Drugs and Cosmetics Act 1940 and Rules 1945 and New Amendments
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.
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.
Study of schedule C and C1, G, H, H1, K, P, M, N, and X.
Sale of Drugs – Wholesale, Retail sale and Restricted license, Records to be kept in a pharmacy
Drugs Prohibited for manufacture and sale in India
Administration of the Act and Rules – Drugs Technical
Advisory Board, Central Drugs Laboratory, Drugs
Consultative Committee, Government analysts, licensing authorities, controlling authorities, Drug Inspectors.
Narcotic Drugs and Psychotropic Substances Act 1985 and Rules Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties.
Ethics Committee, 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
Pharmaceutical Policy 2002, National List of Essential Medicines (NLEM)
Code of Pharmaceutical Ethics: Definition, ethical principles, ethical problem solving, registration, code of ethics for Pharmacist in relation to his job, trade, medical profession and his profession, Pharmacist’s oath.
Good Regulatory practices (documentation, licenses, renewals, e-governance) in Community Pharmacy, Hospital pharmacy, Pharma Manufacturing, Wholesale business, inspections, import, export of drugs and medical devices
Introduction to BCS system of classification, Basic concepts of Clinical Trials, ANDA, NDA, New Drug development, New Drugs and Clinical Trials Rules, 2019.
Brand v/s Generic, Trade name concept, Introduction to Patent Law and Intellectual Property Rights, Emergency Use Authorization
Biomedical Waste Management Rules 2016 – Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and hospitals
