Unit I

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.

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 re- packing license.

(10 Hours)

Unit II

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 Drugs – Wholesale, 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

(10 Hours)

Unit III

1. Pharmacy Act –1948: Objectives, Definitions, Pharmacy Council of India; its constitution and func- tions, Education Regulations, State and Joint state pharmacy councils; constitution and functions, Registration of Pharmacists, Offences and Penalties
2. 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.
3. Narcotic Drugs and Psychotropic substances Act-1985 and Rules: Objectives, Definitions, Au- thorities and Officers, Constitution and Functions of narcotic & Psychotropic Consultative Com- mittee, 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

(10 Hours)

Unit IV

1. 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
2. Prevention of Cruelty to animals Act-1960: Objectives, Definitions, Institutional Animal Ethics Committee, CPCSEA guidelines for Breeding and Stocking of Animals, Performance of Experi- ments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration, Offences and Penalties
3. National Pharmaceutical Pricing Authority: Drugs Price Control Order (DPCO)- 2013. Objec- tives, Definitions, Sale prices of bulk drugs, Retail price of formulations, Retail price and ceiling price of scheduled formulations, National List of Essential Medicines (NLEM)

(08 Hours)

Unit V

1. Pharmaceutical Legislations – A brief review, Introduction, Study of drugs enquiry committee, Health survey and development committee, Hathi committee and Mudaliar committee
2. Code of Pharmaceutical ethics : Definition, Pharmacist in relation to his job, trade, medical profes- sion and his profession, Pharmacist’s oath
3. Medical Termination of Pregnancy Act
4. Right to Information Act
5. Introduction to Intellectual Property Rights (IPR)

(07 Hours)

‘Pharmaceutical Jurisprudence – Theory’ is a course offered in the fifth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours

Scope:

This course is designed to impart basic knowledge on important legislations related to the profes- sion 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 phar- maceuticals.
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

Recommended Books (Latest Editions)

1. Forensic Pharmacy by B. Suresh
2. Text book of Forensic Pharmacy by B.M. Mithal
3. Hand book of drug law-by M.L. Mehra
4. A text book of Forensic Pharmacy by N.K. Jain
5. Drugs and Cosmetics Act/Rules by Govt. of India publications.
6. Medicinal and Toilet preparations act 1955 by Govt. of India publications.
7. Narcotic drugs and psychotropic substances act by Govt. of India publications
8. Drugs and Magic Remedies act by Govt. of India publication
9. Bare Acts of the said laws published by Government. Reference books (Theory)