THE DRUGS AND COSMETICS ACT, 1940
(ACT NO. 23 OF 1940)
[As amended up to 2026]
COMPLETE A2G STUDY GUIDE FOR UPSC DRUG INSPECTOR EXAMINATION 2026
✅ VERIFIED AGAINST OFFICIAL CDSCO & INDIA CODE SOURCES
LIST OF AMENDING ACTS (Major)
| S. No. | Act Name | Act No. (Year) |
|---|
| 1. | The Drugs and Cosmetics (Amendment) Act | 2 of 1955 |
| 2. | The Drugs and Cosmetics (Amendment) Act | 35 of 1960 |
| 3. | The Drugs and Cosmetics (Amendment) Act | 21 of 1962 |
| 4. | The Drugs and Cosmetics (Amendment) Act | 13 of 1964 |
| 5. | The Drugs and Cosmetics (Amendment) Act | 19 of 1972 |
| 6. | The Drugs and Cosmetics (Amendment) Act | 68 of 1982 |
| 7. | The Drugs and Cosmetics (Amendment) Act | 42 of 1986 |
| 8. | The Drugs and Cosmetics (Amendment) Act | 71 of 1995 |
| 9. | The Drugs and Cosmetics (Amendment) Act | 26 of 2008 |
| 10. | The Jan Vishwas (Amendment of Provisions) Act | 18 of 2023 |
| 11. | The Jan Vishwas (Amendment of Provisions) Act | 8 of 2026 |
ARRANGEMENT OF SECTIONS
CHAPTER I — INTRODUCTORY
- Section 1: Short title, extent and commencement
- Section 2: Application of other laws not barred
- Section 3: Definitions
- Section 3A: Construction of references to any law not in force in J&K
- Section 4: Presumption as to poisonous substances
CHAPTER II — DTAB, CDL & DCC
- Section 5: The Drugs Technical Advisory Board (DTAB)
- Section 6: The Central Drugs Laboratory (CDL)
- Section 7: The Drugs Consultative Committee (DCC)
- Section 7A: Sections 5 and 7 not to apply to ASU drugs
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 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
- Section 15: Jurisdiction
CHAPTER IV — MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS
- 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 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/cosmetics manufactured or kept
- Section 25: Reports of Government Analysts
- Section 26: Purchaser of drug/cosmetic enabled to obtain test or analysis
- Section 26A: Power of Central Government to prohibit manufacture, etc. in public interest
- Section 27: Penalty for manufacture, sale, etc. of drugs in contravention
- Section 27A: Penalty for manufacture, sale, etc. of cosmetics in contravention
- Section 28: Penalty for non-disclosure of name of manufacturer
- Section 28A: Penalty for not keeping documents, etc.
- Section 28B: Penalty for manufacture, etc. 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 offences
- Section 32A: Power of Court to implead the manufacturer, etc.
- Section 33: Power of Central Government to make rules
- Section 33A: Chapter not to apply to Ayurvedic, Siddha or Unani drugs
CHAPTER IVA — PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS
- Section 33B: Application of Chapter IVA
- Section 33C: ASU Drugs Technical Advisory Board
- Section 33D: ASU Drugs Consultative Committee
- Section 33E: Misbranded drugs
- Section 33EE: Adulterated drugs
- Section 33EEA: Spurious drugs
- Section 33EEB: Regulation of manufacture for sale of ASU drugs
- Section 33EEC: Prohibition of manufacture and sale of certain ASU drugs
- Section 33EED: Power of Central Government to prohibit manufacture, etc. 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 ASU drugs in contravention
- Section 33J: Penalty for subsequent offences
- Section 33K: Confiscation
- 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 37: Protection of action taken in good faith
- Section 38: Rules to be laid before Parliament
THE FIRST SCHEDULE
THE SECOND SCHEDULE
CHAPTER I — INTRODUCTORY
Section 1: Short Title, Extent and Commencement
| Aspect | Description |
|---|
| Short title | The Drugs and Cosmetics Act, 1940 |
| Extent | Whole of India |
| Commencement | 10th April 1940 |
Section 2: Application of Other Laws Not Barred
Nothing in this Act shall be deemed to prevent the operation of any other law for the time being in force.
