Drug, not cosmetic: CDSCO pulls FatX's registration over misleading claims

The regulator found that the product was being promoted online as a treatment for dissolving fat cells and reducing their size

The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of South Korean cosmetic product FatX solution after finding discrepancies between the claims made on the importer’s website and those on the product label approved by the regulator. The product was being marketed as a treatment to dissolve fat cells and reduce their size, which the regulator classified as drug claims rather than cosmetic claims.

 

“On the website, the product is being marketed as a treatment for dissolving fat cells and reducing the size of fat cells, which are drug claims and do not fall under the definition of cosmetics,” the regulator said in an order dated October 28, 2026.

  

The claims appeared on the official website of the importer, Delhi-based Tekno Midas Aesthetics, and did not match those on the approved product label, the CDSCO said.

What led to the cancellation?

The CDSCO issued a show-cause notice to Tekno Midas Aesthetics on August 10, 2026, for violations of the definition of cosmetics under the Drugs and Cosmetics Act, 1940, and Rule 36 of the Cosmetics Rules, 2020.

 

The company submitted its response on September 1, 2026. However, the Central Licensing Authority found it inconclusive and unsatisfactory. 

 

The order also stated that the company had requested the voluntary surrender of its registration certificate. The Central Licensing Authority subsequently cancelled the certificate under Rule 16 of the Cosmetics Rules, 2020, with effect from October 28, 2026.

Why did CDSCO treat FatX’s claims as drug claims?

The Drugs and Cosmetics Act, 1940, defines a cosmetic under Section 3(aaa) as an article intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearance. The definition also covers articles intended for use as components of cosmetics.

 

The CDSCO said claims about dissolving fat cells and reducing their size fell outside these purposes and therefore did not come within the definition of cosmetics.

 

The regulator also cited Rule 36 of the Cosmetics Rules, 2020, which prohibits false or misleading claims by cosmetic products.

 

The rule states: “No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user.”

How are imported cosmetics regulated in India?

Under Rule 12 of the Cosmetics Rules, 2020, cosmetics must be registered with the Central Licensing Authority before they can be imported into India. Applications are submitted in Form COS-1, and approved products receive an import registration certificate in Form COS-2 under Rule 13.

 

The registration process requires the importer to submit the prescribed documents and obtain approval for the product. The claims made for a product must also comply with the rules governing cosmetics.

 

Under Rule 16, the Central Licensing Authority can suspend or cancel an import registration certificate if the manufacturer, authorised agent or importer fails to comply with its conditions. The authority must provide an opportunity to respond before taking such action and record its reasons in writing.