In a significant regulatory crackdown, India's apex drug authority has revoked the import licence for a popular anti-hair loss solution, citing serious violations of rules against false and misleading claims. The action underscores the strict line between cosmetics and therapeutic drugs.
Why The Licence Was Cancelled
The Central Drugs Standard Control Organisation (CDSCO) issued an order on December 30, 2025, cancelling the licence to import QR678 Neo, a product marketed as containing plant-derived peptides to prevent hair fall. The core issue was a fundamental mismatch: the product was registered and approved as a cosmetic, but its promotional materials pitched it as a treatment for medical conditions.
According to the regulator's findings, the company's website promoted QR678 Neo as a treatment for serious conditions leading to hair loss, including:
- Post-chemotherapy hair loss
- Androgenetic alopecia (male and female pattern baldness)
- Seborrheic dermatitis of the scalp
The CDSCO considered this a clear violation of regulations. In its order, the regulator clarified that a cosmetic, as defined by law, is intended for cleansing, beautifying, promoting attractiveness, or altering appearance. It cannot legally claim to treat, prevent, or cure any disease or condition.
The Company's Response and Regulatory Stand
The regulatory action followed a show-cause notice sent to the company. While the firm subsequently removed the therapeutic claims from its website, the CDSCO found the initial discrepancies severe enough to warrant cancellation.
The order 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." The cancellation was executed under Rule 36 of the Cosmetic Rules, 2020, which explicitly prohibits false or misleading claims.
Understanding QR678 Neo and the Regulatory Landscape
QR678 Neo was described by the company as a plant-derived "biomimetic peptide" solution. These peptides are molecules designed to mimic natural building blocks of proteins, claimed to work as hair growth factors addressing hair fall, thickness, and follicle density.
However, the critical point, as emphasized by the CDSCO, is that it was never registered or approved as a drug or medical therapy for any hair-loss condition. This case highlights a growing challenge in the beauty and wellness industry, where products often blur the lines between cosmetics and drugs, making ambitious health claims without the rigorous clinical trials and approvals required for pharmaceuticals.
This decisive move by the CDSCO serves as a stern warning to other companies in the market. It reinforces the authority's commitment to protecting consumers from misleading advertisements and ensuring that products making medical claims undergo the stringent scrutiny reserved for drugs. For consumers, it is a reminder to critically evaluate product claims and check their regulatory status before use.