Section 3: Definitions — VERY IMPORTANT FOR EXAM
| Term | Definition |
|---|
| "Ayurvedic, Siddha or Unani drug" | Includes all medicines intended for internal or external use in the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine specified in the First Schedule |
| "Board" | The Drugs Technical Advisory Board constituted under Section 5 |
| "Cosmetic" | Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic |
| "Drug" | Includes: (a) all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (b) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette; (c) all substances intended for use as components of a drug including empty gelatin capsules; and (d) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board |
| "Government Analyst" | A Government Analyst appointed under Section 20 or Section 33F |
| "Inspector" | An Inspector appointed under Section 21 or Section 33G |
| "Manufacture" | Includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adopting any drug or cosmetic with a view to its sale or distribution, but does not include the compounding or dispensing of any drug, or the packing of any drug or cosmetic, in the ordinary course of retail business; and "to manufacture" shall be construed accordingly |
| "Patent or proprietary medicine" | In relation to ASU drugs, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the authoritative books of ASU medicine for the time being, and in relation to any other drug or cosmetic, a drug or cosmetic which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by the Central Government after consultation with the Board |
| "Prescribed" | Prescribed by rules made under this Act |
🔑 EXAM POINT: The definition of "Drug" was significantly expanded by the Amendment Act of 2008 to include devices and substances for repelling insects.
Section 4: Presumption as to Poisonous Substances
The Central Government may, by notification in the Official Gazette, declare what substances shall be deemed to be poisonous.
CHAPTER II — DTAB, CDL & DCC
Section 5: The Drugs Technical Advisory Board (DTAB)
The Drugs Technical Advisory Board (DTAB) is a statutory body constituted by the Central Government to advise on technical matters.
| Role | Composition | Number |
|---|
| Chairman (Ex-officio) | Director General of Health Services | 1 |
| Member (Ex-officio) | Drugs Controller General (India) | 1 |
| Member (Ex-officio) | Director of Central Drugs Laboratory | 1 |
| Representatives of Central Government | (Appointed by CG) | 2 |
| Representatives of State Governments | (Appointed by CG) | 2 |
| Representative of Medical Council of India | (Nominated) | 1 |
| Representative of Pharmacy Council of India | (Nominated) | 1 |
| Representative of Indian Medical Association | (Nominated) | 1 |
| Representatives of Pharmaceutical Industry | (3 — one each from large, medium, small scale) | 3 |
| Representative of Indian Pharmaceutical Association | (Nominated) | 1 |
| Representative of Consumers | (Nominated) | 1 |
| Persons with Special Knowledge | (Appointed by CG) | 5 |
| Total Members | | 18 |
Functions of DTAB:
- Advisory body to Central Government and State Governments on technical matters concerning the Act.
🔑 EXAM POINT: DTAB is an ADVISORY body — it has no executive powers. Members serve a term of 3 years.
Section 6: The Central Drugs Laboratory (CDL)
The Central Drugs Laboratory (CDL) is established by the Central Government for testing and analysis of drugs and cosmetics.
Functions:
- Analysis of samples of drugs/cosmetics sent by Customs Collectors or Courts.
- Analysis of samples of drugs/cosmetics sent by Government Analysts.
- Such other functions as may be entrusted by Central Government.
Head: Director, appointed by Central Government.
Location: Kolkata (originally); now multiple regional labs.
Section 7: The Drugs Consultative Committee (DCC)
The Drugs Consultative Committee (DCC) is constituted by the Central Government for consultative purposes.
| Role | Composition | Notes |
|---|
| Representatives of Central Government | | 2 (Appointed by CG) |
| Representatives of State Governments | | (As many as appointed by CG) |
Functions:
- Advise Central Government, State Governments, and DTAB on matters tending to secure uniformity throughout India in administration of this Act.
- Carry out other functions assigned by Central Government.
Section 7A: Sections 5 and 7 Not to Apply to ASU Drugs
Nothing contained in Sections 5 (DTAB) and 7 (DCC) shall apply to Ayurvedic, Siddha or Unani drugs.
ASU drugs have their own Technical Advisory Board (Section 33C) and Consultative Committee (Section 33D).
CHAPTER III — IMPORT OF DRUGS AND COSMETICS
Section 8: Standards of Quality
For imported drugs, a drug is deemed NOT of standard quality if:
- It is not of the strength, quality, or purity claimed.
- It does not comply with the standard of strength, quality, or purity specified in the Second Schedule.
