PHARMACY LAW AND ETHICS (Second Year SY Diploma Pharm. PCI – ER 2020)

1. Pharmaceutical Legislation in India
2. Pharmacy Act, 1948 and Rules
3. Drugs and Cosmetics Act, 1940 and Rules There under 1945
4. The Narcotic Drugs and Psychotropic Substances Act, 1985
5. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules 1955
6. Prevention of Cruelty to Animals Act, 1960
7. THe Poisons Act, 1919
8. Food Safety and Standard Act 2006 (FSS Act) & Rules, Regulations
9. National Pharmaceutical Pricing Authority
10. Code of Pharmaceutical Ethics
11. Medical Termination of Pregnancy Act, 1971 and Rules Thereunder 1975
12. Role of all the Government Pharma Regulatory Bodies
13. Good Regulatory Practices
14. A. Introduction to BCS, ANDA, NDA, and New Drug Development
14. B. Basic Concepts of Clinical Trials, New Drugs and Clinical Trials Rules, 2019
14. C. Introduction to IPR and Patent Law, Trade Name Concept, Emergency Use Authorization, Brand V/S Generic
15. Blood Bank: Basic Requirements and Functions
16. Clinical Establishment Act 2010 Rules
17. Biomedical Waste Management Rules 2016
18. Bioethics
19. Consumer Protection Act, 1986
20. Introduction to the Disaster Management Act, 2005
21. Medical Devices