that law and nothing contained in
this Act shall affect the validity of the marriages registered under that law. Further, the parties
to the marriage, whose marriage has been registered under this Act, shall not be required to
get their marriage registered under the Anand Marriage Act, 1909 or any other law for the
time being in force. Moreover, the registration of marriages there under shall not affect any
right recognized or acquired by any party to marriage under any law, custom or usage.

The proposed Bill will provide for registration of marriages of all persons who are citizens of
India belonging to various religious denominations and be beneficial to women, as the
registration certificate would provide evidentiary value in matrimonial and maintenance cases
and prevent unnecessary harassment meted out to them. It will also provide evidentiary value
in the matters of age of parties, custody of children and the right of children born out of such
marriages.

BILL further to amend the Registration of Births and Deaths Act, 1969.

Be it enacted by Parliament in the Sixty-third Year of the Republic of India as follows:

This Act may be called the Registration of Births and Deaths (Amendment) Act,
2012. It shall come into force on such date as the Central Government may, by notification
In the Official Gazette, appoint.

In the Registration of Births and Deaths Act, 1969 (hereinafter referred to as the
Principal Act), in the long title, for the words “Births and Deaths”, the words “Births,
Marriages
And Deaths” shall be substituted.

In section 1 of the principal Act, in sub-section (1), for the words “Births and
Deaths”, the words “Births, Marriages and Deaths” shall be substituted.

Important Provisions
 (1)Any birth or death, of which information is given to the Registrar after the expiry of the
period specified therefore, but within thirty days of its occurrence, shall be registered on
payment of such late fee as, may be prescribed.

(2) Any birth or death of which delayed information is given to the Registrar after thirty days
but within one year of its occurrence shall be registered only with the written permission of
the prescribed authority and on payment of the prescribed fee and the production of an
affidavit made before a notary public or any other officer authorized in this behalf by the
State Government.

(3) Any birth or death which has not been registered within one year of its occurrence shall
be registered only on an order made by a magistrate of the first class or a Presidency
Magistrate after verifying the correctness of the birth or death and on payment of the
prescribed fee.

(4) The provisions of this section shall be without prejudice to any action that may be taken
against a person for failure on his part to register any birth or death within the time specified
therefore and any such birth or death may be registered during the pendency of any such
action.

(5) If it is proved to the satisfaction of the Registrar that any entry of a birth or death in any
register kept by him under this Act is erroneous in form or substance, or has been
fraudulently or improperly made, he may, subject to such rules as may be made by the State
Government with respect to the conditions on which and the circumstances in which such
entries may be corrected or cancelled, correct the error or cancel the entry by suitable entry in
the margin, without any alteration of the original entry, and shall sign the marginal entry and
add thereto the date of the correction of cancellation.

(6) Subject to any rules made in this behalf by the State Government, including rules relating
to the payment of fees and postal charges, any person may

(a) Cause a search to be made by the Registrar for any entry in a register of births and deaths;
and
(b) Obtain an extract from such register relating to any birth or death: Provided that no extract
relating to any death, issued to any person, shall disclose the particulars regarding the cause
of death as entered in the register.

All extracts given under this section shall be certified by the Registrar or any other officer
authorized by the State Government to give such extracts as provided in section 76 of the
Indian Evidence Act, 1872, and shall be admissible in evidence for the purpose of proving the
birth or death to which the entry relates.
(7) The Registrar may either orally or in writing require any person to furnish any
information within his knowledge in connection with a birth or death in the locality within
which such person resides and that person shall be bound to comply with such requisition.

(8) Throughout the principal Act (except sections 8, 9, 10, and 20), for the words “births and
deaths”, “births or deaths”, “every birth and of every death” wherever they occur, the words
“births, marriages and deaths”, “births or marriages or deaths” and “every birth, every
marriage and of every death”, as the case may be, shall respectively be substituted; and such
other consequential amendments as the rules of grammar may require shall also be made.

(9) After section 1 of the principal Act, the following section shall be inserted, namely:
Every person shall get his marriage registered under this Act.

(10) In section, 2 of the principal Act, in sub-section (1), after clause (d), the following
Clause shall be inserted, namely:

“marriage” means and includes a marriage solemnized between a male and a female
belonging to any caste or religion or tribe under any law for the time being in force and
includes marriages solemnized under any custom or usage in any form or manner recognized
by law or the marriage registered under any law for the time being in force and also includes
remarriage’.

(11) In section 7 of the principal Act, after sub-section (2), the following sub-section shall be
inserted, namely: “(2A) Every Registrar shall, on payment of prescribed fees, enter in the
register maintained for the purpose, all information given to him under section 8 or section
8A or section 9 and shall also take steps to inform himself carefully of every marriage which
takes place in his jurisdiction and to ascertain and register the particulars required to be
registered”.

(12). after section 8 of the principal Act, the following section shall be inserted, namely:
“8A. (1) For the purposes of facilitating the proof of marriages, the parties to the marriages,
who intend to get their marriage registered under this Act shall, either themselves, or from the
persons specified below, give or cause to be given, either orally or in writing, according to
the best of their knowledge and belief, within such time as may be prescribed, information
and requisite documents and fees to the Registrar of the several particulars required to be
entered in the forms prescribed by the State Government under sub-section (1) of section 16,
(a) in respect of marriage in a house, whether residential or non-residential, not being any
place referred to in clauses (b) and (c), the head of the house, and in the absence of any such
person, the oldest adult male person present therein during the said period.

(b) In respect of marriage in a temple, church, mosque, synagogue or such other religious
place, the priest or such other person, by whatever name called, officiating such marriage or
the trustee or any other person in charge thereof.

(c) in respect of marriage in a place specifically used for conducting marriages, including
marriage halls, choultry, chattram, hotels or such other place, the person in charge thereof;
 (d) In respect of marriage in an open place or field or ground, the headman or other
corresponding officer in the case of a village and the officer in charge of the local police
station elsewhere.

(e) In any other place, such person as may be prescribed

8B. The Registrar shall not refuse to register any marriage for which a duly filled up and
signed form has been received by him except on such grounds as may be prescribed:
Provided that different grounds may be specified by rules for different class or classes of
persons to marriage.

(13) After section 10 of the principal Act, the following section shall be inserted, namely:
“10A. (1) Upon the request made by parties to the marriage who intend to get their marriage
registered under this Act, it shall be the duty of the persons referred to in clauses (a) to (e) of
sub section (1) of section 8A to give necessary information and documents relating to such
marriage to the Registrar within such time and in such manner as may be prescribed.

(2) In any area, the State Government, having regard to the facilities available therein in this
behalf, may require that a certificate as to marriage shall be obtained by the Registrar from
such person and in such form as may be prescribed”.

10.12 SUMMARY

It is essential for any hospital and health care providers to know the importance of medical
records and its legal implications. Knowledge regarding the procedure and maintenance of
medico legal records, and how to deal with dying declaration, death, birth etc. in the hospital
will go a long way in preventing avoidable litigation complications.

10.13 KEY WORDS

Dying Declaration
Definition: - It is the written or verbal statement made by a person likely to die because of
some unnatural act done on his/her body, narrating the circumstances and conditions
responsible for his /her present state of health or the cause or manner of likely unnatural
death.

The Kansas Definition: - A person is considered medical and legally dead, in the opinion
of the of physician, based on the ordinary standards of medical practice when there is absence
of
∑ Spontaneous respiratory function
∑ Cardiac function

The Swiss Formula: - That a person must be regarded as dead if one of the following
conditions is fulfilled:
- Irreversible cardiac arrest resulting in interruption of blood circulation in the body
and also causing in interruption of blood circulation to brain(cardio circulatory
death)
- Complete and irreversible failure of cerebral function or brain death.
Harvard Formula: - Brain death which is evidenced by the all of the following:
∑ UN receptivity and unresponsively, that is total unresponsiveness to externally
applied stimuli and complete unresponsiveness to the even most painful stimuli.
∑ Absence of reflexes.
∑ Total absence of spontaneous breathing for 3 minutes.
∑ Flat EEG and ECG.
The Hungarian Formula:-
∑ Deep COMA
∑ Complete ABSENCE OF ALL REFLEXES.
∑ Both pupils fully dilated and unreactive to light.
∑ During repeated examination during next 10 minutes period shows no
spontaneous respiration.
∑ An absolutely linear EEG.
UNIT 11 THE CONSUMER PROTECTION ACT
Learning Objectives

After going through this Unit you will be able to:

∑ understand the concept of consumer;

∑ understand the rights of the consumer;
∑ understand what constitutes goods and service;
∑ understand the legal implications of all types contract between consumer and supplier;
∑ Import of CPA in health and hospital industry.

Structure
11.1 Introduction
11.2 The Consumer Rights
11.3 The Consumer Protection Act 1986
11 .4 Summary
11.5 Key Words

11.1 INTRODUCTION

Consumer Protection Act and Medical Profession

The Doctor patient relationship in our country has undergone a sea change in the last decade
and a half. The lucky doctors of the past were treated like God and people revered and
respected them. We witness today a fast pace of commercialization and globalization on all
spheres of life and the medical profession is no exception to these phenomena. As a result,
the doctor-patients relationship has deteriorated considerably. Earlier too, doctors were
covered by various laws, i.e. the Law of Torts, IPC etc., but since the passing of the
Consumer Protection Act in 1986, litigation against doctors is on the increase. The medical
profession is definitely perturbed by this and a rethink is necessary on standards of medical
practice or ‘defensive medicine’.

Surgeons/Urologists busy themselves in acquiring knowledge, perfecting operative

techniques and assimilating the newest technologies that are evolving so rapidly. Sometimes
the course of the disease or therapeutic decisions does not run along predictable lines. The
patient-doctor relationship is then put to test.

Doctors practicing ethically and honestly should not have any reason for fear. Law whether
civil, criminally or consumer law, can only set the outer limits of acceptable conduct i.e.
minimum standards of professional care and skill, leaving the question of ideal to the
profession itself.
The best way to come directly to the issue would be to know about the rights of the
consumer. The eight rights as defined by the International Organization of Consumers’ Union
(IOCU) are as follows:

11.2 THE CONSUMER RIGHTS

The Right to Safety

Which means the right to be protected against products, production processes and services
which are hazardous to health or life? The right to safety has been broadened to include the
concern for consumers’ long-term interests, not only their immediate desires.

The Right to be informed

Which means the right to be given the facts needed to make an informed choice or decision?
The right to be informed now goes beyond avoiding deception and the protection against
misleading advertising, labelling or other practices. Consumers should be provided with
adequate information, enabling them to act wisely and responsibly.

The Right to Choose

Which means the right to have access to a variety of products and services at competitive
prices and in the case of monopolies, to have an assurance of satisfactory quality and service
at a fair price? The right to choose has been reformulated to read: the right to basic goods and
services. This is because the unrestrained right of a minority to choose can mean for the
majority a denial of its fair share.

The Right to be heard

Which means the right to be represented so that consumers’ interest receives full and
sympathetic consideration in the formulation and execution of economic policy? This right is
being broadened to include the right to be heard and represented in the development of
products and services before they are produced or set up; it also implies a representation, not
only in government policies, but also in those of other economic powers.

The Right to Redress

Which means the right to a fair settlement of just claims? This right has been generally
accepted since the early 1970s. It involves the right to receive compensation for
misrepresentation or shoddy goods or services, and where needed, free legal aid or an
accepted form of redress for small claims should be available.

The Right to Consumer Education

Which means the right to acquire the knowledge and skills to be an informed consumer
throughout life? The right to consumer education incorporates the right to the knowledge and
skills needed for taking action to influence factors which affect consumer decisions.

The Right to a Healthy Environment

Which means the right to a physical environment that will enhance the quality of life? This
right involves protection against environmental problems over which the individual consumer
has control. It acknowledges the need to protect and improve the environment for present and
future generations.

The Right to Basic Needs

The right to basic needs means that availability of articles which are the basic need of every
consumer must be ensured.15th March is celebrated as World Consumer Rights Day. On this
day in 1962, President J.F. Kennedy declared four consumer rights (No.1 to 4) in the special
message to the American Congress. Consumer rights number 5 to 8 were subsequently added
by IOCU.

Govt. of India also included the above rights in its Twenty-Point Programmed. The
Consumer Rights No. 1 to 6 is also enshrined in our Consumer Protection Act, 1986.

11.3 THE CONSUMER PROTECTION ACT, 1986

Statement of Objects and Reasons

The Consumer Protection Bill, 1986 seeks to provide for better protection of the interests of
consumers and for the purpose, to make provision for the establishment of Consumer
councils and other authorities for the settlement of consumer disputes and for matter
connected therewith.

It seeks, inter alia, to promote and protect the rights of consumers such as:

(a) The right to be protected against marketing of goods which are hazardous to life and
Property;

(b) The right to be informed about the quality, quantity, potency, purity, standard and
Price of goods to protect the consumer against unfair trade practices;

(c) The right to be assured, wherever possible, access to an authority of goods at

Competitive prices;

(d) The right to be heard and to be assured that consumer’s interests will receive due
Consideration at appropriate forums;

(e) The right to seek redressal against unfair trade practices or unscrupulous exploitation
Of consumers; and

(F) right to consumer education.

These objects are sought to be promoted and protected by the Consumer Protection Council
to
Be established at the Central and State level.
To provide speedy and simple redressal to consumer disputes, quasi-judicial machinery is
sought to be setup at the district, State and Central levels. These quasi-judicial bodies will
observe the principles of natural justice and have been empowered to give relief of a specific
nature and to award, wherever appropriate, compensation to consumers. Penalties for
noncompliance of the orders given by the quasi-judicial bodies have also been provided.

The Bill seeks to achieve the above objects.

The Consumer Protection Bill, 1986 was passed by both the Houses of Parliament and it
received the assent of the President on 24th December, 1986. It came on the Statutes Book as
the Consumer Protection Act, 1986 (68 of 1986).

An Act to provide for better protection of the interests of consumers and for that purpose to
make provision for the establishment of consumer councils and other authorities for the
settlement of consumers' disputes and for matters connected therewith. Be it enacted by
Parliament in the Thirty-Seventh Year of the Republic of India.

Definitions

“Appropriate laboratory" means a laboratory or organization

(i) Recognized by the Central Government;
(ii) Recognized by a State Government, subject to such guidelines as may be
Prescribed by the Central Government in this behalf; or
(iii) Any such laboratory or organization established by or under any law for the time
Being in force, which is maintained, financed or aided by the Central Government
Or a State Government for carrying out analysis or test of any goods with a view
To determining whether such goods suffer from any defect;

"Branch office"
(i) Any establishment described as a branch by the opposite party; or
(ii) Any establishment carrying on either the same or substantially the same activity as
That carried on by the head office of the establishment;

"Complainant"
(i) A consumer; or
(ii) Any voluntary consumer association registered under the Companies Act, 1956 (1
Of 1956) or under any other law for the time being in force; or
(iii) The Central Government or any State Government;
(iv) One or more consumers, where there are numerous consumers
Having the same interest;]
(v) In case of death of a consumer, his legal heir or representative;
Who or which makes a complaint;

"Complaint" means any allegation in writing made by a complainant that

(i) An unfair trade practice or a restrictive trade practice has been adopted by any
trader or service provider;

(ii) The goods bought by him or agreed to be bought by him suffer from one or more
 Defects;

(iii) The services hired or availed of or agreed to be hired or availed of by him suffer
From deficiency in any respect;

(iv) A trader or the service provider, as the case may be, has charged for the goods or
for
The services mentioned in the complaint, a price in excess of the price:
(A) Fixed by or under any law for the time being in force;
(b) Displayed on the goods or any package containing such goods;
(c) Displayed on the price list exhibited by him by or under any law for the
time being in force;
(D) agreed between the parties;

(v) Goods which will be hazardous to life and safety when used are being-offered for
sale to the public
(a) in contravention of any standard relating to safety of such goods as
required to be complied with, by or under any law for the time being in
force;
(b) If the trader could have known with due diligence that the goods so offered
are unsafe to the public;

(vi) services which are hazardous or likely to be hazardous to life and safety of the
public when used, are being offered by the service provider which such person could
have known with due diligence to be injurious to life and safety;) with a view to
obtaining any relief provided by or under this Act;

"Consumer" means any person who

(i) buys any goods for a consideration which has been paid or promised or partly paid
and partly promised, or under any system of deferred payment and includes any user
of such goods other than the person who buys such goods for consideration paid or
promised or partly paid or partly promised, or under any system of deferred payment
when such use is made with the approval of such person, but does not include a
person who obtains such goods for resale or for any commercial purpose; or

(ii) Hires or avails of] any services for a consideration which has been paid or
Promised or partly paid and partly promised, or under any system of deferred
Payment and includes any beneficiary of such services other than the person who
Hires or avails of] the services for consideration paid or promised, or partly paid
And partly promised, or under any system of deferred payment,

"Defect": means any fault, imperfection or shortcoming in the quality, quantity, potency,
purity or standard which is required to be maintained by or under any law for the time being
in force or under any contract, express or implied or] as is claimed by the trader in any
manner whatsoever in relation to any goods;
"Deficiency" means any fault, imperfection, shortcoming or inadequacy in the quality, nature
and manner of performance which is required to be maintained by or under any law for the
time being in force or has been undertaken to be performed by a person in pursuance of a
contract or otherwise in relation to any service;

"District Forum" means a Consumer Disputes Redressal Forum

"Goods" means goods as defined in the Sale of Goods Act, 1930; (3 of 1930);

"Manufacturer" means a person who

(i) Makes or manufactures any goods or parts thereof; or
(ii) Does not make or manufacture any goods but assembles parts thereof made or
Manufactured by others; or
(iii) Puts or causes to be put his own mark on any goods made or manufactured by
any
Other manufacturer ;)

"MEMBER" includes the President and a member of the National Commission or a State
Commission or a District Forum, as the case may be;

"National Commission" means the National Consumer Disputes Redressal Commission

established under clause (c) of section 9;

"Notification" means a notification published in the Official Gazette;

"Person" includes
(i) A firm whether registered or not;
(ii) A Hindu undivided family;
(iii) A co-operative society;
(iv) Every other association of persons whether registered under the Societies
Registration Act, 1860 (21 of 1860) or not;

"Prescribed" means prescribed by rules made by the State Government, or as the, case may
Be, by the Central Government under this Act;

"Regulation” means the regulations made by the National Commission under this Act;

“Restrictive Trade Practice” means a trade practice which tends to bring about manipulation
of price or its conditions of delivery or to affect flow of supplies in the market relating to
goods or services in such a manner as to impose on the consumers unjustified costs or
restrictions and shall include;
(a) Delay beyond the period agreed to by a trader in supply of such goods or in
providing the services which has led or is likely to lead to rise in the price;

(b) Any trade practice which requires a consumer to buy, hire or avail of any goods
or, as the case may be, services as condition precedent to buying, hiring or availing of other
goods or services ;)
.
"Service" means service of any description which is made available to potential (users and
includes the provision of facilities in connection with banking, financing insurance, transport,
processing, supply of electrical or other energy, board or lodging or both, 2[housing
construction] entertainment, amusement or the purveying of news or other information, but
does not include the rendering of any service free of charge or under a contract of personal
service;

“Spurious Goods & Services” mean such goods and services which are claimed to be
genuine but they are actually not so;

"State Commission" means a Consumer Disputes Redressal Commission established in a

State under clause (b) of section 9;

"Trader" in relation to any goods means a person who sells or distributes any goods for sale
and includes the manufacturer thereof, and where such goods are sold or distributed in
package form, includes the packer thereof;

"Unfair Trade Practice" means a trade practice which, for the purpose of promoting the sale,
use or supply of any goods or for the provision of any service, adopts any unfair method or
unfair or deceptive practice including any of the following practices, namely:

(1) The practice of making any statement, whether orally or in writing or by visible
representation which:

(i) Falsely represents that the goods are of a particular standard, quality, quantity, grade,
composition, style or model;
(ii) Falsely represents that the services are of a particular standard, quality or grade;

(Jay) falsely represents any re-built, second-hand, renovated, reconditioned or old goods as
new goods;

(iv) Represents that the goods or services have sponsorship, approval, performance,
characteristics, accessories, and uses or benefits which such goods or services do not
have;

(V) represents that the seller or the supplier has a sponsorship or approval or affiliation which
such seller or supplier does not have;

(vi) Makes a false or misleading representation concerning the need for, or the usefulness
of, any goods or services;

(vii) gives to the public any warranty or guarantee of the performance, efficacy or length of
life of a product or of any goods that is not based on an adequate or proper test thereof:
Provided that where a defense is raised to the effect that such warranty or guarantee is based
on adequate or proper test, the burden of proof of such defense shall lie on the person raising
such defense;

(viii) makes to the public a representation in a form that purports to be- (i) a warranty or
guarantee of a product or of any goods or services; or (ii) a promise to replace, maintain or
repair an article or any part thereof or to repeat or continue a service until it has achieved a
specified result, if such purported warranty or guarantee or promise is materially misleading
or if there is unreasonable prospect that such warranty, guarantee or promise will be carried
out;

(ix) materially misleads the public concerning the price at which a product or like products or
goods or services, have been or 'are, ordinarily sold or provided, and, for this purpose, a
representation as to price shall be deemed to refer to the price at which the product or goods
or services has or have been sold by sellers or provided by suppliers generally in the relevant
market unless it is clearly specified to be the price at which the product has been sold or
services have been provided by the person by whom or on whose behalf the representation is
made;

(x) Gives false or misleading facts disparaging the goods, services or trade of another person.

Explanation: For the purposes of clause (1) a statement that is:

(a) Expressed on an article offered or displayed for sale, or on its wrapper or container; or

(b) expressed on anything attached to, inserted in, or accompanying, an article offered or
displayed for sale, or on anything on which the article is mounted for display or sale; or

(c) contained in or on anything that is sold, sent, delivered, transmitted or in any other
manner whatsoever made available to a member of the public, shall be deemed to be a
statement made to the public by, and only by, the person who had caused the statement to be
so expressed, made or contained;

(2) Permits the publication of any advertisement whether in any newspaper or otherwise, for
the sale or supply at a bargain price, of goods or services that are not intended to be offered
for sale or supply at the bargain price, or for a period that is, and in quantities that are,
reasonable, having regard to the nature of the market in which the business is carried on, the
nature and size of business, and the nature of the advertisement.

