6 Cancellation of a product 'Elementre - MD Peel-Tri AHA' under Registration Certificate No. RC/COS-005139 dated 15-Jul2O24 valid upto 14-Jul2O29 for import under Cosmetics Rules, 2020- Regarding 2026

File No: COS-I 1 01 1 (1111212025-eottice Government of lndia Central Drugs Standard Control Organization Directorate General of Health Services (Cosmetics Division) FDA Bhawan, Kotla Road, New Delhi- 110002, lndia Dated: ORDER I I l,1AY 2026

Subject: Cancellation of a product "Elementre - MD Peel-Tri AHA" under

Registration Certificate No. RC/COS-005139 dated 15-Jul2O24 valid upto 14-Jul2O29 for import under Cosmetics Rules, 2020- Regarding. Whereas, the firm, M/s. Glow Global LLP, 1st & 2nd Floor, Plot No. 73, H.No. 8-2-6841K13173 Kaushik Society, Road No-12, Banjara Hills, Hyderabad, Telangana - 500034 had registered a cosmetic product "Elementre - MD Peel-Tri AHA" for import vide Registration Certificate No. RC/COS-005139 dated 15-Ju12024 valid upto 14- Jul-2O29. And whereas, as per the Rule 36 of the Cosmetics Rules, 2O2O, no cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user. And whereas, as per the Rule 39 (1) 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, after scrutiny of the above application submitted by the firm, the cosmetic product namely Elementre - MD Peel-Tri AHA were found to contain three alpha hydroxyl acids namely Lactic acid - 20%, Mandelic acid - 2Oo/o and Glycolic acid- 2Oo/o among the list of ingredients with a total of 600/o Alpha Hydroxy Acid (AHA) which is having maximum concentration above 3Oo/o ol total mono-AHA equivalents and claimed the pH in the range of 1.5 to 2.5 for Professional Use which is very low. And whereas, the firm had claimed on the product label that "patient tolerance". And whereas, a show cause notice was issued vide no. Cos- 11011(11)1212025-eoffice, dated 11.04.2025 to the firm M/s. Glow Global LLP, Hyderabad, Telangana for violation of Rule 36 and Rule 39 of the Cosmetics Rules, 2020. And whereas, you have responded that the ingredient concentration, pH, label language does not merit enforcement under existing lndian Cosmetic Regulations. Page 1 ol 2

And whereas, after due consideration of your response, it is determined that you have violated the provisions of Rule 36 & Rule 39 (1) of the Cosm 2020. etics'fules And therefore, the undersigned being the Central Licensing Authority empowered under Rule 16 of the Cosmetics Rules, 2020, keeping in view of the violation of Rule 36 and Rule 39 (1) of the Cosmetics Rules, 2020, and also the provision of Section 10 (ee) & 10-A of the Drugs and Cosmetics Act, 1940, thereby order to cancel the registered product "Elementre - MD Peel-Tri AHA" under RC. No. RC/COS-S139 from the date of issue of this order. (Dr. Raghuvanshi) Drugs Controller General (l) & tce ing Authority To M/s. Glow Global LLP, 1st & 2nd Floor, Plot No. 73, H.No. 8-2-684/l(3/73 Kaushik Society, Road No-12, Banjara Hills, Hyderabad, Telangana - 500034. Coov to:

1. CDSCO website
2. AllZona| Sub-Zonal and Port ffices of CDSCO
3. All State Drugs Controller/UT Page 2 ol 2