India's Central Drugs Standard Control Organisation (CDSCO) has formally brought injectable aesthetic products within the scope of the Drugs and Cosmetics Act, 1940, ending years of regulatory ambiguity that allowed botulinum toxin, hyaluronic acid (HA) dermal fillers and skin boosters to circulate outside the drug licensing regime.

What did the regulator actually change?

The new classification treats injectable cosmetics used in aesthetic procedures as drugs, not cosmetics or medical devices. Products now caught by the directive include:

• Botulinum toxin Type A – Botox, Dysport, Xeomin and biosimilars
• Cross-linked and non-cross-linked hyaluronic acid – face, neck and skin booster formulations
• Bio-stimulators – poly-L-lactic acid (PLLA, trade example Sculptra), calcium hydroxylapatite (CaHA, Radiesse), polycaprolactone (PCL, Ellansé)
• Polynucleotides / PDRN – salmon-DNA-derived injectable skin boosters
• Collagen stimulators and thread lifts

Manufacturers and importers must now hold a Form 10 import licence or Form 25 manufacturing licence for each SKU, with product-specific dossiers submitted to CDSCO and state drug controllers. Stocks already in distribution channels without licences are subject to seizure under Section 22 of the Act.

Why does it matter for product development and procurement?

Until the directive, several HA fillers and skin boosters entered India either as Class B/C medical devices cleared by the Central Drugs Standard Control Organisation's medical device division, or as cosmetics under BIS/ BIS-IS 4011 routes. Both pathways lacked the bioequivalence, sterility and endotoxin data demanded by a drug licence.

For R&D teams, the shift raises the data package: master cell banks, viral inactivation validation, two-year real-time stability and pyrogen testing become mandatory for any new injectable launched in India. For procurement officers at clinics and medspas, batch records must trace back to a CDSCO-licenced manufacturer – a break that several grey-market importers are now scrambling to close.

What happens to clinics already stocking the products?

Practitioners registered under the National Medical Commission can still administer these injections, but only from licensed stock. The All India Association of Aesthetic Plastic Surgeons and the Indian Association of Dermatologists, Venereologists and Leprologists have both flagged that many dermatology clinics and chain medspas sourced Korean, Chinese and European HA fillers without an Indian licence. Those SKUs must now be either re-licensed by the original manufacturer or withdrawn.

Timeline and enforcement

CDSCO issued the classification in mid-2024 and gave existing importers a six-month transition window to file licensing applications or face product recalls. State drug controllers began joint inspections of warehouses and clinic backrooms in the following quarter, with notices served on distributors in Mumbai, Delhi, Bengaluru and Hyderabad. Fines under the Drugs and Cosmetics Act range from INR 10,000 for first offences to imprisonment for repeat offenders.

Market context

India's aesthetic medicine market sits inside a broader medical aesthetics sector that industry trackers estimate at USD 2.3 billion in 2024, with injectables accounting for roughly a third of procedural revenue. Year-on-year growth in non-surgical procedures had been running above 12 percent, a trajectory that pulled in unregulated imports alongside licit ones.

What to watch next

Look for the next quarterly CDSCO list of approved import licences – it will show whether legacy Korean and Chinese HA brands have filed or pulled out. The Cosmetics and Drugs Joint Technical Advisory Committee is also expected to publish harmonised stability guidance for polynucleotide and skin-booster products in the coming months, which will set the bar for dossiers from new entrants entering after the transition window closes.