The Drugs and Cosmetics Act, 1940

Drugs and Cosmetics Act, 1940 As amended by The Jan Vishwas (Amendment of Provisions) Act, 2023

This 2025 edition of The Drugs and Cosmetics Act, 1940 (Act 23 of 1940) reproduces the statute verbatim and consolidates every operative change, including:

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  Jan Vishwas (Amendment of Provisions) Act, 2023 (18 of 2023) — decriminalising minor paperwork lapses and replacing jail terms with graded monetary penalties (notified via S.O. 1577 E, 28-3-2024; in force 31-12-2024)

  
  


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  Subsequent penalty-rationalisation notification S.O. 5255 E, 4-12-2024

  
  

The volume also binds in the complete, updated texts of:

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  Drugs Rules, 1945 (consolidated through G.S.R. 172 E, 11-02-2025)

  
  


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  Drugs (Control) Act, 1950 — retained here for historical reference (formally repealed by Repealing & Amending Act 23 of 2016)

  
  


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  Cosmetics Rules, 2020 — new separate regime for cosmetics manufacture, import & labelling

  
  


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  Drugs and Cosmetics (Compounding of Offences) Rules, 2025 (dt. 24-4-2025, w.e.f. 25-4-2025)

  
  

Concise short comments follow pivotal provisions—flagging the 2025 compounding slab, QR-code–based trace-and-track, on-line licence portal, and joint CDSCO-State inspection norms—while preserving full Bare-Act integrity for examinations and authoritative citation.

Core statutory coverage

• Licensing & registration — e-portal filing, single-window renewals, and G.M.P. compliance for drugs & medical devices

• Standards & labelling — Schedule M, Schedule Y, pharmacopoeial conformity, and 2023 QR-code authentication for high-risk APIs

• Quality control & recalls — test-batch sampling, whistle-blower protection, and accelerated Class-I recall procedure

• Import & export — COFEPRIS-style online clearance, bio-equivalence data, and WHO-GMP certificate mapping

• Clinical trials & new drugs — ethics-committee registration, compensation framework, and fast-track orphan-drug route

• Cosmetics regime — separate licence classes, prohibited ingredients list, nano-material disclosure and animal-testing ban

• Enforcement & penalties — enhanced fines, compounding window (Rules 2025), and seizure / destruction powers of Drug Inspectors

This edition is particularly suited for

• Pharma-company regulatory teams & contract-manufacturers updating SOPs to the decriminalised penalty model

• Druggists, chemists & on-line pharmacies ensuring labelling, storage and e-sale compliance

• CDSCO officials, State Drug Controllers & port-officers referencing authoritative text during inspections and prosecutions

• Healthcare lawyers & compliance consultants handling import clearances, clinical-trial approvals and product-liability defences

• AIBE candidates and law students studying health-law, consumer-protection and pharma-regulation modules

Exact Gazette text · pinpoint explanatory notes · zero superfluous commentary—your fastest route to clarity, authenticity and practical insight on India’s drugs-and-cosmetics regulatory framework.