Drugs and Cosmetics Act 1940 / Section 17A

Section 17A of Drugs and Cosmetics Act 1940 - Adulterated Drugs

Section 17A of the Drugs and Cosmetics Act, 1940 defines the circumstances in which a drug is legally deemed to be adulterated for the purposes of Chapter IV of the Act. The provision focuses on contamination, insanitary preparation or storage, unsafe containers, impermissible colouring, harmful or toxic substances, and dilution or mixing that reduces quality or strength.

Legal meaning: A drug need not satisfy every condition below. If the facts bring it within any one of the statutory clauses of Section 17A, it is deemed to be an adulterated drug for the purposes of Chapter IV.

Text and meaning of Section 17A - Adulterated drugs

For the purposes of this Chapter, a drug shall be deemed to be adulterated:

  1. if it consists in whole or in part of any filthy, putrid or decomposed substance;
  2. if it has been prepared, packed or stored under insanitary conditions whereby it may have been contaminated with filth or whereby it may have been rendered injurious to health;
  3. if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;
  4. if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed;
  5. if it contains any harmful or toxic substance which may render it injurious to health; or
  6. if any substance has been mixed with it so as to reduce its quality or strength.

Explanation of the six grounds of adulteration

Filthy, putrid or decomposed substance

Clause (a) covers a drug consisting wholly or partly of material that is filthy, putrid or decomposed. The provision addresses the condition and composition of the drug itself.

Insanitary preparation, packing or storage

Clause (b) applies where preparation, packing or storage takes place under insanitary conditions capable of contaminating the drug with filth or rendering it injurious to health.

Poisonous or deleterious container

Clause (c) concerns the container. A drug is deemed adulterated where the container is made wholly or partly from a poisonous or deleterious substance that may make its contents injurious to health.

Colour other than a prescribed colour

Clause (d) applies when a drug bears or contains, for colouring purposes only, a colour other than one prescribed under the applicable regulatory framework.

Harmful or toxic substance

Clause (e) covers a drug containing a harmful or toxic substance that may render the drug injurious to health.

Reduction of quality or strength by mixing

Clause (f) treats a drug as adulterated where another substance has been mixed with it so as to reduce its quality or strength.

Section 17A and related provisions

Section 17A is part of Chapter IV, which regulates the manufacture, sale and distribution of drugs and cosmetics. It should be read with Section 18, which contains prohibitions relating to manufacture and sale, and Section 27, which prescribes penalties for specified contraventions involving drugs. The applicable penalty depends on the statutory category and facts of the case.

Adulterated, misbranded and spurious drugs

The Act treats these as distinct statutory categories. Section 17 deals with misbranded drugs, Section 17A deals with adulterated drugs, and Section 17B deals with spurious drugs. Classification should therefore be made by applying the particular statutory definition to the facts.

Official legal resources

For the consolidated statutory text and regulatory material, refer to the official India Code database and the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare.

India Code - Central Acts
CDSCO - Drugs and Cosmetics Act and Rules

Note: This page is intended as a general legal reference. For a specific prosecution, regulatory action, licence issue or compliance question, the current Act, applicable rules, notifications and case-specific facts should be examined.