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CDSCO has directed port officers and State Licensing Authorities to tighten surveillance on imported cosmetics being sold in the domestic market without a valid Import Registration Certificate under the Cosmetics Rules, 2020.
The Directorate General of Health Services, through the Cosmetics Division of CDSCO, has issued a fresh circular instructing intensified vigilance against imported cosmetics circulating in the domestic market without a valid Import Registration Certificate — a compliance gap the regulator says has “come into notice” at the ground level.
The action draws directly on the Cosmetics Rules, 2020, notified on 15 December 2020 under the Drugs and Cosmetics Act, 1940. Rule 12(1) is unambiguous on the threshold requirement for import: no cosmetic product may enter the Indian market unless it has first been registered by the Central Licensing Authority, or by an officer to whom that power has been delegated under Rule 5(1).
“No cosmetic shall be imported into India unless the product has been registered… by the Central Licensing Authority or by any officer to whom such powers may be delegated under sub-rule (1) of rule 5.”
What triggered the circular
CDSCO’s own field intelligence has flagged that imported cosmetics are reaching Indian shelves without the underlying Registration Certificate ever being obtained — meaning the product bypassed the Central Licensing Authority’s pre-market scrutiny entirely. This is not a labelling or documentation lapse; it is an entry-point control failure, which is why the response is calibrated at the border and at the point of sale simultaneously.
Who the circular puts on notice
SLAs & Zonal Heads
Directed to instruct their inspectorate to run enhanced surveillance on cosmetics already circulating in the domestic market, targeting stock without traceable Registration Certificates.
Port Officers
Directed to maintain strict vigil at the point of entry, curbing consignments of cosmetics that arrive without a valid Import Registration Certificate on record.
Importers & Traders
Bear the compliance exposure: unregistered stock already in trade channels is now a live enforcement target, not a dormant paperwork gap.
Reading between the lines
This circular does not create a new obligation — Rule 12(1) has stood since December 2020. What it signals is an enforcement posture shift: CDSCO is closing the gap between border control and market surveillance, so a product that slips past a port on a technicality can still be caught on a retail shelf.
For importers, distributors, and marketing authorisation holders of cosmetic products, the practical implication is that Registration Certificate status is no longer a one-time onboarding check. It is now an audit-grade record that inspectorate staff at both ports and SLAs are actively expected to verify.
Self-audit checklist for importers
- Confirm every imported cosmetic SKU carries a live, product-matched Import Registration Certificate issued by the Central Licensing Authority under Rule 12.
- Cross-check that the Registration Certificate covers the exact variant, pack size, and formulation currently in trade — not a discontinued or superseded version.
- Maintain port-of-entry documentation (Bill of Entry, IRC copy) readily retrievable for zonal or SLA inspection.
- Flag and quarantine any inventory where the IRC cannot be immediately traced, pending internal verification.
- Review distributor and stockist agreements to ensure downstream sellers are not holding unregistered imported stock unknowingly.
The circular has been issued under the signature of Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), with copies marked to all Port Offices, Zonal and Sub-Zonal Offices of CDSCO, all State Licensing Authorities, and the CDSCO website.
