Law Relating to Drugs and Cosmetics

The most comprehensive, authoritative and accurate compilation of the law on the subject, with new materials, the latest amendments and fresh case law.

The present twenty-seventh edition provides the fully amended and updated text of the Drugs and Cosmetics Act, 1940 (as amended by Amending Act 26 of 2008 enforced on August 10, 2009) and the Drugs Rules, 1945 as amended up to the Seventh Amendment Rules, 2021, along with case-law notes, allied Acts, Rules, Orders, and Notifications. Also, recent notifications and Orders have been given to bring the book up to date. This exhaustive work is the most comprehensive and up-to-date manual on the subject.

Fresh new materials covered include:

1. Cosmetics Rules, 2020
2. New Drugs and Clinical Trial Rules, 2019
3. National Medical Commission Act, 2019
4. National Commission for Indian System of Medicine Act, 2020
5. National Commission for Homeopathy Act, 2020
6. Institute of Teaching and Research in Ayurveda Act, 2020
7. National Commission for Allied and Healthcare Professions Act, 2021
8. Telemedicine Practice Guidelines

Brief and coherent case-law notes have been provided under important sections. New case-law notes have been added, especially under the Drugs and Cosmetics Act, of 1940. The Appendices provide several allied and useful statutes. A very detailed subject index and product index facilitates quick and easy searches.

Includes additional useful content available online containing

1. Approved list of drugs for manufacturing and marketing
2. Circulars/Notifications on MRP/Customs on Import/Required documents for permission to conduct bioequivalence studies
3. Circulars/Notifications regarding Bio-medical Waste
4. Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013
5. Narcotic Drugs and Psychotropic Substances Act, 1985
6. Narcotic Drugs and Psychotropic Substances Rules, 1985, etc.

The chapter on Pharmaceuticals and Patents, by Dr. Elizabeth Verkey gives an insight into the new Patent law and how it regulates pharmaceuticals.

This unique work is highly acclaimed among the medical, pharmaceutical as well as a legal fraternity for its practical and vibrant approach.

The pharmaceutical manufacturers and sellers, foreign companies wanting to invest in this sector in India, blood banks, hospitals and medical practitioners, lawyers, and law firms all will find conscientious work indispensable.

CONTENTS OF 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

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

Appendices