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D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 1. General Principles of Law
- History and various Acts related to Drugs and Pharmacy profession
- Hours: 2
- History and various Acts related to Drugs and Pharmacy profession
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 2. Pharmacy Act -1948 and Rules
- Objectives, Definitions, Pharmacy Council of India: its constitution and functions, Education Regulations, State and Joint state pharmacy councils, Registration of Pharmacists. Offenses and Penalties
- Hours: 5
- Objectives, Definitions, Pharmacy Council of India: its constitution and functions, Education Regulations, State and Joint state pharmacy councils, Registration of Pharmacists. Offenses and Penalties
- Hours: 5
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 3. Pharmacy Practice Regulations 2015
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
Hours: 23
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 4. Narcotic Drugs and Psychotropic Substances Act 1985 and Rules
- Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offenses and Penalties
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 5. Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
- Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offenses and Penalties
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 6. Prevention of Cruelty to Animals Act-1960
- Objectives, Definitions, CPCSEA – brief structure and functions, Breeding and Stocking of Animals, performance of experiments, Transfer and acquisition of animals for experiment, Records, Power to suspend or revoke registration. Offenses and Penalties
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 7. Poison Act 1919
- Introduction, objective, definition, possession, and sale of poison
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 8. FSSAI (Food Safety and Standards Authority of India) and Rules
- Brief overview of responsibilities, prohibition and regulations, storage, sale, and labeling of Food Supplements
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 9. 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)
- Hours: 5
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 10. Code of Pharmaceutical Ethics
- Definition, ethical principles, ethical problem solving, registration, code of ethics as related to pharmacist in relation to his job, trade, medical profession and his profession. Pharmacist’s oath
- Hours: 5
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 11. Medical Termination of Pregnancy Act and Rules
- Basic understanding, safe and unsafe abortions
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 12. Role of the government pharma regulatory bodies
- Central Drugs Standards Control Organization (CDSCO), Food and Drugs Administration (FDA)
- Hours: 3
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 13. Roadmap to regulation of Community Pharmacy
- Licenses, renewals, governance in Community Pharmacy, Hospital Pharmacy, retail and wholesale business
- Hours: 3
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 14. Introduction to BCS system of classification
- Basic concepts of Clinical Trials, ANDA, NDA, New Drug development, New Drugs and Clinical Trials Rules 2019, Patent and Proprietary Medicine concept, Introduction to Plant Variety and Intellectual Property Rights, Emergency Use Authorization
- Hours: 4
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 15. Bioethics
- Basic requirements and functions
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 16. Clinical Establishment Act and Rules
- Aspects related to pharmacy
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 17. Biomedical Waste Management Rules 2016
- Basic aspects related to pharmaceutical waste disposal and disposal of expired / medical waste at homes, pharmacies, hospitals etc.
- Hours: 2
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 18. Historical aspects, history and principles of guidelines
- Overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants
- Hours: 1
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 19. Introduction to the Consumer Protection Act
- Hours: 1
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 20. Introduction to the Disaster Management Act
- Hours: 1
D.Pharmacy 2nd Year Pharmacy Law and Ethics :- Chapter 21. Medical Devices
- Categorization, basic aspects related to its manufacture and sale
- Hours: 1
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