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UNIT-I
Drugs and Cosmetics Act, 1940 and its rules 1945:
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
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
Administration of the Act and Rules – Drugs Technical Advisory Board, Central drugsLaboratory, Drugs Consultative Committee, Government drug analysts, Licensingauthorities, controlling authorities, Drugs Inspectors
UNIT-III
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
Study of Salient Features of Drugs and Magic Remedies Act and itsrules:
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)
UNIT-V
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
Recommended books: (Latest Edition)
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)
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