31 Cancellation of registration of cosmetic product QR 678- Neo issued under RC/COS-OO1410 for import of Cosmetics under the Cosmetics Rules, 2020 2025-Dec-23 569 KB

File No: COS-'I 1/1/2025-eoffice Government of lndia Central Drugs Standard Control Organization Directorate General of Health Services (Cosmetics Division) FDA Bhawan, Kotla Road, New Delhi- 1 10002, lndia Dated: ORDER

Subject: Cancellation of registration of cosmetic product QR 678- Neo issued under

RC/COS-OO1410 for import of Cosmetics under the Cosmetics Rules, 2020- Regarding Whereas, M/s. Esthetic Centers lnternational Pvt. Ltd., Shop No.3B, Shraddha Building No.3, CHS, Thakur Complex Kandivali East, Mumbai, Maharashtra, 400101 had registered cosmetics products for import vide Registration Certificate number vide RC/COS-O01410 on 18.04.2022 vatid upto 17.04.2027 And whereas, the firm categorized the said cosmetic products as anti-hair loss products and claimed the product as anti-hair loss solution as per the label submitted And whereas, after scrutiny of the above applications and the official website of the QR 678 products of the firm, discrepancies/mismatches have been observed with respect to the availability of claims on the marketed product labels available in web site yls-a-vls approved product label. On the website, the products are being marketed as treatment for Post-Chemotherapy hair loss, Androgenetic alopecia, Seborrhoeic dermatitis of scalp etc.

in web site yls-a-vls approved product label. On the website, the products are being marketed as treatment for Post-Chemotherapy hair loss, Androgenetic alopecia, Seborrhoeic dermatitis of scalp etc. which are drug claims and does attract the definition of drugs. And whereas, according to the clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 "cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any paft thereof for cleansing, beautifying, promotitlg attractiveness, or altering the appearance, and includes any afticle intended for use as a component of cosmetic" and as per the provisions of Rule 36 of the Cosmetics Rules, 2020, "Prohibition against false or misleading claims.-No cosmetic may purpod or claim to purpoft or convey any idea which is false or misleading to the intending user." And whereas, a show cause notice was issued by the Licensing Authority vide no. Cos-111112025-eoffice, dated 25.02.2025 to the firm M/s. Esthetic Centers lnternational Pvt. Ltd, for violation of clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 and Rule 36 of the Cosmetics Rules, 2020. 2 I DEC 2025 Page 1of 2

e firm M/s. Esthetic Centers lnternational Pvt. Ltd, for violation of clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 and Rule 36 of the Cosmetics Rules, 2020. 2 I DEC 2025 Page 1of 2

And whereas, you have responded that appropriate disclaimers have been issued on your website and removed all reference to disease conditions from the website after receiving the show cause notice. And whereas, the discrepancies/ mismatches have been observed with respect to the availability of claims on the marketed product (OR678 - QR678neo) labels available in web site vis-a-vis approved product label and you have violated the conditions of registration certiflcate and Rule 36 of the Cosmetics Rules, 2020. AND THEREFORE, the undersigned being the Central Licensing Authority empowered under Rule 16(1) of the Cosmetics Rules, 2020, keeping in view of the violation of the provisions of clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940 and Rule 36 of the Cosmetics Rules, 2020, thereby order to cancel the registration of cosmetic product QR678 - QR678neo issued vide Registration Certificate No. RC/COS-00"14'10 dated 18.04.2022 from the date of issue of this order. Dr. Raj h ghuvanshi) g Authority Drugs Controller General ( tcens To M/s. Esthetic Centers lnternational Pvt Ltd, Shop No.38, Shraddha Building No.3, CHS, Thakur Complex Kandivali East, Mumbai, Maharashtra (lndia) - 400101 Copy to:

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