Pharmacy Law and Ethics Notes PDF D.Pharm 2nd Year

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