Drugs & Cosmetics Act, 1940 alongwith Rules

This extensively detailed edition combines the full text of the Drugs & Cosmetics Act, 1940 with the Drugs Rules, 1945, creating a complete, reliable and practical reference for India’s pharmaceutical regulatory system. The book provides clear, clause-wise annotations explaining statutory definitions, regulatory powers, classifications of misbranded, adulterated and spurious drugs, and the compliance framework governing the import, manufacture, distribution and sale of drugs and cosmetics. It incorporates essential schedules such as Schedule H, H1, X and Y, offering simplified guidance on prescription-only drugs, controlled substances, and clinical trial requirements. Readers will also find procedural insights into licensing, inspections, labelling standards, testing protocols, recall mechanisms and offences with corresponding penalties. The commentary highlights applicable case law, CDSCO practices, regulatory obligations for pharmaceutical companies, and practical steps for maintaining statutory compliance. Additional tools such as model forms, checklists and compliance templates make the volume highly valuable for day-to-day operational use. Ideal for professionals seeking clarity and accuracy, this book effectively bridges statute, rules, schedules and practice to create an indispensable resource for legal, regulatory and pharmaceutical stakeholders.