69 Cancellation of products under RC/COS-003211, for import of Cosmetics under Cosmetics Rules, 2020 2025-May-21 582 KB

File No. : COS-1 1 01 1 (1 1112812024-eotfice Government of lndia Directorate General of Health Services Central Drugs Standard Control Organisation (Cosmetics Division) FDA Bhawan, Kotla Road, New Delhi-110002 Dated: 20MAY2[25

Subject: Cancellation of products under RC/COS-003211, for import of Cosmetics

under Cosmetics Rules, 2020- Regarding Whereas, the firm M/s. Spectra Medical lndia Pvt. Ltd., Plot No.43, 1"t and 2nd Floor, Developed Plots lndustrial Estate, Perungudi, Kanchipuram, Tamil Nadu (lndia) - 60009 had registered cosmetics products for import in lndia vide Registration Certificate no. RC/COS-00321'1, Endorsement No. 1 dated 17.07.2023, which is valid upto 31.05.2027. And whereas, 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. And whereas, 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per the condition number 03 of the Registration Certificate issued to you, registered cosmetics will be required to be withdrawn from sale in the events of non-compliance of Standards. And whereas, 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 lS 4707 pan ): 2017, Salicylic acid (CAS No. 69-72-7) is altowed as Cosmetics ingredients at 3 % and 2 % concentration for Rinse-off hair products and other products respectively. And whereas, after scrutiny of the above application submitted by the firm, the cosmetic products named Mesoestetic- Mesopeel Periocula(64), Mesoestetic- Salicylic; variant 100lo(66), Mesoestetic- Salicylic; variant 20o/o(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%, 10o/o, 2Oo/o, 30Yo,1 5o/o,'l Soh, and 1 4o/o respectively. And whereas, a show cause notice was issued by the Licensing Authority vide even no. dated 07.04.2025 to the firm M/s. spectra Medical lndia pvt. Ltd., for violation of Rule 39 of the Cosmetics Rules, 2020 and condition number 03 of the Registration Certificate. PaBe 1 of 2

File No. : COS-I 1 01 1 (1 1112812024-eotfice And whereas, you have responded and expressed willingness to surrender the products containing salicylic acid beyond the prescribed limit. AND THEREFORE, the undersigned being the Licensing Authority empowered under Rule 21(b) of the Drugs and Cosmetics Act, 1940, 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 underRC/COS-0032'1 '1 mentioned at serial Nos.7,3,5,63,64,66 and 67 from the date of issue of this order. i), Drugs Controller General (lndia) & Central Li sing Authority To, M/s. Spectra Medical lndia Pvt. Ltd., Plot No. 43, 1st and 2nd Floor Developed Plots lndustrial Estate, Perungudi, Kanchipuram, Tamil Nadu (lndia) - 600096 E-mail : rama@spectramedicals.com Copy To:

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