- Any substance has been mixed therewith so as to reduce its quality or strength.
- Any cheaper substance has been substituted wholly or in part.
Section 9: Misbranded Drugs
A drug is deemed to be misbranded if:
- It is so coloured, coated, powdered or polished that damage is concealed, or if it is made to appear of greater therapeutic value than it really is.
- It is not labelled in the prescribed manner.
- Its label contains any matter which is false or misleading.
- It is labelled or claimed to be the product of any manufacturer, but is not truly such.
Section 9A: Adulterated Drugs
A drug is deemed to be adulterated if:
- It consists in whole or in part of any filthy, putrid or decomposed substance.
- It has been prepared, packed or stored under insanitary conditions.
- Its container is composed of any poisonous or deleterious substance.
- It bears or contains any harmful or toxic substance.
- Any substance has been mixed therewith so as to reduce its quality or strength.
Section 9B: Spurious Drugs
A drug is deemed to be spurious if:
- It is manufactured under a name which belongs to another drug.
- It is an imitation of, or a substitute for, another drug.
- The label bears the name of an individual or company purporting to be the manufacturer, which is fictitious or does not exist.
- It has been substituted wholly or in part by another drug or substance.
- It purports to be the product of a manufacturer of whom it is not truly a product.
🔑 EXAM POINT: Understand the critical distinctions:
- Misbranded = Labeling/appearance issue.
- Adulterated = Quality/contamination issue (e.g., filthy, insanitary, harmful substance, reduced quality).
- Spurious = Fake/imitation/substituted product (e.g., wrong name, imitation, fictitious manufacturer).
Section 9C: Misbranded Cosmetics
A cosmetic is deemed to be misbranded if:
- It contains a colour which is not prescribed.
- It is not labelled in the prescribed manner.
- Its label contains any matter which is false or misleading.
Section 9D: Spurious Cosmetics
A cosmetic is deemed to be spurious if:
- It is manufactured under a name which belongs to another cosmetic.
- It is an imitation of, or a substitute for, another cosmetic.
- The label bears the name of a fictitious manufacturer.
- It purports to be the product of a manufacturer of whom it is not truly a product.
Section 10: Prohibition of Import of Certain Drugs or Cosmetics
The following drugs or cosmetics shall NOT be imported into India:
- Any drug or cosmetic which is NOT of standard quality.
- Any misbranded, adulterated or spurious drug.
- Any drug or cosmetic for the import of which a licence is prescribed, otherwise than under, and in accordance with, such licence.
- Any patent or proprietary medicine unless there is displayed on the label the true formula or list of active ingredients.
- Any drug which by means of any statement, design or device accompanying it or by any other means, purports or claims to cure or mitigate any disease specified in the First Schedule.
- Any cosmetic containing any ingredient which may render it unsafe for use.
- Any drug or cosmetic the import of which is prohibited by rule made under this Chapter.
Section 10A: Power of Central Government to Prohibit Import in Public Interest
The Central Government may, by notification in Official Gazette, prohibit import of any drug or cosmetic in public interest.
Such prohibition may be absolute or subject to conditions.
Section 11: Application of Law Relating to Sea Customs and Powers of Customs Officers
- All offences under Chapter III shall be deemed to be offences relating to sea customs.
- The law for the time being in force relating to sea customs applies to such offences.
- A Customs Officer has the same powers as a Customs Officer has under the Sea Customs Act.
Section 12: Power of Central Government to Make Rules
The Central Government may make rules for:
- Specifying the drugs or classes of drugs to which Section 10 shall apply.
- Specifying the colours which may be used in cosmetics.
- Prescribing the standards of quality for imported drugs and cosmetics.
- Prescribing the method of test or analysis for imported drugs.
- Prescribing the form of application for licence to import drugs.
- Prescribing the form of licence to import drugs and the conditions subject to which such licence may be issued.
- Specifying the diseases for the cure or mitigation of which no drug shall purport or claim.
- Specifying the drugs or classes of drugs which shall not be imported except under licence.
- Prescribing the conditions to be observed in the packing of imported drugs.
- Regulating the submission of samples of imported drugs for test or analysis.
- Prescribing the fees payable for the test or analysis of imported drugs.
Section 13: Offences
- Import of prohibited drugs/cosmetics constitutes an offence.
- Penalties are as prescribed.
