Drugs & Cosmetics Act, 1940

This authoritative, practice-focused volume consolidates the Drugs & Cosmetics Act, 1940 with the Drugs Rules, 1945 and pertinent schedules (including Schedule H, Schedule X and Schedule Y) into a single, user-friendly reference. The book reproduces statutory text and pairs each provision with plain-English annotations that clarify the scope (import, manufacture, distribution and sale of drugs and cosmetics), definitions of misbranded/adulterated/spurious articles, and powers of central and state regulators (CDSCO/state drug controllers). It explains the licensing and registration process, labelling and packaging obligations, clinical trial requirements and safety standards under Schedule Y, and the special controls for restricted drugs (Schedules H/H1/X). Practical chapters cover inspection, sample testing, prosecution and penalties, offences by companies, and compliance checklists and sample formats for applications, licenses and show-cause replies. Case pointers and references to recent guidance make the text directly usable for compliance officers, litigators and students. Whether preparing for regulatory filings, defending prosecutions or studying pharmaceutical jurisprudence, this edition merges statute, rules and practice aids into an indispensable compliance and courtroom resource.