CDSCO Cancels FatX Registration Over Misleading Claims

On 26 October 2026, the Central Drugs Standard Control Organisation (CDSCO) cancelled the import registration of FatX Solution, an injectable cosmetic product. The cancellation took effect on the same date and followed claims made by Delhi-based importer Tekno Midas Aesthetics.

Reasons for cancellation

FatX was marketed as dissolving fat cells and reducing their size. CDSCO treated these as drug claims, not consistent with the definition of cosmetics, which are intended for external application. It also found differences between the approved product label and claims on the importer’s official website.

CDSCO issued a show-cause notice to the firm on 10 August 2026 for alleged violations of Section 3(aaa) of the Drugs and Cosmetics Act, 1940, and Rule 36 of the Cosmetics Rules, 2020, which prohibits false or misleading claims. The Central Licensing Authority deemed the firm’s response, submitted on 1 September, “inconclusive and unsatisfactory”.

Registration certificate RC/COS-003300 was issued on 15 July 2022 and was valid until 14 July 2027.

Important Facts for Exams

• Cosmetic import forms: Under the Cosmetics Rules, 2020, applicants seek import registration in Form COS-1, while the Central Licensing Authority issues the resulting certificate in Form COS-2.
• DTAB statutory role: Section 5 of the Drugs and Cosmetics Act establishes the Drugs Technical Advisory Board to advise Central and State Governments on technical matters under the Act.
• CDSCO’s administrative position: CDSCO operates under the Directorate General of Health Services in the Union health ministry and is headed by the Drugs Controller General of India.
• Central Licensing Authority: For cosmetics, the Drugs Controller General (India) serves as the Central Licensing Authority, distinguishing the central import-registration role from state-level manufacture licensing.