PHARMACY LAW AND
ETHICS (ER20-26T) CHAPTER-WISE NOTES PDF Download
Chapter 1
- General Principles of Law, History and various Acts related to Drugs and Pharmacy profession
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, Offences and Penalties.
- Pharmacy Practice Regulations 2015
Chapter 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.
Chapter 4
- Narcotic Drugs and Psychotropic Substances Act 1985 and Rules Objectives, Definitions, Authorities and Officers, Prohibition, Control and Regulation, Offences and Penalties.
Chapter 5
- Drugs and Magic Remedies (Objectionable Advertisements) Act 1954
- Objectives, Definitions, Prohibition of certain advertisements, Classes of Exempted advertisements, Offences and Penalties.
Chapter 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.
Chapter 7
- Poisons Act-1919: Introduction, objective, definition, possession, possession for sales and sale of any poison, import of poisons
Chapter 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
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)
Chapter 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.
Chapter 11
- Medical Termination of Pregnancy Act and Rules – basic understanding, salient features, and Amendments
Chapter 12
- Role of all the government pharma regulator bodies – Central Drugs Standards Control Organization (CDSCO),
- Indian Pharmacopoeia Commission (IPC)
Chapter 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
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.
- Brand v/s Generic, Trade name concept, Introduction to Patent Law and Intellectual Property Rights, Emergency Use Authorization
Chapter 15
- Blood bank – basic requirements and functions
Chapter 16
- Clinical Establishment Act and Rules – Aspects related to Pharmacy
Chapter 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
Chapter 18
- Bioethics – Basic concepts, history and principles.
- Brief overview of ICMR’s National Ethical Guidelines for Biomedical and Health Research involving human participants
Chapter 19
- Introduction to the Consumer Protection Act
Chapter 20
- Introduction to the Disaster Management Act
Chapter 21
- Medical Devices – Categorization, basic aspects related to manufacture and sale