MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2013 Certified)
SUMMER 2024-EXAMINATION
Structured Marking Scheme – Only for the Use of RAC Assessors
Subject Name: Pharmacy Law & Ethics Subject Code:
20226
220226
________________________________________________________________________________________________________________
Guidelines to Assessors: 20226
1) While assessing figures, assessor shall award appropriate marks for principle components indicated in the figure.
2) In case of numerical problems, appropriate marks shall be awarded to steps and formulae.
3) Marking scheme being a guideline, assessor can assess the answer based on his/her judgement
4) If the students write answers in Marathi or bilingual language (English +Marathi), the assessor shall consider the same
and assess the answer.
Sub Maximum
Q. Mark Remark if
Que. marks for Key Points, Key Steps, Formula, etc.
No. Distribution necessary
No. Sub Que.
1 30M
Answer any SIX of the following
1 a) 05M Define education regulation. Describe it in detail and
define ‘Central Register’
Marking Scheme:
Definition of education regulation 1M
Provisions under education regulation (What does it 3M
prescribe?)
Definition of Central Register 1M
1 b) 05M Give the constitution and functions of Drugs
Technical Advisory Board
Marking Scheme:
Constitution of Drugs Technical Advisory Board
Ex-officio members 1½ M
Nominated members 1M
Elected members 1½ M
Functions of Drugs Technical Advisory Board 1M
1 c) 05M Discuss the ethics of pharmacists in relation to his
job as per the code of pharmaceutical ethics
Marking Scheme:
Ethics of pharmacists in relation to his job as per the
code of pharmaceutical ethics covering following points 5M
i) Scope of pharmaceutical services (Supply of
medicines) ii) Conduct of pharmacy (Errors during
compounding and dispensing of drugs)
iii) Handling of prescription
iv) Handling of drugs
v) Apprentice pharmacist
1 d) 05M Give the functions of Central Drugs Laboratory
(CDL)
Marking Scheme: 5M
Functions of Central Drugs Laboratory (Any five
functions)
1 | 6 Page
MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2013 Certified)
SUMMER 2024-EXAMINATION
Structured Marking Scheme – Only for the Use of RAC Assessors
Subject Name: Pharmacy Law & Ethics Subject Code:
20226
220226
________________________________________________________________________________________________________________
1 e) 05M Give the formula for calculation of retail price of
drug formulation and explain the terms involved in it 20226
as per DPCO, 1995 and define ‘Ceiling Price’
Marking Scheme:
Formula for calculation of retail price of drug
formulation 2M
R. P. = [(M.C. + C.C. + P.C. + P.M.) X (1+ MAPE/100)]
+ E.D.
Explanation of each term 2M
1M
Definition of Ceiling Price
1 f) 05M What is clinical trial and explain various phases of
clinical trials
Marking Scheme:
Clinical trial meaning 1M
Explanation of 4 phases of clinical trials 4M
1 g) 05M Define government analyst. State qualifications for
appointment of government analyst as per D and C
Act, 1940
Marking Scheme:
Definition of government analyst 2M
Qualifications of government analyst 3M
2 Attempt any TEN of the following 30M
2 a) 03M Write the classes of drugs and cosmetics prohibited
for manufacture as per D and C Act and Rules.
Marking Scheme:
Classes of drugs prohibited for manufacture (any three) 1½ M
Classes of cosmetics prohibited for manufacture 1½ M
(any three)
2 b) 03M Give any three bonafide reasons for termination of
pregnancy under Medical Termination of
Pregnancies Act, 1971.
Marking Scheme:
Bonafide reasons for termination of pregnancy (any 3M
three)
2 c) 03M Describe documentation, licenses and renewals of
pharma manufacturing as per good regulators
practices.
Marking Scheme: Pharma manufacturing:
Documentation 1M
licenses and 1M
renewals 1M
2 | 6 Page
MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2013 Certified)
SUMMER 2024-EXAMINATION
Structured Marking Scheme – Only for the Use of RAC Assessors
Subject Name: Pharmacy Law & Ethics Subject Code:
20226
220226
________________________________________________________________________________________________________________
2 d) 03M Write recommendation of 'Drug Enquiry Committee'.
Marking Scheme: 20226
Recommendation of 'Drug Enquiry Committee'.(any 3M
three)
2 e) 03M State the classes of prohibited advertisements as per
DMR Act, 1954. (any three)
Marking Scheme:
Classes of prohibited advertisements (any three) 3M
2 f) 03M What are the labelling particulars required to
appear on label of Ophthalmic preparations’
Marking Scheme:
Labelling particulars of Ophthalmic preparations 3M
2 g) 03M Define 'Poison' as per Poison Act, 1919 and name
any two poisons specified in list 'A' and list 'B' each.
Marking Scheme:
Definition of Poison
Name of poisons in List A (any two) 1M
Name of poisons in List B (any two) 1M
1M
2 h) 03M Write penalties for punishment for contravention in
relation to coca plant under NDPS Act and the rules.
Marking Scheme:
Penalties 3M
2 i) 03M Define 'Repacking of drugs and state any four
conditions for grant of repacking licence.
Marking Scheme:
Definition of 'Repacking of drugs 1M
Conditions for grant of repacking licence (any four) 2M
2 j) 03M Differentiate Brand name and Generic name of
drugs.
Marking Scheme:
Difference between Brand name & Generic name 3M
(any six point of differentiation)
2 k) 03M What are the functions of the National Council for
clinical establishments?