Section 14: Confiscation
- Any drug or cosmetic in respect of which an offence has been committed shall be liable to confiscation.
- Any animal, vehicle, vessel or other conveyance used in carrying such drug/cosmetic shall also be liable to confiscation.
Section 15: Jurisdiction
- No Court inferior to that of a Metropolitan Magistrate or Judicial Magistrate of the First Class shall try any offence punishable under this Chapter.
CHAPTER IV — MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS
Section 16: Standards of Quality
For manufactured drugs (same as Section 8 for imported drugs), a drug is deemed NOT of standard quality if:
- Not of strength/quality/purity claimed.
- Does not comply with Second Schedule standards.
- Substance mixed to reduce quality/strength.
- Cheaper substance substituted.
Section 17: Misbranded Drugs
(Same as Section 9 for imported drugs)
Section 17A: Adulterated Drugs
(Same as Section 9A for imported drugs)
Section 17B: Spurious Drugs
(Same as Section 9B for imported drugs)
Section 17C: Misbranded Cosmetics
(Same as Section 9C for imported cosmetics)
Section 17D: Spurious Cosmetics
(Same as Section 9D for imported cosmetics)
Section 18: Prohibition of Manufacture and Sale of Certain Drugs and Cosmetics
No person shall:
- (a) Manufacture for sale, or sell, stock or exhibit for sale, or distribute:
- Any drug which is NOT of standard quality.
- Any misbranded, adulterated or spurious drug.
- Any drug in contravention of any provision of this Chapter or rules.
- (b) Sell, stock or exhibit for sale, or distribute:
- Any drug/cosmetic imported/manufactured in contravention of this Act.
- (c) Manufacture for sale, or sell, stock or exhibit for sale, or distribute:
- Any drug/cosmetic, except under and in accordance with a licence.
Proviso 1: Nothing applies to manufacture of small quantities for examination, test or analysis under prescribed conditions.
Proviso 2: Central Government may permit manufacture/sale of non-standard quality drugs under notification after consultation with Board.
Section 18A: Disclosure of the Name of the Manufacturer, etc.
Every person (not being manufacturer or his agent) shall, if required, disclose to Inspector:
- Name, address and other particulars of person from whom he acquired the drug/cosmetic.
Section 18B: Maintenance of Records and Furnishing of Information
Every person holding a licence under clause (c) of Section 18 shall:
- Keep and maintain prescribed records, registers and documents.
- Furnish information to any officer/authority as required.
Section 19: Pleas (Defenses against Prosecution)
(1) No person shall be convicted of an offence under clause (a) or clause (b) of Section 18 if he proves:
- (a) That he acquired the drug/cosmetic from a duly licensed manufacturer/dealer.
- (b) That he did not know and could not with reasonable diligence have known that the drug/cosmetic was of the nature described in Section 18.
- (c) That the drug/cosmetic was being sold in the same sealed condition as when he acquired it.
(2) No person shall be convicted of an offence under Section 18 if he proves:
- That the drug/cosmetic was sold under a prescription of a Registered Medical Practitioner.
- That the drug was certified by the purchaser to be for the treatment of animals.
Section 20: Government Analysts
(1) Central Government or State Government may appoint Government Analysts for such areas as assigned.
(2) Qualifications and conditions are as prescribed.
(3) No person with financial interest in manufacture/sale of drugs shall be appointed.
Section 21: Inspectors
(1) Central Government or State Government may appoint Inspectors with prescribed qualifications.
(2) Powers, duties, conditions are as prescribed.
(3) No person with financial interest in manufacture/sale of drugs shall be appointed.
(4) Every Inspector is deemed to be a public servant under Section 21 of IPC (now BNS 2023).
Section 22: Powers of Inspectors
(1) An Inspector may, with prior approval (or in urgent cases, with subsequent report):
- Enter any place where drugs/cosmetics are manufactured/kept.
- Take samples of drugs/cosmetics.
- Search premises.
- Seize stocks of drugs/cosmetics.
- Examine records, registers, documents.
(2) Power to stop and search vehicles/vessels/conveyances.
(3) Power to break open doors, etc. if resistance offered.
(4) Seized articles to be produced before a Magistrate.
Section 23: Procedure of Inspectors
(1) An Inspector shall tender payment for samples taken.
(2) Receipt to be given for samples seized.
(3) Samples to be divided into portions and sealed.
