Pharmacy Law and Ethics

 

 

PHARMACY LAW AND ETHICS – THEORY

 

Course Code: ER20-26T

 

Scope: This course is designed to impart basic knowledge on several important legislations related to the profession of pharmacy in India

 

Course Objectives: This course will discuss the following

1. General perspectives, history, evolution of pharmacy law in India

2. Act and Rules regulating the profession and practice of pharmacy in India

3. Important code of ethical guidelines pertaining to various practice standards

4. Brief introduction to the patent laws and their applications in pharmacy

 

Course Outcomes: Upon successful completion of this course, the students will be able to

1. Describe the history and evolution of pharmacy law in India

2. Interpret the act and rules regulating the profession and practice of pharmacy in India

3. Discuss the various codes of ethics related to practice standards in pharmacy

4. Interpret the fundamentals of patent laws from the perspectives of pharmacy

 

 

1. General Principles of Law, History and various Acts related to Drugs and Pharmacy profession

 

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, Offences and Penalties.

Pharmacy Practice Regulations 2015

 

3. 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.

 

4. Narcotic Drugs and Psychotropic Substances Act 1985 and Rules Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties.

 

5. Drugs and Magic Remedies (Objectionable Advertisements) Act 1954

Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties.

 

6. Prevention of Cruelty to Animals Act-1960: 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.

 

7. Poisons Act-1919: Introduction, objective, definition, possession, possession for sales and sale of any poison, import of poisons

 

8. FSSAI (Food Safety and Standards Authority of India) Act and Rules: brief overview and aspects related to manufacture, storage, sale, and labelling of Food Supplements

 

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)

10. 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.

 

11. Medical Termination of Pregnancy Act and Rules - basic understanding, salient features, and Amendments

 

12. Role of all the government pharma regulator bodies Central Drugs Standards Control Organization (CDSCO), Indian Pharmacopoeia Commission (IPC)

 

13. 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

 

14. 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

 

15. Blood bank - basic requirements and functions

 

16. Clinical Establishment Act and Rules - Aspects related to Pharmacy

 

17. Biomedical Waste Management Rules 2016 - Basic aspects, and aspects related to pharma manufacture to disposal of pharma / medical waste at homes, pharmacies, and hospitals

 

18. Bioethics Basic concepts, history and principles. Brief overview of ICMR's National Ethical Guidelines for Biomedical and Health Research involving human participants

 

19. Introduction to the Consumer Protection Act

 

20. Introduction to the Disaster Management Act

 

21. Medical Devices - Categorization, basic aspects related to manufacture and sale

 

Assignments

The students shall be asked to submit written assignments on the following topics (One assignment per student per sessional period. i.e., a minimum of THREE assignments per student)

1. Requirements for Ayurvedic, Homeopathic manufacturing, sale, and licensing requirements

2. Layout and contents of official websites of various agencies regulating the profession of pharmacy in India: e.g., CDSCO, SUGAM portal, PCI, etc.

3. Licenses required, application processes (online/offline), drug regulatory office website of the respective state

4. Case studies - actions taken on violation of any act / rule related to pharmacy 5. Schedule H1 drugs and its implementation in India

6. Counterfeit / Spurious medicines

7. Drug Testing Labs in India

8. Overview of Pharma marketing practices

9. Generic Medicines