Marking Scheme:
Functions of the National Council for clinical 3M
establishments (any six)
3 Attempt All of the following 20M
3 a) Define ‘Chemists and Druggist’
1M Marking Scheme:
Definition of Chemist and Druggist:
Answer: 1M
3 | 6 Page
MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2013 Certified)
SUMMER 2024-EXAMINATION
Structured Marking Scheme – Only for the Use of RAC Assessors
Subject Name: Pharmacy Law & Ethics Subject Code:
20226
220226
________________________________________________________________________________________________________________
Chemist and Druggist: It is a licensed premise for the
sale of drug which requires services of “Qualified Person” 20226
but where drugs are not compounded against
prescription.
3 b) 1M Clandestine arrangements as per code of
pharmaceutical ethics means
Marking Scheme:
Answer: i) Secret agreements 1M
3 c) 1M CPCSEA stands for_____.
Marking Scheme:
Answer: 1M
Committee for the Purpose of Control and Supervision
of Experiments on Animals
3 d) 1M What does Schedule G to the rules prescribe?
Marking Scheme:
Answer: 1M
Schedule G prescribes list of drugs which are required to
be taken only under the supervision of Registered Medical
Practitioner
OR
It is dangerous to take this preparation except under the
supervision of medical practitioner
3 e) 1M Give the function of Food Authority. Any other
Marking Scheme: function
Answer: 1M related to
Function of Food Authority (Any one) food
1. To laydown science based standards for food articles articles
and 2.To regulate manufacture, storage, distribution, will be
sale and import of food articles considered
3. To ensure availability of safe and wholesome food for
human consumption
3 f) 1M What is the objective of DPCO (Any two)?
Marking Scheme: 0.5M for each objective (Any Two)
Answer: 1M
1. To ensure that necessary and life-saving
medications are available at fair prices without
compromising quality.
2. To promote rational use of medications.
3. To encourage cost effective production of drugs.
4. To offer list of prices of controlled drugs.
5. To provide process of price fixation of scheduled
and non-scheduled formulations.
4 | 6 Page
MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2013 Certified)
SUMMER 2024-EXAMINATION
Structured Marking Scheme – Only for the Use of RAC Assessors
Subject Name: Pharmacy Law & Ethics Subject Code:
20226
220226
________________________________________________________________________________________________________________
6. To regulate equitable distribution of bulk drugs &
to make the drugs available at fair prices from 20226
different manufacturers
7. To fix the maximum retail price of the formulation
8. To fix the maximum sale price of bulk drugs
3 g) 1M Name of local body which allows experiments on
small animals.
Marking Scheme:
Answer: ii) IAEC 1M
3 h) 1M Medical Termination of Pregnancy Act was passed
in ____.
Marking Scheme:
Answer: 1971 1M
3 i) 1M For production from basic stage post tax return of
____ on net worth is considered.
Marking Scheme:
Answer: iv) 18% 1M
3 j) 1M Give two examples of Schedule J Any other
Marking Scheme: (Any Two examples of disease) examples
Answer: 1M of diseases
Appendicitis, arteriosclerosis, blood poisoning, falling
blindness, cancer, diabetes, optical system/ nervous under
system/ disorders, epilepsy, fever, glaucoma, goiter, Schedule J
leprosy, small pox, trachoma, typhoid fever, etc. or will be
considered
1M State the principles of bioethics
Marking Scheme:
Answer: (Any two principles)
3 1. Principle of autonomy
k) 1M
2. Principle of beneficence
3. Principle of non-maleficence
4. Principle of justice
3 l) 1M Mention different classes of medical devices.
Marking Scheme:
Answer: (Any two classes) 1M
1. Class A (Low risk devices)
2. Class B (Low to moderate risk devices)
3. Class C (Moderate to high risk devices)
4. Class D (High risk devices)
3 m) 1M GRP stands for _______
Marking Scheme:
Answer: Good Regulatory Practices 1M
5 | 6 Page
MAHARASHTRA STATE BOARD OF TECHNICAL EDUCATION
(Autonomous)
(ISO/IEC - 27001 - 2013 Certified)
SUMMER 2024-EXAMINATION
Structured Marking Scheme – Only for the Use of RAC Assessors
Subject Name: Pharmacy Law & Ethics Subject Code:
20226
220226
________________________________________________________________________________________________________________
3 n) 1M National Institute of Disaster Management authority
comes under 20226
Marking Scheme:
Answer: i) Ministry of home affairs 1M
3 o) 1M Who is the head of Central Authority’s Investigation
wing?
Marking Scheme:
Answer: i) Director General 1M
1M ICMR stands for _______.
Marking Scheme:
3 p) 1M
Answer:
Indian Council of Medical Research
3 q) 1M Who is the head of Central Drugs Standard Control
Organization (CDSCO)?
Marking Scheme:
Answer: 1M
Directorate General of Health Services, Ministry of
Health and Family Welfare, Government of India
3 r) 1M Human Anatomical waste is categorized in which
colour bag as per Biomedical Waste Management
Act?
Marking Scheme:
Answer: 1M
Yellow colored non-chlorinated plastic bags
3 s) 1M Minimum haemoglobin requires to donate blood is
____.
Marking Scheme:
Answer: not less than 12.5 grams 1M
3 t) 1M Define ‘Bioethics’.
Marking Scheme:
Answer: 1M
Bioethics is the study of the ethical, social and legal
issues that arise in biomedicine and biological sciences
OR
The discipline dealing with the ethical implications of
biological research and applications especially in
medicine.
6 | 6 Page
