Pharmaceutical Jurisprudence (Theory)

Objectives, Definitions, Legal definitions of schedules to the Act and Rules, CDSCO guidelines for Import & export of Pharmaceuticals 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.

Drugs and Cosmetics Act, 1940 and its rules 1945. Detailed study of Schedule G, H, H1, M, N, P, T, U, V, X, Y, Sch F, Part XII B. 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

Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations including ER20, 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, 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

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, CCSEA 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).

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, Medical Termination of Pregnancy Act Brief Introduction to Right to Information Act Introduction New Drugs and Clinical Trials Rules, 2019 and amendments. Cosmetic rules 2020 Regulatory guidelines on similar biologics. Overview of Medical Device Regulations, Guidelines on Probiotics, Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016