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India CDSCO Issues Public Notice Clarifying Cosmetic Product Boundaries: Injections and Treatment Claims Prohibited

May 22, 2026
India
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On May 18, 2026, India's Central Drugs Standard Control Organisation (CDSCO) has issued a public notice (File No. COS-1211/2026-eoffice), reaffirming the legal boundaries of cosmetic products under the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. The notice explicitly prohibits the use of cosmetics as injectable preparations, for treatment purposes, and the use of prohibited ingredients or misleading label claims.

Key Provisions of the Notice

1. Injectable Preparations Are Not Cosmetics

CDSCO clarified that products supplied as injectable preparations do not fall under the definition of "cosmetic" under the Drugs and Cosmetics Act, 1940. No cosmetic is permitted to be administered by injection — whether by consumers, professionals, or aesthetic clinics. By definition, cosmetics are products intended to be rubbed, poured, sprinkled, or sprayed on the human body.

2. Cosmetics Cannot Be Used for Treatment

The notice reinforces that cosmetics may only be used for their intended purposes — cleansing, beautifying, promoting attractiveness, or altering appearance. They shall not be used for therapeutic or medical treatment by professionals or individuals. This provision targets a growing concern where aesthetic clinics and practitioners have been using cosmetic products beyond their regulatory scope.

3. Prohibition of Misleading Claims

Under the labeling provisions, no cosmetic may convey any false or misleading claims to the intending user. Additionally, no person shall alter, obliterate, or deface any inscription or mark made by the manufacturer on the container, label, or wrapper of any cosmetic product.

4. Prohibited and Restricted Ingredients

The notice references the list of ingredients that are "generally not recognised as safe" (GNRAS) and restricted ingredients, as published by the Bureau of Indian Standards (BIS). The use of prohibited ingredients in cosmetic products constitutes a violation of the Act and Rules.

Regulatory Context

Under the Drugs and Cosmetics Act, 1940, a "cosmetic" is defined as any article intended to be rubbed, poured, sprinkled, or sprayed on, or otherwise applied to, the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance. The manufacturing and import of cosmetics for sale and distribution in India are regulated under the Cosmetics Rules, 2020, which require all imported cosmetics to obtain a Registration Certificate (RC) from CDSCO.

Violations and Consequences

CDSCO warned that the following actions constitute violations of the Drugs and Cosmetics Act and the Cosmetics Rules, 2020:

  • Use of prohibited ingredients in cosmetic products
  • Misleading claims on product labels
  • Use of cosmetics for treatment purposes
  • Application of cosmetics through injection

CIRS Reminder

As India strengthens its oversight of cosmetic compliance, companies operating in the Indian market are advised to take the following actions:

  • Verify product labels and marketing materials to ensure they contain no therapeutic or misleading claims, in compliance with Rule 36 of the Cosmetics Rules, 2020.
  • Ensure cosmetic products are used strictly within their defined regulatory scope — cleansing, beautifying, promoting attractiveness, or altering appearance.
  • Review ingredient formulations against the BIS-published list of GNRAS and restricted ingredients, and ensure compliance with the Ninth Schedule requirements.
  • For injectable products, confirm appropriate classification under drug regulations rather than cosmetic regulations, and obtain necessary approvals accordingly.

Further Information:

India CDSCO

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