Explanation: For the purpose of clause (2), "bargaining price" means:

(a) A price that is stated in any advertisement to be a bargain price, by reference to an

ordinary price or otherwise, or

(b) a price that a person who reads, hears or sees the advertisement, would reasonably
understand to be a bargain price having regard to the prices at which the product advertised or
like products are ordinarily sold;

Permits
(a) the offering of gifts, prizes or other items with the intention of not providing them as
offered or creating impression that something is being given or offered free of charge
when it is fully or partly covered by the amount charged, in the transaction as a whole; the
conduct of any contest, lottery, game of chance or skill, for the purpose of promoting, directly
or indirectly, the sale, use or supply of any product or any business interest;
(3A) withholding from the participants of any scheme offering gifts, prices or other items free
of charge on its closure the information about final results of the scheme.

Explanation: For the purpose of this sub clause, the participants of a scheme shall be deemed
to
Have been informed of the final results of the scheme where such results are within a
reasonable time published, prominently in the same newspaper in which the scheme was
originally advertised;

Permits the sale or supply of goods intended to be used, or are of a kind likely to be used, by
consumers, knowing or having reason to believe that the goods do not comply with the
standards prescribed by competent authority relating to performance, composition, contents,
design, constructions, finishing or packaging as are necessary to prevent or reduce the risk of
injury to the person using the goods;

Permits the hoarding or destruction of goods, or refuses to sell the goods or to make them
available for sale or to provide any service, if such hoarding or destruction or refusal raises or
tends to raise or is intended to raise, the cost of those or other similar goods or services.

Manufacture of spurious goods or offering such goods for sale or adopting deceptive
practices in the provision of services;

Any reference in this Act to any other Act or provision thereof which is not in force in any
area to which this Act applies shall be construed to have a reference to the corresponding Act
or provision thereof in force in such area.

Comments
1. Persons buying goods either for re-sale or for use in large scale profit making activity
will not be `consumers’.

2. The government servants and the staff of the Accountant General Office of the
Comptroller and Auditor General maintains the records of provident fund of
government servants, issue slips of deposits of fund and on retirement final payments
are made to the subscribers. The government servants and the staff of the Accountant
General in discharging their duties does not render any service for consideration, nor
hiring of any service is involved hence, maintenance of General Provident Fund
Accounts does not fall within the meaning of `service’;

3. When the National Commission as a matter of fact, recorded the findings as to the
discharge of the liability of the carrier, the Supreme Court did not interfere on the
issue;

4. The insurance company is not a consumer. Hence the consumer complaint by

insurance company is not maintainable;
 5. The repudiation of the claim by the Insurance Company on the ground that the driver
was not holding a valid driving license at the time of the accident could not be termed
as deficiency in service or negligence on the part of the Insurance Company within
the meaning of section Pushpa Yashwant Ghatge, I996NCJ 195.

6. Medical services are covered under the definition of "service". Service includes
rendering of consultation, diagnosis and treatment, both medical and surgical; Indian
Medical Association v. VP. Shantha, 1995 SCALE 273.

7. "Contract of personal service" has to be distinguished from a "contract for personal

service". In the absence of relationship of master and servant between the patient and the
medical practitioner, the service rendered by a medical practitioner to the patient cannot
be regarded as service rendered under a contract of personal service. It is "contract for
personal services". Wherever, there is relationship like that of master and servant it is a
"contract of personal service" and is excluded from the purview of the Act; Indian
Medical Association v. VP. Shantha, 1995.

1. A licensee to run a phone is not a consumer;

2. A lottery ticket holder is not "consumer" within the ambit of the definition of
"consumer" under the Act;

10. Applicant who merely applies for allotment of shares is not a consumer;

11. The beneficial consumer jurisdiction cannot be extended to lotteries and wagering
transactions or consequential rights flowing from void contracts;

12. If somebody does not perform his part of the contract, it amount/ to deficiency in service.

13. The agreement for hypothecation does not create the ownership right, and as such no
complaint can be maintained for deficiency in service;

14. Undue delay in declaration of examination result is obviously deficiency in service;

15. The student is a consumer of service of educational institute;

16. A person who receives medical treatment in a Government hospital is not a consumer
under the Act;

17. The remedy provided under the Act is in addition to the provisions of any other law for
the time being in force. The provisions of this Act give the consumer an additional remedy
besides those that may be available under other existing laws;
18. When a case is pending in a court in which full evidence is to be recorded the Forums
constituted under the Consumer Protection Act, 1986 should not entertain the complaint with
respect to the same cause of action;

19. It is authoritatively settled that the arbitration clause is not a bar to the entertainment of
the
Complaint by the Redressal Agency constituted under the Act, even if the arbitration
provision has been laid down in a statute

Consumer Protection Councils

The Central Consumer Protection Council: The Central Government shall, by notification,
establish with effect from such date as it may specify in such notification, a Council to be
known as the Central Consumer Protection Council (hereinafter referred to as the Central
Council). The Central Council shall consist of the following members, namely:-

(a) The Minister in charge of the 1[consumer affairs] in the Central Government, who shall
Be its Chairman, and

(b) Such number of other official or non-official members representing such interests as
May be prescribed.

Procedure for meetings of the Central Council: The Central Council shall meet as and when
necessary, but at least one meeting] of the Council shall be held every year. The Central
Council shall meet at such time and place as the Chairman may think fit and shall observe
such procedure in regard to the transaction of its business as may be prescribed.

Objects of the Central Council: The objects of the Central Council shall be to promote and
protect the rights of the consumers such as:

(a) The right to be protected against the marketing of goods 3[and services] which are
hazardous to life and property;

(b) The right to be informed about the quality, quantity, potency, purity, standard and price of
goods3 [or services, as the case may be] so as to protect the consumer against, unfair trade
practices;

(c) The right to be 'assured, wherever possible, access to a variety of goods 3[and services] at
competitive prices;

(d) The right to be heard and to be assured that consumer's interests will receive due
consideration at appropriate Fora;

(e) The right to seek redressal against unfair trade practices 3[or restrictive trade practices] or
unscrupulous exploitation of consumers; and

(f) The right to consumer education.

The State Consumer Protection Councils: The State Government shall, by notification,
establish with effect from such date as it may specify in such notification, a Council to be
known as the Consumer Protection Council. The State Council shall consist of the following
members, namely:

(a) The Minister in charge of consumer affairs in the State Government who shall be its
Chairman;

(b) Such number of other official or non-official members representing such interests as may
'be prescribed by the State Government.

(c) Such number of other official or non-official members, not exceeding ten, as may be
nominated by the Central Government.)

The State Council shall meet as and when necessary but not less than two meetings shall be
held every year. The State Council shall meet at such time and place as the Chairman think fit
and shall observe such procedure in regard to the transaction of its business as may be
prescribed by the State Government.

Objects of the State Council: The objects of every State Council shall be to promote and
protect within the State the rights of the consumers laid down in clauses.

The District Consumer Protection Council: The State Government shall establish for every
district, by notification, a council to be known as the District Consumer Protection Council
with effect from such date as it may specify in such notification.

The District Consumer Protection Council (hereinafter referred to as the District Council)
shall consist of the following members, namely –

(a) The Collector of the district (by whatever name called), who shall be its Chairman;
And

(b) Such number of other official and non-official members representing such interests as
May be prescribed by the State Government.

The District Council shall meet as and when necessary but not less than two meetings shall be
held every year. The District Council shall meet as such time and place within the district as
the Chairman may think fit and shall observe such procedure in regard to the transaction of its
business as may be prescribed by the State Government.)

Objectives of the District Council: The objectives of every District Council shall be to
promote and protect within the district the rights of the consumers laid down in clauses (a) t
(f) of section

Consumer Disputes Redressal Agencies

1. A Consumer Disputes Redressal Forum to be known as the "District Forum" established

by the State Government in each district of the State by notification,[Provided that the State
Government may, if it deems fit, establish more than one District Forum in a district.

2. A Consumer Disputes Redressal Commission to be known as the "State Commission"

established by the State Government in the State by notification; and (c) A National
Consumer Disputes Redressal Commission established by the Central Government by
notification.

Composition of the District Forum: Each District Forum shall consist of:

(a) A person who is, or has been, or is qualified to be a District Judge, who shall be its
President;

(b) Two other members, one of whom shall be a woman, who shall have the following
qualifications, namely:
(i) Be not less than thirty-five years of age
(ii) Possess a bachelor’s degree from a recognized university
(iii) Be persons of ability, integrity and standing, and have adequate problems relating
To economics, law, commerce, accountancy, industry public affairs or administration:
Provided that a person shall be disqualified for appointment as a member, if he:

(a) Has been convicted and sentenced to imprisonment for an offence which, in
the opinion of the State Government, involves moral turpitude; or
(b) Is an undercharged insolvent; or
(c) Is of unsound mind and stands so declared by a competent court; or
(d) Has been removed or dismissed from the service of the Government or a
body corporate owned or controlled by the Government; or
(e) has, in the opinion of the state Government, such financial or other interest
as is likely to affect prejudicially the discharge by him of his functions as a
member; or
(f) Has such other disqualifications as may be prescribed by the State
Government ;)

Every appointment under sub-section shall be made by the State Government on the
recommendation of a selection committee consisting of the following, namely:

(i) The President of the State Commission - Chairman

(ii) Secretary, Law Department of the State - Member
(iii) Secretary, incahrge of the Department – Member dealing with consumer
affairs in the State

Every member of the District Forum shall hold office for a term of five years or up to the age
of 65 years, whichever is earlier. Provided that a member shall be eligible for re-appointment
for another term of five years or up to the age of sixty-five years, whichever is earlier, subject
to the condition that he fulfilsthe qualifications and other conditions for appointment
mentioned and such re-appointment is also made on the basis of the recommendation of the
Selection Committee.

When a member may resign his office in writing under his hand addressed to the State
Government and on such resignation being accepted, his office shall become vacant
and may be filled by appointment of a person possessing any of the qualifications
mentioned in
The salary or honorarium and other allowances payable to, and the other terms and conditions
of service of the members of the District Forum shall be such as may be prescribed by the
State Government.

Jurisdiction of the District Forum: Subject to the other provisions of this Act, the District
Forum shall have jurisdiction to entertain complaints where the value of the goods or services
and the compensation, if any, claimed 2[does not exceed rupees twenty lakhs]. A complaint
shall be instituted in a District Forum within the local limits of whose jurisdiction-

Comments
(i) Objection & regarding territorial jurisdiction should be taken at the earliest opportunity or
the same deemed to have been waived;
(ii) A petition of complaint can be filed against corporation carrying on business within the
territory of District Forum or Commission even though its sole or principal office is situated
outside state limits;

Manner in Which Complaint Shall Be Made

A complaint in relation to any goods sold or delivered or agreed to be sold or delivered or any
service provided or agreed to be provided may be filed with a District Forum by:

(a) The consumer to whom such goods are sold or delivered or agreed to be sold or delivered
or such service provided or agreed to be provided;

(b) any recognized consumer association whether the consumer to whom the goods sold or
delivered or agreed to be sold or delivered or service provided or agreed to be provided is a
member of such association or not;

(c) one or more consumers, where there are numerous consumers having the same interest,
with the permission of the District Forum, on behalf of, or for the benefit of, all consumers so
interested; or

(d) The Central or the State Government, as the case may be, either in its individual capacity
or as a representative of interests of the consumers in general.

Every complaint filed under sub-section (1) shall be accompanied with such amount of fee
and payable in such manner as may be prescribed. On receipt of a complaint made under sub-
section the District Forum may, by order, allow the complaint to be proceeded with or
rejected:
The admissibility of the complaint shall ordinarily be decided within twenty-one days from
the date on which the complaint was received. Where a complaint is allowed to be proceeded
with under sub-section (3), the District Forum may proceed with the complaint in the manner
provided under this Act: Provided that where a complaint has been admitted by the District
Forum, it shall not be transferred to any other court or tribunal or any authority set up by or
under any other law for the time being in force.

Explanation: For the purpose of this section, "recognized consumer association" means any
voluntary consumer association registered under the Companies Act, 1956 (1 of 1956) or any
other law for the time being in force.

Procedure on Receipt of Complaint

(1) The District Forum shall, on admission of a complaint, if it relates to any goods:

(a) Refer a copy of the complaint to the opposite party mentioned in the complaint directing
him
to give his version of the case within a period of thirty days or such extended period not
exceeding fifteen days as may be granted by the District Forum;

(b) where the opposite party on receipt of a complaint referred to him under clause (a) denies
or disputes the allegations contained in the complaint, or omits or fails to take any action to
represent his case within the time given by the District Forum, the District Forum shall
proceed to settle the consumer dispute in the manner specified in clauses (c) to (g);

(c) where the complaint alleges a defect in the goods which cannot be determined without
proper analysis or test of the goods, the District Forum shall obtain a sample of the goods
from the complainant, seal it and authenticate it in the manner prescribed and refer the sample
so sealed to the appropriate laboratory along with a direction that such laboratory make an
analysis or test, whichever may be necessary, with a view to finding out whether such goods
suffer from any defect alleged in the complaint or from any other defect and to report its
findings thereon to the District Forum within a period of forty-five days of the receipt of the
reference or within such extended period as may be granted by the District Forum;

(d) Before any sample of the goods is referred to any appropriate laboratory under clause (c),
the District Forum may require the complainant to deposit to the credit.

(e) the District Forum shall remit the amount deposited to its credit under clause (d) to the
appropriate laboratory to enable it to carry out the analysis or test mentioned in clause (c) and
on receipt of the report from the appropriate laboratory, the District Forum shall forward a
copy of the report along with such remarks as the District Forum may feel appropriate to the
opposite party;

(f) if any of the parties disputes the correctness of the findings of the appropriate laboratory,
or disputes the correctness of the methods of analysis or test adopted by the appropriate
laboratory, the District Forum shall require the opposite party or the complainant to submit in
writing his objections in regard to the report made by the appropriate laboratory;

(g) The District Forum shall thereafter give a reasonable opportunity to the complainant as
well as the opposite party of being heard as to the correctness or otherwise of the report made
by the appropriate laboratory and also as to the objection made in relation thereto under
clause (f)
And issue an appropriate order.

The District Forum shall, if the complaint relates to any services:

(a) refer a copy of such complaint to the opposite party directing him to give his version of
the case within a period of thirty days or such extended period not exceeding fifteen days as
may be granted by the District Forum.

(b) Where the opposite party, on receipt of a copy of the complaint, referred to him under
clause (a) denies or disputes the allegations contained in the complaint, or omits or fails to
take any action to represent his case within the time given by the District Forum, the District
Forum shall proceed to settle the consumer dispute.

(c) on the basis of evidence brought to its notice by the complainant and the opposite party,
where the opposite party denies or disputes the allegations contained in the complaint, or (ex-
parte on the basis of evidence) brought to its notice by the complainant where the opposite
party omits or fails to take any action to represent his case within the time given by the
Forum. Where the complainant fails to appear on the date of hearing before the District
Forum, the District Forum may either dismiss the complaint for default or decide it on
merits.)

Every complaint shall be heard as expeditiously as possible and endeavor shall be made to
decide the complaint within a period of three months from the date of receipt of notice by
opposite party where the complaint does not require analysis or testing of commodities and
within five months if it requires analysis or testing of commodities. Provided that no
adjournment shall be ordinarily granted by the District Forum unless sufficient cause is
shown and the reasons for grant of adjournment have been recorded in writing by the Forum:

For the purposes of this section, the District Forum shall have the same powers as are vested
in a civil court under Code of Civil Procedure, 1908 while trying a suit in respect of the
following matters, namely:
(i) The summoning and enforcing the attendance of any defendant or witness and
examining the witness on oath,
(ii) The discovery and production of any document or other material object producible
as evidence,
(iii) The reception of evidence on affidavits,
(iv) The requisitioning of the report Qi the concerned analysis or test from the
Appropriate laboratory or from any other relevant source.
(v) Issuing of any commission for the examination of any witness, and
(vi) Any other matter which may be prescribed.

Every proceeding before the District Forum shall be deemed to be a judicial proceeding
within the meaning of sections 193 and 228 of the Indian Penal Code (45 of 1860), and the
district Forum shall be deemed to be a civil court for the purposes of section'" 195, and
Chapter XXVI of the Code of Criminal Procedure, 1973 (2 of 1974).

In the event of death of a complainant who is a consumer or of the opposite party against
whom the complaint has been filed, the provisions of Order XXII of the First Scheduled to
the Code of Civil Procedure, 1908 (5 of 1908) shall apply subject to the modification that
every reference therein to the plaintiff and the defendant shall be construed as reference to a
complainant or the opposite party, as case may be.)

Finding of the District Forum

If, after the proceeding conducted under section 13, the District Forum is satisfied that the
goods complained against suffer from any of the defects specified in the complaint or that
any of the allegations contained in the complaint about the services are proved, it shall issue
an order to the opposite party directing him to [do] one or more of the following things,
namely:
(a) To remove the defect pointed but by the appropriate laboratory from the goods in
question;
(b) To replace the goods with new goods of similar description which shall be free from any
defect?
(c) To return to the complainant the price, or, as the case may be, the charges paid by the
complainant;
(d) to pay such amount as may be awarded by it as compensation to the consumer for any loss
or injury suffered by the consumer due to the negligence of the opposite party; (Provided that
the District Forum shall have the power to grant punitive damages in such circumstances as it
deems fit: )
(e) To discontinue the unfair trade practice or the restrictive trade practice or not to repeat
them;
(f) Not to offer the hazardous goods for sale;

(g) To withdraw the hazardous goods from being offered for sale;

(h) to cease manufacture of hazardous goods and to desist from offering services which are
hazardous in nature; to pay such sum as may be determined by it, if it is of the opinion that
loss or injury has been suffered by a large number of consumers who are not identifiable
conveniently: Provided that the minimum amount of sum so payable shall not be less than
five per cent of the value of such defective goods sold or services provided, as the case may
be, to such consumers: Provided further that the amount so obtained shall be credited in favor
of such person and utilized in such manner as may be prescribed; to issue corrective
advertisement to neutralize the effect of misleading advertisement at the cost of the opposite
party responsible for issuing such misleading advertisement.

(i) To provide for adequate costs to parties.

Every order made by the District Forum under sub-section (l) shall be signed by its President
and the member or members who conducted the proceeding: Provided that where the
proceeding is conducted by the President and one member and they differ on any point or
points, they shall state the point or points on which they differ and refer the same to the other
member for hearing on such point or points and the opinion of the majority shall be the order
of the District Forum.

Appeal
Any person aggrieved by an order made by the District Forum may prefer an appeal against
such order to the State Commission within a period of thirty days from the date of the order,
in such form and manner as may be prescribed: Provided that the State commission may
entertain an appeal after the expiry of the said period of thirty days If it is satisfied that there
was sufficient cause for not filing it within that period. (Provided further that no appeal by a
person, who is required to pay any amount in terms of an order of the District Forum, shall be
entertained by the State Commission unless the appellant has deposited in the prescribed
manner fifty per cent of that amount of twenty-five thousand rupees, whichever is less.)
Composition of the State Commission
Each State Commission shall consist of:

(a) A person who is or has been a Judge of a High Court, appointed by the State Government,
who shall be its President.

(b) not less than two, and not more than such number of members, as may be prescribed, and
one of who shall be a woman, who shall have the following qualifications, namely:
(I) am not less than thirty-five years of age;
(ii) Possess a bachelor’s degree from a recognized university; and
(iii) be persons of ability, integrity and standing, and have adequate knowledge and
experience of at least ten years in dealing with problems relating to economics, law,
commerce, accountancy, industry, public affairs or administration: Provided that not more
than fifty per cent of the members shall be from amongst persons having a judicial
background.

Explanation: For the purposes of this clause, the expression “persons having a judicial
background” shall mean persons having knowledge and experience for at least a period of ten
years as a presiding officer at the district level court or any tribunal at equivalent level:

Provided further that a person shall be disqualified for appointment as a member, if he:

(a) Has been convicted and sentenced to imprisonment for an offence which, in the opinion of
the State Government, involves moral turpitude; or

(b) Is an undercharged insolvent; or

(c) Is of unsound mind and stands so declared by a competent court; or

(d) Has been removed or dismissed from the service of the Government or a body corporate
owned or controlled by the Government; or

(e) has, in the opinion of the State Government, such financial or other interest, as is likely to
affect prejudicially the discharge by him of his functions as a member; or

(f) Has such other disqualifications as may be prescribed by the State Government.

Every appointment under Sub-section (1) shall be made by the State Government on the
recommendation of a Selection Committee consisting of the following members, namely:

(i) President of the State Commission -Chairman

(ii) Secretary of the Law Department of the State -Member
(iii) Secretary, in charge of Department
Dealing with consumer affairs in the State -Member

(1B) (i) the jurisdiction, powers and authority of the State Commission may be exercised by
Benches thereof.
 The salary or honorarium and other allowances payable to, and the other terms and
conditions of service 2[* * *] of, the members of the State Commission shall be such as may
be prescribed by the State Government.

Every member of the State Commission shall hold office for a term of five years or up to the
age of sixty-seven years, whichever is earlier: Provided that a member shall be eligible for re-
appointment for another term of five years or up to the age of sixty-seven years, whichever is
earlier, subject to the condition that he fulfils the qualifications and other conditions for
appointment mentioned.

Jurisdiction of the State Commission.-Subject to the other provisions of this Act,

The State Commission shall have jurisdiction

(a) to entertain (i) complaints where the value of the goods or services and
compensation, if any, claimed exceeds rupees 1 [exceeds rupees twenty lakhs but does not
exceed rupees one crore ; ) and (ii) appeals against the orders of any District Forum within
the State; and (b) to call for the records and pass appropriate orders in any consumer dispute
which is pending before or has been decided by any District Forum within the State, where it
appears to the State Commission that such District Forum has exercised a jurisdiction not
vested in it by law, or has failed to exercise a jurisdiction so vested or has acted in exercise of
its jurisdiction illegally or with material irregularity.

A complaint shall be instituted in a State Commission within the limits of whose jurisdiction:

(a) the opposite party or each of the opposite parties, where there are more than one, at the
time of the institution of the complaint, actually and voluntarily resides or carries on business
or has a branch office or personally works for gain; or

(b) any of the opposite parties, where there are more than one, at the time of the institution of
the complaint, actually and voluntarily resides, or carries on business or has a branch office
or personally works for gain, provided that in such case either the permission of the State
Commission is given or the opposite parties who do not reside or carry on business or have a
branch office or personally works for gain, as the case may be, acquiesce in such institution;
or

(c) The cause of action, wholly or in part, arises.

Circuit Benches: The State Commission shall ordinarily function in the State Capital but
may perform its functions at such other place as the State Government may, in consultation
with the State Commission, notify in the Official Gazette, from time to time.

