What a cosmetic may not claim: Rule 36 and the drug line

The Cosmetics Rules 2020 define a cosmetic by what it does: cleanse, beautify, promote attractiveness or alter appearance. Rule 36 polices the boundary. A cosmetic may not be labelled, packed or advertised in a way that is false or misleading, and it may not claim to treat, cure or prevent a disease or condition. A claim of that kind makes the product a drug, which needs a drug licence and clinical evidence.

CDSCO applied the rule four times in six months. It cancelled the registration of QR 678 Neo on 22 Dec 2025 because the product was marketed for hair loss after chemotherapy and for androgenetic alopecia. It cited Rule 36 alongside labelling rules when it cancelled Kult App's 27 registrations on 6 Feb 2026. It cancelled Elementre MD Peel-Tri AHA on 11 May 2026, where a 60 per cent acid peel was sold with a 'patient tolerance' claim. And its public notice of 18 May 2026 stated the principle in general terms: cosmetics are not for the treatment of disease, and no cosmetic may be injected.

Advertising claims about fairness are a separate, softer regime. The Advertising Standards Council of India's 2014 guidelines, which are industry self-regulation, bar advertisements that present darker skin as a disadvantage; Rule 36's misleading-claim limb is the legal backstop. Neither bans fairness products.