The Central Drugs Standard Control Organization (CDSCO) has cancelled the registration of cosmetic product QR678 - Neo manufactured by Esthetic Centers International Pvt Ltd, citing misleading marketing claims.

 

The cancellation underscores the regulator’s strict stance against misleading cosmetic claims and signals heightened scrutiny for companies marketing products at the intersection of cosmetics and medical treatments.

 

The company in question had initially registered the product for import under Registration Certificate RC/COS-001410 on April 18, 2022, valid until April 17, 2027. The product was marketed as an “anti-hair loss solution”.

 

However, a CDSCO review revealed discrepancies between the product label and claims on the company’s website. While the approved label described it as an anti-hair loss cosmetic, the product was marketed online as a treatment for “Post-Chemotherapy hair loss, Androgenetic alopecia, Seborrhoeic dermatitis of scalp”, claims that classify it as a drug.

 

According to the order, "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 cosmetic."

 

The order also cited Rule 36 of the Cosmetics Rules, 2020, which states, "No cosmetic may purport or claim to purport or convey any idea which is false or misleading to the intending user."

 

The Licensing Authority had issued a show-cause notice on February 25, 2025. In response, the company said that "appropriate disclaimers have been issued on your website and removed all reference to disease conditions from the website."

 

Despite this, the CDSCO concluded that discrepancies persisted between the marketed claims and the approved label, violating the conditions of the registration certificate.

 

The authority’s final order, signed by Dr. Rajiv Ghuvanshi, Drugs Controller General, stated: "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, hereby order to cancel the registration of cosmetic product QR678 - QR678neo issued vide Registration Certificate No. RC/COS-001410 dated 18.04.2022 from the date of issue of this order.”