Appeals
Any person aggrieved by an order made by the State Commission in exercise of its powers
conferred by sub-clause (i) of clause (a) of section 17 may prefer an appeal against such order
to the National Commission within a period of thirty days from the date of the order in such
form and manner as may be prescribed:

Provided that the National Commission may entertain an appeal after the expiry of the said
period of thirty days if it is satisfied that there was sufficient cause for not filing it within that
period. (Provided further that no appeal by a person, who is required to pay any amount in
terms of an order of the state Commission, shall be entertained by the National Commission
unless the appellant has deposited in the prescribed manner fifty per cent of the amount or
rupees thirty-five thousand, whichever is less.)

Hearing of appeal An appeal filed before the State Commission or the National Commission
shall be heard as expeditiously as possible and an endeavor shall be made to finally dispose
of the appeal within a period of ninety days from the date of its admission: Provided that no
adjournment shall be ordinarily granted by the State Commission or the National
Commission, as the case may be, unless sufficient cause is shown and the reasons for grant of
adjournment have been recorded in writing by such Commission: Provided further that the
State Commission or the National Commission, as the case may be, shall make such orders as
to the costs occasioned by the adjournment as may be provided in the regulations made under
this Act: Provided also that in the event of an appeal being disposed of after the period so
specified, the State Commission or the National Commission, as the case may be, shall record
in writing the reasons for the same at the time of disposing of the said appeal.

Composition of the National Commission

The National Commission shall consist of:

(a) a person who is or has been a Judge of the Supreme Court, to be appointed by the Central
Government, who shall be its President; Provided that no appointment under this clause shall
be made except after consultation with the Chief Justice of India;

(b) Not less than four, and not more than such number of members, as may be prescribed,
And one of whom shall be a woman, who shall have the following qualifications, namely:

(I) am not less than thirty-five years of age;

(ii) Possess a bachelor’s degree from a recognized university; and
(iii) be persons of ability, integrity and standing and have adequate knowledge and
experience of at least ten years in dealing with problems relating to economics, law,
commerce, accountancy, industry, public affairs or administration: Provided that not more
than fifty per cent of the members shall be from amongst the persons having a judicial
background.

Explanation: - For the purposes of this clause, the expression “persons having judicial
background” shall mean persons having knowledge and experience for at least a period of ten
years as a presiding officer at the district level court or any tribunal at equivalent level:
Provided further that a person shall be disqualified for appointment, (refer to clauses for
state commission)

Every appointment under this clause shall be made by the Central Government on the
recommendation of a Selection Committee consisting of the following, namely:

(a) A person who is a Judge of the Supreme Court, to be nominated by the Chief Justice of
India -Chairman.
(b) The Secretary in the Department of Legal Affairs in the Government of India -Member.
(c) Secretary of the Department dealing with consumer affairs in the Government of India -
Member.
(i) The jurisdiction, powers and authority of the National Commission may be exercised by
Benches thereof.
(ii) A Bench may be constituted by the President with one or more members as the President
may deem fit.
(iii) If the members of a Bench differ in opinion on any point, the points shall be decided
according to the opinion of the majority, if there is a majority, but if the members are equally
divided, they shall state the point or points on which they differ, and make a reference to the
President who shall either hear the point or points himself or refer the case for hearing on
such point or points by one or more or the other members and such point or points shall be
decided according to the opinion of the majority of the members who have heard the case,
including those who first heard it.)

Every member of the National Commission shall hold office for a term of five years or up to
the age of seventy years, whichever is earlier and shall not be eligible for reappointment.
Provided that a member shall be eligible for re-appointment for another term of five years or
up to the age of seventy years, whichever is earlier, subject to the condition that he fulfills the
qualifications and other conditions for appointment completion of his term

Jurisdiction of the National Commission

Subject to the other provisions of this Act, the National Commission shall have jurisdiction-
(a) To entertain:
(i) Complaints where the value of the goods or services and compensation, if any,
Claimed exceeds rupees l [twenty lakhs]; and
(ii) Appeals against the orders of any State Commission; and

(b) to call for the records and pass appropriate orders in any consumer dispute which is
pending before or has been decided by any State Commission where it appears to the
National Commission that such State Commission has exercised a jurisdiction not vested in it
by law, or has failed to exercise a jurisdiction so vested, or has acted in the exercise of its
jurisdiction illegally or with material irregularity.

Power of and procedure applicable to the National Commission

(1) The provisions of sections 12, 13 and 14 and the rules made there under for the disposal
of complaints by the District Forum shall, with such modifications as may be considered
necessary by the Commission, be applicable to the disposal of disputes by the National
Commission.

(2) without prejudice to the provisions contained in sub-section (1) the National Commission
shall have the power to review any order made by it, when there is an error apparent on the
face of record.)

Power to set aside ex parte orders: Where an order is passed by the National Commission ex
parte against the opposite party or a complainant, as the case may be, the aggrieved party may
apply to the Commission to set aside the said order in the interest of justice.

Transfer of cases: On the application of the complainant or of its own motion, the National
Commission may, at any stage of the proceeding, in the interest of justice, transfer any
complaint pending before the District Forum of one State to a District Forum of another State
or
Before one State Commission to another State Commission.

Circuit Benches: The National Commission shall ordinarily function at New Delhi and,
perform its functions at such other place as the Central Government may, in consultation with
the National Commission, notify in the official Gazette, from time to time.

Appeal
Any person, aggrieved by an order made by the National Commission may prefer an appeal
against such order of the Supreme Court within a period of thirty days from the date of the
order:

Provided that the Supreme Court may entertain an appeal after the expiry of the said period of
thirty days if it is satisfied that there was sufficient cause for not filing it within that period.
(Provided further that no appeal by a person who is required to pay any amount in terms of an
order of the National Commission shall be entertained by the Supreme Court unless that
person has deposited in the prescribed manner fifty per cent of that amount or rupees fifty
thousand, whichever is less.

Finality of Orders: Every order of a District Forum, the State Commission or the National
Commission shall, if no appeal has been preferred against such order under the provisions of
this Act, be final.

Limitation period: The District Forum, the State Commission or the National Commission
shall not admit a complaint unless it is filed within two years from the date on which the
cause of action has arisen. Notwithstanding anything contained in sub-section ,a complaint
may be entertained after the period specified in sub-section ,if the complainant satisfies the
District Forum, the State Commission or the National Commission, as the case may be, that
he had sufficient cause for not filing the complaint within such period: Provided that no such
complaint shall be entertained unless the National Commission, the State Commission or the
District Forum, as the case may be, records its reasons for condoning such delay.

Administrative control: The National Commission shall have administrative control

Over all the State Commissions in the following matters, namely:
(I) calling for periodical return regarding the institution, disposal, pendency of cases;

(ii) issuance of instructions regarding adoption of uniform procedure in the hearing

of matters, prior service of copies of documents produced by one party to the
opposite parties, furnishing of English translation of judgments written in any
language, speedy grant of copies of documents;
(iii) Generally overseeing the functioning of the State Commissions or the District
Fora to ensure that the objects and purposes of the Act are best served
without in any way interfering with their quasi-judicial freedom.

The State Commission shall have administrative control over all the District For a
Within its jurisdiction in all matters referred to in sub-section (1).

Enforcement of orders by the Forum, the State Commission or the National

Commission
(1) Where an interim order made under this Act is not complied with, the District Forum or
the State Commission or the National Commission, as the case may be, may order the
property of the person, not complying with such order to be attached.

(2) No attachment made shall remain in force for more than three months at the end of which,
if the non-compliance continues, the property attached may be sold and out of the proceeds
thereof, the District Forum or the State Commission or the National Commission may award
such damages as it thinks fit to the complainant and shall pay the balance, if any, to the party
entitled thereto.

(3) Where any amount is due from any person under an order made by a District Forum, State
Commission or the National Commission, as the case may be, the person entitled to the
amount may make an application to the District Forum, the State Commission or the National
Commission, as the case may be, and such District Forum or the State Commission and the
National Commission may issue a certificate for the said amount to the Collector of the
district (by whatever name called) and the Collector shall proceed to recover the amount in
the same manner as arrears of land revenue.)

Dismissal of frivolous or vexatious complaints: Where a complaint instituted before the

District Forum, the State Commission or, as the case may be, the National Commission is
found to be frivolous or vexatious, it shall, for reasons to be recorded in writing, dismiss the
complaint and make an order that the complainant shall pay to the opposite party such cost,
not exceeding ten thousand rupees, as may be specified in the order.

Comments: (i) Where the complaint is mala fide, vexatious and frivolous and the opposite
party has to incur expenses for contesting the complaint, the Redressal Fora should saddle the
complainant with costs.

Penalties
Where a trader or a person against whom a complaint is made l[ or the complainant] fails or
omits to comply with any order made by the District Forum, the State Commission or the
National Commission, as the case may be, such trader or person ([or complainant] shall be
punishable with imprisonment for a term which shall not be less than one month but which
may extend to three years, or with fine which shall not be less than two thousands rupees but
which may extend to ten thousand rupees, or with both:

Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), the
District Forum or the State Commission or the National Commission, as the case may be,
shall have the power of a Judicial Magistrate of the first class for the trial of offences under
this Act, and on such conferment of powers, the District Forum or the State Commission or
the National Commission, as the case may be, on whom the powers are so conferred, shall be
deemed to be a Judicial Magistrate of the first class for the purpose of the Code of Criminal
Procedure, 1973 (2 of 1974).

All offences under this Act may be tried summarily by the District Forum or the State
Commission or the National Commission, as the case may be.
 Amount of
Compensation You Court President Other Members
Seek

District Consumer Two other

Must be qualified to be a
Up to Rs. 20 Lakh Disputes Redressal members; one must
District Judge.
Forum be a woman

State Consumer Must be a person who is

Rs. 20 Lakh to Rs. 1 At least two other
Disputes Redressal or has been a Judge of a
Crore members.
Commission High Court.

National Consumer Must be a person who is

Higher than Rs. 1 At least four other
Disputes Redressal or has been a Judge of the
Crore members.
Commission Supreme Court

Consumer Awareness Tips

Cooling Off Period: Let’s say you make a purchase or sign a contract in your home and then
change your mind. If the deal is worth more than Rs 1000, you may have the right to cancel
within 10 days. It’s best to cancel by registered mail or fax to get your money back. Not all
contracts have a cooling off period. Under the Consumer Protection Act, 2002 the 10 day
cooling off period applies to Direct Sales Agreements, Time Share Agreements, Personal
Development Agreements, Credit Repair Agreements and Loan Broker Agreements.

Clear and Comprehensible Contracts: All required information in contracts must be clear,
comprehensible and prominent. If contracts are missing required information, you have the
right to cancel the contract, usually within 1 year.

Timely Remedies: When you cancel a contract under the CPA (preferably in writing), the
business has 15 days to return your money. The business is entitled to any goods the
consumer received under the agreement, and may be entitled to some money for goods or
services actually used.

No Obligation For Goods Not Requested: In fact, you may use them or throw them out. The
exception is if the good was addressed to someone else and delivered by mistake. You’re not
responsible for an unsolicited credit card either – unless you use the card.

What Are My Rights under The Consumer Protection Act?

Full Disclosure of Credit Terms: Anyone providing goods or services on credit must give the
consumer a written statement showing details of the credit terms, including the annual
percentage rate.
 Truthful Explanation of all Costs: All charges in a contract must be what they say they are.
For example, a business may not add a $20 surcharge for a “tax” that is not really for tax.
Make sure you understand what each charge is for and that it’s valid.

Freedom from False, Misleading or Deceptive Representations: This includes any falsehood,
such as representing that used goods are new, exaggerating the quality of goods or services,
or suggesting that a repair is needed when it is not.

Goods Cannot Be Repossessed If You Have Paid 2/3 Or More: A seller can’t take back goods
you’ve bought but not paid for fully, as long as you have paid two-thirds or more of the cost,
except by court order. But remember, if you miss a payment, the seller can take you to court
to get full payment.

Deliveries Made on Time: If delivery of a good doesn’t arrive within 30 days of the promised
date, you can cancel the contract by sending a cancellation letter. Get that promised date in
writing! But you lose the right to cancel the agreement if you accept delivery after the 30
days.

Written Estimates: A consumer is not required to pay more than 10 percent above the written
estimate provided by the supplier. If a supplier charges an amount that is 10 percent more
than the estimate the consumer may require the supplier to provide the goods or services for
the estimated amount.

Before You Sign Any Contract …

I. Know who you are dealing with. Don’t do business with any business that won’t provide
its name, street address and telephone number.

II. Protect your personal information. Share credit card or other personal information only
when you’re buying from a business you know and trust.

III. Take your time. Resist any urge to “act now” despite the offer and the terms. Once you
turn over your money, you may never get it back.

IV. Read the small print. Get all promises in writing and review all the documents carefully
before you pay any money or sign a contract.

V. Never pay for a “free” gift. Throw away any offer that asks you to pay for a gift. If it’s
free or a gift, you shouldn’t have to pay for it. Free is free.

VI. Check carefully for written warranties and guarantees.

VII. Under the Consumer Protection Act, 2002 consumers may have 10 days to cancel
contracts signed in their home, for any reason, and up to 1 year to cancel if the contract
fails to meet certain requirements. This cancellation may be subject to reasonable
compensation to the supplier.
VIII. Once you have decided on a business, check the Ministry’s Consumer Beware List, the
Better Business Bureau and with friends and family.

IX. Get written detailed estimates from three or four contractors and stay away from a
contractor who quotes a flat rate before inspecting your house.

X. Don’t be pressured to sign a contract right away in order to take advantage of a door-to-
door special.

XI. Keep down-payments to a minimum; ten per cent of the total estimate is fair and never
pay the full amount until the work has been completed.

XII. Make sure everything you agree to in an agreement is in writing: the cost; start and end
dates; and who is responsible for the clean-up.

XIII. A consumer is not required to pay more than 10 percent above the written estimate
provided by the supplier.

XIV. For large amounts of money, consider obtaining legal advice to review the contract terms.

What Was the Necessity of The Consumer Protection Act, and it’s Application to the
Medical Profession?

This is the foremost question which comes to the mind of the doctors. This necessity arose
because the existing laws of the land which provide for action in cases of medical negligence
under the Law of Tort and Indian Penal Code have some well documented problems. These
include the following: (i) Delay, which, in medical negligence cases, tends to be greater; (ii)
the cost of bringing an action, which is notoriously high in relation to the sums recovered in
damages; (iii) limited access to the courts; (iv) success depends on proof of both negligence
and causation ( which can be particularly difficult in cases of medical negligence).

Hence necessity to provide for an alternate system which would be easily accessible, speed
and cheap, gave birth to the Consumer Protection Act. This Act was made applicable to the
doctors because there are no provisions in the Indian Medical Council Act, 1956;

(i)to entertain any complaint from the patient;

(ii) to take action against the Medical Practitioner in case any negligence has been
committed;
(iii) to award any compensation, etc. in case the negligence is proved.
Who is a consumer? Consumer is (a) a patient who pays to get services of doctor /hospital;
(b) any person who pays for the patient; (c) legal heirs /representatives of such patients; (d)
spouse, parents and children of the patient.

Does the service rendered by doctors / hospitals stand excluded because it is under a contract
of personal service as distinguished from a contract for service? This is the key clause being
disputed by the doctors. The judgments till date have held that the medical services rendered
by doctors / hospitals for payment are covered under this Act as they are not Contract of
Personal Services but Contract for Services. Contract of Personal Service involves ‘Master -
Servant Relationship ‘hereunder:-

Master -Servant Relationship (as per National Commission Decision)

i) The employer’s (master’s) power of selection of his employee (servant).

ii) The payment of wages or other remuneration.

iii) The employer’s right of suspension or dismissal.

iv) The employer’s right to control the method of doing the work.

Doctor-Patient Relationship (as per doctors’ contention)

(i) A patient /guardian have full power of selecting his doctor/hospital. He is not under any
compulsion.

(ii) A doctor is also paid remuneration and steps into the shoes of an ‘employee’ during the
period he gives treatment or performs operation.

(iii) The patients/guardians also have the right to reject the services of doctor/hospital (which
is equivalent to suspension /dismissal) any moment they are not satisfied, they feel that they
have a better alternative without any reason.

On the basis of these three criteria the relationship between doctor and patient is similar to
master and servant. Patient can choose any doctor/hospital, go for treatment if the charges are
suitable and reject the services at any moment without assigning any reason.

(iv) Coming to the 4th criteria, which has been considered as cardinal in distinguishing
between Contract of personal service and Contract for Service is the EXISTENCE OF THE
RIGHT TO CONTROL. This control is never 100% even in Master-Servant contract, as
servant is not a machine. You can order a servant to suspend all other work and clean the
utensils but cannot control his response, how quick and well he will clean the utensils, how
many utensils he will break etc. We all know how much exactly, we can control the servant.
We all know the consequences, if we are rude, harsh, physically or verbally abusive with the
servant. We have got to be polite with him and respect his sensibilities. We must distinguish
between Master-Servant and Master-Slave relationship.

Medical professionals strongly feel that the relationship between Doctor - Patient is that of
Contract of Personal Service, where they consider patient to be the master and themselves as
servants with the exception that God has bestowed them with professional skill to serve the
master (human body) with a difference. They do not deny accountability, nor do they deny
existence of erring hospitals, deviant doctors and malpractice. But, the percentage of this is
too small to give to the general public daggers to run after doctors.

Medical professionals fully agree that efforts should continue so that the master (human
body) can be served even better. If the master losses faith in them, their very existence will be
threatened.

What exactly is the degree of control a doctor has over his patient? Kindly ponder over these
aspects: A patient may show up very late in course of illness - sometimes in terminal stages.
If consulting time / waiting time for consultation / treatment does not suit patient he is free to
approach someone else. Patient may come without any record whatsoever of treatment
already taken. Patient may be hiding facts from the doctor. The Doctor does not have any
foolproof method to know whether the history is true. Patient may question the probable
diagnosis, drugs prescribed, their role, side-effects, cost, interaction etc. and may avoid taking
the prescribed medicine. After the consumer (patient) leaves the doctor’s clinic with the
prescription, can a doctor control subsequent actions? Will all the prescribed medicines be
purchased? Will the prescribed doses he administered at correct intervals? Will the full
course of treatment be given? What if patient takes treatment for only 2 days instead of 5?
Will other precautions advised be taken? Can the doctor control follow-up of patient? Patient
may not come at all or come according to convenience. Doctor does not know he has
improved / deteriorated / gone elsewhere. Follow-up, which is cardinal component of medical
management, is entirely beyond the control of the doctor. Irregular treatment is tubercular
patients, rheumatic heart disease, epileptics etc. is well known.

Patient may comply with doctor’s prescription but concomitantly use Homeopathic,
Ayurvedic or Unani medicines, the interactions of which are not known. Patient may resort to
magic / faith healing. How can a doctor control this? A case of jaundice is advised certain
tests, precautions and medicines. Patient may not bother about these and after leaving
doctor’s clinic may go for "Hare" (Magic healing). In case of deterioration, how can a
doctor’s service be held deficient?
Some patients refuse investigations without which at times correct management is not
possible.
Whenever a patient feels that he is not getting well with the treatment of a doctor/ hospital he
is free to leave any moment, or to consult any other doctor. Most private hospitals permit
consultation with any doctor the patient /attendants wish to. They can always question the
rationale of treatment, progress of illness during the course of treatment. Doctor does not
guarantee a diagnosis. It may be a provisional diagnosis or a differential diagnosis on which
the treatment may be based. Doctor never guarantees a cure. He makes his best efforts
because he knows that much more than anything else, his professional reputation is at stake.

Preventive Steps against Litigation

It is not as if this aspect has not crossed the minds of doctors before the application of
Consumer Protection Act (CPA) to medics. Complaints have been lodged with State Medical
Councils and M.C.I.., and there have been instances of action taken against doctors. More
frequently patients have been suing & prosecuting doctors in Civil and Criminal Courts. The
medical professionals have been exercising due caution while dealing with patients. With the
coming into existence of compensation oriented Consumer Forums, the medical profession
has been suddenly made to sit-up. What they were doing till the other day in mutual trust
could land them into trouble, if they do not exercise extra precautions.

Where the doctor feels that the patient is suffering from some major illness in which
complications are pre-existing or are likely to occur, he should take proper precautions. The
precautions desired to be taken may be summarized as “Do’s and Don’ts" which are as
follows:

Some Do's

1. Mention your qualifications on the prescription. Qualifications mean recognized degrees /

diplomas as regulated by the Indian Medical Degrees Act, 1916 as amended from time to
time.

2. Mention of scholarships/training / membership/awards which are not qualifications should

be avoided.

3. Always mention date and timing of the consultation.

4. Mention age, sex, weight (if child).

5. in complicated cases record precisely history of illness and substantial physical findings
about the patient on your prescription.

6. If the patient/attendants are erring on any count (history not reliable, refusing
investigations, refusing admission) make a note of it or seek written refusal preferably in
local language with proper witness.

7. Mention the condition of patient in specific /objective terms. Avoid vague / non-specific
terminology.

8. Record history of drug allergy.

9. Write name of drugs clearly. Use correct dosages (by revising knowledge periodically) and
mention clearly method and interval of administration. Here one must use local or sign
language. Do not forget writing precautions like Sat./p.c./arc./locally/with milk/has. Etc.

10. If a drug is a poison (e.g., certain local applications), warn in writing.

11. Mention additional precautions e.g., food, rest, avoidance of certain drugs, allergens,
alcohol, smoking etc. if indicated.

12. Mention whether prognosis explained. If necessary take a signature of patient /attendant,
after explaining the prognosis in written local language.

13. In case of any deviation from standard care, mention reasons.

14. Specifically mention review, SOS/or follow-up schedule.

15. Mention if patient /attendant are/is under effect of alcohol/drugs.

16. In case a particular drug/equipment is not available, make a note.

17. Mention where the patient should contact in case of your non-availability /emergency.

18. Keep updating your knowledge. Read again what you think you already know. You will
be in for surprises.

19. Routinely advice X-rays in injury to bones /joints.

Some Don’ts

1. Do not hesitate to discuss the case with your colleagues.

2. Do not hesitate to discuss the case with patients /attendants.

3. Do not write Ayurvedic formulations.

4. Do not allow substitutions.

5. For goodness sake do not examine a patient if you are sick, exhausted, under effect of
alcohol.

6. Never talk loose of your colleagues, despite intense professional rivalry. Never criticize
your brother in profession.

7. The patient /attendants may incite you to say/do something. They may seek your comments
on the other doctor’s treatment. There is always a polite way to set aside their queries.

8. Remember if you had seen the case from start you would done the same. If your colleague
has made error of judgement regarding diagnosis or treatment, you never know under what
circumstances this happened.

9. Do not adopt experimental method in treatment. If there is some rationale do it only after
informed consent.

10. If you go back and read the Duties and Obligations of Doctors carefully and apply them
religiously in your day to day practice, you are safe.