(4) One portion sent to Government Analyst; one portion retained; one portion given to person from whom sample taken.
(5) If person refuses to accept portion, Inspector shall send intimation to Government Analyst.
Section 24: Persons Bound to Disclose Place Where Drugs/Cosmetics are Manufactured or Kept
Every person is bound to disclose to an Inspector the place where drugs/cosmetics are manufactured or kept.
Section 25: Reports of Government Analysts
(1) A Government Analyst shall deliver a report in the prescribed form.
(2) The report shall be sent to:
- Court (if sample taken under Court order).
- Inspector (if sample taken by Inspector).
- Person from whom sample taken (copy).
(3) The report shall be evidence of facts stated.
(4) The certificate of a Government Analyst is admissible as evidence.
Section 26: Purchaser of Drug/Cosmetic Enabled to Obtain Test or Analysis
A purchaser may apply to have a drug/cosmetic tested by a Government Analyst.
Procedure and fees are as prescribed.
Section 26A: Power of Central Government to Prohibit Manufacture, etc. in Public Interest
The Central Government may, by notification, prohibit manufacture, sale or distribution of any drug/cosmetic in public interest.
This power has been used extensively to ban FDCs (Fixed Dose Combinations).
🔑 EXAM POINT: Section 26A is the provision used for banning FDCs. The famous 2016 FDC ban (S.O. 4616(E)) was under this section.
Section 27: Penalty for Manufacture, Sale, etc. of Drugs in Contravention
| Offence Type | Description | Punishment (First Offence) |
|---|
| Section 27(1)(a) | Manufacture, sale, etc., of any spurious drug | Imprisonment NOT LESS than 3 years but may extend to life imprisonment AND fine NOT LESS than ₹10,000 |
| Section 27(1)(b) | Manufacture, sale, etc., of any adulterated drug | Imprisonment NOT LESS than 1 year but may extend to 3 years AND fine NOT LESS than ₹5,000 |
| Section 27(1)(c) | Manufacture, sale, etc., of any misbranded drug | Imprisonment up to 1 year OR fine up to ₹1,000 OR both |
| Section 27(1)(d) | Any other contravention of this Chapter or rules | Imprisonment up to 6 months OR fine up to ₹500 OR both |
| Section 27(2) | Conviction under (a) or (b) for causing grievous hurt or death | Imprisonment NOT LESS than 5 years (may extend to life) AND fine NOT LESS than ₹10,000 |
Proviso: Court may impose a lesser sentence for adequate and special reasons.
Section 27A: Penalty for Manufacture, Sale, etc. of Cosmetics in Contravention
| Offence Type | Punishment |
|---|
| (i) Spurious cosmetic | Imprisonment up to 3 years AND fine |
| (ii) Any other cosmetic in contravention | Imprisonment up to 1 year OR fine up to ₹1,000 OR both (Note: This is subject to Jan Vishwas Act 2026 changes) |
Section 28: Penalty for Non-Disclosure of Name of Manufacturer
Contravention of Section 18A (disclosure) or Section 24 (disclose place) → Imprisonment up to 1 year OR fine up to ₹1,000 OR both.
Section 28A: Penalty for Not Keeping Documents, etc.
Contravention of Section 18B (maintenance of records) → Imprisonment up to 1 year OR fine up to ₹1,000 OR both.
🔑 JAN VISHWAS 2023/2026 UPDATE: This section has been amended to convert violations into administrative penalties (for minor compliance issues), replacing imprisonment and fine.
Section 28B: Penalty for Manufacture, etc. in Contravention of Section 26A
Contravention of notification under Section 26A → Imprisonment up to 3 years AND fine up to ₹5,000.
Section 29: Penalty for Use of Government Analyst's Report for Advertising
Use of Government Analyst's report for advertising → Fine up to ₹500.
🔑 JAN VISHWAS 2026 UPDATE: This section has been OMITTED ENTIRELY by the Jan Vishwas (Amendment of Provisions) Act, 2026.
