Law Relating to Drugs & Cosmetics in 2 volumes
Author: Vijay Malik
Edition: Twenty Eighth Edition (2025)
About the Book:
This definitive volume delivers a complete, updated, and annotated reference on the Drugs and Cosmetics Act, 1940, and Drugs Rules, 1945 (amended up to the First Amendment Rules, 2025). Authored by legal expert Vijay Malik, this edition includes vital policy additions like the National Medical Devices Policy, 2023, and the R&D Innovation Policy in the Pharma-Med Tech Sector. The work incorporates practical case law notes, orders, allied Acts, rules, and notifications essential for pharma professionals, legal advisors, and regulatory authorities.
Key Features:
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Covers the Drugs and Cosmetics Act, 1940, updated with the Amending Act 26 of 2008
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Incorporates Drugs Rules, 1945, amended up to 2025
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Includes National Medical Devices Policy, 2023 and Pharma-Med Tech R&D Policy
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Contains Schedule ‘M’ for GMP and New Drugs and Clinical Trials Rules, 2019
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Valuable appendices on banned drugs, NSQ drugs, MRP/customs circulars, and biomedical waste rules
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Covers NDPS Act, 1985 with Regulation of Controlled Substances Order, 2013
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Notes across Allopathy, Homeopathy, Ayurveda, Unani, and Siddha systems
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Includes updates from CDSCO, NPPA, ICMR, Consumer Protection Law & more
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Thorough Subject and Product Index for easy reference
Ideal For:
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Drug and cosmetics law practitioners
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Pharmaceutical companies and compliance heads
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Health policy researchers and regulators
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Legal professionals and judiciary members
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Students of medical, pharmaceutical, and legal disciplines
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Caveat Legalis: Description based on available details—interpret with due diligence!