Amid the growing popularity of skincare procedures using compounds such as botox and glutathione, the country’s apex drug regulator has issued a public advisory stating that no cosmetic product should be injectable. “No cosmetic is permitted to be used as an injection by consumers or professionals or aesthetic clinics. Cosmetics are only intended to be rubbed, poured, sprinkled or sprayed on to the human body,” the advisory by the Central Drugs Standard Control Organisation (CDSCO) says.

According to officials in the know of the matter: “While these products have been in use over the last several years, adverse reactions linked to such procedures were being reported. This is the reason the public advisory was issued.”

What did the advisory say?

The advisory states that the Drugs and Cosmetics Act, 1940 — which continues to govern the manufacture, storage and sale of all medicines and cosmetics in the country — defines cosmetic 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.”

Aside from warning against injectables, the advisory goes on to state that the articles should not carry labels that may “purport or convey any idea which is false or misleading to the intending user of cosmetics.” And, nothing marked on the packages by the manufacturer should be changed or altered by anyone, the advisory said.

“Use of prohibited ingredients in cosmetic products, misleading claims on label, use of cosmetics for treatment and application of cosmetics through injection attracts violations,” it added.

Why is this significant?
The advisory could trigger tighter scrutiny of India’s booming aesthetic and skincare industry, particularly clinics and wellness centres offering injectable “beauty treatments” that often operate in a regulatory grey zone. India has previously seen repeated instances of misuse involving skin-lightening injections, unapproved glutathione drips, steroid-laced cosmetic products, and misleading “medical-grade” beauty claims marketed through salons and social media influencers.

Experts have long warned that many such procedures are administered by inadequately trained personnel, sometimes using imported or improperly labelled products with little oversight. By explicitly stating that cosmetics cannot be injectable under the Drugs and Cosmetics Act, regulators may now have stronger grounds for enforcement actions against clinics, importers, and manufacturers making unauthorised cosmetic injection claims

What does this mean for your botox injection?

There are several cosmetic procedures that use injectables. The most common ones include skin boosters (injectable compounds such as hyaluronic acid that can improve hydration, texture, elasticity, and firmness of the skin), botox (a toxin that can smoothen wrinkles and lines), fillers (injections used to restore facial volume), and PDRN+ exosomes (to help reduce inflammation and improve regeneration). Dr Rashmi Sharma, clinical dermatologist at Fortis, Vasant Kunj, says although the notification is not clear on what is meant by injectable cosmetics, it guarantees safe procedures. “If they are talking about common treatments such as botox and glutathione, they are already regulated as drugs. These treatments should not be provided by anyone other than qualified dermatologists or plastic surgeons. Yet, there are so called wellness specialists who do it and that should be strictly regulated,” she says. One way of doing that would be to ensure that these products are dispensed only on prescription of the specialists. “At present, many dentists and physiotherapists offer these. Always trust a board certified dermatologist,” she adds.

What can you do?

The advisory asks people to report any such observations to the drug controller at cosmetics@cdsco.nic.in.

What prompted the advisory?

Aside from the increased use of injectable cosmetics, the drug regulator had reportedly cancelled the registration of a Telangana-based company importing a face cream with three alpha hydroxyl acids (AHAs), the total concentration of which stood at 60%, higher than the mandated 30%.

The product had also said “patient tolerance” on the packaging that appeared to be a misleading claim.