Section 30: Penalty for Subsequent Offences
| Previous Conviction Under | Subsequent Offence Punishment |
|---|
| Section 27(1)(a) (Spurious drug) or 27(1)(b) (Adulterated drug) | Imprisonment NOT LESS than 5 years but may extend to 10 years AND fine NOT LESS than ₹10,000 |
| Section 27(1)(c) (Misbranded drug) | Imprisonment up to 2 years OR fine up to ₹2,000 OR both |
| Section 27(1)(d) (Other contraventions) | Imprisonment up to 1 year OR fine up to ₹1,000 OR both |
| Section 27A(i) (Spurious cosmetic) | Imprisonment up to 5 years AND fine |
| Section 27A(ii) (Other cosmetic contravention) | Imprisonment up to 2 years OR fine up to ₹2,000 OR both |
Section 31: Confiscation
- Any drug/cosmetic in respect of which an offence has been committed is liable to confiscation.
- Implements, machinery, receptacles, packages, coverings, animals, vehicles, vessels, conveyances used in the offence are also liable to confiscation.
Section 31A: Application of Provisions to Government Departments
Provisions of this Chapter (except Section 31) apply to Government departments as they apply to other persons.
Section 32: Cognizance of Offences
(1) No prosecution except by:
- Inspector; OR
- Person aggrieved; OR
- Recognised consumer association (whether member or not).
(2) No Court inferior to Metropolitan Magistrate or Judicial Magistrate of First Class shall try offences.
(3) Nothing prevents prosecution under any other law.
Section 32A: Power of Court to Implead the Manufacturer, etc.
A Court may direct the manufacturer, distributor or dealer to be impleaded as a party in a proceeding under this Act.
Section 33: Power of Central Government to Make Rules
The Central Government may make rules for:
- Prescribing standards of quality for drugs/cosmetics.
- Prescribing methods of test/analysis.
- Prescribing forms of licences.
- Prescribing conditions for licences.
- Regulating import of small quantities for examination/test/analysis.
- Prescribing forms of application for licences.
- Prescribing fees for test/analysis.
- Specifying diseases for cure/mitigation.
- Any other matter necessary for carrying out the purposes of this Chapter.
Section 33A: Chapter Not to Apply to Ayurvedic, Siddha or Unani Drugs
This Chapter (IV) does NOT apply to ASU drugs.
ASU drugs are regulated under Chapter IVA.
CHAPTER IVA — PROVISIONS RELATING TO AYURVEDIC, SIDDHA AND UNANI DRUGS
Section 33B: Application of Chapter IVA
This Chapter specifically applies to Ayurvedic, Siddha and Unani (ASU) drugs.
Section 33C: ASU Drugs Technical Advisory Board
A Board similar to DTAB but specifically for ASU drugs, constituted by the Central Government.
Section 33D: ASU Drugs Consultative Committee
A Committee similar to DCC but specifically for ASU drugs.
Section 33E: Misbranded ASU Drugs
An ASU drug is deemed misbranded if:
- Not labelled in prescribed manner.
- Label contains false or misleading matter.
- Claims to be the product of a manufacturer but is not.
Section 33EE: Adulterated ASU Drugs
An ASU drug is deemed adulterated if:
- Mixed with any substance which reduces its quality/strength.
- Any substance substituted wholly or in part.
- Any valuable constituent abstracted.
- Prepared under insanitary conditions.
Section 33EEA: Spurious ASU Drugs
An ASU drug is deemed spurious if:
- Manufactured under a name belonging to another drug.
- Imitation of another drug.
- Label bears fictitious manufacturer name.
- Substituted by another drug/substance.
Section 33EEB: Regulation of Manufacture for Sale of ASU Drugs
No person shall manufacture for sale ASU drugs except under and in accordance with a licence.
Section 33EEC: Prohibition of Manufacture and Sale of Certain ASU Drugs
No person shall manufacture for sale, sell, stock or exhibit for sale:
- Any ASU drug deemed to be misbranded, adulterated or spurious.
- Any ASU drug in contravention of provisions of this Chapter.
- Any ASU drug except under and in accordance with a licence.
Section 33EED: Power of Central Government to Prohibit Manufacture, etc. in Public Interest
Similar to Section 26A but specifically for ASU drugs.
Section 33F: Government Analysts (ASU)
Central Government or State Government may appoint Government Analysts for ASU drugs.
Section 33G: Inspectors (ASU)
Central Government or State Government may appoint Inspectors for ASU drugs.
These inspectors are also deemed public servants.
Section 33H: Application of Provisions of Sections 22, 23, 24 and 25
Sections 22 (Powers of Inspectors), 23 (Procedure of Inspectors), 24 (Disclosure of place), and 25 (Reports of Government Analysts) apply to ASU drugs with necessary modifications.
