PHARMACEUTICAL JURISPRUDENCE - B. Pharma 5th Semester Complete PDF Notes


 Scope: This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.

Objectives: Upon completion of the course, the student shall be able to understand:

1.  The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.

2.  Various Indian pharmaceutical Acts and Laws

3.  The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals

4.  The code of ethics during the pharmaceutical practice

Course Content:


Drugs and Cosmetics Act, 1940 and its rules 1945: Objectives, Definitions, Legal definitions of schedules to the Act and Rules

Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties.

Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of  license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.


Drugs and Cosmetics Act, 1940 and its rules 1945.

Detailed study of Schedule G, H, M, N, P, T, U, V, X, Y, Part XII B, Sch F & DMR (OA) Sale of DrugsWholesale, Retail sale and Restricted license. Offences and penalties

Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offences and penalties.

Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugs Laboratory, Drugs Consultative Committee, Government drug analysts, licensing authorities, controlling authorities, Drugs Inspectors


Pharmacy Act –1948:  Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties

Medicinal and Toilet Preparation Act –1955: Objectives, Definitions, Licensing, Manufacture In bond   and Outside bond, Export of alcoholic preparations, Manufacture of Ayurvedic, Homeopathic, Patent &   Proprietary Preparations. Offences and Penalties.

Narcotic  Drugs and  Psychotropic substances Act-1985 and  Rules: Objectives, Definitions, 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 and production of poppy straw, manufacture, sale and export of opium, Offences and Penalties


Study of Salient Features of Drugs and Magic Remedies Act and its rules: Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties

Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking  of Animals, Performance of Experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties

National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO) - 2013. Objectives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM)


Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee

Code of Pharmaceutical ethics - Definition, Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath

Medical Termination of Pregnancy Act

Right to Information Act

Introduction to Intellectual Property Rights (IPR)

Pharmaceutical Policy 2002

Pharmaceutical Industries and Education in India

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