Law Relating to Drugs And Cosmetics by Vijay Malik

The present edition incorporates 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 and Cosmetics Rules, 1945 as amended up to the Second Amendment Rules, 2016, 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. 

Fresh new materials covered include: 

• Transplantation of Human Organs and Tissues Rules, 2014,
• Pharmacy Practice Regulations, 2015,
• Number of Licensed Blood Banks in India,
• Pharmacovigilance Programme of India (PvPI),
• Reporting of Adverse Drug Reactions and Haemovigilance Programme of India (HvPI),
• List of Drugs approved during January 2006 to March 2016. 

Also includes: 

• Transplantation of Human Organs and Tissues Act, 1994
• Transplantation of Human Organs Rules, 1995
• National List of approved Testing Laboratories
• List of Schedule H1 Drugs.
• Updated chapter on Patents and Pharmaceuticals by Elizabeth Verkey 

A FREE CD-ROM provides numerous guidelines and useful lists featuring regulations regarding Clinical Trials, I.V. Fluids, Recall and Rapid Alert System for Drugs; Sources of Medicinal Herbs in India, National Blood Policy and Guidelines for Blood Banks, etc. 

SHORT CONTENTS (Book)

1. Quick Guide to Relevant Provisions of Drugs and Cosmetics Act & Rules
2. Drug Control - Functions of Central and State Governments
3. Drug Control setup 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 (annonated)
9. Drugs and Cosmetics Rules, 1945 (annotated)

Appendices
Subject and Product Index

SHORT CONTENTS (CD-Rom)

1. National Drug Policy on Malaria (2013)
2. Circulars
3. Code of Marketing Practice for Indian Pharmaceutical Industry
4. Guidelines for Blood Banks
5. Guidelines for determining quantum of financial compensation to be paid in case of clinical trial related injury or death
6. Guidelines for I.V Fluids Distribution, Storage and Administration
7. Guidelines on Recall and Rapid Alert System for Drugs (Including Biologicals and Vaccines)
8. List of Drugs approved during January 2006 to March 2016
9. List of Equipment Manufacturers in India
10. Major Associations in Pharmaceuticals Industry
11. Manufacturers of Herbal Cosmetics and Eucalyptus Oil in India
12. Manufacturers of Herbal Formulations in India
13. Manufacturers of Standardized Herbal Extracts, Phytochemicals and Essential Oils in India
14. National Blood Policy
15. Pre-screening Checklist for the submission of Application submitted to CDSCO
16. Ryan Haight Online Pharmacy Consumer Protection Act of 2008
17. Source of Medicinal Herbs in India
18. World Importers of Herbal Products