Section 33I: Penalty for Manufacture, Sale, etc. of ASU Drugs in Contravention
| Offence Type | Description | Punishment (First Offence) |
|---|
| Section 33I(1)(a) | Manufactures for sale/distribution: Any ASU drug deemed adulterated OR without valid licence. | Imprisonment up to 1 year AND fine NOT LESS than ₹2,000 |
| Section 33I(1)(b) | Manufactures for sale/distribution: Any ASU drug deemed spurious. | Imprisonment NOT LESS than 1 year but may extend to 3 years AND fine NOT LESS than ₹5,000 |
| Section 33I(2) | Contravenes any other provision of this Chapter. | Imprisonment up to 3 months AND fine NOT LESS than ₹500 |
Section 33J: Penalty for Subsequent Offences (ASU)
| Previous Conviction Under | Subsequent Offence Punishment |
|---|
| Section 33I(1)(a) (Adulterated ASU/No Licence) | Imprisonment up to 2 years AND fine up to ₹2,000 |
| Section 33I(1)(b) (Spurious ASU) | Imprisonment NOT LESS than 2 years but may extend to 6 years AND fine NOT LESS than ₹5,000 |
| Section 33I(2) (Other ASU contraventions) | Imprisonment up to 6 months AND fine NOT LESS than ₹1,000 |
Section 33K: Confiscation (ASU)
Similar provisions to Section 31 apply for confiscation of ASU drugs and associated items.
Section 33L: Application of Provisions to Government Departments (ASU)
Similar provisions to Section 31A apply for ASU drugs offences by Government departments.
Section 33M: Cognizance of Offences (ASU)
Similar provisions to Section 32 apply for cognizance of offences relating to ASU drugs.
Section 33N: Power of Central Government to Make Rules (ASU)
Central Government may make rules specifically for ASU drugs, covering standards, licences, etc.
Section 33O: Power to Amend First Schedule
Central Government may, by notification, amend the First Schedule (which lists authoritative books of ASU medicine).
CHAPTER V — MISCELLANEOUS
Section 33P: Power to Give Directions
Central Government may give directions to State Governments for carrying out the provisions of this Act.
Section 34: Offences by Companies
If an offence is committed by a company:
- Every person in charge of, and responsible to, the company for the conduct of its business, as well as the company itself, shall be deemed guilty and liable to be proceeded against.
Defence: A person can prove the offence was committed without his knowledge OR that he exercised all due diligence to prevent the commission of such offence.
Where offence proved to have been committed with consent/connivance of, or attributable to neglect by:
- Director, Manager, Secretary or other officer — such individual shall also be deemed guilty.
Section 34A: Offences by Government Departments
The Head of the department is deemed guilty unless he proves the offence was committed without his knowledge or that he exercised all due diligence.
Section 34AA: Penalty for Vexatious Search or Seizure
An Inspector who:
- Without reasonable ground of suspicion, enters premises.
- Vexatiously and unnecessarily searches premises or person.
- Vexatiously and unnecessarily seizes any drug/cosmetic.
- Commits criminal trespass.
→ Punishable with a fine up to ₹1,000.
Section 35: Publication of Sentences Passed Under This Act
The Court shall cause particulars of the sentence to be published in the Official Gazette and in such newspapers as the Court may direct.
Expenses are borne by the convicted person.
Section 36: Magistrate's Power to Impose Enhanced Penalties
Notwithstanding anything in Section 29 of CrPC, it shall be lawful for any Metropolitan Magistrate or Judicial Magistrate of First Class to pass any sentence authorised by this Act.
Section 36A: Certain Offences to be Tried Summarily
Offences punishable under the following sections may be tried summarily:
- Section 27(1)(c), 27(1)(d), 27A(ii), 28, 28A, 28B, 29
- Section 33I(2)
Section 37: Protection of Action Taken in Good Faith
No suit, prosecution or other legal proceeding shall lie against any person for anything done or intended to be done in good faith under this Act.
Section 38: Rules to be Laid Before Parliament
Every rule made by the Central Government under this Act shall be laid before each House of Parliament.
