BP505T Pharmaceutical Jurisprudence Theory
Pharmaceutical Jurisprudence PCI Syllabus
UNIT-I: Drugs and Cosmetics Act, 1940 and its rules 1945
Objectives / Legislative intent and Definitions
Schedules to the Act and Rules
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 a 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)
Wholesale, Retail sale, and Restricted license. Offences and penalties
Labelling & Packing of drugs
General labelling requirements and specimen labels for drugs and cosmetics,
List of permitted colors.
Offences and penalties.
Administration of the Act and Rules –
Advisory:
Drugs Technical Advisory Board
Drugs Consultative Committee
Analytical:
Central drugs Laboratory
Drug Control laboratories in State
Government analysts
Executive:
Licensing authorities (Central and State)
Drugs Inspectors
Custom collectors
UNIT-III: Pharmacy Act –1948
Objectives / Legislative intent of Pharmacy Act & Definitions
Pharmacy Council of India; constitution and functions
State and Joint state pharmacy councils; constitution and functions
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:
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,
UNIT-IV: Drugs and Magic Remedies Act and its rules
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 the 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 the drugs inquiry 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,
Medical Termination of Pregnancy Act
Right to Information Act
Introduction to Intellectual Property Rights (IPR)
Pharmaceutical Jurisprudence Recommended books: (Latest Edition)
- Forensic Pharmacy by B. Suresh
- Textbook of Forensic Pharmacy by B.M. Mithal
- Handbook of drug law-by M.L. Mehra
- A textbook 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 act of the said laws published by Government. Reference books (Theory)
Third Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
Pharmaceutical Jurisprudence Notes
Pharmaceutical Jurisprudence PDF