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Text Book of Pharmacy Law & Ethics (ER2020-26T)

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Pharmacy Law means study of fundamental laws and in case of Jurisprudence, it is laws relating to pharmacy. Pharmaceutical laws & ethics is that branch of pharmacy, which deals with various legislations pertaining to drugs and pharmaceuticals, and profession of pharmacy. This subject encompasses the knowledge of various Acts, Rules, Statutes, Schedules, Sections etc., which directly or indirectly influence the profession of pharmacy in the country and various operations pertaining to procurement, manufacture and distribution of different kinds of dosage forms. Three important components of pharmacy profession – education, industry and pharmacy practice are regulated by the pieces of legislation enacted from time to time. The knowledge of Forensic Pharmacy is essential to understand the legal aspects pertaining to practice of pharmacy. The qualified persons are required to profess and should also be engaged in manufacturing, sales and distribution of drugs. Pharmacy is a noble and dedicated profession with a commitment to the cause of health care system of the country.

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SKU: DP206 Categories: , , , ,
ISBN 978-93-91334-54-3
Publishers R. Narain Publishers & Distributors
Author Dr. Manoj Katual & Dr. Gurfateh Singh
Binding Paperback
Edition 1/e
Price 390
Year 2022
Pages 360
Subject Text Book of Pharmacy Law & Ethics (ER2020-26T)
Weight 300 g

Table of Content

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 2
16 Clinical  Establishment  Act and  Rules  – Aspects  related  to


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 1
20 Introduction to the Disaster Management Act 1
21 Medical  Devices  – Categorization, basic aspects related  to

manufacture and sale




  1. Comprehensive coverage of theoretical and diagrammatical aspects of pharmaceutics.
  2. All intricate aspects are explained by simple, lucid and specific explanations and substantiated with neat and elaborate diagrammatic sketches.
  3. Examples from pharmaceutics are included extensively.


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