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CDSCO cancels registration of certain products from Spanish skincare brand Mesoestetic
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Gireesh Babu, New Delhi
May 23 , 2025
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The Central Drugs Standard Control Organisation (CDSCO) has cancelled the registration of certain products from Spanish skincare brand Mesoestetic, identifying that they contain salicylic acid beyond the prescribed limit.
The products are 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, has provided validity for imports of these products upto May 31, 2027
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India) and the Central Licensing Authority, has in a circular issued on May 20, said that the licensing authority, "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-003211 mentioned at serial Nos.7,3,5,63,64,66 and 67 from the date of issue of this order."
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.
As per the condition number 03 of the Registration Certificate issued to you, registered cosmetics will be required to be withdrawn from sale in the event of non-compliance of Standards.
According to the provision of the Rule 39 of the Cosmetics Rules, 2020, along with the standards related to the substances which cosmetic products must not contain except subject to restrictions and conditions laid down, salicylic acid is allowed as Cosmetics ingredients at 3% and 2% concentration for Rinse-off hair products and other products respectively.
The drug regulator said that after scrutiny of the application submitted by Spectra Medical India, "the cosmetic products named Mesoestetic- Mesopeel Periocula(64), Mesoestetic- Salicylic; variant 100lo(66), Mesoestetic- Salicylic; variant 20o/o(51), Mesoestetic- Salicylic; variant30%(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 has issued a show cause notice to the importer on April 7, 2025, 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.
Mesoestetic is a skincare brand based in Spain, which has presence in 105 countries and has almost 87 per cent of sales from international business, according to the company website.
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