Law Relating to Drugs and Cosmetics by Vijay Malik (Set of 2 Vols.) – 28th Edition 2025

Description

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