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Description
The new Nineteenth Edition has been made more comprehensive and useful with the addition of new material, latest amendments and fresh case-law.
This edition incorporates the fully amended and updated Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 which have been amended up to the (Fifth Amendment) Rules, 2006. Also given are DPCO, DMR and several other Allied Acts, Rules, Notifications, etc. Guidelines for Bioavailability & Bioequivalence Studies, for Import and Manufacture of Medical Devices, and for Clinical Trials in India have been incorporated in this edition. The wealth of material contained in the book makes it an indispensable work.
All systems of medicine such as Allopathic, Ayurvedic, Unani and Siddha, have been brought under the ambit of the stringent drug control law and this work will be indispensable to all manufacturers, sellers, blood banks, hospitals and practitioners and students of these various branches of medicine. A very detailed subject and product index is provided to help in locating very quickly and effortlessly the information sought for.
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Contents
• Pharmaceuticals and Patents
• Drug Control in India
• Drug Control - Functions of Central and State Governments
• Drug Control set up at centre
• Addresses of Central Drug Control Authorities
• Quick Guide to Relevant Provisions of Drugs and Cosmetics Act & Rules
• List of Drugs approved during January to December, 2006
• Guidelines for Patients/Consumers of Drugs and Cosmetics
• Guidelines for Bioavailability & Bioequivalence Studies
• Guidelines for Import and Manufacture of Medical Devices
• Provisions of Consumer Protection under Drugs and Cosmetics Act, 1940
and Rules, 1945 Adverse Drug Reactions (ADRs)
• Good Clinical Practice Guidelines for Clinical Trials in India
• Global Clinical Trial—Requirements for Filling Applications
• Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
• Indian Council of Medical Research
• National Pharmaceutical Pricing Authority
• Drugs and Cosmetics Act, 1940
• Drugs and Cosmetics Rules, 1945
Appendices
1. Pharmaceutical Policy, 2002
2. Drug Policy
3. Drugs (Prices Control) Order, 1995
4. Supreme Court Ruling on Price Control on Seven Bulk Drugs
5. Breeding of and Experiments on Animals (Control and Supervision) Rules, 1998
6. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
Drugs and Magic Remedies (Objectionable Advertisements) Rules, 1995
7. Infant Milk Substitutes, Feeding-Bottles and Infant Foods (Regulation of
Production, Supply and Distribution) Act, 1992
Infant Milk Substitutes, Feeding-Bottles and Infant Foods (Regulation of
Production, Supply and Distribution) Rules, 1993
8. Medicinal and Toilet Preparations (Excise Duties) Act, 1955
9. Pharmacy Act, 1948
10. Poisons Act, 1919
11. Drugs (Control) Act, 1950
12. Epidemic Diseases Act, 1897
13. Medical Termination of Pregnancy Act, 1971
Medical Termination of Pregnancy Rules, 2003
Medical Termination of Pregnancy Regulations, 2003
14. Clinical Thermometers (Quality Control) Order, 2001
15. Cigarettes and other Tobacco Products (Prohibition of Advertisement and
Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003
16. Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex
Selection) Act, 1994
Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex
Selection) Rules, 1996
17. Essential Commodities Act, 1955
Essential Commodities (Special Provisions) Act, 1981
18. Dangerous Drugs Act, 1930
19. OpiumAct, 1878
20. Central Opium Rules, 1934
21. Relevant Provisions of CrPC and IPC
22. Sources of Medicinal Herbs in India
23. Manufacturers of Herbal Formulations in India
24. Manufacturers of Herbal Cosmetics and Eucalyptus Oil in India
25. Manufacturers of Standardized Herbal Extracts, Phytochemicals and
Essential Oils in India
26. List of Equipment Manufacturers in India
27. Major Associations in Pharmaceutical Industry
28. World Importers of Herbal Products
29. Restricted items for Imports under EXIM Policy, 2002-2007
30. Circular regarding printing of MRP of medicines on labels
Subject and Product Index
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Author Details
Vijay Malik, B.A., LL.B., M.B.A
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