Import control
Chapter III regulates standards, prohibited imports, misbranded, adulterated and spurious drugs and cosmetics, offences, confiscation and jurisdiction.
Pharmaceutical & Cosmetics Law - India
Drugs and Cosmetics Act, 1940: Sections, Penalties, Rules and Current Amendments
The Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940) regulates the import, manufacture, distribution and sale of drugs and cosmetics in India. The Act establishes quality standards, regulatory authorities, inspection and testing powers, restrictions on misbranded, adulterated and spurious products, offences, penalties and special procedural provisions.
Act No.23 of 1940
Enacted10 April 1940
Administered byMinistry of Health & Family Welfare
Current amendment position as on 4 September 2026:
amendments made by the Jan Vishwas (Amendment of Provisions) Act, 2023 relating to the Drugs and Cosmetics Act came into force on 31 December 2024. These include changes to Section 29, Section 30(2) and the compounding scope under Section 32B. The Drugs and Cosmetics (Compounding of Offences) Rules, 2025 now provide the procedural framework for compounding specified offences. The Jan Vishwas (Amendment of Provisions) Act, 2026 has also been enacted; however, the Central Government has notified 30 June 2027 as the commencement date for the amendments corresponding to the Drugs and Cosmetics Act specified in that enactment, so those future amendments are not treated here as presently operative.
What the Act regulates
Manufacture and sale
Chapter IV regulates manufacture, sale and distribution, licensing-related prohibitions, records, inspectors, Government Analysts, testing, offences and penalties.
Traditional medicines
Chapter IVA contains a dedicated framework for Ayurvedic, Siddha and Unani drugs, including standards, manufacture, prohibition, inspection and penalties.
Enforcement and courts
The Act provides for cognizance, compounding of specified offences, Special Courts, enhanced penalties, appeals, revision and confiscation.
Important current penalty and compounding changes
Following the Jan Vishwas (Amendment of Provisions) Act, 2023, Section 29 now provides for a monetary penalty that may extend to ₹1 lakh for prohibited use of a Government Analyst's report for advertising. Section 30(2), dealing with specified subsequent offences, was also rationalised by substituting the earlier imprisonment/fine formulation with a minimum fine of ₹5 lakh. Section 32B was expanded so that specified offences under Section 27(d) and Section 27A(ii), in addition to other listed offences, may be compounded in accordance with law.
The Drugs and Cosmetics (Compounding of Offences) Rules, 2025 prescribe the procedure for applications and compounding under Section 32B. Whether a particular contravention is compoundable depends on the exact statutory provision and the applicable rules.
Related subordinate legislation
The principal Act operates with detailed subordinate legislation. The Drugs Rules, 1945 continue to govern many drug-related licensing, import, manufacture, sale, labelling, testing and quality requirements. Cosmetics are governed separately through the Cosmetics Rules, 2020. Regulatory requirements are frequently updated through Gazette notifications, so the latest CDSCO notifications should be checked for compliance-sensitive matters.
Section-wise Drugs and Cosmetics Act, 1940
Use the chapter-wise links below to read individual provisions of the Act. Statutory section headings are retained for reference, including headings that continue to use older procedural-law terminology in the text of the principal Act.
Chapter I - Introductory
Chapter II - Drugs Technical Advisory Board, Central Drugs Laboratory and Drugs Consultative Committee
Chapter III - Import of Drugs and Cosmetics
- Section 8 Standards of quality
- Section 9 Misbranded drugs
- Section 9A Adulterated drugs
- Section 9B Spurious drugs
- Section 9C Misbranded cosmetics
- Section 9D Spurious cosmetics
- Section 10 Prohibition of import of certain drugs or cosmetics
- Section 10A Power of Central Government to prohibit import of drugs and cosmetics in public interest
- Section 11 Application of law relating to sea customs and powers of Customs officers
- Section 12 Power of Central Government to make rules
- Section 13 Offences
- Section 14 Confiscation
Chapter IV - Manufacture, Sale and Distribution of Drugs and Cosmetics
- Section 15 Jurisdiction
- Section 16 Standards of quality
- Section 17 Misbranded drugs
- Section 17A Adulterated drugs
- Section 17B Spurious drugs
- Section 17C Misbranded cosmetics
- Section 17D Spurious cosmetics
- Section 17E Adulterated cosmetics
- Section 18 Prohibition of manufacture and sale of certain drugs and cosmetics
- Section 18A Disclosure of the name of the manufacturer, etc
- Section 18B Maintenance of records and furnishing of information
- Section 19 Pleas
- Section 20 Government Analysts
- Section 21 Inspectors
- Section 22 Powers of Inspectors
- Section 23 Procedure of Inspectors
- Section 24 Persons bound to disclose place where drugs or cosmetics are manufactured or kept
- Section 25 Reports of Government Analysts
- Section 26 Purchaser of drug or cosmetic enabled to obtain test or analysis
- Section 26A Powers of Central Government to [regulate, restrict or prohibit] manufacture, etc., of drug and cosmetic in public interest.