PENALTY SUMMARY TABLE (AS AMENDED UP TO 2026)
| Section | Offence | Punishment |
|---|
| 27(1)(a) | Spurious drug | 3 years to life imprisonment + fine NOT LESS than ₹10,000 |
| 27(1)(b) | Adulterated drug | 1 year to 3 years + fine NOT LESS than ₹5,000 |
| 27(1)(c) | Misbranded drug | Up to 1 year OR fine up to ₹1,000 OR both |
| 27(1)(d) | Other contraventions | Up to 6 months OR fine up to ₹500 OR both |
| 27(2) | Grievous hurt/death by spurious/adulterated drug | NOT LESS than 5 years (up to life) + fine NOT LESS than ₹10,000 |
| 27A(i) | Spurious cosmetic | Up to 3 years + fine |
| 27A(ii) | Other cosmetic contravention | Up to 1 year OR fine up to ₹1,000 OR both (Note: Administrative penalty under Jan Vishwas 2026) |
| 28 | Non-disclosure (Sec 18A/24) | Up to 1 year OR fine up to ₹1,000 OR both |
| 28A | Not keeping documents (Sec 18B) | Administrative penalty (Jan Vishwas 2023/2026) |
| 28B | Contravention of Sec 26A notification | Up to 3 years + fine up to ₹5,000 |
| 29 | Use of Analyst's report for advertising | OMITTED by Jan Vishwas 2026 |
| 30(1) | Subsequent offence - Spurious/Adulterated drug | 5 to 10 years + fine NOT LESS than ₹10,000 |
| 30(2) | Subsequent offence - Spurious cosmetic | Up to 5 years + fine |
| 33I(1)(a) | ASU adulterated/without licence | Up to 1 year + fine NOT LESS than ₹2,000 |
| 33I(1)(b) | ASU spurious | 1 to 3 years + fine NOT LESS than ₹5,000 |
| 33I(2) | Other ASU contraventions | Up to 3 months + fine NOT LESS than ₹500 |
| 34AA | Vexatious search/seizure by Inspector | Fine up to ₹1,000 |
JAN VISHWAS (AMENDMENT OF PROVISIONS) ACT, 2026 — VERIFIED CHANGES IN D&C ACT
Source: PIB Official Press Release (26th June 2026) — Authority: Government of India
The Government of India operationalised key reforms under the Jan Vishwas Act, 2026 relating to the Drugs and Cosmetics Act, 1940 on 26th June 2026, decriminalising minor offences and introducing administrative penalties.
Specific Changes in D&C Act, 1940:
| Section | Previous Provision | Current Provision (After Jan Vishwas 2026) |
|---|
| Section 29 | Penalty of up to ₹1 lakh for use of Government Analyst's report for advertising | SECTION 29 OMITTED ENTIRELY |
| Section 27A(ii) | Imprisonment up to 1 year or fine up to ₹1,000 or both for cosmetic contraventions (other than spurious) | Administrative penalty of ₹1 lakh or three times value of cosmetics confiscated, whichever is higher |
| Section 28A | Imprisonment up to 1 year or fine up to ₹1,000 or both for not keeping documents | Administrative penalty framework |
| Low-risk cosmetics | Criminal penalties for minor quality/labelling issues | Administrative penalties for minor quality parameters or labelling deficiencies |
| Spurious/Adulterated cosmetics | Criminal penalties | STRICT CRIMINAL PROVISIONS RETAINED |
Key Principles of Jan Vishwas 2026:
- Decriminalisation of minor offences: Technical and procedural violations converted to administrative penalties.
- Public health safeguard: Offences involving spurious or adulterated cosmetics/drugs CONTINUE to attract strict penal provisions.
- Adjudicating Authorities: Introduced for timely and transparent disposal of administrative penalty cases.
- Appeal Mechanism: Introduced for challenging administrative penalties.
- Proportionate Justice: Punishment fits the nature of the default without compromising public safety.
What REMAINS Criminal (Non-Negotiable):
- Spurious drugs (Section 27(1)(a))
- Adulterated drugs (Section 27(1)(b))
- Spurious cosmetics (Section 27A(i))
- Offences causing grievous hurt or death (Section 27(2))
- Contravention of Section 26A notification (Section 28B)
What is Now Administrative Penalty:
- Misbranded drugs (Section 27(1)(c)) — May be converted (depending on specific rules).
- Minor cosmetic violations (Section 27A(ii)) — Converted.
- Document maintenance issues (Section 28A) — Converted.
