The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of certain skincare products from US-based Mediderma after finding salicylic acid levels far above the permissible limit.  

Delhi-based Satnam and Company had obtained registration for importing the products on May 2, 2023, valid until May 1, 2028.

However, in a recent circular issued on August 21, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi cancelled the certificate for MediDerma’s Salipeel Plus and Salipeel LIC, citing violation of the Cosmetics Rules, 2020. 

As per Rule 39 of the Cosmetics Rules, 2020, read with Serial Number 98 of Annex B of IS 4707 (Part 2):2017, salicylic acid is permitted as a cosmetic ingredient only up to 3 percent in rinse-off hair products and 2 percent in all other cosmetic products.

The drug regulator said that, after scrutinising the firm’s application, MediDerma's Salipeel Plus was found to contain 25 percent salicylic acid as per its label claim, while another product, Salipeel LIC, contained 15 percent salicylic acid as listed in its ingredients.

As per Rule 39 of the Cosmetics Rules, no cosmetic shall be imported or manufactured unless it complies with the specifications prescribed under the ninth schedule or any other standards of quality and safety applicable to it and other provisions under the rules.

According to condition number 3 of the registration certificate issued to Satnam and Company, registered cosmetics will be required to be withdrawn from sale in the event of non-compliance of the standards.

The DCGI had issued a show-cause notice to Satnam and Company on April 7, 2025, for violating the rules. In its reply, the firm stated that these products were no longer part of its import activities in the country.

Following the review, the regulator cancelled the import registration for the products on August 21, 2025, with immediate effect.