Cosmetics Rules, 2020
No cosmetic may be imported into India until it is registered
Rule 12 of the Cosmetics Rules, 2020 is absolute: a cosmetic has to be registered with the Central Licensing Authority before it reaches an Indian port. Registration is not granted to a product in the abstract. It is granted against a defined combination of brand, category, variant and manufacturing premises, and that combination is what determines both the fee and the scope of what you are allowed to land.
Medfins International prepares and files the application, acts as the authorised agent in India where you need one, and manages the registration through its life, including the retention payment that most importers forget.
How the registration works
- Application: Form COS-1, filed online through the CDSCO portal at cdscoonline.gov.in.
- Certificate granted: Form COS-2, the Import Registration Certificate.
- Authority: the Drugs Controller General (India), acting as Central Licensing Authority.
- Fees, under the Third Schedule: USD 1,000 for grant or retention of the registration certificate for each category, USD 1,000 for each additional category, USD 500 for registration of each manufacturing site, and USD 50 for each variant. Payment is made through Bharatkosh only.
Who may hold the registration
Rule 12(2) allows the application to be made by the manufacturer himself, by his authorised agent, by the importer in India, or by a subsidiary in India authorised by the manufacturer. That choice matters more than it looks. The registration is issued in the applicant’s name, and the applicant carries the regulatory relationship with CDSCO.
If you appoint an agent and later change agent, you do not transfer the certificate. You begin again, with the fees and the timeline that implies. We act as authorised agent for overseas cosmetic manufacturers who want a technically competent holder in India without surrendering the registration to a distributor whose commercial interests may diverge from theirs later.
Validity is perpetual, but only if you pay
Under Rule 14(1) the registration certificate remains valid in perpetuity, subject to payment of a retention fee every five years. Rule 14(2) then does the damage: if the retention fee is not paid, a late fee of 2% per month applies, and if it remains unpaid beyond 180 days the certificate is deemed cancelled.
There is no renewal application to remind you. A certificate you believed was permanent can lapse silently while your shipments are in transit.
Labelling obligations that follow the registration
Rule 34(5) requires the import registration certificate number to appear on the label, together with the name and address of the importer. Rule 34(9) requires the registration certificate number of the product and the name and address of the registration certificate holder. A consignment whose labels omit these is a detention waiting to happen, and relabelling under customs supervision is slow and expensive.
The animal testing prohibition
Rule 18(4) prohibits the import of cosmetics that have been tested on animals after 12 November 2014, and Rule 39(7) prohibits the use of any animal for the testing of cosmetics in India. For manufacturers in markets where animal testing is still lawful or mandated, this is a documentary and sourcing question that has to be resolved before filing, not after.
Where this goes wrong
- Counting products instead of categories. The fee structure runs on category, variant and manufacturing site. Firms budget for a handful of SKUs and then discover the application spans three categories and two factories.
- Missing the five-year retention. By far the most common failure. The certificate does not announce its own expiry, and 180 days after the due date it is gone.
- Registering the wrong manufacturing premises. If production moves to a second site, that site is not covered. Goods made there are unregistered goods.
- Treating the agent as administrative. The applicant holds the certificate. Choosing a freight forwarder or a single distributor as the registration holder hands them leverage over your market access.
- Assuming registration is a licence to sell. Import registration addresses import. Sale, distribution and any manufacturing in India carry their own requirements under the same Rules.
Frequently asked questions
Can an Indian distributor hold the registration on our behalf?
Yes, as importer or as authorised agent under Rule 12(2). Consider carefully whether you want them to, because the certificate is theirs and does not travel with you if the relationship ends.
How long does CDSCO take to grant a Form COS-2?
CDSCO does not publish a statutory timeline for grant. Timelines in practice depend on the completeness of the dossier and on query cycles, which is where most of the elapsed time is spent.
Is a separate registration needed for each shade or size?
Variants attract a fee of USD 50 each and must be declared. Pack size, variant and manufacturing premises all form part of what is registered.
Do we need registration if we import only for exhibition or testing?
Imports for purposes other than sale are treated differently under the Rules and should be assessed case by case before shipment, not justified afterwards.
Does the certificate cover products we add to the range later?
No. New categories, variants or sites require the registration to be amended, with the corresponding fee.