Protection against Outcome of Litigation

A tertiary level of protection against outcome of litigation would be to go for Insurance

cover. PROFESSIONAL INDEMNITY INSURANCE cover became available for Doctors
and Medical establishments only recently, i.e. from December, 1991.

The term “indemnity “means reimbursement, to compensate. The principle of indemnity is

strictly observed in liability insurances. These insurances (e.g., Professional Indemnity
Insurance) are designed to provide the insured person protection against the financial
consequences of legal liability. If the insured is legally liable to pay damages to others, the
policy will indemnify him subject to the terms, conditions and limitations of the contract.
Indemnity is also available in respect of legal costs awarded against the insured as well as
legal costs and expenses incurred by the insured with the written consent of the insurers in the
defense of settlement of claims.

Professional Indemnity Insurance: Salient features and terms and conditions of Professional
Indemnity Insurance Policy as provided by the General Insurance Corporation of India are
given hereunder :-

General Rules and Regulations:

1. Applicability -The policy provides insurance cover in respect of ERRORS and
OMISSIONS on the part of the professionals whilst rendering their services. This applies to
Doctors and Medical Establishments, Engineers, Financial Consultants, Management
Consultants, Lawyers, Advocates, Solicitors and Counsels. The agreeable limits within India
and including Nepal / Bhutan, for any one year/during the policy period, shall not exceed Rs.
2 crores.

2. Standard Proposal Form -Insurers shall obtain duly completed Standard Proposal Form
from the prosecutors at inception and subsequent renewals. No cover shall be granted unless
a declaration as provided for in the proposal form is obtained from the proposer to the effect
that all statutory requirements relating to the business activities are complied with.

3. Standard Policy Form -All policies fresh and renewals issued shall be in the Standard
Policy Form prescribed by the insurance company / corporation.

4.Liabilities covered -Policies issued under this scheme shall cover all sums which the
Insured becomes legally liable to pay as damages to third party in respect of ERRORS and/or
OMISSIONS on the part of the Insured whilst rendering professional services, arising out of
claims first made in writing against the insured during the policy period, including legal costs
and expenses incurred with the prior consent of insurer, subject always to the limits of
indemnity and other terms, conditions and exceptions of the policy. It shall not be permissible
to issue any Professional Indemnity Insurance Policy with unlimited liability.

5. Premium -The rates of premium under the Agreement are annual rates. Full premium under
the policy shall be paid at inception. It is not permissible to accept premium in installments.
Turnover figure whenever required shall be as far as possible accurately assessed and
declared by the proposer at inception of the policy. In case the insured anticipates any
increase /decrease in turnover during the policy period such fluctuations should be
immediately notified to the Insurer and necessary adjustments made. Under no circumstances
it shall be permissible to adjust the premium for the turnover after expiry of the policy.

6.Retroactive Date -Retroactive Date is the date when the risk is first incepted under a claims
made policy and thereafter renewed without break in the period of cover.

7. Revision in Limits of Indemnity -No revisions (increase / decrease) shall be allowed in the
limits of Indemnity during the currency of the policy. For any upward revision in indemnity
limits at renewals, the retroactive date shall be the inception date of the Policy renewal, so far
as the increased limits are applicable.

8.Compulsory Excess -All policies issued under the Agreement shall be subject to
compulsory excess of certain fixed percentage of the limit of indemnity per any one accident
or any one year subject to a minimum of Rs. 1,000 and maximum of Rs. 1,00,000 ( Rupees
One Lakh Only) . The Insured shall bear this Compulsory Excess which is applicable to
property damage claims and death /bodily injury claims inclusive of defense costs arising out
of any one accident. This excess is not applicable for Doctors and Medical Practitioners.

9. Voluntary Excess -The following discounts on the premium may be allowed for Voluntary
Excess opted by the Insured except for policy for Doctors and Medical Practitioners. But
these are applicable in case of insurance policies obtained by Hospitals and Medical
Establishments.

10. Short Period Premium -It shall not be permissible to issue Policies for periods more than
12 months. The following short period scale of premium shall apply to (i) policies issued for
periods less than 12 months and (ii) policies cancelled during the currency at the request of
the insured subject to no claims:

Case Studies in CPA

The ‘Bolam’ test electro convulsive therapy

Mr. Bolam was advised electro convulsive therapy for mental illness. He was however, not
warned of the risks of fractures involved in the treatment. There were two bodies of opinion.
One preferred the use of relaxant drugs. Using relaxants, the patient sustained dislocation of
both hip joints with fracture of pelvis. The doctor was not held negligent because he acted in
accordance with practice accepted as proper by a responsible body of medical men skilled in
that art.

The ‘Bolam’ principle implies that a doctor is not negligent if he acts in accordance with a
practice accepted at the time as proper by a responsible body of medical opinion even though
other doctors adopt a different practice, has been accepted by House of Lords as applicable
not only to diagnosis and treatment but also to advice and warning. A doctor is not liable for
taking one choice out of two for favoring one school rather than another. He is only liable
when he falls below the standard of a reasonable component practitioner in this field, so
much so that his conduct may deserve censure.

Alleged removal of testes

In the case of Tarun Kumar Pramanik V. Dr. Kunal Chakraborty & Others the complainant
alleged that during operation for left inguinal hernia his left testis was removed negligently
and without consent. On account of this suffered and has become handicapped.

The State Commission on the basis of evidence placed on record, and opinion of expert
witness held that the removal of testis was done of expert witness held that the removal of
testis was done to avoid gangrenous infection, operation was done with reasonable care and
skill and had not resulted in any handicap.
Complainant was held to be vexatious and complainant liable to pay cost of 1st opposite
party.

Amputation of penis

In the case of C. Sivakumat V. Dr. Jalin Arthur & Anr the complainant, a 23 years old boy
approached Dr. John for blockage in passage or urine (phimotic penis) who took him another
clinic for operation. After the operation there was over-bleeding from the penis and
ultimately he had to admit to Jumper Hospital. The hospital authorities reported the matter to
the police. Here he came to know that his penis had been cut off (amputated) and only a small
stump had been left, and he was passing urine only through an artificial hole made at Jumper
Hospital. He, in the process, had become permanently impotent.

Compensation of Rs.8 lakhs was awarded to be paid by the first opposite party.

Torsion Testis

Negligence in diagnosis and treatment of a case of torsion testis as ‘orchitis leading to

gangrene of the testis. The commission held that mistaking torsion for orchitis in itself does
not constitute negligence because the symptoms of the two mimic each other. There was also
evidence that the patient was suffering from the disease for 4 to 5 days prior to admission and
as such performing surgery would still not have save the testis. The complaint was dismissed.

Chronic Renal Failure

Alleged negligence in a case of chronic renal failure requiring kidney transplantation who has
infection in thigh at the site of veinflon insertion through which dialysis was repeatedly being
performed. There was an arteriovenous fistula formation and gangrene leading to amputation
of the leg and later death. The opposite did not appear in court. Allegations made by the
complainant were duly supported by the sworn affidavit of the expert witness Dr. Prakash
Tathed who has an extensive experience in this field. A compensation of Rupees two lakhs
was allowed.

11.4 SUMMARY

The industrial revolution and the development in the international trade and commerce has
led to the vast expansion of business and trade, as a result of which a variety of consumer
goods have appeared in the market to cater to the needs of the consumers and a host of
services have been made available to the consumers like insurance, transport, electricity,
housing, entertainment, finance and banking. A well-organized sector of manufacturers and
traders with better knowledge of markets has come into existence, thereby affecting the
relationship between the traders and the consumers making the principle of consumer
sovereignty almost inapplicable. The advertisements of goods and services in television,
newspapers and magazines influence the demand for the same by the consumers though there
may be manufacturing defects or imperfections or short comings in the quality, quantity and
the purity of the goods or there may be deficiency in the services rendered. In addition, the
production of the same item by many firms has led the consumers, who have little time to
make a selection, to think before they can purchase the best. For the welfare of the public, the
glut of adulterated and sub-standard articles in the market has to be checked. Inspire of
various provisions providing protection to the consumer and providing for stringent action
against adulterated and sub-standard articles in the different enactments like Code of Civil
Procedure, 1908, the Indian Contract Act, 1872, the Sale of Goods Act, 1930, the Indian
Penal Code, 1860, the Standards of Weights and Measures Act, 1976 and the Motor Vehicles
Act, 1988, very little could be achieved in the field of Consumer Protection. Though the
Monopolies and Restrictive Trade Practices Act, 1969 arid the Prevention of Food
Adulteration Act, 1954 have provided relief to the consumers yet it became necessary to
protect the consumers from the exploitation and to save them from adulterated and sub-
standard goods and services and to safe guard the interests of the consumers. In order to
provide for better protection of the interests of the consumer the Consumer Protection Bill,
.1986 was introduced in the Lok Sabha on 5th December, 1986.

11.5 KEY WORDS

"Complainant" means-
(i) A consumer; or
(ii) Any voluntary consumer association registered under the Companies Act, 1956 (1
Of 1956) or under any other law for the time being in force; or
(iii) The Central Government or any State Government;
(iv) One or more consumers, where there are numerous consumers
Having the same interest;]
(v) In case of death of a consumer, his legal heir or representative ;)
Who or which makes a complaint;

"Complaint" means any allegation in writing made by a complainant that-

(i) An unfair trade practice or a restrictive trade practice has been adopted by (any
trader or service provider;]
(ii) The goods bought by him or agreed to be bought by him] suffer from one or more
Defects;
(iii) The services hired or availed of or agreed to be hired or availed of by him] suffer
From deficiency in any respect;
(iv) A trader or the service provider, as the case may be, has charged for the goods or
for
The services mentioned in the complaint, a price in excess of the price-
(A) Fixed by or under any law for the time being in force;
(b) Displayed on the goods or any package containing such goods;
(c) Displayed on the price list exhibited by him by or under any law for the
time being in force;
(d) Agreed between the parties ;)
(v) Goods which will be hazardous to life and safety when used are being-offered
for sale to the public-
 (a) in contravention of any standard relating to safety of such goods as
required to be complied with, by or under any law for the time being in
force;
(b) If the trader could have known with due diligence that the goods so offered are
unsafe to the public ;)
(vi) Services which are hazardous or likely to be hazardous to life and safety of the
Public when used, are being offered by the service provider which such person could
have known with due diligence to be injurious to life and safety ;)
With a view to obtaining any relief provided by or under this Act;
.
"Consumer" means any person who-
(i) Buys any goods for a consideration which has been paid or promised or partly
Paid and partly promised, or under any system of deferred payment and includes
Any user of such goods other than the person who buys such goods for
Consideration paid or promised or partly paid or partly promised, or under any
System of deferred payment when such use is made with the approval of such
Person, but does not include a person who obtains such goods for resale or for any
Commercial purpose; or
(ii) Hires or avails of] any services for a consideration which has been paid or
Promised or partly paid and partly promised, or under any system of deferred
Payment and includes any beneficiary of such services other than the person who
Hires or avails of] the services for consideration paid or promised, or partly paid
And partly promised, or under any system of deferred payment,

"Defect":- means any fault, imperfection or shortcoming in the quality, quantity,

potency, purity or standard which is required to be maintained by or under any law for the
time being in force or under any contract, express or implied or] as is claimed by the trader in
any
Manner whatsoever in relation to any goods;

. "Deficiency" means any fault, imperfection, shortcoming or inadequacy in the quality,

nature
And manner of performance which is required to be maintained by or under any law for the
Time being in force or has been undertaken to be performed by a person in pursuance of a
Contract or otherwise in relation to any service;
UNIT 12 PRE-CONCEPTION AND PRE-NATAL DIAGNOSTICS TECHNIQUES
(PROHIBITION OF SEX SELECTION) ACT, 1994 (PCPNDT ACT)

Learning Objectives

After going through this Unit you will be able to:

∑ understand the importance of PCPNDT Act;

∑ understand what constitutes illegal sex determination practices;
∑ procedures to prevent illegal sex determination practices;
∑ understand the legal implications of illegal sex determination practices;
∑ Understand the unethical genetic studies.

Structure
12.1 Background
12.2 Definitions
12.3 Regulation of Genetic Counseling Centers, Genetic Laboratories and Genetic
Clinics
12.4 Regulation of Pre-Natal Diagnostic Techniques
12.5 Central Supervisory Board
12.6 Appropriate Authority and Advisory Committee
12.7 Registration of Genetic Counseling Centers Genetic Lab and Genetic Clinics
12.8 Offences and Penalties
12.9 Miscellaneous
12.10 Towards Stronger Implementation of the PCPNDT Act
12.11 Amendments
12.12 Summary
12.13 Key Words

12.1 BACKGROUND

Discrimination against women and girls is widespread in India and manifests itself in many ways,
Including gender-biased sex selection. The practice of sex selection is evident in the severe decline in
the Child Sex Ratio (CSR) from 976 girls per 1000 boys in 1961 to 914 in 2011. One of the major
reasons for the decline in CSR is attributed to the introduction and proliferation of modern
technology such as ultrasound that enables sex determination, thereby reinforcing societal mindsets
for son preference.

In order to prohibit sex selection and prevent misuse of technology for preconception and prenatal
sex determination, the Government of India enacted the Pre-conception and Pre-natal Diagnostics
Techniques (Prohibition of Sex Selection) Act, 1994 (PCPNDT Act).
Although the Act came into force in 1996 and was subsequently amended in 2003, implementation
of the provisions of the Act has been a challenge for State Governments. Since the enactment of the
Act there have been few prosecutions registered and few convictions under the Act. Effective
implementation of this significant social legislation requires commitment to the ideal of gender
equality and entails capacity building of all stakeholders involved in implementation of the PCPNDT
Act. Pre-Natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994 An Act to
provide for the regulation of the use of pre-natal diagnostic techniques for the purpose of detecting
genetic or metabolic disorders or chromosomal abnormalities or certain congenital malformations or
sex linked disorders and for the prevention of the misuse of such techniques for the purpose of pre-
natal sex determination leading to female foeticide; and, for matters connected there with or
incidental thereto.

12.2 DEFINITIONS

"Appropriate Authority" means the Appropriate Authority appointed under section 17;

"Board" means the Central Supervisory Board constituted under section 7;

"Genetic Counseling Centre" means an institute, hospital, nursing home or any place, by whatever
name called, which provides for genetic counselling to patients;

"Genetic Clinic" means a clinic, institute, hospital, nursing home or any place, by whatever name
called, which is used for conducting pre-natal diagnostic procedures;

"Genetic Laboratory" means a laboratory and includes a place where facilities are provided for
conducting analysis or tests of samples received from Genetic Clinic for pre-natal diagnostic test;

"Gynecologist" means a person who possesses a post- graduate qualification in gynecology and
obstetrics;

"Medical geneticist" means a person who possesses a degree or diploma or certificate in medical
genetics in the field of pre-natal diagnostic techniques or has experience of not less than two years
in such field after obtaining: (i) any one of the medical qualifications recognized under the Indian
Medical Council Act, 1956 (102 of 1956); or (ii) a post-graduate degree in biological sciences;

"Pediatrician" means a person who possesses a post- graduate qualification in pediatrics;

"Pre-natal diagnostic procedures" means all gynecological or obstetrical or medical procedures such
as ultrasonography foetoscopy, taking or removing samples of amniotic fluid, chorionic villi, blood or
any tissue of a pregnant woman for being sent to a Genetic Laboratory or Genetic Clinic for
conducting pre-natal diagnostic test;

"Pre-natal diagnostic techniques" includes all pre-natal diagnostic procedures and pre-natal
diagnostic tests;
"Pre-natal diagnostic test" means ultrasonography or any test or analysis of amniotic fluid, chorionic
villi, blood or any tissue of a pregnant woman conducted to detect genetic or metabolic disorders
or chromosomal abnormalities or congenital anomalies or haemoglobinopathies or sex-linked
diseases;

"Registered Medical Practitioner" means a medical practitioner who possesses any recognized
medical qualification as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956,
(102 of 1956.) and whose name has been entered in a State Medical Register;

"Regulations" means regulations framed by the Board under this Act.

12.3 REGULATION OF GENETIC COUNSELLING CENTRES, GENETIC

LABORATORIES AND GENETIC CLINICS

(1) No Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic unless registered
under this Act, shall conduct or associate with, or help in, conducting activities relating to pre-
natal diagnostic techniques;

(2) No Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic shall employ or cause to be
employed any person who does not possess the prescribed qualifications;

(3) No medical geneticist, gynecologist, pediatrician, registered medical practitioner or any other
person shall conduct or cause to be conducted or aid in conducting by himself or through any other
person, any pre-natal diagnostic techniques at a place other than a place registered under this Act.

12.4 REGULATION OF PRE-NATAL DIAGNOSTIC TECHNIQUES

(1) No place including a registered Genetic Counselling Centre or Genetic Laboratory or Genetic
Clinic shall be used or caused to be used by any person for conducting pre-natal diagnostic
techniques except for the purposes specified in clause (2) and after satisfying any of the conditions
specified in clause (3);

(2) No pre-natal diagnostic techniques shall be conducted except for the purposes of detection of
any of the following abnormalities, namely:
(i) Chromosomal abnormalities;
(ii) Genetic metabolic diseases;
(iii) Haemoglobinopathies;
(iv) Sex-linked genetic diseases;
(v) Congenital anomalies;
(vi) Any other abnormalities or diseases as may be specified by the Central Supervisory
Board;

(3) No pre-natal diagnostic techniques shall be used or conducted unless the person qualified to
do so is satisfied that any of the following conditions are fulfilled, namely:
(i) Age of the pregnant woman is above thirty-five years;
(ii) The pregnant woman has undergone of two or more spontaneous abortions or foetal
loss;
 (iii) The pregnant woman had been exposed to potentially teratogenic agents such as
drugs, radiation, infection or chemicals;
(iv) The pregnant woman has a family history of mental retardation or physical deformities
such as spasticity or any other genetic disease;
(v) Any other condition as may be specified by the Central Supervisory Board;

(4) No person, being a relative or the husband of the pregnant woman shall seek or encourage the
conduct of any pre-natal diagnostic techniques on her except for the purpose specified in clause (2).

(5) Written consent of pregnant woman and prohibition of communicating the sex of foetus.
(1) No person referred to in clause (2) of section 3 shall conduct the pre-natal diagnostic
procedures unless:
(a) He has explained all known side and after effects of such procedures to the pregnant
woman concerned;
(b) He has obtained in the prescribed form her written consent to undergo such procedures
in the language which she understands; and
(c) A copy of her written consent obtained under clause (b) is given to the pregnant
woman.
(2) No person conducting pre-natal diagnostic procedures shall communicate to the pregnant
woman concerned or her relatives the sex of the foetus by words, signs or in any other
manner.

(6) Determination of sex prohibited. - On and from the commencement of this Act:

(a) No Genetic Counseling Centre or Genetic Laboratory or Genetic Clinic shall conduct or
cause to be conducted in its Centre, Laboratory or Clinic, pre-natal diagnostic techniques
including ultrasonography, for the purpose of determining the sex of a foetus;

(b) No person shall conduct or cause to be conducted any pre-natal diagnostic techniques
including ultrasonography for the purpose of determining the sex of a foetus.

12.5 CENTRAL SUPERVISORY BOARD

Constitution of Central Supervisory Board

(1) The Central Government shall constitute a Board to be known as the Central Supervisory Board
to exercise the powers and perform the functions conferred on the Board under this Act.

(2) The Board shall consist of:

(a) The Minister in charge of the Ministry or Department of Family Welfare, who shall be the
Chairman, ex officio;
(b) The Secretary to the Government of India in charge of the Department of Family Welfare,
who shall be the Vice-Chairman, ex-officio;
(c) two members to be appointed by the Central Government to represent the Ministries of
Central Government in charge of Woman and Child Development and of Law and
(d) The Director General of Health Services of the Central Government, ex officio;
(e) Ten members to be appointed by the Central Government, two each from amongst:
(i) Eminent medical geneticists;
(ii) Eminent gynecologists and obstetricians;
(iii) Eminent pediatricians;
(iv) Eminent social scientists; and
(v) Representatives of women welfare organizations;
(f) three women Members of Parliament, of whom two shall be elected by the House of the
People and one by the Council of States;
(g) four members to be appointed by the Central Government by rotation to represent the
States and the Union territories, two in the alphabetical order and two in the reverse alphabetical
order: Provided that no appointment under this clause shall be made except on the
recommendation of the State Government or, as the case may be, the Union territory;

(h) an officer, not below the rank of a Joint Secretary or equivalent of the Central
Government, in charge of Family Welfare, who shall be the Member-Secretary, ex
officio.

Term of office of members:

(1) The term of office of a member, other than an ex officio member, shall be:

(a) in case of appointment under clause (e) or clause (f) of sub-section (2) of section 7, three years;
and (b) in case of appointment under clause (g) of the said subsection, one year.

(2) If a casual vacancy occurs in the office of any other members, whether by reason of his death,
resignation or inability to discharge his functions owing to illness or other incapacity, such vacancy
shall be filled by the Central Government by making a fresh appointment and the member so
appointed shall hold office for the remainder of the term of office of the person in whose place he is
so appointed.

(3) The Vice-Chairman shall perform such functions as may be assigned to him by the Chairman from
time to time.

(4) The procedure to be followed by the members in the discharge of their functions shall be such as
may be prescribed.

Meetings of the Board

(1) The Board shall meet at such time and place, and shall observe such rules of procedure in regard
to the transaction of business at its meetings (including the quorum at such meetings) as may be
provided by regulations: Provided that the Board shall meet at least once in six months.

(2) The Chairman and in his absence the Vice-Chairman shall preside at the meetings of the Board.

(3) If for any reason the Chairman or the Vice-Chairman is unable to attend any meeting of the
Board, any other member chosen by the members present at the meeting shall preside at the
meeting.

(4) All questions which come up before any meeting of the Board shall be decided by a majority of
the votes of the members present and voting, and in the event of an equality of votes, the Chairman,
or in his absence, the person presiding, shall have and exercise a second or casting vote.
(5) Members other than ex officio members shall receive such allowances, if any, from the Board as
may be prescribed.

Vacancies
Not to invalidate proceedings of the Board. - No act or proceeding of the Board shall be invalid
merely by reason of:

(a) Any vacancy in, or any defect in the constitution of, the Board; or

(b) Any defect in the appointment of a person acting as a member of the Board; or

(c) Any irregularity in the procedure of the Board not affecting the merits of the case.

Temporary association of persons with the Board for particular purposes.

(1) The Board may associate with itself, in such manner and for such purposes as may be determined
by regulations, any person whose assistance or advice it may desire in carrying out any of the
provisions of this Act.

