Handwritten Notes
BP 505 T. PHARMACEUTICAL JURISPRUDENCE (Theory)
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. Offenses and penalties.
Manufacture of drugs – Prohibition of the manufacture and sale of certain drugs,
Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for the test, examination, and analysis, manufacture of the 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 Drugs – Wholesale, Retail sale, and Restricted license. Offenses and penalties
Labeling & Packing of drugs- General labeling requirements and specimen labels for drugs and cosmetics, List of permitted colors. Offenses 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. Offenses 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 the experiment, Records, Power to suspend or revoke a 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 inquiry the committee, Health survey, and development committee, Hathi committee, and Mudaliar committee
• Code of Pharmaceutical ethics Definition, Pharmacist in relation to his job, trade, the 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)
2. Textbook of Forensic Pharmacy by B.M. Mithal
3. Handbook of drug law-by M.L. Mehra
4. A textbook 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)
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