This course is designed to impart basic knowledge on important legislations related to the profession of pharmacy in India.
Upon completion of the course, the student shall be able to understand:
- The Pharmaceutical legislations and their implications in the development and marketing of pharmaceuticals.
- Various Indian pharmaceutical Acts and Laws
- The regulatory authorities and agencies governing the manufacture and sale of pharmaceuticals
- The code of ethics during the pharmaceutical practice
UNIT-I 10 Hours
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.
UNIT-II 10 Hours
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
UNIT-III 10 Hours
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
UNIT-IV 08 Hours
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)-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)
UNIT-V 07 Hours
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 D efinition, 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)
Recommended Books: (Latest Edition)
- Forensic Pharmacy by B. Suresh
- Text book of Forensic Pharmacy by B.M. Mithal
- Hand book of drug law -byM.L. Mehra
- A text book of Forensic Pharmacy by N.K. Jain
- Drugs and Cosmetics Act/Rules by Govt. of India publications.
- Medicinal and Toilet preparations act 1955 by Govt. of India publications.
- Narcotic drugs and psychotropic substances act by Govt. of India publications
- Drugs and Magic Remedies act by Govt. of India publication
- Bare Acts of the said laws published by Government. Reference books (Theory)