Section 17E of Drugs and Cosmetics Act 1940 - Adulterated Cosmetics
Section 17E of the Drugs and Cosmetics Act, 1940 specifies the circumstances in which a cosmetic is legally deemed to be adulterated. The provision forms part of Chapter IV of the Act, which regulates the manufacture, sale and distribution of drugs and cosmetics in India.
Current regulatory context: Cosmetics continue to be regulated under the Drugs and Cosmetics Act, 1940 together with the Cosmetics Rules, 2020. The Cosmetics Rules, 2020 apply to a cosmetic as defined in section 3(aaa) of the Act and contain the current regulatory framework for matters including import, manufacture, standards, labelling and related requirements.
Meaning of cosmetic under Section 3(aaa)
For understanding Section 17E, the expression cosmetic should be read with section 3(aaa) of the Act. Broadly, it covers an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearance, and also includes an article intended for use as a component of a cosmetic.
Section 17E - When a cosmetic is adulterated
For the purposes of Chapter IV, a cosmetic is deemed to be adulterated in any of the following circumstances:
(a) if it consists in whole or in part of any filthy, putrid or decomposed substance; or
(b) 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; or
(c) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(d) if it bears or contains, for purposes of colouring only, a colour other than one which is prescribed; or
(e) if it contains any harmful or toxic substance which may render it injurious to health; or
(f) if any substance has been mixed with it so as to reduce its quality or strength.
How the clauses operate
Filthy, putrid or decomposed material
Clause (a) addresses the composition of the cosmetic itself. A cosmetic containing filthy, putrid or decomposed matter, whether wholly or partly, falls within the statutory category of adulterated cosmetics.
Insanitary preparation, packing or storage
Clause (b) focuses on the conditions in which the product is prepared, packed or stored. The provision applies where insanitary conditions may contaminate the cosmetic with filth or may render it injurious to health.
Unsafe containers
Under clause (c), adulteration can arise from the container where poisonous or deleterious material in the container may make the cosmetic contents injurious to health.
Unauthorised colouring
Clause (d) covers a cosmetic bearing or containing, for colouring purposes only, a colour other than a prescribed colour. The applicable regulatory requirements should therefore be read with the Cosmetics Rules, 2020 and the standards referred to under those Rules.
Harmful or toxic substances
Clause (e) applies where a harmful or toxic substance in the cosmetic may render the product injurious to health.
Reduction of quality or strength
Clause (f) addresses mixing of another substance with a cosmetic where the effect is to reduce the quality or strength of the cosmetic.
Related provisions and regulatory effect
Section 17E should not be read in isolation. Section 18 contains prohibitions concerning the manufacture and sale of specified drugs and cosmetics, while Section 27A provides the penalty framework for manufacture, sale, stocking, exhibition or offering for sale of cosmetics in contravention of Chapter IV. In particular, Section 27A expressly covers cosmetics deemed adulterated under Section 17E.
The Cosmetics Rules, 2020 are also relevant to present-day compliance. CDSCO states that cosmetics must meet applicable quality and safety specifications and that cosmetics not included in the Ninth Schedule must satisfy the requirements of the Rules and the applicable specifications and standards in the country of origin.
Official legal resources
For the latest statutory text, amendments, notifications and regulatory material, refer to the official Government sources below. Where an electronic consolidation and an Official Gazette notification differ, the notified Gazette text should be checked for authoritative legal use.
India Code - Drugs and Cosmetics Act, 1940
CDSCO - Drugs and Cosmetics Act, 1940
CDSCO - Cosmetics Rules, 2020
CDSCO - Cosmetics regulatory information