CDSCO’s cosmetic regulations: The rules exist. The enforcement does not

People have died in India’s aesthetic clinics. Not in rare surgical catastrophes, but in routine cosmetic procedures performed by people who should never have held the syringe. The Indian Association of Dermatologists, Venereologists and Leprologists has documented at least five deaths, along with cases of disfigurement and lasting psychological trauma, and has formally asked the government to intervene. That intervention has not come. As a practising dermatologist, I am writing this not to explain the Cosmetics Rules, 2020 to my colleagues, but to ask our regulators a more uncomfortable question. The framework exists on paper. Why does so little of it exist on the ground?

A market regulated in theory

On paper, India’s framework looks respectable. The Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020 give CDSCO authority over imports, give State Licensing Authorities control over manufacturing, and give the Bureau of Indian Standards the mandate to define what is safe to put on human skin. Imported cosmetics must be registered on the SUGAM portal before sale, with registration certificates valid for five years. Products making therapeutic claims must clear the far stricter drug pathway. The revised IS 4707 standards of 2025 tightened the lists of restricted substances and permitted preservatives further.

In practice, walk through any metro market or scroll through any shopping app. Unregistered imported cosmeceuticals are sold openly. In May 2025, a single enforcement action by Gujarat’s FDCA seized counterfeit cosmetics worth Rs. 71.5 lakh, much of it marketed on social media without licences or labelling. That seizure was reported as a success. I read it as an indictment. If one state raid uncovers that much in one sweep, the steady state of the market is not compliance. It is impunity punctuated by occasional raids.

The grey zone the regulator refuses to close

The most consequential gap is definitional. “Cosmeceutical”, the category in which most of modern dermatology-adjacent retail actually operates, has no legal status in India. A product is either a cosmetic or a drug, and the classification turns almost entirely on the claims a marketer chooses to print. The result is a market that has learned to write its way around the law. Brands make quasi-therapeutic promises in advertising, retreat to cosmetic language on the label, and face essentially no consequence for the distance between the two.

This ambiguity does not just enable mischief by sellers. It punishes honest clinicians, who restrict themselves to defensible claims while competing against brands and clinics that do not. A regulatory regime that disadvantages the compliant is not a neutral regime. It is an active distortion, and only CDSCO can correct it.

Procedures without a referee

The injectable and device economy is where the stakes stop being commercial and become bodily. Botulinum toxin, dermal fillers, glutathione infusions and energy-based devices are now marketed to young consumers through influencer reels and subscription packages, frequently administered in premises with no dermatologist, no anaesthetist, no emergency protocol and no meaningful inspection history. India’s aesthetic medicine market was estimated at around two billion dollars in 2024 and is projected to more than triple by 2033. A sector of that size, performing invasive procedures, is operating without a dedicated referee.

And when something goes wrong, India has no system to even know. There is no structured cosmetovigilance framework. Adverse reactions to cosmetic products are common in dermatological practice, yet patients have no designated reporting channel, and dermatologists, the clinicians who actually see these complications, are not integrated into any monitoring system. Compare this with the United States, where MoCRA now mandates facility registration, ingredient disclosure and adverse-event reporting within 15 days. Indian law requires none of this proactively.

What we are asking for

So let me be specific, because vague calls for “stronger regulation” are how this issue has been managed into stasis for a decade. First, define the cosmeceutical category in law, with claim tiers linked to evidence, so that the line between a cosmetic and a drug is decided by the regulator and not by a copywriter. Second, build a national cosmetovigilance system with mandatory adverse-event reporting and dermatologists formally embedded as sentinel reporters. Third, restrict injectable and energy-based procedures to registered medical practitioners with defined qualifications, and make premises licensing for aesthetic procedures a legal requirement, not a market courtesy. Fourth, move enforcement from sporadic raids to systematic post-market surveillance, including of e-commerce and social media sellers, where the worst offenders now live. The Compounding of Offences Rules notified in April 2025 show the machinery for accountability is being assembled. It must now be pointed at the right targets.

Our side of the bargain

None of this absolves my own profession. Dermatologists who lend their names to products they have not scrutinised, who dispense imported ranges without checking registration certificates, or who let their clinic marketing drift into therapeutic claims for cosmetic products are part of the problem we are asking the state to solve. Clean claims, verified supply chains and documented procedures are obligations we owe our patients regardless of how slowly the law catches up.

But individual ethics cannot substitute for institutional enforcement. Patients are being injected, infused and resurfaced in a market where the gap between the rulebook and the street has become a business model. CDSCO has the statute, the portal and now the penalty framework. What the public is still waiting for is the will. The deaths the IADVL has counted should be treated as what they are: not unfortunate anomalies, but the predictable output of a regulated industry that is not, in any meaningful sense, being regulated.

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