(2) A person associated with it by the Board under sub-section (1) for any purpose shall have a right
to take part in the discussions relevant to that purpose, but shall not have a right to vote at a
meeting of the Board and shall not be a member for any other purpose.

Appointment or Officers and Other Employees of the Board

(1) For the purpose of enabling it efficiently to discharge its functions under this Act, the Board may,
subject to such regulations as may be made in this behalf, appoint (whether on deputation or
otherwise) such number of officers and other employees as it may consider necessary:

Provided that the appointment of such category of officers, as may be specified in such regulations,
shall be subject to the approval of the Central Government.

(2) Every officer or other employee appointed by the Board shall be subject to such conditions of
service and shall be entitled to such remuneration as may be specified in the regulations.

Authentication of orders and other instruments of the Board: All orders and decisions of the Board
shall be authenticated by the signature of the Chairman or any other member authorized by the
Board in this behalf, and all other instruments issued by the Board shall be authenticated by the
signature of the Member-Secretary or any other officer of the Board authorized in like manner in
this behalf.

Disqualifications for Appointment as Member

A person shall be disqualified for being appointed as a member if, he:

(a) Has been convicted and sentenced to imprisonment for an offence which, in the
opinion of the Central Government, involves moral turpitude; or

(b) Is an undercharged insolvent; or

(c) Is of unsound mind and stands so declared by a competent court; or

 (d) Has been removed or dismissed from the service of the Government or a Corporation
owned or controlled by the Government; or

(e) has, in the opinion of the Central Government, such financial or other interest in the Board
as is likely to affect prejudicially the discharge by him of his functions as a member; or

(f) Has, in the opinion of the Central Government, been associated with the use or promotion
of pre-natal diagnostic technique for determination of sex.

Eligibility of Member for Reappointment:

Subject to the other terms and conditions of service as may be prescribed, any person ceasing to be
a member shall be eligible for reappointment as such member.

Functions of the Board:

The Board shall have the following functions, namely:

(i) To advise the Government on policy matters relating to use of pre-natal diagnostic techniques;

(ii) To review implementation of the Act and the rules made thereunder and recommend changes in
the said Act and rules to the Central Government;

(iii) To create public awareness against the practice of pre-natal determination of sex and female
foeticide;

(iv) to lay down code of conduct to be observed by persons working at Genetic Counseling Centers,
Genetic Laboratories and Genetic Clinics;

(v) Any other functions as may be specified under the Act.

12.6 APPROPRIATE AUTHORITY AND ADVISORY COMMITTEE

(1) The Central Government shall appoint, by notification in the Official Gazette, one or more
Appropriate Authorities for each of the Union territories for the purposes of this Act.

(2) The State Government shall appoint, by notification in the Official Gazette, one or more
Appropriate Authorities for the whole or part of the State for the purposes of this Act having regard
to the intensity of the problem of pre-natal sex determination leading to female foeticide.

(3) The officers appointed as Appropriate Authorities under sub- section (1) or sub-section (2) shall
be: (a) when appointed for the whole of the State or the Union territory, of or above the rank of the
Joint Director of Health and Family Welfare; and (b) when appointed for any part of the State or
the Union territory, of such other rank as the State Government or the Central Government, as the
case may be, may deem fit.
(4) The Appropriate Authority shall have the following functions, namely:

(a) To grant, suspend or cancel registration of a Genetic Counselling Centre, Genetic

Laboratory or Genetic Clinic;

(b) To enforce standards prescribed for the Genetic Counselling Centre, Genetic Laboratory
and Genetic Clinic;

(c) To investigate complaints of breach of the provisions of this Act or the rules made
thereunder and take immediate action; and

(d) To seek and consider the advice of the Advisory Committee constituted under sub-section
(5), on application for registration and on complaints for suspension or cancellation of registration.

(5) The Central Government or the State Government, as the case may be, shall constitute an
Advisory Committee for each Appropriate Authority to aid and advise the Appropriate Authority in
the discharge of its functions, and shall appoint one of the members of the Advisory Committee to
be its Chairman.

(6) The Advisory Committee shall consist of:

(a) Three medical experts from amongst gynecologists, obstetricians, pediatricians and medical
geneticists;

(b) One legal expert;

(c) One officer to represent the department dealing with information and publicity of the State
Government or the Union territory, as the case may be;

(d) Three eminent social workers of whom not less than one shall be from amongst
representatives of women's organizations.

(7) No person who, in the opinion of the Central Government or the State Government, as the case
may be, has been associated with the use or promotion of pre-natal diagnostic technique for
determination of sex shall be appointed as a member of the Advisory Committee.

(8) The Advisory Committee may meet as and when it thinks fit or on the request of the Appropriate
Authority for consideration of any application for registration or any complaint for suspension or
cancellation of registration and to give advice thereon: Provided that the period intervening
between any two meetings shall not exceed the prescribed period.
9) The terms and conditions subject to which a person may be appointed to the Advisory Committee
and the procedure to be followed by such Committee in the discharge of its functions shall be such
as may be prescribed.

12.7 REGISTRATION OF GENETIC COUNSELLING CENTRES, GENETIC

LABORATORIES AND GENETIC CLINICS

Registration of Genetic Counseling Centers, Genetic Laboratories or Genetic Clinics.

(1) No person shall open any Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic after
the commencement of this Act unless such Centre, Laboratory or Clinic is duly registered separately
or jointly under this Act.

(2) Every application for registration under sub-section (1), shall be made to the Appropriate
Authority in such form and in such manner and shall be accompanied by such fees as may be
prescribed.

(3) Every Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic engaged, either partly or
exclusively, in counselling or conducting pre-natal diagnostic techniques for any of the purposes
mentioned in section 4, immediately before the commencement of this Act, shall apply for
registration within sixty days from the date of such commencement.

(4) Subject to the provisions of section 6, every Genetic Counselling Centre, Genetic Laboratory or
Genetic Clinic engaged in counselling or conducting pre-natal diagnostic techniques shall cease to
conduct any such counselling or technique on the expiry of six months from the date of
commencement of this Act unless such Centre, Laboratory or Clinic has applied for registration and
is so registered separately or jointly or till such application is disposed of, whichever is earlier.

(5) No Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic shall be registered under this
Act unless the Appropriate Authority is satisfied that such Centre, Laboratory or Clinic is in a position
to provide such facilities, maintain such equipment and standards as may be prescribed.

Certificate of registration

(1) The Appropriate Authority shall, after holding an inquiry and after satisfying itself that the
applicant has complied with all the requirements of this Act and the rules made thereunder and
having regard to the advice of the Advisory Committee in this behalf, grant a certificate of
registration in the prescribed form jointly or separately to the Genetic Counselling Centre, Genetic
Laboratory or Genetic Clinic, as the case may be.

(2) If, after the inquiry and after giving an opportunity of being heard to the applicant and having
regard to the advice of the Advisory Committee, the Appropriate Authority is satisfied that the
applicant has not complied with the requirements of this Act or the rules, it shall, for reasons to be
recorded in writing, reject the application for registration.

(3) Every certificate of registration shall be renewed in such manner and after such period and on
payment of such fees as may be prescribed.

(4) The certificate of registration shall be displayed by the registered Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic in a conspicuous place at its place of business.

Cancellation or Suspension of Registration

(1) The Appropriate Authority may sue moto, or on complaint, issue a notice to the Genetic
Counselling Centre, Genetic Laboratory or Genetic Clinic to show because why its registration should
not be suspended or cancelled for the reasons mentioned in the notice.

(2) If, after giving a reasonable opportunity of being heard to the Genetic Counselling Centre,
Genetic Laboratory or Genetic Clinic and having regard to the advice of the Advisory Committee, the
Appropriate Authority is satisfied that there has been a breach of the provisions of this Act or the
rules, it may, without prejudice to any criminal action that it may take against such Centre,
Laboratory or Clinic, suspend its registration for such period as it may think fit or cancel its
registration, as the case may be.

(3) Notwithstanding anything contained in sub-sections (1) and (2), if the Appropriate Authority is, of
the opinion that it is necessary or expedient so to do in the public interest, it may, for reasons to be
recorded in writing, suspend the registration of any Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic without issuing any such notice

The Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic may, within thirty days from
the date of receipt of the order of suspension or cancellation of registration passed by the
Appropriate Authority under section 20, prefer an appeal against such order to: (i) the Central
Government, where the appeal is against the order of the Central Appropriate Authority; and (ii) the
State Government, where the appeal is against the order of the State Appropriate Authority, in the
prescribed manner.
12.8 OFFENCES AND PENALTIES

Prohibition of advertisement relating to pre-natal determination of sex and punishment for

contravention

(1) No person, organization, Genetic Counseling Centre, Genetic Laboratory or Genetic Clinic shall
issue or cause to be issued any advertisement in any manner regarding facilities of pre-natal
determination of sex available at such Centre, Laboratory, Clinic or any other place.

(2) No person or organization shall publish or distribute or cause to be published or distributed any
advertisement in any manner regarding facilities of pre-natal determination of sex available at any
Genetic Counselling Centre, Genetic Laboratory, Genetic Clinic or any other place.

(3) Any person who contravenes the provisions of sub-section (1) or sub-section (2) shall be
punishable with imprisonment for a term which may extend to three years and with fine which may
extend to ten thousand rupees.

Explanation.--For the purposes of this section, "advertisement" includes any notice, circular, label
wrapper or other document and also includes any visible representation made by means of any light,
sound, smoke or gas.

Offences and penalties

(1) Any medical geneticist, gynecologist, registered medical practitioner or any person who owns a
Genetic Counselling Centre, a Genetic Laboratory or a Genetic Clinic or is employed in such a Centre,
Laboratory or Clinic and renders his professional or technical services to or at such a Centre,
Laboratory or Clinic, whether on an honorary basis or otherwise, and who contravenes any of the
provisions of this Act or rules made there under shall be punishable with imprisonment for a term
which may extend to three years and with fine which may extend to ten thousand rupees and on any
subsequent conviction, with imprisonment which may extend to five years and with fine which may
extend to fifty thousand rupees.

(2) The name of the registered medical practitioner who has been convicted by the court under sub-
section (1), shall be reported by the Appropriate Authority to the respective State Medical Council
for taking necessary action including the removal of his name from the register of the Council for a
period of two years for the first offence and permanently for the subsequent offence.

(3) Any person who seeks the aid of a Genetic Counselling Centre, Genetic Laboratory or Genetic
Clinic or of a medical geneticist, gynecologist or registered medical practitioner for conducting pre-
natal diagnostic techniques on any pregnant woman (including such woman unless she was
compelled to undergo such diagnostic techniques) for purposes other than those specified in clause
(2) of section 4, shall, be punishable with imprisonment for a term which may extend to three years
and with fine which may extend to ten thousand rupees and on any subsequent conviction with
imprisonment which may extend to five years and with fine which may extend to fifty thousand
rupees.

Presumption in the case of conduct of pre-natal diagnostic techniques. - Notwithstanding anything

in the Indian Evidence Act, 1872 (1 of 1872), the court shall presume unless the contrary is proved
that the pregnant woman has been compelled by her husband or the relative to undergo pre-natal
diagnostic technique and such person shall be liable for abetment of offence under sub-section (3) of
section 23 and shall be punishable for the offence specified under that section.

Penalty for contravention of the provisions of the Act or rules for which no specific punishment is
provided: Whoever contravenes any of the provisions of this Act or any rules made there under, for
which no penalty has been elsewhere provided in this Act, shall be punishable with imprisonment
for a term which may extend to three months or with fine, which may extend to one thousand
rupees or with both and in the case of continuing contravention with an additional fine which may
extend to five hundred rupees for every day during which such contravention continues after
conviction for the first such contravention.

Offences by companies

(1) Where any offence, punishable under this Act has been committed by a company, every person
who, at the time the offence was committed was in charge of, and was responsible to the
company for the conduct of the business of the company, as well as the company, shall be
deemed to be guilty of the offence and shall be liable to be proceeded against and punished
accordingly:

Provided that nothing contained in this sub-section shall render any such person liable to any
punishment, if he proves that the offence was committed without his knowledge or that he had
exercised all due diligence to prevent the commission of such offence.

(2) Notwithstanding anything contained in sub-section (1), where any offence punishable under this
Act has been committed by a company and it is proved that the offence has been committed with
the consent or connivance of, or is attributable to any neglect on the part of, any director, manager,
secretary or other officer of the company, such director, manager, secretary or other officer shall
also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished
accordingly.

Explanation

(a) "Company" means anybody corporate and includes a firm or other association of individuals, and

(b)"director", in relation to a firm, means a partner in the firm.

Offence to be cognizable, non-bailable and non-compoundable: Every offence under this Act
shall be cognizable, non-bailable and non-compoundable.

Cognizance of offences

(1) No court shall take cognizance of an offence under this Act except on a complaint made by--
 (a) the Appropriate Authority concerned, or any officer authorized in this behalf by
the Central Government or State Government, as the case may be, or the Appropriate Authority;
or

(b) A person who has given notice of not less than thirty days in the manner prescribed, to the
Appropriate Authority, of the alleged offence and of his intention to make a complaint to the court.

Explanation.--For the purpose of this clause, "person" includes a social organization.

(2) No court other than that of a Metropolitan Magistrate or a Judicial Magistrate of the first class
shall try any offence punishable under this Act.

(3) Where a complaint has been made under clause (b) of subsection (1), the court may, on demand
by such person, direct the Appropriate Authority to make available copies of the relevant records in
its possession to such person.

12.9 MISCELLANEOUS

Maintenance of records

(1) All records, charts, forms, reports, consent letters and all other documents required to be
maintained under this Act and the rules shall be preserved for a period of two years or for such
period as may be prescribed:

Provided that, if any criminal or other proceedings are instituted against any Genetic Counselling
Centre, Genetic Laboratory or Genetic Clinic, the records and all other documents of such Centre,
Laboratory or Clinic shall be preserved till the final disposal of such proceedings.

(2) All such records shall, at all reasonable times, be made available for inspection to the Appropriate
Authority or to any other person authorized by the Appropriate Authority in this behalf.

Power to search and seize records

(1) If the Appropriate Authority has reason to believe that an offence under this Act has been or is
being committed at any Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic, such
Authority or any officer authorized thereof in this behalf may, subject to such rules as may be
prescribed, enter and search at all reasonable times with such assistance, if any, as such authority or
officer considers necessary, such Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic
and examine any record, register, document, book, pamphlet, advertisement or any other
material object found therein and seize the same if such Authority or officer has reason to believe
that it may furnish evidence of the commission of an office punishable under this Act.

(2) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974) relating to searches and
seizures shall, so far as may be, apply to every search or seizure made under this Act.

Protection of action taken in good faith: No suit, prosecution or other legal proceeding shall lie
against the Central or the State Government or the Appropriate Authority or any officer
authorized by the Central or State Government or by the Authority for anything which is in good
faith done or intended to be done in pursuance of the provisions of this Act.

Power to make rules

(1) The Central Government may make rules for carrying out the provisions of this Act.

(2) In particular and without prejudice to the generality of the foregoing power, such rules may
provide for--
(i) the minimum qualifications for persons employed at a registered
Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic under clause (1) of section 3;
(ii) The form in which consent of a pregnant woman has to be obtained under section 5;
(iii) The procedure to be followed by the members of the Central Supervisory Board in the
discharge of their functions under sub-section (4) of section 8;
(IV) allowances for members other than ex officio members admissible under sub-section (5) of
section 9;
(v) the period intervening between any two meetings of the Advisory
Committee under the proviso to sub-section (8) of section 17;
(vi) The terms and conditions subject to which a person may be appointed to the Advisory
Committee and the procedure to be followed by such Committee under sub-section (9) of section
17;
(vii) The form and manner in which an application shall be made for registration and the fee payable
thereof under sub-section (2) of section 18;
(viii) the facilities to be provided, equipment and other standards to be maintained by
the Genetic Counselling Centre, Genetic Laboratory or Genetic Clinic under sub-section (5) of
section 18;
(ix) The form in which a certificate of registration shall be issued under sub-section (1) of section 19;
(x) the manner in which and the period after which a certificate of registration shall be renewed
and the fee payable for such renewal under sub-section (3) of section 19;
(xi) The manner in which an appeal may be preferred under section 21;
(xii) The period up to which records, charts, etc., shall be preserved under sub-section (1) of section
29;
(xiii) the manner in which the seizure of documents, records, objects, etc., shall be made and
the manner in which seizure list shall be prepared and delivered to the person from whose
custody such documents, records or objects were seized under sub-section (1) of section 30;
(xiv) Any other matter that is required to be, or may be, prescribed.

Power to make regulations: The Board may, with the previous sanction of the Central Government,
by notification in the Official Gazette, make regulations not inconsistent with the provisions of this
Act and the rules made thereunder to provide for--

(a) The time and place of the meetings of the Board and the procedure to be followed for the
transaction of business at such meetings and the number of members which shall form the quorum
under sub-section (1) of section 9;

(b) The manner in which a person may be temporarily associated with the Board under sub-section
(1) of section 11;

(c) The method of appointment, the conditions of service and the scales of
pay and allowances of the officer and other employees of the Board appointed under section 12;
(d) Generally for the efficient conduct of the affairs of the Board.

Rules and regulations to be laid before Parliament

Every rule and every regulation made under this Act shall be laid, as soon as may be after it is made,
before each House of Parliament, while it is in session, for a
total period of thirty days which may be comprised in one session or in two or more successive
sessions, and if, before the expiry of the session immediately following the session or the successive
sessions aforesaid, both Houses agree in making any modification in the rule or regulation or both
Houses agree that the rule or regulation should not be made, the rule or regulation shall thereafter
have effect only in such modified form or be of no effect, as the case may be;
so, however, that any such modification or annulment shall be without prejudice
to the validity of anything previously done under that rule or regulation.

12.10 TOWARDS STRONGER IMPLEMENTATION OF THE PCPNDT ACT

Action points for strengthening effective implementation of the PCPNDT Act are summarized below:
1. States require to focus on effective implementation of the PCPNDT Act to curb the misuse of medical
technology for sex determination.

2. Constitute State Inspection and Monitoring Committees (SIMC) for checking the activities of ultrasound
facilities indulging in advertisement of services and/or determination/revealing of the sex of the foetus.

3. Conduct regular surveys, update registrations and renewals to avoid multiple registrations and
irregularities including registration of on-call machines and unrestrained use of portable machines. Copy
of Notification to regulate the use of portable ultrasound equipment and services offered by mobile
genetic clinics, notified vide GSR 80 (E), dated 7t h February, 2012 is attached in Annexure II.

4. Sustained advocacy and communication strategies for community awareness with focus on
Information, Education, Communication; involvement of community leaders and Panchayats, NGOs and
public service messages for affirmative action to nurture the girl child.

5. Online filing of F-Forms to capture real time data and swift action against violations of the Act.

6. Surprise inspections of ultrasound diagnostic facilities by State Inspection and Monitoring

Committees

7. Capacity building of implementing agencies at all levels at State/district and sub district level.

8. Setting up dedicated PNDT cells at State/district level with adequate infrastructure and human
resource capacity.

9. Surveillance against increasing sale of cheaper foreign brands and refurbished/second hand ultrasound
machines by dealers.
10. The circular on conduct of effective decoy operations, issued by Government of Maharashtra. To be
translated into English for dissemination amongst States. Copy of the Circular and guidelines (Marathi
and English translation) is attached in Annexure III.

11. States may consider digitization of registration records to streamline maintenance of mandated
records under the Act.

12. Sensitize and conduct training programmer for judiciary, public prosecutors, medical practitioners and
other members of the civil society for effective implementation of the Act.

13. There is no provision for issuing a, temporary registration under the Act. Appropriate Authorities
should therefore not issue any such temporary registration either to the suppliers, professional bodies of
doctors or individual practitioners for using ultrasound machines for demonstration purposes in
conferences or at clinics.

14. With reference to the installation of Silent Observer-Active Tracker in ultrasound equipment for
tracking scans, it was clarified that the Ministry has reviewed the findings of the study undertaken by the
Government of Maharashtra and UNFPA which showed that the findings on the impact of silent observer
are not conclusive.

15. State/District Appropriate Authorities to examine Block/Panchayat /village wise data on child

12.11 AMENDMENTS
Amended Rule 11(2) substituted by G.S.R. 426(E), dated 31 -05-2011 (i.e. 31 -5-2011)

The Appropriate Authority or the officer authorized by it may seal and seize any ultrasound machine,
Scanner or any other equipment, capable of detecting sex of foetus, used by any organization if the
Organization has not got itself registered under the Act. These machines of such organizations shall
Be confiscated and further action taken as per the Section 23 of the Act (Section 23 dictates
Imprisonment up to 3 years and fine up to INR 50,000.00).

Amendment with regard to regulation of portable Ultrasound equipment

G.S.R. 80(E), dated 07-02-2012
∑ The use of portable machines is to be permitted only in the following conditions:
∑ Portable machine being used within the premises it is registered, for providing bedside
Services to the patients
∑ As part of a mobile medical unit, offering a bouquet of other health and medical services
∑ The machine under no circumstances will be used for sex determination of the foetus, as
Mentioned under Section 6 of the said Act

Amendments approved by the CSB:

Amendment restricting the Registration of a radiologist/ sinologist with ultrasound clinics - It was decided
that registration of doctors would be allowed for a maximum of 2 centers that too within the district
only. Number of hours for which the Registered Medical Practitioner would be present in each clinic
would be specified clearly in the registration itself.
 Increase in Registration fee of facilities/clinics registered under the PNDT Act- INR 25, 000 for Genetic
Counseling Centre, Genetic Laboratory, Genetic Clinic, Ultrasound Clinic or Imaging Centre and INR
35,000 f or an institute, hospital, nursing home, or any place providing jointly the service of a Genetic
Counselling Centre, Genetic Laboratory and Genetic Clinic, Ultrasound Clinic or Imaging Centre or any
combination thereof.

Amendment to Rule 13 of the PNDT Rules- Every Genetic Counselling Centre, Genetic Laboratory, Genetic
Clinic, Ultrasound Clinic and Imaging Centre shall intimate every change of employee, place, address and
equipment installed, to the APPROPRIATE AUTHORITY at least 30 days in advance of the expected date of
such change, and seek issuance of a new certificate with the changes duly incorporated.

Text on the board (As suggested by the Training guidebook for Appropriate Authorities) Sex
determination is a criminal offence under the Pre-Natal Diagnostic Techniques (Regulation and
Prevention of Misuse) Act. The penalty for doctors performing this test includes rigorous imprisonment
up to 3 years and fine of INR 10,000. For the family members demanding the test the
Punishment includes up to five years of rigorous imprisonment and fine of INR 50,000. The pregnant
Woman will not be charged with criminal offence.

