Pharmacy Law & Ethics 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