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Section 3 of the Drugs and Cosmetics Act 1940 - Definitions

Section 3 contains the principal definitions used throughout the Drugs and Cosmetics Act, 1940. These definitions determine the statutory meaning of important expressions such as Ayurvedic, Siddha or Unani drug, cosmetic, drug, Government Analyst, Inspector, manufacture, import, patent or proprietary medicine and prescribed.

Current regulatory context: The definition of "drug" in section 3(b) is broad and includes notified medical devices. Medical devices are regulated under the Drugs and Cosmetics Act, 1940 together with the Medical Devices Rules, 2017. Cosmetics are also governed by the Act and the applicable Cosmetics Rules, 2020.
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Section 3 - Definitions

In this Act, unless there is anything repugnant in the subject or context:

(a) Ayurvedic, Siddha or Unani drug: includes all medicines intended for internal or external use for, or in the diagnosis, treatment, mitigation or prevention of, disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of the Ayurvedic, Siddha and Unani Tibb systems of medicine specified in the First Schedule.
(aa) The Board: means, in relation to an Ayurvedic, Siddha or Unani drug, the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted under section 33C; and, in relation to any other drug or cosmetic, the Drugs Technical Advisory Board constituted under section 5.
(aaa) Cosmetic: means any article intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part of it for cleansing, beautifying, promoting attractiveness or altering appearance, and includes an article intended for use as a component of a cosmetic.
(b) Drug includes:
  1. medicines for internal or external use of human beings or animals, and substances intended for diagnosis, treatment, mitigation or prevention of disease or disorder, including preparations applied to the human body to repel insects such as mosquitoes;
  2. specified substances, other than food, intended to affect the structure or any function of the human body, or intended for destruction of vermin or insects causing disease in human beings or animals;
  3. substances intended for use as components of a drug, including empty gelatin capsules; and
  4. devices intended for internal or external use in diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as specified by the Central Government by notification in the Official Gazette after consultation with the Board.
(c) Government Analyst: means, for an Ayurvedic, Siddha or Unani drug, a Government Analyst appointed by the Central Government or a State Government under section 33F; and, for any other drug or cosmetic, a Government Analyst appointed under section 20.
(e) Inspector: means, for an Ayurvedic, Siddha or Unani drug, an Inspector appointed by the Central Government or a State Government under section 33G; and, for any other drug or cosmetic, an Inspector appointed under section 21.
(f) Manufacture: in relation to any drug or cosmetic, includes any process or part of a process for making, altering, ornamenting, finishing, packing, labelling, breaking up or otherwise treating or adapting a drug or cosmetic with a view to its sale or distribution. It does not include compounding or dispensing a drug, or packing a drug or cosmetic, in the ordinary course of retail business. "To manufacture" is construed accordingly.
(g) To import: with its grammatical variations and cognate expressions, means to bring into India.
(h) Patent or proprietary medicine:
  1. for Ayurvedic, Siddha or Unani systems of medicine, formulations containing only ingredients mentioned in the formulae described in the authoritative books specified in the First Schedule, subject to the statutory exclusions; and
  2. for other systems of medicine, a drug presented as a remedy or prescription ready for internal or external administration to human beings or animals and not included in the Indian Pharmacopoeia for the time being or another Pharmacopoeia authorised by the Central Government after consultation with the Drugs Technical Advisory Board.
(i) Prescribed: means prescribed by rules made under the Act.

Meaning and practical scope of the definitions

Meaning of drug under section 3(b)

The expression "drug" is not confined to conventional medicines. It also covers specified substances, drug components and medical devices brought within the statutory framework by Central Government notification. Whether a product is regulated as a drug therefore depends on its intended use, composition and, where relevant, the applicable notification and rules.

Meaning of cosmetic under section 3(aaa)

A cosmetic is identified principally by its intended application to the human body for cleansing, beautifying, promoting attractiveness or altering appearance. Components intended for use in cosmetics are also included in the statutory definition.

Meaning of manufacture under section 3(f)

The definition is wider than the physical production of a product. Processes such as altering, finishing, packing and labelling may amount to manufacture when carried out with a view to sale or distribution. The statutory exclusion protects ordinary retail compounding, dispensing and packing described in the clause.

Medical devices and section 3(b)

Section 3(b)(iv) enables the Central Government to bring devices intended for diagnosis, treatment, mitigation or prevention of disease or disorder within the definition of "drug" by notification. The Medical Devices Rules, 2017 provide the principal regulatory framework for medical devices, and CDSCO states that medical devices in India are regulated under the Drugs and Cosmetics Act, 1940 and those Rules.

The Central Government notification S.O. 648(E), dated 11 February 2020, expanded the notified medical-device framework. Readers dealing with a specific device should check the current CDSCO notifications, classifications and Medical Devices Rules in addition to section 3.

Legislative notes

The section has been amended on several occasions. Among the historical changes reflected in the statutory text are amendments made by Acts 11 of 1955, 35 of 1960, 21 of 1962, 13 of 1964, 19 of 1972 and 68 of 1982. Clause (d) was omitted by Act 19 of 1972. The present lettering of clauses should therefore be read as it appears in the current official text.

Legal use: For pleadings, compliance, licensing or enforcement matters, verify the latest Act, applicable rules and Gazette notifications because subordinate legislation and notified product categories may change without altering the wording of every definition in section 3.