BP505T:PHARMACEUTICAL JURISPRUDENCE

L:3 T:1 P:0 Credits:4

Course Outcomes: Through this course students should be able to

CO1 :: Discuss the history and legislations governing profession of pharmacy

CO2 :: Study various guidelines related to statutory bodies associated with profession of
Pharmacy

CO3 :: Understand the regulatory and administrative authorities governing manufacture and sale
of pharmaceuticals or cosmetic products
CO4 :: Employ regulations associated to restricted drug products and prohibited advertisements

CO5 :: Explain various ethical guidelines according to IAEC, CPCSEA and warehousing of alcoholic
preparations
CO6 :: Study importance of IPR in pharmacy and guidelines in accordance with termination of
pregnancy

Unit I
Pharmaceutical legislations : introduction, study of drugs enquiry committee, Health survey and
development committee, Hathi committee, Mudaliar committee
Code of pharmaceutical ethics : pharmacist in relation to his job, profession, trade and medical
profession, pharmacist’s oath
Right to information act : definitions, right to information and obligations of public authorities,
information to be refused, central information commission, state information commission
Unit II
Pharmacy act-1948 : definition, objectives, functions and constitution of pharmacy council of India,
state pharmacy council, joint state pharmacy council, registration of pharmacist, offences and
penalties
Unit III
Drug and cosmetics act, 1940 and its rules 1945 : definition, Objectives, Drugs Technical
Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, licensing authorities and
controlling authorities, government drug analysts, drugs inspectors, import of drugs – classes of
drugs and cosmetics prohibited from import, import under license or permit, manufacture of drugs –
prohibition of manufacture and sale of certain drugs, conditions for grant of license for manufacture of
drugs, manufacture of drugs for test, examination and analysis, manufacture of new drug, loan
license and repacking license, sale of drugs – wholesale, retail sale and restricted license, general
labeling requirements and specimen labels for drugs and cosmetics, list of permitted colors, general
study of the special references to the C, C1, F, G, H,N, U,Y,T,V, M, P and X schedule, offences and
penalties
Unit IV
Narcotic Drugs and Psychotropic substances Act-1985 and Rules : definitions, objectives,
authorities and officers, constitution and functions of narcotic & psychotropic consultative committee,
national fund for controlling the drug abuse, prohibition, control and regulation, opium poppy
cultivation, production of poppy straw, manufacture, sale and export of opium, offences and penalties
Drugs and Magic Remedies Act and its
rules : introduction, definitions, prohibition of certain advertisements, classes of exempted
advertisements, offences and penalties
Unit V
Medicinal and Toilet Preparation Act –1955 : introduction, definitions, manufacture in bond and
outside bond, export of alcoholic preparations, manufacture of ayurvedic, homeopathic, patent &
proprietary Preparations, offences and penalties
Prevention of Cruelty to animals Act-1960: : definitions, objectives, institutional animals ethics
committee (IAEC), breeding and stocking of animals, performance of experiments, transfer and
acquisition of animals for experiment, records, contract animal experiments, power to suspend or
revoke registration, offences and penalties
Unit VI
National pharmaceutical pricing authority-Drug price control order, 2013 : definition,
objectives, sale prices of bulk drugs,, retail price and ceiling price of scheduled formulations, National
List of Essential Medicines (NLEM)

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Unit VI Medical Termination of Pregnancy Act : introduction, definitions, termination of pregnancies,
experience or training, approval of a place, admission register, custody of forms, power to make rules
and regulations
Introduction to Intellectual Property Rights (IPR) : definition, types of IPR, types of patents,
inventions not patentable, patentable invention, procedure for obtaining a patent, offences and
penalties, importance of IPR in pharmacy

Text Books:
1. A TEXTBOOK OF FORENSIC PHARMACY by JAIN N.K., VALLABH PRAKASHAN

References:
1. A TEXTBOOK OF FORENSIC PHARMACY by MITHAL B. M, VALLABH PRAKASHAN

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