CDSCO Cancels Import Registration of Cosmetic Hair Product Marketed as Drug

The order, issued by the Cosmetics Division of CDSCO, formally withdraws the Registration Certificate RC/COS-001410, which had been granted on 18 April 2022 and was valid up to 17 April 2027.

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

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.

The order stated that 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 on the website vis-a-vis the approved product label.

On the website, the products are being marketed as treatments for post-chemotherapy hair loss, androgenetic alopecia, seborrheic dermatitis of the scalp, etc., which are drug claims and do attract the definition of drugs.

CDSCO referred to clause (aaa) of Section 3 of the Drugs and Cosmetics Act, 1940, which defines cosmetics:

"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 part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of a cosmetic."

As per the provisions of Rule 36 of the Cosmetics Rules, 2020:

"Prohibition against false or misleading claims— No cosmetic may purport or claim to purport or convey any idea that is false or misleading to the intending user."

The regulator concluded that the company’s marketing practices violated both the statutory definition of cosmetics and the conditions of the registration certificate.

In line with the above, a show cause notice was issued by the Licensing Authority vide no. Cos-111112025-eoffice, dated 25.02.2025, to the firm Esthetic Centers International for violation of clause (aaa) of section 3 of the Drugs and Cosmetics Act, 1940, and Rule 36 of the Cosmetics Rules, 2020.

In its response, the company stated that it had issued disclaimers and removed disease-related references from its website after receiving the notice.

However, CDSCO found the explanation unsatisfactory, noting continued mismatches between marketed claims and approved labels, and held that the violations had already occurred.

The order states:

“The discrepancies/mismatches have been observed with respect to the availability of claims on the marketed product (QR678 – QR678neo) labels available in web site vis-a-vis approved product label and you have violated the conditions of registration certificate and Rule 36 of the Cosmetics Rules, 2020.”

In view of the above, invoking powers under Rule 16(1) of the Cosmetics Rules, 2020, the Central Licensing Authority ordered the cancellation of the product’s registration with immediate effect.

The order concludes:

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.

To view the official order, click the link below: