Why drug regulator cancelled the import licence of popular hair-loss product: Cosmetic, plant-derived product cannot be pitched as a cure

The drug regulator considered this to be a violation of the rules to prohibit false and misleading claims.

Making a clear distinction between cosmetic products and drugs, the country’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has cancelled the licence to import an anti-hair loss solution called QR678 Neo — plant-derived peptides to prevent hair fall. While it had been registered as a cosmetic product, it claimed on its website to be a treatment for conditions such as post-chemotherapy hair loss.

The company, on its website, describes the product as a plant-derived “biomimetic peptide” — molecules that represent the natural peptides or the building blocks of proteins, essential for many bodily functions. The website goes on to say that these peptides work as several hair growth factors that can address multiple problems such as hair fall, thickness and density of hair follicles.

The challenge, however, is that the product is not registered as a drug or medical therapy for any of the hair-loss conditions the company apparently mentioned on its website.

As per the order by the CDSCO, the company on its website promoted the product as a treatment for several conditions that might lead to hair loss such as after-effects of chemotherapy, androgenetic alopecia (a condition that leads to the male and female pattern hair loss), and seborrheic dermatitis of the scalp (a condition that causes red, inflamed skin and flakes that can lead to hair loss because of the inflammation, scratching, or clogged follicles).

While the company removed these claims from the website following a show cause notice from the drug regulator, the latter went on to say: “…discrepancies/ mismatches have been observed with respect to the availability of claims on the marketed product labels available on web site vis-a-vis approved product label and you have violated the conditions of registration.”

The regulator, in its order, clarified that the product had been registered as a cosmetic product. It added that cosmetic is defined in the act as: “…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.”

This essentially means that a cosmetic cannot claim to treat any condition. Therefore, the notice and subsequent order to cancel the licence for importing the product was issued by CDSCO as per Rule 36 of the cosmetic rules, 2020 that prohibits any false or misleading claims to the user.