The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator, has revoked the import license of QR678 Neo, a plant-derived anti-hair loss solution, citing misleading claims about its therapeutic benefits. While the product was registered as a cosmetic, its website described it as a treatment for conditions such as post-chemotherapy hair loss, a move deemed a violation of regulatory rules.
What is QR678 Neo?
QR678 Neo is marketed by its manufacturer as a “biomimetic peptide” formulation — plant-based molecules designed to mimic natural peptides, the building blocks of proteins essential for bodily functions. According to the company, these peptides act as hair growth factors, addressing issues like hair fall, follicle thickness, and hair density.
However, the CDSCO noted that the product is not approved as a drug or medical therapy for any of the hair-loss conditions cited on the company’s website.
Company Claims Under Scrutiny
The regulator’s order highlighted that the company promoted QR678 Neo as a treatment for various hair loss conditions, including androgenetic alopecia (pattern hair loss), post-chemotherapy hair loss, and seborrheic dermatitis, which can cause hair loss due to scalp inflammation and follicle damage.
Although the company removed these claims after receiving a show-cause notice, the CDSCO observed discrepancies between the product’s marketed claims and its approved labeling. The regulator stated: “…discrepancies/mismatches have been observed with respect to the availability of claims on the marketed product labels available on website vis-a-vis approved product label and you have violated the conditions of registration.”
Regulatory Basis for Action
Under Indian law, cosmetics are defined as products intended to cleanse, beautify, promote attractiveness, or alter appearance. They are not permitted to claim treatment for medical conditions. The CDSCO cited Rule 36 of the Cosmetic Rules, 2020, which prohibits false or misleading claims to users, as the basis for canceling the product’s import license.
This action underscores the regulator’s ongoing efforts to clearly distinguish between cosmetic products and medical treatments, protecting consumers from unverified health claims.
