CDSCO finds over 160 drug samples as ‘not of standard quality’ for December

NEW DELHI: Promising to dissolve fat cells may sound like an attractive pitch for a slimming product, but it has landed FatX Solution in trouble with the country’s drug regulator. The Central Drugs Standard Control Organisation (CDSCO) has cancelled the product’s registration after finding that it was being promoted with claims that are not permitted for cosmetics.In an order dated October 28, CDSCO said Delhi-based importer Tekno Midas Aesthetics was marketing FatX Solution on its website as a product that could dissolve fat cells and reduce their size. The regulator said these were drug-related claims and did not fit the definition of a cosmetic under the Drugs and Cosmetics Act, 1940.The action followed a scrutiny of the company’s application and website, during which CDSCO found differences between the claims being made online and those mentioned on the approved product label.Under the Cosmetics Rules, 2020, cosmetic products cannot make false or misleading claims. The rules define cosmetics as products meant for cleansing, beautifying, promoting attractiveness or altering appearance. Claims to dissolve fat cells go beyond this definition, the regulator said.CDSCO had issued a show-cause notice to the company on August 10, citing violations of the Drugs and Cosmetics Act and the Cosmetics Rules. The company submitted its response on September 1, but the regulator found it inconclusive and unsatisfactory. The firm also requested that its registration certificate be voluntarily surrendered.

Rajan Bhatnagar of Tekno Midas Aesthetics told TOI that the product had been registered as a cosmetic more than four years ago. “At that time, the licence was granted because the product was registered as a cosmetic. The authorities have now changed their interpretation of the category under which the product falls. Earlier, it was considered a cosmetic, but now they say it falls under another category,” he said.He said the company had decided not to contest the matter after receiving the notice. “We did not want to get into any dispute or challenge the notification. We voluntarily requested the surrender of the licence, and the authorities cancelled it,” he said.The Central Licensing Authority subsequently cancelled the registration certificate, RC/COS-003300, which was issued in July 2022 and was valid until July 14, 2027. The cancellation took effect from October 28.