53 Cancellation of products under RC/COS-003827, for import of Cosmetics under Cosmetics Rules, 2020 2025-Aug-21 536 KB

File No.: COS-1 1 01 1 (1 1112812024-eoffice Government of lndia Directorate General of Health Services Central Drugs Standard Control Organisation (Cosmetics Division) FDA Bhawan, Kotla Road, New Delhi-1 10002 '"t"o,l ; AUo 2i-;

Subject: Cancellation of products under RC/COS-003827, for import of Cosmetics

under Cosmetics Rules, 2020- Regarding Whereas, the firm M/s Satnam and Company, Second, 1730/2, Shop No.9, Ram Gali, Mangal Building, Bhagirath Place, Chandni Chowk, NewDelhi, Delhi, 110006 had registered cosmetics products for import in lndia vide Registration Certificate no. RC/COS-0038 27, 02-May -2Q23 valid upto 0 1 -May-2028. 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per the condition number 03 of the Registration Certificate issued to you, registered cosmetics will be required to be withdrawn from sale in the events of non-compliance of Standards.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 @an 4 2017, Salicylic acid (CAS No.

ad 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 @an 4 2017, Salicylic acid (CAS No. 69-72-7) is a[owed as Cosmetics ingredients al 3 Yo 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 product MEDIDERMA - SALIPEEL PLUS was found to contain salicylic acid in concentration al 25Yo as per the label claim and another product MEDIDERMA - SALIPEEL Llc was found to contain salicylic acid in concentration of 15 o/o as per the list of ingredients. And whereas, a show cause notice was issued by the Licensing Authority vide even no. dated 07.04.2025 to the firm M/s. satnam and company, for violation of Rule 39 of the cosmetics Rules, 2020 and condition number 03 of the Registration Certificate. And whereas, you have responded and stated that these products are no longer part of your import activities in lndia. Page 1 of 2

Rules, 2020 and condition number 03 of the Registration Certificate. And whereas, you have responded and stated that these products are no longer part of your import activities in lndia. Page 1 of 2

File No.: COS-1 1 01 1(11)12812024-eoffice 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 under RC/COS-003827 mentioned at serial Nos.76 and 81 from the date of issue of this order. Dr. Raghuvanshi), Drugs Controller General (lnd entral L nsing Authority To, M/s. Satnam and Company, Second, 1730/2, Shop No.9, Ram Gali, Mangal Building, Bhagirath Place, Chandni Chowk, New Delhi, Delhi, 1 10006 E-mail: satnam. company@g mail. com Copy To:

1. All Zonal, Sub-Zonal and Port Offices of CDSCO
2. All State Drugs Controller Page 2 ol 2