Things to remember when conducting a decoy operation

1. Seek participation of a woman who is 14 to 22 weeks pregnant and is willing to be involved in
The decoy operation. Counsel the selected woman on the purpose of the decoy.

2. An affidavit from the woman should be obtained stating that she is ready to take part in the
Decoy operation. Note the numbers on the currency notes to be used. These are to be
Mentioned in the affidavit. Give these currency notes to the decoy woman or the witness.

3. Prepare two witnesses to accompany the woman.

4. Keep an audio-video system handy if possible. Check beforehand if the pregnant woman and the
Witness can operate it correctly. They should be comfortable in using these. It is important to
Avoid any confusion in this regard.

5. Keep ready three main witnesses and two inspectors. They should be friendly enough with each
Other to work as a team, with excellent nonverbal communication. They should be trained so as
To gather and collect evidence, have a good knowledge of the Act and learn things to keep in
Mind for a decoy operation

6. Appropriate Authorities should be available close by where the decoy operation is to take place.

7. Upon learning that the decoy operation has been successful, Appropriate Authorities should take
The accused in their custody.

8. See to it that the accused is not able to make phone calls to anybody. All his phones should be
Switched off and other contacts not reachable.
9. Search for the currency notes, verify and record after a Panchnama.

10. Take a statement from the accused after inquiry.

11. Statements from the co-accused (other paramedical staff, agent, PRO) should also be taken.

12. The center should be thoroughly inspected and all important documents in the case should be
Seized and sealed.

13. All authorized, unauthorized machines should be taken into custody after sealing them. After a
Panchnama, the accused should be given an acknowledgement of all seized machines and
Documents.

14. Inspection report should be fully prepared. The entire premises, house, garage, hospital should
Be thoroughly searched for an unregistered machine.

15. At the place of the crime, statements of the pregnant woman and the witnesses should be
Recorded and all the evidence in the form of audio, video cassettes should be taken into custody.
The pregnant woman and the witnesses should be given copies of their statements and
Cassettes.

16. After making sure that investigation has been carried out thoroughly, a case should be registered
In the court after discussing the matter with lawyers.

17. As the Appropriate Authority is the complainant, she / he or a representative should be present
At all times for the hearing of the case.

12.12 SUMMARY
The PCPNDT Act is a welcome step by the Govt to prevent the declining female sex ratio and female
feticide. However it requires strict implementation and stringent monitoring.

12.13 KEY WORDS

Appropriate Authority" means the Appropriate Authority appointed under

section 17;
"Board" means the Central Supervisory Board constituted under section 7;
"Genetic Counseling Centre" means an institute, hospital, nursing home or any
place, by whatever name called, which provides for genetic counselling to
patients;
 "Genetic Clinic" means a clinic, institute, hospital, nursing home or any place, by
whatever name called, which is used for conducting pre-natal diagnostic procedures;
"Genetic Laboratory" means a laboratory and includes a place where facilities are
provided for conducting analysis or tests of samples received from Genetic Clinic for
pre-natal diagnostic test;
"pre-natal diagnostic procedures" means all gynecological or obstetrical or
medical procedures such as ultrasonography foetoscopy, taking or removing
samples of amniotic fluid, chorionic villi, blood or any tissue of a pregnant
woman for being sent to a Genetic Laboratory or Genetic Clinic for conducting
pre-natal diagnostic test;
"Pre-natal diagnostic techniques" includes all pre-natal diagnostic procedures and
pre-natal diagnostic tests;
"pre-natal diagnostic test" means ultrasonography or any test or analysis of
amniotic fluid, chorionic villi, blood or any tissue of a pregnant woman conducted
to detect genetic or metabolic disorders or chromosomal abnormalities or congenital
anomalies or haemoglobinopathies or sex-linked diseases;
UNIT 13 DRUGS AND COSMETICS ACT
Learning Objectives

After going through this Unit you will be able to:

∑ understand the concept of drugs and cosmetics;

∑ understand what constitutes Drugs Technical Advisory Board;
∑ understand functions of Drug Consultative Committee;
∑ understand offences under this act;
∑ understand the various penalties under this Act;
∑ import regulations on Drugs and Cosmetics;
∑ Understand what constitutes adulterated, misbranded and spurious drugs.

Structure
13.1 Introduction
13.2 Definition
13.3 Drugs Technical Advisory Board
13. 4 Drug Consultative Committee
13.5 Prohibition of Import of Certain Drugs or Cosmetics
13.6 Powers of Central Government to Make Rules
13.7 Offences
13.8 Manufacture, Sale and Distribution of Drugs
13.9 Penalties
13.10 Ayurvedic & Unani Drug Technical Advisory Board
13.11 Miscellaneous
13.12 Schedules
13.13 Summary
13.14 Key Words

13.1 INTRODUCTION
The Drug and Cosmetics Act was passed by Indian Legislature and received assent of Governor
General on 10 April 1940. Subsequently it was passed by Indian Parliament and received assent of
President of India on 15 Apr 1955.The act was extend to whole of India.

13.2 DEFINITION

Ayurveda (including siddha) or unani drug

- includes all medicines intended for internal or external use.
Or
- On diagnosis, treatment, mitigation or prevention of disease in humans.
 And
-processed and manufactured exclusively in accordance with formulae described in the
authoritative books of Ayurveda & Unani.

Board
- In relation to Ayurveda or unani drug, the Ayurveda & unani drug technical advisory board under
section 33c.

- In relation to any other drug or cosmetic, the drugs technical advisory board under section 5.

Cosmetic
Any article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or applied to
human body and part thereof for cleansing, beautifying, promoting attractiveness or altering the
appearance and includes any article intended for use as component of cosmetic, but does not
includes soap.

Drug
- All medicines for internal or external use of human beings or animals and all substances intended
to be used for diagnosis, treatment, mitigation or prevention of disease in humans and animals.
- Substances other than food intended to affect the structure or function of the human body or used
for destruction of vermin/insects which cause disease in humans/animals as specified by central
government by notification in official gazette.

Government Analyst Means

- In relation to Ayurvedic/unani drug, Government analyst appointed by central Government or state
Govt.
- In relation to any other drug or cosmetic, Government analyst appointed by central Government or
state Govt.

Inspector
- As appointed by central Government or state Government under section 33G & 21.

Manufacture

- Includes any process or part of process for making, altering, finishing, packing, labeling, breaking up
or adopting any drug with a view to its sale & distribution BUT does not include compounding or
dispensing.

To Import
- Means to bring into India.

Patent or Proprietary medicine

- means drug which is a remedy or prescriptions presented in a form ready for internal or external
examination of humans/animals and which is not included in the edition of IP for time being or any
other pharmacopoeia authorized in this behalf by the central Govt.
Prescribed
- Means prescribed by rules made under this act.

13.3 DRUGS TECHNICAL ADVISORY BOARD

Central Government may constitute this board to advice central/state Government on technical
matters.

Board shall constitute of the following members:

DGHS, GOI – Chairman
Drug controller of India
Director central drug lab Kolkata
Director CRI, Kasauli
Director IVRI, Izatnagar
Director CDRI Lucknow
President MCI
President pharmacy council of India
10 other members nominated by the Central Government

∑ Members shall hold office for 3 years but eligible for re-nomination.

∑ Bear with the approval of the Central Government make byelaws for regulating procedures
and conduct of business by it.

∑ Board may constitute sub committees for a period not more than 3 years for consideration
of particular matters.

∑ Central Government shall appoint a secretary of the board and shall provide clerical and
other staff for its functioning.

Central drug laboratory

Central Government may, after consultation with the board, make rules prescribing the functioning
of the CDL:
- The procedure for submission of samples of drugs for tests
- Form for laboratory reports
- Fees payable in such reports

13.4 DRUG CONSULTATIVE COMMITTEE

Central Government may constitute this committee to advise central Government /state
Government & drug tech advisory board on matters tending to secure uniformity throughout India
in administration of this act.
 ∑ This committee shall consist of 2 reps of Central Government (nominated by the Central
Government) & one rep of State Government (nominated by the State Government).

∑ This committee shall meet when required to do so by the Central Government and have
powers to regulate its own procedure.

Import of Drugs

Standards of quality, means

- In relation to the drug, that the drug complies with the standard set out in 2nd
schedule.

- In relation to the cosmetic, that the cosmetic complies with such standards as may
be prescribed.

Misbranded drugs

A drug shall deemed to be misbranded if

- It is so colored, coated, powdered or polished that damage is concealed or if it is

made to appear of better or greater therapeutic value than it really is.

- It is not labeled in the prescribed manner.

- If its label or container bears any statement, design or device which makes any
false claim for the drug or misleading in particular.

Spurious Drugs

A drug shall deemed to be spurious

- If it is imitation of /substitutes of /resembles in a manner likely to deceive

another drug or on its label is name of another drug.

- If it purports to be product of place /country of which it is not a product.

- If imported under a name which belongs to another drug.

Adulterated drugs

- If consists in whole or part of any filthy, putrid or decomposed substance.

- If proposed, packed or stored under insanitary conditions whereby it may have been
contaminated.

- If container is compose of any poisonous or deleterious substance which may be injurious to

health.

- If substances are mixed into it to reduce its quality or strength.

 - If substances are mixed into it to reduce its quality or strength.

Misbranded cosmetics

- If it contains color which is not prescribed.

- If imported under a name which belongs to another cosmetic.

Spurious Cosmetics

- If imitation of, substitution for or resembles in a manner likely to deceive another cosmetic.

- If it purports to be a product of a place or a country of which it is not truly a product.

- It is imported under a name which belongs to another cosmetic.

- It is an intimation of, or is a substitute for, another drug or not truly a product.

13.5 PROHIBITION OF IMPORT OF CERTAIN DRUGS OR COSMETICS

As fixed by the central Government by notification, no person shall import:

- Drug / cosmetic not of standard quality

- Any misbranded drug or cosmetic
- Any adulterated drug
- Any drug /cosmetic for which license is required
- Any patent or proprietary medicine
- Any cosmetic containing ingredients which may render it unsafe or harmful for use

Application of the Law In Relation To Sea Customs

∑ The law in force relating to sea customs and to goods, the import of which is prohibited by
section 18 of sea customs act, 1878.

∑ The custom collector or an officer authorized by the central Govt on its behalf, may detain
any imported package which he suspects to contain any drug /cosmetic, the import of which
is prohibited and reports this to drug controller India and if necessary forward the sample of
SUSPECTED DRUG TO CDL.
 13.6 POWERS OF CENTRAL GOVT TO MAKE RULES
Central Government after consultation with the board and after publication in the official gazette
notification, make rules for the purpose of giving effect to the provision of this chapter.

Such rules may:

- specify drugs /classes of drugs for import of which a license is required and
prescribe the form and condition of such license, authority empowered to give it and
the fees payable

-prescribe the methods of test or analysis to be employed in determining

whether drugs of standard quality.

- prescribe in respect of biological & organ metallic compounds, the methods of

standardization.

- specify diseases / ailments which an imported drug may not purport to claim.

- prescribe the conditions, subject to which small quantities of drugs, the

import of which is otherwise prohibited ,may be imported for examination / test
/analysis .

∑ Require the date of manufacture, date of expiry to be clearly stated on the label
container.
∑ Prescribe fees for the test or analysis by CDL.
∑ Prescribe the evidence to be supplied whether by accompanying documents or
otherwise of the quality of drugs sought to be imported.
∑ Prescribe the conditions to be observed in the packing in bottles, packages or other
containers of imported drugs.
∑ Regulate the mode of labeling drugs/cosmetics imported for sale in packages.
∑ Prescribe the maximum proportion of any poisonous substance which may be added to
or contained in any imported drug, prohibit import of any drug in which that
proportion is exceeded and specify substances which shall be deemed to be
poisonous.
∑ Require that accepted scientific name of any specified drug shall be displayed on the
label/wrapper.

13.7 OFFENCES

Whoever himself or by any other person on his behalf imports:

 - any drug seem to be adulterated or spurious or any spurious cosmetic shall be punishable
with imprisonment which may extend to three years or fine up to Rs 5000/- . Or both.

- For those who again get convicted under this section, shall in addition to penalty be
punishable with imprisonment which may extend to 5 years or Rs 10000 or both.

Confiscation

-Where an offence has been committed, the consignment of drugs/cosmetic in respect of

which the offence has been committed shall be liable to confiscation.

Jurisdiction

-No court inferior to its class magistrate shall try the offence punishable under this act.

13.8 MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS

Standards of quality – means

- In relation to the drug, that the drug complies with the standard set out in the 2nd
schedule.

- In relation to the cosmetic, that the cosmetic complies with such standards as may be
prescribed.

-Central Government after consultation with the board and after giving official gazette
notification & not less than 3 months’ notice of its intention to do so, may add or amend the
2nd schedule for this chapter.

Disclosure of the Name of the Manufacturer

-Every person not being the manufacturer/distributor of drug/cosmetic, shall if so require to

disclose to the inspector the name and address of the person from whom he acquired the
drug.

Pleas

-It shall be no defense under this chapter to prove merely that the accused was ignorant of
the nature of substance or quality of the drug in respect of which the offence has been
committed
Or
Of the circumstances of its manufacture /import
Or
That a purchaser having bought only for the purpose of test or an analysis has not been
prejudiced by the sale.

Section 18
 For the purpose of section 18, a drug shall not deem to misbranded / adulterated or below
standard quality nor shall a cosmetic may deemed to be misbranded / below standard
quality only by the reason of the fact that:

- There has been added some substance or ingredient because the same is required for
manufacture of the drug and not to increase the bulk weight/ measure of the drug or to
conceal its inferior quality or other defects.

-In the process of manufacture, preparation or conveyance some extraneous substances

get unavoidably intermixed with it. This clause will not apply in relation to
sale/distribution after the vendor became aware of such intermixture.

A person not being the manufacturer of a drug/cosmetic or a distributor shall not be liable
for contravention of section 18, if he proves that:
- He acquired the drug/cosmetic from a duly licensed manufacturer /distributor/ dealer.
- He did not know and couldn't have ascertained that the drug/cosmetic contravened the
provision of the section.
- The drug/cosmetic, while in his possession was properly stored ad remained in the
same state as when he acquired it.

Government analysts

∑ The state Govt official gazette notification appoint such persons as it thinks fit, having the
prescribed qualifications to be Govt analysts for such areas in the state & in respect of drugs
specified in the notification.

∑ The central Govt by official gazette notification appoint Govt analysts in respect of drugs as
may be specified in the notification.

∑ Neither central Govt or state Govt nor central Govt shall appoint a Govt analyst who is not
serving under it and without the consent of the Govt under which he is serving.

Inspectors

∑ Central/state Govt by official gazette notification appoint persons with prescribed

qualifications as inspectors for such areas as may be assigned to them by the
central/state govt.

∑ The powers which may be exercised by an inspector, the duties which may be
performed by him, and the drugs in relation to which the
conditions/limitations/restrictions may be preferred shall be as such prescribed.

∑ No person who has any financial interest (in import/manufacturing/sale of drugs) shall
be appointed to be an inspector.

∑ Every inspector shall be deemed to be a public servant within the meaning of section 21
of IPC.

Powers of inspectors
 ∑ Subject to provisions of section 23 & rules by the central Govt, an inspector may within local
limits of area for which he is appointed may :

∑ Inspect any premise where drug/cosmetic is being manufactured.

And

In case of sera/vaccines visit the plant to see the process of manufacture & means employed
for standardization and testing of drugs.

∑ Take samples of any drug/cosmetic which is being manufactured/stocked/exhibited for

sale/sold or distributed

∑ Enter and search at all times (if necessary), any place in which he has reason to believe that
an offense under this chapter has been or is being committed and order in writing that the
person is in possession of such drug in respect of which the offense is committed and should
not dispose of any stock of such drug for a period not more than 20days.if the alleged
offense is such that the defect may be removed by the possessor of the drug, he may seize
the stock of the drug.

∑ Examine any record, register document or any other material found in any place and seize
the same if he has reason to believe that it may furnish evidence in the court of law.

∑ Code of criminal procedures 1898 (5 of 1898) shall apply to any search or seizure under this
chapter.

∑ If any person willfully obstructs an inspector in the exercise of the powers conferred on him,
he shall be punishable with imprisonment which may extend to 3 yrs. or fine or both.

Procedures for Inspectors

∑ Where an inspector takes any sample of a drug, he shall tender the fair price thereof & may
require a written acknowledgement.

∑ Where the price tendered is refused or where the inspector seizes the drug, he shall tender
a specific receipt thereof in the prescribed form.

∑ Where an inspector takes a sample of the drug for test/analysis/ he shall intimate such
purpose in writing in the prescribed form to the person from whom he takes it.

∑ He shall divide the sample into four portions & effectively seal and mark the same. He may
permit such person to add his own seal & mark to all the portions so sealed/marked.

∑ If the drug/cosmetic is in small containers of small volume, instead of dividing the sample,
he shall take four containers and suitably mark the same. The disposal of the 4 portions shall
be as follows :

- One portion sent to Government analyst for test /analysis.

- Second portion sent to the court.

 - Third portion to the person whose name. Address and particulars disclosed (as having
received from him- if any).

- Fourth portion to the person from who seized.

Where an inspector takes action under the above clauses:

- He shall ascertain whether or not the drug/cosmetic contravenes any of the provisions
of section 18.

- If the drug/cosmetic, does not contravene he shall revoke the order passed under the
clause or take such action as necessary for return of the stock seized.

∑ If the inspector seizes the stock of drug/cosmetic, he shall as soon as possible info a
magistrate & take orders for the custody of the same.

∑ Without prejudice to the institution of any prosecution, if the defect is remedied by the
possessor of the drug up to the satisfaction of the inspector, then the later will revoke his
order under the clause.

∑ Persons bound to disclose place of manufacture of drugs

∑ Every person in charge of any premises where the drug/cosmetic is manufactured /kept for
sale /distribution shall on being enquired by the inspector. Be legally bound to disclose to
the inspector the place where drug/cosmetic is being manufactured/kept

Reports of Government Analyst

∑ The Government analyst to whom drug/cosmetic has been submitted for test shall deliver to
the inspector a signed report in triplicate in the prescribed form.

∑ On receipt of the report, the inspector shall distribute the same as follows :

- One copy of the report to the person whose sample was taken.

- One copy to the person whose name, address and other particulars were taken (if any).

- One copy to be retained by the inspector for muse in any prosecution in respect of the
sample

∑ Any document purporting to be a report duly signed by the Govt analyst shall be evidence of
the facts and such evidence shall be conclusive unless the person from whom the sample
was taken has within 28days of receipt of the copy of the report, notifies in writing (to the
inspector or the court) that he intends to adduce evidence in controversial of the report.

∑ When the person has notified its intention in writing, the court on its own or on request of
the complainant orders the sample produced before the magistrate to be sent for
 test/analysis to CDL and the report in writing signed by the director CDL shall be the
conclusive evidence of the facts.

∑ The cost of test/analysis made by the CDL will be paid by the complainant or the accused.

∑ Purchaser of the drug/cosmetic enabled to obtain test/analysis

Any person shall on application in prescribed manner and payment of prescribed fees is entitled to
submit for test/analysis to a Government analyst any drug/cosmetic purchased by him and to
receive a report signed by the Government analyst.

13.9 PENALTIES

Penalty (drugs)

∑ Whoever himself or any other person on his behalf manufactures /sells /stocks /distributes :
∑ any drug – deemed to be adulterated or spurious or which when used by any person for or
in diagnosis, treatment, mitigation or prevention of any disease is likely to cause his
death or likely to cause a grievous hurt is punished with imprisonment not less than 5 year
extendable to life term and fine of Rs10000/-
∑ Drugs other than above deemed to be adulterated punished with imprisonment up to 3
years and fine of Rs 5000/-.

Penalty (cosmetics)

- Punishable with imprisonment up to three year or fine of Rs 1000/- or both

- Penalty for non-disclosure of the name of the manufacturer
- Imprisonment up to one year or fine of Rs 1000/- or both.

Penalty for use of Govt analyst report for advertising

-Use of Govt analyst report/CDL report for advertising is punishable with fine up to Rs 500.

Penalty for Subsequent Offenses

-Whoever is convicted again for the same offense shall be punishable with imprisonment not
less than 2 years extendable to 6 years and fine of Rs 10000/- or both.

Confiscation

-Where any person has been convicted under the chapter for contravening the provisions or
any rule, the stock of the drug/cosmetic I respect of which the contravention has been made
shall be liable to confiscation.

-Such contravention may be in respect of:

- Manufacture of any drug deemed to be misbranded or adulterated.

 - Manufacture for sale/stocking/distribution of any drug without a valid license.

∑ Application of the provisions to Government department

∑ The provisions of this chapter except for confiscation shall also apply to manufacture /sale
/distribution of drug by any Government department.

Cognizance of Offences

∑ No prosecution under this chapter shall be instituted except by the inspector.

∑ No court inferior to that of presidency magistrate or 1st class magistrate shall try an offence
punishable under this chapter.

∑ Nothing contained in this chapter shall deemed to prevent any person from being
prosecuted under any other law foe any act of commission.

Power of Court to Implied the Manufacturer

At any time during the trial of an offence alleged to have been committed by any person, not
being the manufacturer of a drug/cosmetic nor his agent for distribution and the court is
satisfied with the evidence before it that the manufacturer or his agent are also connected
with the offence, the court may proceed against them.

Such rules may:

- provide for establishment of lab for testing/analyzing of drugs/cosmetics.

- Prescribe the qualifications and duties of the Govt analysts & qualification of the I
inspectors.

- prescribe methods of tests/analysis to be employed in determining whether a

drug/cosmetic is of standard quality.

- prescribe in respect of biological & organometallic compounds the units and methods of
standardization.

- prescribe form of licenses for manufacture for sale/distribution of drugs, the form for
application of such licenses, the condition for issue of licenses, authority empowered to
issue license and the fees payable.

- require date of manufacture and date of expiry to be clearly and truly stated on the
label or the container of any drug.

- prohibit sale /stocking /exhibition for sale /distribution of said drug after of a specified
period from the date of manufacture.
 -Prescribe conditions to be observed for packing in bottles and other containers and
prohibit sale /stocking /distribution of drugs/cosmetics packed in contravention
such conditions.

- Regulate mode of packing of drugs/ cosmetics & prescribe the matters which shall or
shall not be included in such labels.

- prescribe maximum proportion of any poisonous substance which may be added to or

contained in any drug;

- prohibit manufacture /sale /stocking /distribution of any drug in which this proportion
exceeds and specify substances which shall deemed to be poisonous for the purpose of this
chapter.

- require that accepted scientific name of any specified drug shall be displayed in the
prescribed manner on the label/wrapper.

