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CDSCO cancels import registration of products from Mediderma containing salicylic acid
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Our Bureau, New Delhi
August 26 , 2025
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The Central Drugs Standard Control Organisation (CDSCO) has cancelled the import registration of certain skin care products from US-based Mediderma, identifying that the product contains salicylic acid beyond the prescribed limit.
The drug regulator said that Delhi-based Satnam and Company had registered the cosmetic products for import in May 2, 2023 and the registration is valid upto May 1, 2028.
In a circular cancelling the registration certificate for import of MediDerma's Salipeel Plus, Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), pointed out, "according to the provision of the Rule 39 of the Cosmetics Rules, 2020 read with Serial Number 98 of Annex B (list of substances which cosmetic products must not contain except subject to restrictions and condition laid down) of lS4707 (Part 2) 2017, Salicylic acid (CAS No. 69-72-7) is allowed as Cosmetics ingredients at 3% and 2% concentration for Rinse-off hair products and other products respectively."
As per the Rule 39 of the Cosmetics Rules, 2020, 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 the 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number 3 of the Registration Certificate issued to Satnam and Company, registered cosmetics will be required to be withdrawn from sale in the event of non-compliance of Standards.
The drug regulator said that after scrutiny of the application submitted by the firm, the product 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.
The licensing authority on April 7, 2025 had issued a show cause notice to Satnam and Company for violation of the rules and the company responded stating that these products are no longer part of its import activities in the country.
Following this, the DCGI has in an order on August 21, decided to cancel the registration of the products containing salicylic acid, from the date of issue of the order.
It may be noted that the DCGI has in May, this year, cancelled the registration of certain products from Spanish skincare brand Mesoestetic, identifying that they contain salicylic acid beyond the prescribed limit.
The products were imported to India by Mesoestetic's official partner Tamil Nadu-based Spectra Medical India, and the latter has expressed its willingness to surrender the products, according to the CDSCO. The registration certificate issued in the year 2023, had provided validity for imports of these products upto May 31, 2027.
The DCGI observed that the cosmetic products named Mesoestetic- Mesopeel Periocula(64), Mesoestetic- Salicylic; variant 10%(66), Mesoestetic- Salicylic; variant 20%(51), Mesoestetic- Salicylic; variant 30%(67), Dermamelan lntimate Gel(7), Dermamelan Mask(31), and Mesopeel Modified Jessner(63) were found to contain salicylic acid in concentration of 7%, 10%, 20%, 30%, 15%, 15%, and 14% respectively".
The regulator issued a show cause notice to the importer on April 7, 2025, in the matter, for violation of Rule 39 of the Cosmetics Rules, 2020 and conditions of the Registration Certificate. The company responded and expressed willingness to surrender the products containing salicylic acid beyond the prescribed limit.
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