Section 9C of Drugs and Cosmetics Act 1940 - Misbranded Cosmetics

Section 9C explains when a cosmetic is treated as "misbranded" for the purposes of Chapter III of the Drugs and Cosmetics Act, 1940. Chapter III deals with import of drugs and cosmetics into India.

Text of Section 9C - Misbranded cosmetics

Meaning of "cosmetic" under the Act

Section 3(aaa) of the Drugs and Cosmetics Act, 1940 defines a cosmetic broadly as an article intended to be applied to the human body, or any part of it, for cleansing, beautifying, promoting attractiveness or altering appearance. The definition also includes an article intended for use as a component of a cosmetic.

When is a cosmetic misbranded under Section 9C?

Section 9C creates three separate grounds. A cosmetic may be misbranded if any one of them is satisfied.

1. Use of a colour that is not prescribed

Clause (a) covers a cosmetic containing a colour that is not permitted under the applicable regulatory requirements. The Cosmetics Rules, 2020 now contain the principal rules governing cosmetics, including standards and regulatory requirements.

2. Failure to comply with prescribed labelling

Clause (b) applies where the cosmetic is not labelled in the prescribed manner. Chapter VI of the Cosmetics Rules, 2020 contains labelling, packing and related requirements. CDSCO guidance states that imported cosmetics should comply with Rule 34 read with Chapter VI of those Rules.

3. False or misleading statement

Clause (c) covers a false or misleading statement appearing on the label, container or anything accompanying the cosmetic. The rule is not confined to the principal display panel: accompanying material may also be relevant. Rule 36 of the Cosmetics Rules, 2020 separately provides that a cosmetic must not purport or claim to convey an idea that is false or misleading to the intending user.

Section 9C and prohibition on import

Section 10 of the Act prohibits import of specified drugs and cosmetics, including misbranded or spurious cosmetics. Section 9C therefore operates as a classification provision: if an imported cosmetic falls within any of its three clauses, the import restrictions and other applicable provisions of Chapter III may become relevant.

Cosmetics Rules, 2020

The Cosmetics Rules, 2020 were made under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 and apply to cosmetics as defined in Section 3(aaa). They separately regulate import registration, manufacture, standards, labelling, packing and claims. For current compliance, Section 9C should therefore be read with the applicable provisions of the Cosmetics Rules, 2020 and amendments or official directions issued from time to time.

Practical compliance points

• Check that colours used in the cosmetic comply with the applicable prescribed requirements.
• Review the complete label and package against the current Cosmetics Rules, 2020.
• Check product claims, descriptions and accompanying material for statements that may be false or misleading.
• For imported cosmetics, verify the applicable registration and import requirements before import into India.
• Use the latest CDSCO notifications, circulars and amendments when assessing compliance.

Related provisions

For a complete reading, see Section 9D - Spurious cosmetics, Section 10 - Prohibition of import of certain drugs or cosmetics, and the main Drugs and Cosmetics Act, 1940 page.

This page is an informational summary of the statutory provision. For a regulatory decision or proceeding, consult the current Act, the Cosmetics Rules, 2020, applicable amendments, notifications and official directions.