Manual on Drugs & Cosmetics (2 Volumes) is a comprehensive and authoritative commentary on the regulatory regime governing drugs and cosmetics in India. Published by Lexis Nexis, this detailed work analyzes the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, along with subsequent amendments and judicial developments.
The book provides in-depth discussion on licensing requirements, manufacture, sale, distribution, import, and quality control of drugs and cosmetics. It examines regulatory standards, inspection procedures, powers of drug inspectors, and compliance obligations of manufacturers, distributors, and retailers. Offences, penalties, and prosecution mechanisms under the Act are thoroughly explored.
Special attention is given to classification of drugs, spurious and adulterated drugs, labeling requirements, regulatory approvals, and enforcement actions. The commentary integrates significant judicial decisions to clarify statutory interpretation and practical implementation.
Designed for pharmaceutical companies, regulatory affairs professionals, compliance officers, advocates, judges, and students of pharmaceutical law, this two-volume manual bridges statutory analysis with real-world regulatory practice. With its analytical depth and practical orientation,






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