CDSCO Cancels Import Licence of Mediderma Salipeel Products
New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of two cosmetic products of Satnam and Company after finding them in violation of the Cosmetics Rules, 2020, due to excessive concentration of salicylic acid beyond permissible limits.
According to the order issued by the Licensing Authority, a show cause notice had been served to the firm on April 7, 2025, for violation of Rule 39 of the Cosmetics Rules, 2020 and condition number 03 of the Registration Certificate. The notice was issued after scrutiny revealed that “the cosmetic product MEDIDERMA - SALIPEEL PLUS was found to contain salicylic acid in concentration at 25% as per the label claim and another product MEDIDERMA - SALIPEEL LIC was found to contain salicylic acid in concentration of 15% as per the list of ingredients.”
As per regulatory provisions, Salicylic acid (CAS No. 69-72-7) is allowed as a cosmetic ingredient only at restricted levels—“3% and 2% concentration for rinse-off hair products and other products respectively”—under Serial Number 98 of Annex B of IS 4707 (Part 4:2017).
The CDSCO order notes that the firm admitted in response to the show cause notice that these products are no longer part of its import activities in India.
Taking into account the violations, Dr Raghuvanshi, Drugs Controller General (India) and Central Licensing Authority, stated in the cancellation order, “Keeping in view of the violation of Rule 39 of the Cosmetics Rules, 2020 and condition number 03 of the Registration Certificate, thereby order to cancel the registration of the products containing salicylic acid, registered under RC/COS-003827 mentioned at serial Nos.76 and 81 from the date of issue of this order.”
The cancelled registration pertained to RC/COS-003827, originally granted to the firm on May 2, 2023, valid until May 1, 2028. The order has been circulated to all Zonal, Sub-Zonal and Port Offices of CDSCO, as well as State Drug Controllers, to ensure compliance.
