Law Relating to Drugs And Cosmetics by Vijay Malik

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Law Relating to Drugs And Cosmetics With CD

by Vijay Malik

Edition: 26th Edition, 

Format: Hardback, eBook
Pages: 2088 pages
Publisher: Eastern Book Company
Language: English



The current twenty-sixth edition, provides the fully amended and updated text of the Drugs and Cosmetics Act, 1940, as amended by Amending Act No. 26 of 2008 enforced on August 10, 2009 and the Drugs and Cosmetics Rules, 1945 as amended up to the Sixth Amendment Rules, 2018, 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.

The compendium has now been updated with supplement containing:


  • Drugs and Cosmetics (Amendment) Rules up to Drugs (3rd Amendment) Rules, 2021
  • Medical Devices (Amendment) Rules up to Medical Devices (Amendment) Rules, 2020
  • Drugs (Prices Control) Amendment Order, 2019
  • Bio-Medical Waste Management (Second Amendment) Rules, 2019
  • Cigarettes and other Tobacco Products (Packaging and Labelling) Third Amendment Rules, 2020
  • Central Drugs Laws made applicable to UT of J&K and Ladakh by Jammu and Kashmir Reorganisation Act, 2019
  • Epidemic Diseases (Amendment) Act, 2020
  • Essential Commodities (Amendment) Act, 2020
  • Medical Termination of Pregnancy (Amendment) Act, 2021
  • Pre-conception and Pre-natal Diagnostic Techniques (Prohibition of Sex Selection) Amendment Rules, 2021


       …and other important amendment statutes and Notifications.

Also includes:


Free updates

 CD-ROM contains 


  • Approved list of drugs for manufacturing and marketing,
  • Circulars/Notifications on MRP/Customs on Import/Required documents for permission to conduct bioequivalence studies,
  • Circulars/Notifications regarding Bio-medical Waste,
  • Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013,
  • Narcotic Drugs and Psychotropic Substances Act, 1985,
  • Narcotic Drugs and Psychotropic Substances Rules, 1985,
  • Ryan Haight Online Pharmacy Consumer Protection Act of 2008,
  • List of Drugs approved during January 2006 to March 2018, and much more.


 Special Features:


  • It is the most comprehensive and up-to-date work on the subject.
  • This unique work is highly acclaimed among the medical, pharmaceutical as well as legal fraternity for its practical and vibrant approach.
  • Brief and coherent case-law notes have been provided under important sections.
  • New case-law notes have been added, especially under Drugs and Cosmetics Act, 1940.
  • The Appendices provide several allied and useful statutes.
  • A very detailed subject index and product index facilitate quick and easy search.
  • An updated chapter by Dr Elizabeth Verkey on ‘Pharmaceuticals and Patents’ gives an insight into the new Patent law and how it regulates pharmaceuticals. 


Table Of Contents:


  • Quick Guide to Relevant Provisions of Drugs and Cosmetics  Act & Rules 
  • Drug Control — Functions of Central and State Governments 
  • Drug Control setup at the Central Level 
  • Drug Control in India 
  • List of Drugs and Combination of Drugs Banned in India 
  • Not of Standard Quality Drugs
  • Pharmaceuticals and Patents 
  • Drugs and Cosmetics Act, 1940 (annotated) 
  • Drugs and Cosmetics Rules, 1945 (annotated) 
  • Medical Devices Rules, 2017


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