- Section 26B Power of Central Government to regulate or restrict, manufacture, etc., of drug in public interest
- Section 27 Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter
- Section 27A Penalty for manufacture, sale, etc., of cosmetics in contravention of this Chapter
- Section 28 Penalty for non-disclosure of the name of the manufacturer, etc
- Section 28A Penalty for not keeping documents, etc., and for non-disclosure of information
- Section 28B Penalty for manufacture, etc., of drugs or cosmetics in contravention of section 26A
- Section 29 Penalty for use of Government Analyst's report for advertising
- Section 30 Penalty for subsequent offences
- Section 31 Confiscation
- Section 31A Application of provisions to Government departments
- Section 32 Cognizance of offence
- Section 32A Power of Court to implead the manufacturer, etc.
- Section 32B Compounding of certain offences
- Section 33 Power of Central Government to make rules
- Section 33A Chapter not to apply to Ayurvedic, Siddha or Unani drugs
- Section 33B Application of Chapter IVA
- Section 33C Ayurvedic and Unani Drugs Technical Advisory Board
- Section 33D The Ayurvedic, Siddha and Unani Drugs Consultative Committee
Chapter IVA - Ayurvedic, Siddha and Unani Drugs
- Section 33E Misbranded drugs
- Section 33EE Adulterated drugs
- Section 33EEA Spurious drugs
- Section 33EEB Regulation of manufacture for sale of Ayurvedic, Siddha and Unani drugs
- Section 33EEC Prohibition of manufacture and sale of certain Ayurvedic, Siddha and Unani drugs
- Section 33EED Power of Central Government to prohibit manufacture, etc., of Ayurvedic, Siddha or Unani drugs in public interest
- Section 33F Government Analysts
- Section 33G Inspectors
- Section 33H Application of provisions of sections 22, 23, 24 and 25
- Section 33I Penalty for manufacture, sale, etc., of Ayurvedic, Siddha or Unani drug in contravention of this Chapter
- Section 33J Penalty for subsequent offences
- Section 33K Confiscation
- Section 33KA Disclosure of name of manufacturer, etc
- Section 33KB Maintenance of records and furnishing of information
- Section 33L Application of provisions to Government departments
- Section 33M Cognizance of offences
- Section 33N Power of Central Government to make rules
- Section 33O Power to amend First Schedule
Chapter V - Miscellaneous
- Section 33P Power to give directions
- Section 34 Offences by companies
- Section 34A Offences by Government departments
- Section 34AA Penalty for vexatious search or seizure
- Section 35 Publication of sentences passed under this Act
- Section 36 Magistrate's power to impose enhanced penalties
- Section 36A Certain offences to be tried summarily
- Section 36AB Special Courts
- Section 36AC Offences to be cognizable and non-bailable in certain cases
- Section 36AD Application of Code of Criminal Procedure, 1973 to proceedings before Special Court
- Section 36AE Appeal and revision
- Section 37 Protection of action taken in good faith
- Section 38 Rules to be laid before Parliament
Legal and regulatory requirements for drugs, cosmetics, medical devices, new drugs, clinical trials and related products may also arise under separate rules, notifications and other legislation. For regulatory action, prosecution, licensing or compliance, always verify the current Gazette notification and the latest applicable rules.