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Law Relating to Drugs and Cosmetics with Free CD (26th Edition, 2018) / Malik, Vijay
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Law Relating to Drugs and Cosmetics with Free CD (26th Edition, 2018)
Malik, Vijay
 
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  Book ID : 18829
  ISBN-10 : 93-87487-94-6 / 9387487946
  ISBN-13 : 978-93-87487-94-9 / 9789387487949
  Place of Publication : Lucknow
  Year of Publication : 2018
  Edition : (Twenty Sixth Edition)
  Language : English
  viii+104+1623p., Index, 25 cm. (1st Edition pub. in 1979) (24th Edition pub. in 2014)
   
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 CONTENTS
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CONTENTS:-

Part I : Drugs and Cosmetics Act, 1940:
I. Introductory
II. Drugs Technical Advisory Board, Central Drugs Laboratory & Drugs Consultative Committee
III. Import Of Drugs And Cosmetics
IV. Manufacture, Sale and Distribution of Drugs and Cosmetics
IV a. Provisions Relating to Ayurvedic, Siddha and Unani Drugs
V. Miscellaneous

Part II : Drugs and Cosmetics Rules, 1945:
I. Preliminary
II. The Central Drugs Laboratory
III. Omitted
IV. Import and Registration
V. Government Analysts, Inspectors, Licensing Authorities and Controlling Authorities
VI. Sale of Drugs other than Homeopathic Medicines
VIa. Sale of Homeopathic Medicines
VII. Manufacture for Sale or for Distribution of Drugs other than Homeopathic Medicines
VIIa. Manufacture for Sale or for Distribution of Homeopathic Medicines
VIII. Manufacture For Examination, Test or Analysis
IX. Labelling and Packing of Drugs other than Homeopathic Medicines
IXa. Labelling and Packing of Homeopathic Medicines
X. Special Provisions Relating to Biological and other Special Products
Xa. Import or Manufacture of a New Drug for Clinical Trials or Marketing
Xb. Requirements for the Collection, Storage, Processing and Distribution of Whole Human Blood, Human Blood Components by Blood Banks and Manufacture of Blood Products
XI. Exemptions
XII. Standards
XIII. Import and Registration of Cosmetics
XIV. Manufacture of Cosmetic for Sale or for Distribution
XV. Labelling, Packing and Standards of Cosmetics
XVa. Approval of Institutions for Carrying out Tests on Drugs, Cosmetics and Raw Materials used in their Manufacture on behalf of Licensees for Manufacture for Sale of Drugs/Cosmetics
XVI. Manufacture for Sale of Ayurvedic (Including Siddha) Or Unani Drugs
XVIa. Approval of Institutions for Carrying Out Tests on Ayurvedic, Siddha and Unani Drugs and Raw Materials Used in their Manufacture on Behalf of Licensees for Manufacture for Sale of Ayurvedic, Siddha and Unani Drugs
XVII. Labelling, Packing and Limit Of Alcohol in Ayurvedic (Including Siddha) or Unani Drugs
XVIII. Government Analysts and Inspectors for Ayurvedic (Including Siddha) or Unani Drugs
XIX. Standards of Ayurvedic, Siddha and Unani Drugs

Schedules
Appendices
Subject and Product Index

SHORT CONTENTS (CD-Rom):
1. Guidelines for determining quantum of financial compensation to be paid in case of clinical trial related injury or death.
2. Guidelines for I.V Fluids Distribution, Storage and Administration.
3. Guidelines on Recall and Rapid Alert System for Drugs (Including Biologicals and Vaccines).
4. Pre-screening Checklist for the submission of Application submitted to CDSCO (HQ).
5. Sources of Medicinal Herbs in India.
6. Manufacturers of Herbal Formulations in India.
7. Manufacturers of Herbal Cosmetics and Eucalyptus Oil in India.
8. Manufacturers of Standardized Herbal Extracts, Phytochemicals and Essential Oils in India.
9. List of Equipment Manufacturers in India.
10. Major Associations in Pharmaceuticals Industry.
11. World Importers of Herbal Products.
12. List of Drugs approved during January 2006 to April 2013.

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 DESCRIPTION
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OVERVIEW:

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.


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.


REVIEWS:

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.

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