- prescribe powers and duties of inspectors in relation to which and the conditions
/limitations /restrictions subjected to which such powers and duties may be exercised or
performed.

- prescribe the form of reports to be given by the Govt analysts and manner of application
for test/analysis and the fees payable.

- specify the offences against this chapter.

- provide for exemptions from all or any of the provisions in this chapter.

- Nothing contained in this chapter shall apply to Ayurvedic or unani drugs.

13.10 AYURVEDIC & UNANI DRUG TECHNICAL ADVISORY BOARD

∑ Central Government by official, gazette notification constitute a board (called Ayurvedic and
unani drug technical advisory board ) to advice central/state Government on technical
matters and to carry out other functions.

∑ Ayurvedic & unani drug technical advisory board

∑ Board shall consist of the following members:

- DGHS – ex officio

- Drug controller of India – ex officio

- Advisor in indigenous system of medicine, Min of health & FW – ex officio

- Director CDL Kolkata – ex officio

- One person holding appointment of Govt analyst – to be nominated by the central

Government
 - One pharmacologist – nominated by central Govt

∑ Ayurvedic & unani drug technical advisory board

- One photochemistry – nominated by the Central Government.

- 2 persons nominated from central council of Ayurvedic research.

- 1 teacher in Dravyaguna & Bhaishajya Kalpana.

- 1 teacher in IL ul advia & Taklis-wa-dawa-saja.

- 2 persons each to represent Ayurvedic &unani drug industry.

- 2 persons each to represent Ayurvedic and unani practitioners.

w Central Government shall appoint a member of the board as chairman.

w Nominated members shall hold office for 3 years but eligible for denomination.

w Board by previous of the Central Government make bye laws fixing a quorum and regulation
its own procedure and code of conduct.

w Central Government shall appoint person to be the Secretary of the board and shall provide
clerical and other staff considered necessary.

w From such date as fixed by the State Government by official gazette notification, no person
himself/or on his behalf shall manufacture for sale and Ayurvedic/unani drug :

- except under prescribed hygienic conditions.

- except under supervision of persons having prescribed qualifications.

- except under and in accordance with the conditions of license issued for this purpose.

- Unless the raw material used in preparation of the drug are genuine and properly
identified.

- Unless such drug is labeled with the true list of all ingredients contained in it.

- In contravention of any of the provision of this chapter.

Restriction on Sale

No person himself/or on his behalf shall stock/sell/exhibit/distribute any Ayurvedic /unani

drug other than that manufactured by a licensed manufacturer.

13.11 MISCELLANEOUS

Power to give directions

 - Central Govt may give such direction to the state Govt as may appear necessary for
execution of the provisions of this act.

Offences by companies

- when an offence under this act has been committed by company, every person who at the
time of offence was in charge & was responsible for the conduct of business company shall be
guilty of the offence and liable to be punished accordingly.

- provided that nothing contained in this subsection shall render any person liable to
punishment if he proves that offence was committed without his knowledge or he
exercised adequate diligence to prevent commission of such crime.

- where an offence has been committed by accompany & proved that the offence has
been committed with consent /connivance /attributable to neglect on the part of the
director /manager /secretary /any other officer, then such official will be deemed to
be guilty & punished accordingly.

∑ For this section

- Company means body corporate, and includes firm or other association of individuals.

- Director means director in relation to a firm means a partner in the firm.

∑ Offenses by Government Department

- When an offence has been committed by any Govt department, then the head of the
department shall be deemed to be guilty of the offense & liable to punishment.

- Such authority is not liable to punishment if he proves that the offense was committed
without his knowledge & due diligence was exercised to prevent commission of such
crime.

∑ Publication Of Sentences Passed Under This Act

- if a person is convicted of an offense under this act, it shall be lawful for the court to
cause the offenders name, residence, nature of offense and the penalty inflicted to
be published at the expense of such person in the newspapers or in any such manner as
the court may direct.

∑ Magistrate Power To Impose Enhanced Punishments

- It shall be lawful for the it’s class magistrate to pass any sentence authorized by this act
in excess of the powers under the said code.

∑ Protection Of Action Taken In Good Faith

- No suit, prosecution or legal proceedings shall be made against any person for anything
which is in good faith.

∑ Rules To Be Laid Before Parliament

 - every rule made under this act shall be laid before each house of the parliament while it is
in session for a total period of 30 days which may be in one session or two or more
sessions for its concurrence or modifications.

13.12 SCHEDULE OF DRUGS

First Schedule:

i. A – Ayurvedic and siddha system.

ii. B – Unani Tibb system.

Second Schedule:

iii. Allopathic & Homeopathic drugs

Second Schedule –Class of Drugs

1- Patent or proprietary medicines (other than Homeopathic medicines).

2- Substances commonly known as vaccines, sera, toxin, toxoids, antitoxins and biological
products.
3- Vitamins, hormones, and analogous products.
4- Substances intended to affect the structure or function of human body or used for
destruction of vermin’s or insects causing disease in human beings/animals.

Second schedule –class of drugs

2. 4A – Homeopathic Medicines :
- Drugs included in Homeopathic pharmacopoeia of India.
- Drugs not included in India but include in Homeopathic pharmacopeias of USA or UK
or German homeopathic pharmacopoeia.
- Drugs not included in any of the above.
3. Other Drugs
- - Drugs included in Indian Pharmacopeias.
- Drugs not included in Indian Pharmacopeias but included in the official
pharmacopeias of any other country.

13.13 SUMMARY
The Drug and Cosmetics Act is a guiding policy for the pharmaceutical Industry and hospital. It acts
as a big deterrent for spurious, adulterated and misbranded drugs. It also has curbed unethical
practices associated with practice of medicine.

13.14 KEY WORDS

Cosmetic

- Any article intended to be rubbed, poured, sprinkled, sprayed on, introduced into or applied to
human body and part thereof for cleansing, beautifying, promoting attractiveness or altering the
appearance and includes any article intended for use as component of cosmetic, but does nor
includes soap.

Drug

- All medicines for internal or external use of human beings or animals and all substances intended
to be used for diagnosis, treatment, mitigation or prevention of disease in humans and animals.

- Substances other than food intended to affect the structure or function of the human body or used
for destruction of vermin/insects which cause disease in humans/animals as specified by central
government by notification in official gazette
 UNIT 14 INDUSTRIAL DISPUTE ACT
Learning Objectives

After going through this Unit you will be able to:

∑ understand the concept of industry and Industrial Dispute;

∑ learn the meaning of lay off, strike, layout, retrenchment;
∑ Understand the procedures associated with settling of Industrial dispute.

Structure

14.1. Introduction
14.2 Strikes and Lockout
14.3 General Prohibition of Strikes and Lockouts
14.4 Illegal Strikes and Lock-Outs
14.5 Layoff and Retrenchment
14.6 Special Provisions Relating To Lay-Off, Retrenchment and Closure in Certain
Establishments
14.7 Penalties

14.1 INTRODUCTION

The Industrial Disputes Act 1947 extends to the whole of India and regulates Indian labour law so far
as that concerns trade unions as well as Individual workman employed in any Industry within the
territory of Indian mainland. It came into force April 1, 1947.

The objective of the Industrial Disputes Act is to secure industrial peace and harmony by providing
machinery and procedure for the investigation and settlement of industrial disputes by conciliation,
arbitration and adjudication machinery which is provided under the statute. The main and ultimate
objective of this act is "Maintenance of Peaceful work culture in the Industry in India" which is
clearly provided under the Statement of Objects & Reasons of the statute.

The laws apply only to the organized sector. Chapter V talks about the most important and often in
news topic of 'Strikes and Lockouts'. It talks about the Regulation of strikes and lockouts and the
proper procedure which is to be followed to make it a Legal instrument of 'Economic Coercion' either
by the Employer or by the Workmen. Chapter V-B, introduced by an amendment in 1976, requires
firms employing 300 or more workers to obtain government permission for layoffs, retrenchments and
closures. A further amendment in 1982 (which took effect in 1984) expanded its ambit by reducing
the threshold to 100 workers.

The Act also lays down:

∑ The provision for payment of compensation to the workman on account of closure or lay off
or retrenchment.
∑ The procedure for prior permission of appropriate Government for lying off or retrenching the
workers or closing down industrial establishments.
∑ Unfair labour practices on part of an employer or a trade union or workers.
The Industrial Disputes Act extends to whole of India and applies to every Industry and its various
industrial establishments carrying on any business, trade, manufacture or distribution of goods and
services irrespective of the number of workmen employed therein.

Every person employed in an establishment for hire or reward including contract labour, apprentices
and part-time employees to do any manual, clerical, skilled, unskilled, technical, operational or
supervisory work, is covered by the Act.

This Act though does not apply to persons mainly in managerial or administrative capacity, persons
engaged in a supervisory capacity and drawing > 10,000 p.m. or executing managerial functions and
persons subject to Army Act, Air Force and Navy Act or those in police service or officer or
employee of a prison.

1.2 STRIKES AND LOCK-OUT

Prohibition of Strikes and Lock-Outs

1. No person employed in a public utility service shall go on strike, in breach of contract:

(a) without giving to the employer notice of strike, as hereinafter provided, within six weeks before
striking; or

(b) Within fourteen days of giving such notice; or

(c) Before the expiry of the date of strike specified in any such notice as aforesaid; or

(d) During the pendency of any conciliation proceedings before a conciliation officer and seven days
after the conclusion of such proceedings.

1. No employer carrying on any public utility service shall lock-out any of his workmen:

(a) without giving them notice of lock-out as hereinafter provided, within six weeks before locking-
out; or

(b) Within fourteen days of giving such notice; or

(c) Before the expiry of the date of lock-out specified in any such notice as aforesaid; or

(d) During the pendency of any conciliation proceedings before a conciliation officer and seven days
after the conclusion of such proceedings.

3. The notice of lock-out or strike under this section shall not be necessary where there is already in
existence a strike or, as the case may be, lock out in the public utility service, but the employer shall
send intimation of such lock-out or strike on the day on which it is declared, to such authority as may
be specified by the appropriate Government either generally or for a particular area or for a particular
class of public utility services.

4. The notice of strike referred to in sub-section (1) shall be given by such number of persons to such
person or persons and in such manner as may be prescribed.

5. The notice of lock-out referred to in sub-section (2) shall be given in such manner as may be
prescribed.
6. If on any day an employer receives from any person employed by him any such notices as are
referred to in sub-section (1) or gives to any persons employed by him any such notices as are referred
to in sub-section (2), he, within five days, thereof report to the appropriate Government or to such
authority as that Government may prescribe the number of such notices received or given on that day.

General Prohibition of Strikes and Lockouts

No workman who is employed in any industrial establishment shall go on strike in breach of contract
and no employer of any such workman shall declare a lock-out:

(a) During the pendency of conciliation proceedings before a Board

(b) During the pendency of proceedings before a Labour Court, Tribunal or National Tribunal
(c) During the pendency of arbitration proceedings before an arbitrator
(D) during any period in which a settlement or award is in operation, in respect of any of the matters
covered by the settlement or award.

Illegal Strikes and Lock-Outs

A strike or a lock-out shall be illegal if:

(i) It is commenced or declared in contravention of section 22 or section 23; or

(ii) It is continued in contravention of an order made under sub-section (3) of section 10 [lda-136 or
sub-section (4A) of section 10A;
(iii) Where a strike or lock-out in pursuance of an industrial dispute has already commenced
(iv)Lock-out declared in consequence of an illegal strike or a strike declared in consequence of an
illegal lock-out shall not be deemed to be illegal.

No person shall knowingly expend or apply any money in direct furtherance or support of any
illegal strike or lock-out.

14.3 LAY-OFF AND RETRENCHMENT

Application of sections 25C to 25E

∑ Sections 25C to 25E shall not apply to Industrial Establishments in which less than fifty
workmen on an average per working day have been employed in the preceding calendar
month; or

∑ To industrial establishments which are of a seasonal character or in which work is performed

only intermittently?

Definition of Continuous Service

(1) a workman shall be said to be in continuous service for a period if he is, for that period, in
uninterrupted service, including service which may be interrupted on account of sickness or
authorized leave or an accident or a strike which is not illegal, or a lock-out or a cessation of work
which is not due to any fault on the part of the workman;

(2) Where a workman is not in continuous service within the meaning of clause (1) for a period of
one year or six months, he shall be deemed to be in continuous service under an employer:

(a) for a period of one year, if the workman, during a period of twelve calendar months preceding the
date with reference to which calculation is to be made, has actually worked under the employer for
Not less than—
(I) one hundred and ninety days in the case of a workman employed below ground in a mine; and
(Ii) two hundred and forty days, in any other case;

(b)for a period of six months, if the workman, during a period of six calendar months preceding the
date with reference to which calculation is to be made, has actually worked under the employer for
not less than.

(I) ninety-five days, in the case of workman employed below ground in a mine; and
(Ii) one hundred and twenty days, in any other case.

Right of Workmen Laid-Off For Compensation

Whenever a workman (other than a badly workman or a casual workman) whose name is borne on the
muster rolls of an industrial establishment and who has completed not less than one year of
continuous service under an employer is laid-off, whether continuously or intermittently, he shall be
paid by the employer for all days during which he is so laid-off, except for such weekly holidays as
may intervene, compensation which shall be equal to fifty per cent, of the total of the basic wages and
dearness allowance that would have been payable to him had he not been so laid-off:

1. Provided that if during any period of twelve months, a workman is so laid- off for more than
forty-five days, no such compensation shall be payable in respect of any period of the lay-off after
the expiry of the first forty-five days.

2. if there is an agreement to that effect between the workman and the employer: Provided further
that it shall be lawful for the employer in any case falling within the foregoing proviso to retrench
the workman in accordance with the provisions contained in section 25F at any time after the
expiry of the first forty-five days of the lay-off and when he does so, any compensation paid
to the workman for having been laid-off during the preceding twelve months may be set off
against the compensation payable for retrenchment.

Explanation
“Badli workman” means a workman who is employed in an industrial establishment in the place of
another workman whose name is borne on the muster rolls of the establishment, but shall cease to be
regarded as such for the purposes of this section, if he has completed one year of continuous service in
the establishment.

Duty of an Employer to Maintain Muster Rolls of Workmen

Notwithstanding that workmen in any industrial establishment have been laid off, it shall be the duty
of every employer to maintain for the purposes of this unit a muster roll, and to provide for the
making of entries therein by workmen who may present themselves for work at the establishment at
the appointed time during normal working hours.
 Workmen Not Entitled To Compensation in Certain Cases
No compensation shall be paid to a workman who has been laid-off:

(i) if he refuses to accept any alternative employment in the same establishment from which he has
been laid-off, or in any other establishment belonging to the same employer situate in the same town
or village or situate within a radius of five miles from the establishment to which he belongs, if, in the
opinion of the employer, such alternative employment does not call for any special skill or previous
experience and can be done by the workman, provided that the wages which would normally have
been paid to the workman are offered for the alternative employment also;

(ii) If he does not present himself for work at the establishment at the appointed time during normal
working hours at least once a day;

(iii) if such laying-off is due to a strike or slowing-down of production on the part of workmen in
another part of the establishment.

Conditions Precedent to Retrenchment of Workmen

No workman employed in any industry who has been in continuous service for not less than one year
under an employer shall be retrenched by that employer until:

(a) the workman has been given one month’s notice in writing indicating the reasons for retrenchment
and the period of notice has expired, or the Industrial Disputes Act, 1947 workman has been paid in
lieu of such notice, wages for the period of the notice;

(b) the workman has been paid, at the time of retrenchment, compensation which shall be equivalent
to fifteen days’ average pay 2 [for every completed year of continuous service] or any part thereof in
excess of six months; and

(c) Notice in the prescribed manner is served on the appropriate Government or such authority as may
be specified by the appropriate Government by notification in the Official Gazette. If the termination
of an employee is based on no inquiry, no charge and not by way of punishment, then it becomes a
case of illegal retrenchment.

Transfer
Employee before such transfer shall be entitled to notice and compensation in accordance with the
provisions of section 25F, as if the workman had been retrenched:

Provided that nothing in this section shall apply to a workman in any case where there has been a
change of employers by reason of the transfer, if:

(a) The service of the workman has not been interrupted by such transfer;

(b) the terms and conditions of service applicable to the workman after such transfer are not in any
way less favorable to the workman than those applicable to him immediately before the transfer; and

(c) The new employer is, under the terms of such transfer or otherwise, legally liable to pay to the
workman, in the event of his retrenchment, compensation on the basis that his service has been
continuous and has not been interrupted by the transfer.

Sixty Days’ Notice to Be Given of Intention to Close down Any Undertaking

(1) An employer who intends to close down an undertaking shall serve, at least sixty days before the
date on which the intended closure is to become effective, a notice, in the prescribed manner, on the
appropriate Government stating clearly the reasons for the intended closure of the undertaking:
Provided that nothing in this section shall apply to:

(a) An undertaking in which

(i) Less than fifty workmen are employed, or
(ii) Less than fifty workmen were employed on an average per working day
In the preceding twelve months,

(b) An undertaking set up for the construction of buildings, bridges, roads, canals, dams or for other
construction work or project.

(2) Notwithstanding anything contained in sub-section (1), the appropriate Government, may, if it is
satisfied that owing to such exceptional circumstances as accident in the undertaking or death of the
employer or the like it is necessary so to do, by order, direct that provisions of subsection shall not
apply in relation to such undertaking for such period as may be specified in the order.

Compensation to Workmen In Case Of Closing down Of Undertakings

(1) Where an undertaking is closed down for any reason whatsoever, every workman who has been in
continuous service for not less than one year in that undertaking immediately before such closure
shall, subject to the provisions of sub-section.

(2) Be entitled to notice and compensation in accordance with the provisions of section 25F, as if the
workman had been retrenched:

Provided that where the undertaking is closed down on account of unavoidable circumstances beyond
the control of the employer, the compensation to be paid to the workman under clause (b) of section
exhaustion of the minerals in the area in which operations are carried on, shall not be deemed to be
closed down on account of unavoidable circumstances beyond the control of the employer within the
meaning of the proviso to this sub-section.

Notwithstanding anything contained in sub-section (1), where an undertaking engaged in mining

operations is closed down by reason merely of exhaustion of the minerals in the area in which such
operations are carried on, no workman referred to in that sub-section shall be entitled to any notice or
compensation in accordance with the provisions of section 25F, if—

(a) the employer provides the workman with alternative employment with effect from the date of
closure at the same remuneration as he was entitled to receive, and on the same terms and conditions
of service as were applicable to him, immediately before the closure;

(b) The service of the workman has not been interrupted by such alternative employment; and

(c) The employer is, under the terms of such alternative employment or otherwise, legally liable to
pay to the workman, in the event of his retrenchment, compensation on the basis that his service has
been continuous and has not been interrupted by such alternative employment.

The Industrial Tribunal has no power to enquire into the motive of closure in order to find out whether
the closure is justified or not when indiscipline is established. It can only consider the question of
bona fides and nothing more
 Procedure for Retrenchment
Where any workman in an industrial establishment, who is a citizen of India, is to be retrenched and
he belongs to a particular category of workmen in that establishment, in the absence of any agreement
between the employer and the workman in this behalf, the employer shall ordinarily retrench the
workman who was the last person to be employed in that category, unless for reasons to be recorded
the employer retrenches any other workman.

Re-Employment of Retrenched Workmen

Where any workmen are retrenched, and the employer proposes to take into his employ any persons,
he shall, in such manner as may be prescribed, give an opportunity 1[to the retrenched workmen who
are citizens of India to offer themselves for reemployment, and such retrenched workmen] who offer
themselves for reemployment shall have preference over other persons.

14.4 SPECIAL PROVISIONS RELATING TO LAY-OFF, RETRENCHMENT AND

CLOSURE IN CERTAIN ESTABLISHMENTS

(1) No workman (other than a badly workman or a casual workman) whose name is borne on the
muster rolls of an industrial establishment to which this Unit applies shall be laid-off by his
employer except:

∑ with the prior permission of the appropriate Government or such authority as may be specified by
that Government by notification in the Official, obtained on an application made in this behalf,
unless such lay-off is due to shortage of power or to natural calamity, and in the case of a mine,
such lay-off is due also to fire, flood, excess of inflammable gas or explosion

∑ An application for permission under sub-section shall be made by the employer in the prescribed
manner stating clearly the reasons for the intended lay-off and a copy of such application shall
also be served simultaneously on the workmen concerned in the prescribed manner.

∑ Where the workmen (other than Badli workmen or casual workmen) of an industrial
establishment, being a mine, have been laid-off under subsection for reasons of fire, flood or
excess of inflammable gas or explosion, the employer, in relation to such establishment, shall,
within a period of thirty days from the date of commencement of such lay-off, apply, in the
prescribed manner, to the appropriate Government or the specified authority for permission to
continue the lay-off.

An order of the appropriate Government or the specified authority granting or refusing to grant
permission shall, subject to the provisions of be final and binding on all the parties concerned and
shall remain in force for one year from the date of such order.

The appropriate Government or the specified authority may, either on its own motion or on the
application made by the employer or any workman, review its order granting or refusing to grant
permission under sub-section or refer the matter or, as the case may be, cause it to be referred, to a
Tribunal for adjudication:

Provided that where a reference has been made to a Tribunal under this sub-section, it shall pass an
award within a period of thirty days from the date of such reference.
Conditions Precedent to Retrenchment of Workmen

(1) No workman employed in any industrial establishment , who has been in continuous service
for not less than one year under an employer shall be retrenched by that employer until—

(a) the workman has been given three months’ notice in writing indicating the reasons for
retrenchment and the period of notice has expired, or

(b) the workman has been paid in lieu of such notice, wages for the period of the notice; and the
prior permission of the appropriate Government or such authority as may be specified by that
Government by notification in the Official Gazette (hereafter in this section referred to
as the specified authority) has been obtained on an application made in this behalf.

Procedure for Closing down An Undertaking

(1) An employer who intends to close down an undertaking of an industrial establishment to which
this Chapter applies shall, in the prescribed manner, apply, for prior permission at least ninety days
before the date on which the intended closure is to become effective, to the appropriate Government,
stating clearly the reasons for the intended closure of the undertaking and a copy of such application
shall also be served simultaneously on the representatives of the workmen in the prescribed manner:

(2) An order of the appropriate Government granting or refusing to grant permission shall, subject to
the provisions of sub-section), be final and binding on all the parties and shall remain in force for one
year from the date of such order.

Penalty for Closure

(1) Any employer, who closes down an undertaking without complying with the provisions of sub-
section (1) of section 25-O shall be punishable with imprisonment for a term which may extend to
six months, or with fine which may extend to five thousand rupees, or with both.

