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 caselaw notes, allied acts, rules, orders and notifications.Also recent notifications and orders have been given to bring the book up to date.
Fresh new material added to this edition:
- Medical Devices Rules, 2017,
- Bio-Medical Waste Management Rules, 2016,
- Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (Prevention and Control) Act, 2017,
- Indian Medical Council Act and Pre-natal Diagnostic Techniques(Regulation and Prevention of Misuse) (Advisory Committees) Rules, 1996.
- Guidelines for Patients/Consumers and the advice issued by CDSCO,
- Law relating to Consumer Protection, etc.
CD-ROM contains l Approved list of drugs for manufacturing and marketing l Circulars/Notifications on MRP/Customs on Import/Required documents for permission to conduct bioequivalence studies l Circulars/ Notifications regarding Bio-medical Waste l Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013 l Narcotic Drugs and Psychotropic Substances Act, 1985 l Narcotic Drugs and Psychotropic Substances Rules, 1985 l Ryan Haight Online Pharmacy Consumer Protection Act of 2008 l List of Drugs approved during January 2006 to March 2018, and much more.
- 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.
Pharma Times: This book is one of the most comprehensive and up-to-date Manuals on Drugs & Cosmetics Act and the Rules thereunder and is regularly updated with the latest amendments in the drug laws.
The Indian Journal of Hospital Pharmacy: This book has been well designed to provide the entire statute law relating to drugs and up-to-date amendments with illustrative case-law notes in the most comprehensive and exhaustive fashion.
CIMS: Under each section of the book, concise and coherent notes illustrative of the topic are given. All systems of medicine-Allopathic, Ayurvedic, Unani and Siddha have been brought under the purview of the Drugs & Cosmetics Act, and hence the information contained in this book will be indispensable to all pharmaceutical manufacturers, booksellers, blood banks, hospitals, libraries, academic institutions and practitioners of the various branches of medicine.
Kerala Law Times: This book is a must for the Drugs and Cosmetics Industry, Manufacturers, Distributors, Central and State Governments, Bar and the Bench, Government Departments, Committees and others concerned with the subject.