Law Relating to Drugs and Cosmetics (In 2 Volumes)

An Exhaustive, Authoritative Book featuring New Materials, Latest Amendments, and Updated Case Law!

The New Twenty-eighth Edition, provides the fully amended and updated text of the Drugs and Cosmetics Act, 1940 (with amendments by Amending Act 26 of 2008 enforced on August 10, 2009) and the Drugs Rules, 1945 as amended up to the First Amendment Rules, 2025, along with case-law notes, allied Acts, Rules, Orders and Notifications. Additionally, the New Twenty-Eighth Edition incorporates the following fresh materials: National Medical Devices Policy, 2023, and National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector in India.

The Appendices provide several allied and useful statutes. Concise and coherent notes that are illustrative as well as instructive have been provided under important sections. New case law notes have been added, especially under the Drugs and Cosmetics Act, 1940. All systems of medicine such as Allopathic, Homeopathic and Ayurvedic, Unani and Siddha, have been brought under the ambit of the stringent drug control. The book will be useful for the conduct of clinical trials and the measures that ought to be complied with.

New Material included:

1. National Medical Devices Policy, 2023
2. National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector in India.

Valuable Content in the Book:

1. Approved list of drugs for manufacturing and marketing.
2. List of Drugs and Combination of Drugs Banned in India.
3. Drugs Not of Standard Quality.
4. Circulars and notifications on MRP, customs for imports, and required documents for bioequivalence study permissions.
5. Circulars on biomedical waste management.
6. Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013.
7. Narcotic Drugs and Psychotropic Substances Act, 1985, and its associated rules.

Key Features:

• Also, recent notifications and Orders have been given to bring the book up to date.
• Separate chapters provide an overview of the Drug Control organisation in India, the functions of the Central and State Governments, the set-up at the Centre, Guidelines for Patients/Consumers and the advice issued by CDSCO, the relevant law relating to Consumer Protection, Adverse Drug Reactions, the role and activities of the ICMR and the National Pharmaceutical Pricing Authority, etc.
• Concise and coherent notes that are illustrative as well as instructive have been provided under important sections
• All systems of medicine such as Allopathic, Homeopathic and Ayurvedic, Unani and Siddha, have been brought under the ambit of the stringent drug control law.
• A very detailed subject index and product index is provided to help in locating very quickly and effortlessly the information sought for

Reviews

...this book will be indispensable to all pharmaceutical manufacturers (Allopathic, Homeopathic, Ayurvedic, Unani and Siddha), booksellers, blood banks, hospitals, libraries, academic institutions and practitioners of the various branches of medicine.

- CIMS

...well designed to provide the entire statute law and up-to-date amendments with illustrative case-law notes in the most comprehensive and exhaustive fashion.

- The Indian Journal of Hospital Pharmacy

...These new additions help in easy referencing: of the relevant legal provisions and the effect of different legal provisions on this specialised branch of law... The book is ably supplemented by a comprehensive Subject and Product Index...

- Review Projector (India)

...most comprehensive and up-to-date... regularly updated with the latest amendments in the drug laws.

- Pharma Times

Volume I
1. Quick Guide to Relevant Provisions of Drugs and Cosmetics Act & Rules
2. Drug Control - Functions of Central and State Governments
3. Drug Control set up at the Central Level
4. Drug Control in India
5. List of Drugs and Combination of Drugs Banned in India
6. Not of Standard Quality Drugs
7. Pharmaceuticals and Patents
8. Drugs and Cosmetics Act, 1940 (annotated)
9. Drugs Rules, 1945 (annotated)
10. Medical Devices Rules, 2017
11. Cosmetics Rules, 2020
12. New Drugs and Clinical Trials Rules, 2019

Volume II
1. Drugs (Prices Control) Order, 2013
2. Drug Policy
3. National Pharmaceuticals Pricing Policy, 2012 (NPPP-2012)
4. Pharmaceutical Policy, 2002

Appendices