CDSCO Cancels Registration of 'Elementre-MD Peel-Tri AHA' Over Safety, Misleading Claim Concerns
New Delhi: The Central Drugs Standard Control Organization (CDSCO) has cancelled the registration of the imported cosmetic product "Elementre - MD Peel-Tri AHA" registered by Glow Global LLP over alleged violations of the Cosmetics Rules, 2020, citing concerns regarding misleading claims and safety standards.
According to an order issued by the Cosmetics Division of CDSCO under the Directorate General of Health Services, the product had been imported under Registration Certificate No. RC/COS-005139 dated July 15, 2024, which was originally valid till July 14, 2029. The registration has now been cancelled with immediate effect.
The order stated that the cosmetic product contained three Alpha Hydroxy Acids (AHAs) — Lactic Acid 20%, Mandelic Acid 20%, and Glycolic Acid 20% — amounting to a total AHA concentration of 60%. CDSCO observed that the concentration exceeded the permissible limit of 30% total mono-AHA equivalents. The authority also flagged the product’s claimed pH range of 1.5 to 2.5 for professional use as “very low”, raising concerns regarding consumer safety.
Further, the regulator noted that the product label carried the claim “patient tolerance”, which came under scrutiny during regulatory assessment.
CDSCO stated that under Rule 36 of the Cosmetics Rules, 2020, no cosmetic product can purport or convey any false or misleading claim to the intended user. The authority further referred to Rule 39(1), which mandates that imported or manufactured cosmetics must comply with prescribed standards of quality and safety under the Ninth Schedule and other applicable provisions of the rules.
Following scrutiny of the application and product details submitted by the company, CDSCO issued a show cause notice dated April 11, 2025 to Glow Global LLP Hyderabad, Telangana, for alleged violations of Rules 36 and 39 of the Cosmetics Rules, 2020.
In its response, the company reportedly argued that the ingredient concentration, pH level, and label language did not merit enforcement action under existing Indian cosmetic regulations.
However, after considering the response submitted by the firm, CDSCO concluded that the company had violated the provisions of Rule 36 and Rule 39(1) of the Cosmetics Rules, 2020.
Invoking powers under Rule 16 of the Cosmetics Rules, 2020, along with Sections 10(ee) and 10-A of the Drugs and Cosmetics Act, 1940, the Central Licensing Authority ordered cancellation of the registration of “Elementre - MD Peel-Tri AHA” from the date of issuance of the order.
To view the official order, click the link below:
