History and various Acts related to Drugs and Pharmacy profession Objectives, Definitions, Pharmacy Council of India; its constitution and functions, Education Regulations, State and Joint state pharmacy councils, Registration of Pharmacists, Offences and Penalties. Pharmacy Practice Regulations 2015 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.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.

Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties, Objectives, Definitions, CPCSEA - brief overview, Institutional Animal 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. Poisons Act-1919- Introduction, objective, definition, possession, possession for sales and sale of any poison, import of poisons

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. Medical Termination of Pregnancy Act and Rules – basic understanding, salient features, and Amendments Role of all the government pharma regulator bodies – Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC) 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

Blood bank – basic requirements and functions Clinical Establishment Act and Rules – Aspects related to Pharmacy Biomedical Waste Management Rules 2016 – Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and hospitals

Bioethics - Basic concepts, history and principles. Brief overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants Introduction to the Consumer Protection Act 1 Introduction to the Disaster Management Act 1 Medical Devices – Categorization, basic aspects related to manufacture and sale