(2) Any employer, who contravenes an order refusing to grant permission to close down an
undertaking a direction given under section shall be punishable with imprisonment for a term which
may extend to one year, or with fine which may extend to five thousand rupees, or with both, and
where the contravention is a continuing one, with a further fine which may extend to two thousand
rupees for every day during which the contravention continues after the conviction.

Unfair Labour Practices

Prohibition of unfair labour practice—No employer or workman or a trade union, whether

registered under the Trade Unions Act, 1926 (16 of 1926), or not, shall commit any unfair labour
practice.

Penalty for committing unfair labour practices—any person who commits any unfair labour
practice shall be punishable with imprisonment for a term which may extend to six months or with
fine which may extend to one thousand rupees or with both.

14.5 PENALTIES

Penalty for Illegal Strikes and Lock-Outs

 Any workman who commences, continues or otherwise acts in furtherance of, a strike which is illegal
under this Act, shall be punishable with imprisonment for a term which may extend to one month, or
with fine which may extend to fifty rupees, or with both.

Any employer, who commences, continues, or otherwise acts in furtherance of a lock-out which is
illegal under this Act, shall be punishable with imprisonment for a term which may extend to one
month, or with fine which may extend to one thousand rupees, or with both.

Penalty for instigation, etc.: Any person who instigates or incites others to take part in, or otherwise
acts in furtherance of, a strike or lock-out which is illegal under this Act, shall be punishable with
imprisonment for a term which may extend to six months, or with fine which may extend to one
thousand rupees, or with both.

Penalty for giving financial aid to illegal strikes and lock-outs: Any person who knowingly expends
or applies any money in direct furtherance or support of any illegal strike or lock-out shall be
punishable with imprisonment for a term which may extend to six months, or with fine which may
extend to one thousand rupees, or with both.

Penalty For Breach of Settlement or Award: Any person who commits a breach of any term of any
settlement or award, which is binding on him under this Act, shall be punishable with imprisonment
for a term which may extend to six months, or with fine, or with both, 2 [and where the breach is a
continuing one with a further fine which may extend to two hundred rupees for every day during
which the breach continues after the conviction for the first], and the Court trying the offence, if it
fines the offender, may direct that the whole or any part of the fine realized from him shall be paid, by
way of compensation, to any person who, in its opinion has been injured by such breach.

Penalty for disclosing confidential information: Any person who willfully discloses any such
information in contravention of the provisions of that section shall, on complaint made by or on
behalf of the trade union or individual business affected, be punishable with imprisonment for a term
which may extend to six months, or with fine which may extend to one thousand rupees, or with both.

Penalty for closure without notice: Any employer who closes down any undertaking without
complying with the provisions shall be punishable with imprisonment for a term which may extend to
six months, or with fine which may extend to five thousand rupees, or with both.

Penalty for other offences

(1) Any employer who contravenes the provisions of section 33 shall be punishable with
imprisonment for a term which may extend to six months, or with fine which may extend to one
thousand rupees, or with both.

(2) Whoever contravenes any of the provisions of this Act or any rule made there under shall, if no
other penalty is elsewhere provided by or under this Act for such contravention, be punishable with
fine which may extend to one hundred rupees.

14.6 SUMMARY

The IDA is caught between efficiency and fairness. To prevent this conflict it may require different
construction. Indian system of law provides natural justice. Thus, surely, to remedy the situation
Indian labour law needs to reinvent itself on the basis of a moral theory that values the individual to
escape the prevalent tradeoff between fairness and conflict.

14.7 KEY WORDS

“Industrial Dispute" means any dispute or difference between employers and employers, or between
employers and workmen, or between workmen and workmen, which is connected with the
employment or non-employment or the terms of employment or with the conditions of labour, of any
person’s Labour Court" means a Labour Court constituted under section

“Lay-Off" (with its grammatical variations and cognate expressions) means the failure, refusal or
Inability of an employer on account of shortage of coal, power or raw materials or the accumulation
Of stocks or the break-down of machinery or natural calamity or for any other connected reason to
give
Employment to a workman whose name is borne on the muster-rolls of his industrial establishment
and
Who has not been retrenched?

“Lock-Out" means the temporary closing of a place of employment or the suspension of work, or
the
Refusal by an employer to continue to employ any number of persons employed by him;

"Industry" means any systematic activity carried on by co-operation between an employer and his
workmen (whether such workmen are employed by such employer directly or by or through any
agency, including a contractor) for the production, supply or distribution of goods or services with a
view to satisfy human wants or wishes
 TH UNIT 15 – WORKMEN COMPENSATION ACT

Learning Objectives

After going through this Unit you will be able to:

∑ understand the concept of compensation;

∑ understand the different types of disabilities;
∑ understand Compensation liability for each type of disability;
∑ understand the Doctrine of Notional Extension;
∑ Learn how to calculate the compensation to be paid?

Structure

15.1. Introduction
15.2 History
15.3 Scope and Coverage
15.4 Definitions
15.5 Doctrine of Notional Extension
15.6 Amount of Compensation
15.7 Appeals
15.8 Schedules
15.9 ESMA 1984
15.10 Summary
15.11 Key words

15.1 INTRODUCTION
The Workmen Compensation Act is an important labour law which aims at providing Social Justice,
equitable distribution of profits, Social Equity, Uniformity of Justice to workmen. It also aims at
safeguarding the interests and prevention of exploitation of workmen.

The Essential Services Maintenance Act,1984 (ESMA) which can be invoked for health care industries is
a measure which will ensure that the provisions of various labour Acts, will not disrupt the
functioning of many industries required for lifeline support system of the society.

15.2 OBJECTIVES
The Workmen's Compensation Act, 1923, aims to provide workmen and/or their dependents some
relief in case of accidents arising out of and in the course of employment and causing either death or
disablement of workmen.

15.3 SCOPE AND COVERAGE

∑ The Act extends to the whole of India.

∑ The Workmen's Compensation (Amendment) Act, 2000 has brought all the workers within
its sphere irrespective of their nature of employment i.e. whether employed on casual basis
or otherwise than for the purposes of the employer's trade or business.

∑ Under Section 2(12) The Act is applicable to the factories employing 10 or more persons
irrespective of whether power is used in the process of manufacturing or not.

∑ Under Section 1(5) of the Act, the Scheme has been extended to shops, hotels, restaurants,
cinemas including preview theatre, road motor transport undertakings and newspaper
establishment employing 20 or more persons.

Employees Entitled

∑ Every employee including those employed through a contractor and also casual employees,
who suffers an injury in any accident arising out of and in the course of his employment,
shall be entitled for compensation under the Act.

∑ A person employed in a factory which is yet to commence production would not be deprived
of the benefit of the provisions of the Act.

∑ The workman employed in a premises where manufacturing process is intended to be

carried on is not necessarily required to be actually connected with manufacturing process.

∑ Any person engaged in such premises who is contributing for the intended manufacturing
process would be deemed to be workman for the purpose of the Act.

Administrative Authority

∑ The State Governments administer the provisions of this Act through the Commissioners
appointed for specified areas.

∑ The State Governments also make rules for ensuring that the provisions of the Act are
complied with.

15.4 DEFINITION

Dependent: Dependent means any of the following:

∑ relatives of a dead workman, namely: a widow, a minor legitimate or adopted son and
unmarried legitimate or adopted daughter, or a widowed mother,
 ∑ and if wholly dependent on the earnings of the workman at the time of his death, a
son or a daughter who has attained the age of 18 years and who is infirm,

∑ And any of the following wholly or partly dependent on the workman at the time of
his death— a widower, a parent other than a widowed mother, a minor illegitimate
son, a unmarried illegitimate daughter, a widowed daughter in law, a minor child of
the dead son & daughter & a paternal grandparent if not the parent of the workman is
alive.

∑ Commissioner means a Commissioner for Workmen’s Compensation appointed under

Sec.20.

Employer" includes

∑ Anybody of persons whether incorporated or not;

∑ Any managing agent of an employer; and

∑ The legal representative of a deceased employer.

Disablement

∑ Injury caused to a workman by an accident usually results in the loss of the earning capacity
of the workman concerned and this loss of earning capacity is technically "disablement".

∑ Disablements can be classified as

(a) Total, and

{B) Partial

It can further be classified into

(i) Permanent, and

{Ii) Temporary

Partial disablement

This means any disablement as reduces the earning capacity of a workman as a result of some
accident. It may be temporary or permanent.

∑ Temporary partial disablement means any disablement as reduces the earning capacity of a
workman in any employment in which he was engaged at the time of the accident resulting in
the disablement.

∑ Permanent partial disablement is one which reduces the earning capacity of a workman in every
employment which he was capable of undertaking at that time of injury.
Total disablement
Total disablement’ means such disablement, whether of a temporary or permanent nature, as
incapacitates a workman for all work which he was capable of performing at the time of the accident
resulting in such disablement
Wages

Wages’ includes any privilege or benefit which is capable of being estimated in money, other than a
travelling allowance or the value of any travelling concession or a contribution paid by the employer
a workman towards any pension or provident fund or a sum paid to a workman to cover any special
expenses entailed on him by the nature of his employment.

Workman

∑ ‘workman’ means any person who is-

∑ (a) a railway servant as defined in clause (34) of section 2 of the Railways Act, 1989 (24 of
1989), not permanently employed in any administrative, district or sub-divisional office of a
railway and not employed in any such capacity as is specified in Schedule II, or

∑ (b) A master, seaman or other member of the crew of a ship, etc.

∑ It does not include a person whose employment is of casual nature.

Total Disablement

Employer’s Liabilities for Compensation

An employer is liable to pay compensation to workman for:

1. Personal injury by accident- An employer is liable to pay compensation to workman if personal

injury is caused to him by accident arising out of & in the course of his employment.

2. Occupational diseases- workers employed in certain occupations are exposed to certain diseases
which are inherent in those occupation.

Accident Compensation-when payable:

∑ The employer of any establishment covered under this Act, is required to compensate an
employee: who has suffered an accident arising out of and in the course of his employment,
resulting into
 (i) Death,

(ii) Permanent total disablement,

(iii) Permanent partial disablement,

(iv) Temporary disablement

∑ What is the condition for receiving compensation for Personal Injury caused by the accident?

- At the time of injury workman must have been engaged in the business of the
employer and must not be doing something for his personal benefit;

- That accident occurred at the place where he was performing his duties; and Injury
must have resulted from some risk incidental to the duties of the service, or
inherent in the nature or condition of employment.

15.5 DOCTRINE OF NOTIONAL EXTENSION

The expression in the course of his employment', connotes not only actual work but also any other
engagement natural and necessary thereto, reasonably extended both as regards work-hours and
work-place. It refers to the time during which the employment continues. . However, this is subject
to the theory of notional extension of the employer's premises so as to include an area which the
workman passes and re-passes in going to and in leaving the actual place of work. There may be
some reasonable extension in both time and place and a workman may be regarded as in the course
of his employment even though he had not reached or had left his employer's premises. This is also
called as the Doctrine of Notional Extension. The doctrine of notional extension could not be placed
in a strait jacket; it was merely a matter of sound common sense as to when and where and to what
extent this doctrine could be applied.

When Is an Employer Not Liable To Pay Compensation?

∑ If the injury did not result in total or partial disablement of a workman for a period
exceeding three days.

∑ if the workman was at the time of the accident under the influence of drink of drug, or

∑ if the workman willfully disobeyed an order expressly given or a rule expressly framed for
the purpose of securing safety of workman, or

∑ If the workman willfully removed or disregarded any safety guard or other device which to
his knowledge was provided for the purpose of securing his safety.

15.6 AMOUNT OF COMPENSATION

∑ The amount of compensation payable to a workman depends

 ∑ on the nature of injury caused by accident,

∑ the monthly wages of the workman concerned,

∑ And the relevant factor for working out lump sum equivalent of compensation amount.

∑ There is no distinction between an adult and a minor worker with respect to the amount of
compensation.

Compensation for Death:

In case of death resulting from injury, the amount of compensation shall be equal 50% of the
monthly wages of the deceased workman multiplied by the relevant factor. Or an amount of Rs
80,000/- whichever is more.

Example: A workman is employed in a factory on a monthly wage of Rs 3000. While working he met
with an accident and dies on cot 2000. His date of birth is July 18, 1970. The amount of
compensation payable to his dependent would be

50* monthly wages* Relevant factor of age 30

100

0r 80,000 whichever is higher

50* 3000* 207.98 = 3, 11,970

100

Since Rs 311970 is more than 80000 the compensation payable to him shall be Rs 311,970

COMPENSATION FOR TEMPORARY DISABLEMENT (TOTAL OR PARTIAL)

If the temporary disablement, whether total or partial results from the injury, the amount of
compensation shall be a half monthly payment of the sum equivalent to 25% of the monthly wages
of the workman to be paid in accordance with the provisions. The half monthly payment shall be
payable on the sixteenth day from the date of disablement In cases where such disablement lasts for
a period of 28 days or more compensation is payable from the date of disablement In other cases
After the expiry of a waiting period of three days from the date of disablement.

Compensation to Be Paid When Due and Penalty for Default (section 4A

As per this section, compensation has to paid as soon as it is due In case the employer does not
accept the liability of paying the compensation, he is bound to make provisional payment to the
extent of the liability he accepts. Such amount has to be deposited with the commissioner or paid to
the workman. If he defaults, the commissioner may order: the payment of the amount with interest
at12 % per year if the default to be unjustifiable then the commissioner may order payment of a
further sum not exceeding 50% of the amount due, by way of penalty.

Accident Report

Accident Report Where the accident results in death or serious physical injury, the employer should
send a report to the Commissioner, within 7 days of the accident, in the prescribed from giving the
circumstances attending the death or serious bodily injury.

Compensation to be paid when due & penalty for default [Sec.4A

∑ As per this section, compensation has to paid as soon as it is due

∑ In case the employer does not accept the liability of paying the compensation, he is bound to
make provisional payment to the extent of the liability he accepts. Such amount has to be
deposited with the commissioner or paid to the workman. If he defaults, the commissioner may
order:

∑ the payment of the amount with interest at12 % per year

∑ If the default to be unjustifiable then the commissioner may order payment of a further sum not
exceeding 50% of the amount due, by way of penalty.

Method of Calculating Monthly Wages

∑ The monthly wages of the workman shall be one-twelfth of the total wages which have
fallen due for payment to him by the employer in the last twelve months of that period.

∑ where the whole of the continuous period of service immediately preceding the accident
during which the workman was in the service of the employer who is liable to pay the
compensation was less than one month, the monthly wages of the workman shall be the
average monthly amount which, during the twelve months immediately preceding the
accident, was being earned by a workman employed on the same work by the same
employer,

∑ Or, if there was no workman so employed, by a workman employed on similar work in the
same locality.

∑ in other cases [including cases in which it is not possible for want of necessary information
to calculate the monthly wages under clause (b), the monthly wages shall be thirty times the
total wages earned in respect of the last continuous period of service immediately preceding
the accident from the employer who is liable to pay compensation, divided by the number of
days comprising such period.

15.7 APPEALS
(1) An appeal shall lie to the High Court from the following orders of a Commissioner,
namely:
 (a) an order awarding as compensation a lump sum whether by way of redemption of a half-
monthly payment or otherwise or disallowing a claim in full or in part for a lump sum;

(AA) an order awarding interest or penalty under section 4A;

(b) An order refusing to allow redemption of a half-monthly payment;

(c) An order providing for the distribution of compensation among the dependents of a
deceased workman, or disallowing any claim of a person alleging himself to be such
dependent;

(d) An order allowing or disallowing any claim for the amount of an indemnity under the
provisions of sub-section (2) of section 12

(2) The period of limitation for an appeal under this section shall be sixty days.

(3) The provision of section 5 of the Limitation Act, 1963 (36 of 1963) shall be applicable to
appeals under, this section.

Compensation Claims

Form of application

∑ Claim should be initiated

∑ Give details of circumstances

∑ About claims being asked for

∑ Date of serving of notice and any delay with justification

∑ Names and addresses of both parties

∑ Matters on which agreement has been made and matters on which agreement is
required

Show cause notice- when commissioner feels that compensation of death is not adequate

∑ Notice for more money

∑ Pay for penalty in delays

Power & Procedures of Commissioner

∑ All powers of civil court for taking evidence on oath

∑ Ensuring presence of witnesses
∑ Compelling production of documents
∑ Shall be deemed to be a civil court

∑ Costs- to be borne by as directed by commissioner

∑ Power of submitting case- to High court & decisions are as per high court
 ∑ Agreement Registration

∑ Agreement between employee and employer checked for genuineness and recorded in a
register

15.8 SCHEDULES

Schedule-I Part I:

List of injuries deemed to result in Permanent total disablement

Part II: gives List of injuries deemed to result in Permanent Partial disablement & other injuries

Schedule-II

List of persons subject to provisions of act

Schedule- III

List of Occupational diseases

15.9 ESSENTIAL SERVICES MAINTENANCE ACT- 1981(ESMA)

∑ Act is for providing the maintenance of certain essential services

∑ Enacted in Parliament in 1981

∑ Extends to whole of India except state of J & K

Definition

Any service, employment or class where parliament has powers to make laws under such
constitution & Government feels that strikes in such areas would prejudiciously affect the main of
Public utility services, public safety or the main of supplies and services necessary for life of the
community.

Includes
∑ any postal, telegraph or telephone service

∑ any transport service for the carriage of passengers or goods by air, railway or any other
transport service;

∑ any service connected with the operation or maintenance of aerodromes, or aircraft,

∑ any service in, or in connection with the working of, any major port, including loading,
unloading, movement or storage of goods
 ∑ any service connected with the clearance of goods or passengers through the customs

∑ any service in connection with the working of, public conservancy, sanitation or water
supply, hospitals or dispensaries, in any Union territory, cantonment area or undertaking
owned or controlled by the Central Government;

∑ in relation to banking;

∑ establishment or undertaking dealing with the production, supply or distribution of coal,

power, steel or fertilizers;

∑ any service in any oil field or refinery or dealing with the production, supply or distribution
of petroleum and petroleum products;

∑ any service in connection with elections to Parliament or to the Legislatures of the States;

∑ any service in connection with the affairs of the Union,

15.10 SUMMARY

Object: The objective of this Act is that in the case of an employment injury
Compensation be provided to the injured workman and in case of his death to his
Dependents.

Employer to pay compensation: In case a personal injury is caused to a workman by

Accident arising out of and in the course of his employment, his employer is liable to pay
Compensation in accordance with the provision of the Act within 30 days from the date
When it fell due otherwise he would also be liable to pay interest and penalty.

When employer is not liable

In case the disablement of workman is three or less days;
Except in case of death when the injury is caused due to influence of drink or drug taken
By the workman or upon his willful disobedience to obey safety rules or removal of safety
Guards by him.

Amount of compensation:
(1) in case of death:- an amount equal to 50% of the monthly wage multiplied by the relevant
factor as given in Schedule IV of the Act or Rs. 80,000/-whichever is more.
(2) In case of permanent total disablement, it is 60% or Rs. 90,000/-whichever is more and

(3) In case of permanent partial disablement occurs then the

Compensation is proportionate to the disability arrived as at (2) above.

Notice: An injured person or his dependents have to give a notice to the employer to pay
Compensation.

Claim: Upon the failure or refusal of an employer to give compensation, an application is

To the made in Form - F to the Commissioner under the Workmen's Compensation Act,
1923 who is the Assistant Labour Commissioner or the Labour-cum-Conciliation Officer
Of the area where the accident took place or where the claimant ordinarily resides or
Where the employer has his registered office. After hearing both the parties, the
Commissioner decides the claim.

Contracting out: Any contract or agreement whereby an injured person or his dependent
Relinquishes or reduce his right to receive compensation is null and void to that extent.

Appeal: An appeal lie to the High Court against the orders of the Commissioner with
Regard to the awarding or refusing to award compensation, or imposing interest or
Penalty or regarding distribution of compensation etc.

Recovery: The amount of compensation awarded by the Commissioner is to be

Recovered as arrears of land revenue.
E INDUSTRIAL DISPUTES ACT, 1947
15.11 KEY WORDS

DEPENDANT:-Dependent means any of the following:-

∑ relatives of a dead workman, namely: a widow, a minor legitimate or adopted son and
unmarried legitimate or adopted daughter, or a widowed mother,
∑ and if wholly dependent on the earnings of the workman at the time of his death, a
son or a daughter who has attained the age of 18 years and who is infirm,
∑ And any of the following wholly or partly dependent on the workman at the time of
his death— a widower, a parent other than a widowed mother, a minor illegitimate
son, a unmarried illegitimate daughter, a widowed daughter in law, a minor child of
the dead son & daughter & a paternal grandparent if not the parent of the workman is
alive.
∑ Commissioner means a Commissioner for Workmen’s Compensation appointed under
Sec.20.

Employer" includes

∑ Anybody of persons whether incorporated or not;

∑ Any managing agent of an employer; and
∑ The legal representative of a deceased employer.

Disablement

Injury caused to a workman by an accident usually results in the loss of the earning capacity
of the workman concerned and this loss of earning capacity is technically "disablement".

o Disablements can be classified as

(a) Total, and

{B) Partial.

It can further be classified into

(i) Permanent, and

 {Ii) Temporary

Partial disablement-

This means any disablement as reduces the earning capacity of a workman as a result of some
accident. It may be temporary or permanent.

∑ Temporary partial disablement means any disablement as reduces the earning capacity
of a workman in any employment in which he was engaged at the time of the accident
resulting in the disablement.

∑ Permanent partial disablement is one which reduces the earning capacity of a workman
in every employment which he was capable of undertaking at that time of injury.

Total disablement-

Total disablement’ means such disablement, whether of a temporary or permanent nature, as

incapacitates a workman for all work which he was capable of performing at the time of the
accident resulting in such disablement

Wages

wages’ includes any privilege or benefit which is capable of being estimated in money, other
than a travelling allowance or the value of any travelling concession or a contribution paid by the
employer a workman towards any pension or provident fund or a sum paid to a workman to
cover any special expenses entailed on him by the nature of his employment.

Workman

‘Workman’ means any person who is-

(a) A railway servant as defined in clause (34) of section 2 of the Railways Act, 1989 (24 of 1989),
not permanently employed in any administrative, district or sub-divisional office of a railway and
not employed in any such capacity as is specified in Schedule II, or

(b) A master, seaman or other member of the crew of a ship, etc.

It does not include a person whose employment is of casual nature.

Definition of ESMA

Any service, employment or class where parliament has powers to make laws under such
constitution & Govt feels that strikes in such areas would prejudiciously affect the main of Public
utility services, public safety or the main of supplies and services necessary for life of the
community.