Drugs and Cosmetics Act, 1940 - Overview

Structure of the Act

Key Definitions (Section 3)

• Drug: All medicines for internal/external use in humans or animals; substances for diagnosis, treatment, mitigation, or prevention of disease; substances intended to affect body structure/function; substances used in the manufacture of any drug.
• Cosmetic: Any article intended for use on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.
• Manufacture: Includes any process of making, altering, finishing, packing, labelling, breaking up, or otherwise treating/adapting a drug with a view to its sale or distribution.
• Misbranded drug: A drug whose label is false, misleading, or fails to carry required information.
• Adulterated drug: A drug whose strength/quality/purity falls below or differs from prescribed standards.
• Spurious drug: A drug substituted wholly or partly for another drug, or imitates another drug, or bears a false name.

Chapter IV - Manufacture, Sale and Distribution of Drugs and Cosmetics (Sections 16-33A)

• Section 16 - Standards of quality: Drugs must comply with standards in the Second Schedule; cosmetics with prescribed standards.
• Section 17 - Misbranded drugs defined.
• Section 17A - Adulterated drugs defined.
• Section 17B - Spurious drugs defined.
• Section 18 - Prohibition on manufacture/sale of substandard, misbranded, adulterated, spurious drugs, or without a valid licence.
• Section 22 - Powers of Inspectors to enter, inspect, search, seize, and take samples.
• Section 23 - Procedure for taking samples.
• Section 25 - Reports of Government Analysts to be used as evidence in court.
• Section 27 - Penalties for manufacture/sale of spurious/adulterated/misbranded drugs (imprisonment 1-3 years + fine for spurious; can extend to life imprisonment in cases causing death).
• Section 33A - Chapter IV does not apply to Ayurvedic, Siddha or Unani drugs (they are governed by Chapter IV-A).

Chapter IV-A - Provisions Relating to Ayurvedic, Siddha and Unani (ASU) Drugs (Sections 33B to 33N)

Section 33B - Application

Section 33C - Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB)

• Constituted by the Central Government by Gazette notification.
• Advises Central and State Governments on technical matters arising under the chapter.
• Membership includes experts in Ayurveda, Siddha, Unani, modern medicine, and pharmacognosy.

Section 33D - ASU Drugs Consultative Committee

• Facilitates uniformity of action by State Governments in administering Chapter IV-A.
• Acts as a liaison between Central and State authorities.

Section 33E - Misbranded ASU Drugs

• It is so coloured, coated, powdered, or polished that damage is concealed.
• It is made to appear better/of greater therapeutic value than it really is.
• Its label is false or misleading.
• It does not carry required statutory label information.

Section 33EE - Adulterated ASU Drugs

Section 33EEA - Spurious ASU Drugs

Section 33EEB - Regulation of Manufacture for Sale

• No person shall manufacture an ASU drug for sale without a valid licence issued by the prescribed authority.
• Exception: Vaidyas (Ayurvedic practitioners) and Hakims (Unani practitioners) who manufacture drugs solely for their own patients are exempted from the licensing requirement.
• Small quantities prepared for examination, test, or analysis are also exempted.

Section 33EEC - Prohibition on Manufacture/Sale of Certain ASU Drugs

Section 33EED - Power of Central Government to Prohibit in Public Interest

• The Central Government may, by Gazette notification, ban the manufacture, sale, or distribution of any ASU drug if it is satisfied that:
  • The drug poses a risk to human beings or animals, OR
  • The drug lacks the therapeutic value claimed for it.
• This is a precautionary public interest power.

Section 33F - Government Analysts

• Central or State Governments may appoint Government Analysts for ASU drugs.
• Their reports serve as evidence in legal proceedings.

Section 33G - Inspectors

• Governments appoint Inspectors specifically for ASU drugs.
• They must possess prescribed qualifications (typically an Ayurvedic/Siddha/Unani degree or a B.Pharm in Ayurveda plus 5 years' experience in ASU drug manufacture/testing/enforcement).
• Inspectors are deemed public servants under Section 21 IPC.

Section 33H - Application of Inspection Provisions

Section 33-I - Penalties

Section 33J - Penalty for Subsequent Offences

Section 33K - Confiscation

Section 33L - Application to Government Departments

Section 33M - Cognizance of Offences

Drugs and Cosmetics Rules, 1945 - Chapter IVA Related Rules

• Schedule T: Requirements for factory premises, plant, equipment, and hygienic conditions for manufacture of ASU drugs (the ASU equivalent of GMP).
• Schedule E(i): List of poisonous substances used in Ayurvedic, Siddha and Unani systems (e.g., certain heavy metals, plant toxins) requiring special handling.
• Schedule A: Forms for licensing applications under Chapter IV-A.
• Rule 162A: Qualifications of the State Drug Licensing Authority for ASU drugs - must hold an Ayurvedic/Siddha/Unani qualification (per CCIM Act 1970) or B.Pharm (Ayurveda) plus at least 5 years' experience in ASU drug manufacture, testing, or enforcement.
• First Schedule of the Act: Lists authoritative books (Ayurvedic Pharmacopoeia of India, Siddha Pharmacopoeia, Unani Pharmacopoeia, etc.) to define what constitutes a standard ASU formulation.

Important Schedules Under the Rules (Overview)

Summary: Why Chapter IV-A Matters

1. Dedicated regulation - Creates a separate, tailored framework for traditional medicines rather than forcing them into modern pharmaceutical standards.
2. Licensing control - Mandates manufacturing licences while protecting traditional practitioners (Vaidyas/Hakims) treating their own patients.
3. Quality standards - Defines misbranding, adulteration, and spuriousness specifically for ASU drugs based on classical texts.
4. Public safety powers - Gives the Central Government swift authority to ban dangerous or fraudulent products.
5. Enforcement machinery - Separate Inspectors, Analysts, Advisory Board and Consultative Committee dedicated to the ASU sector.