Cosmetic Registration COS 1 and COS 2 in India

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Due to stringent safety and labelling standards, applying for import registration licenses for cosmetics can be painstakingly overwhelming. CliniExperts, with its trained professionals, provides a seamless cosmetic registration journey and ensures the application processes of Form COS-1 and COS-2 and approvals are handled on time and without a hitch.

Cosmetic Registration COS 1 and COS 2 – Overview

The Central Drugs Standard Control Organisation (CDSCO) is the Indian regulatory body that issues import licenses for cosmetic items. The applicant or manufacturer must complete out form COS-2 to import a cosmetic product into India for marketing purposes. The applicant must register the cosmetic products and the manufacturing site by submitting an application in Form COS-1 for the grant of an Import Registration Certificate in Form COS-2 for the import of cosmetics into India.

Who Can Apply?

The following parties can apply for the grant of an Import License Registration Certificate for the import of cosmetics products into India :-

Any manufacturer or importer intending to import cosmetic products in India.
Any authorised agent working on behalf of a manufacturer or importer.
Any importer or person based in India aiming to start an import business directly in India.
Any subsidiary in India authorised by the manufacturer.

How To Apply?

The Applicant must follow the following process:

Visit the SUGAM portal by CDSCO. Sign up/Log in to register.

For the Import Registration Certificate, click on it to fill in the application Form COS-1. Duly fill in the details requested about the cosmetic product description, manufacturing premise, brand name of the cosmetic item, pack size and their variants, and more.

Upload all the necessary supporting documents along with the duly signed and stamped Form COS-1 application on the SUGAM portal.
Pay the fee challan along with the details of the importer.
The regulatory officials will review and verify the submitted application, supporting documents and fee challan.
Once the application is successfully reviewed and verified, it will be approved. The approved letter in Form COS-2 will be posted online on the applicant’s dashboard of the SUGAM portal.
Form COS-2 (Import Registration Certificate) will grant the license and authority to sell and distribute imported cosmetic items anywhere in India.

Validity

The validity of the Import Registration Certificate in Form COS-2 is five years from the date of issuance unless suspended or cancelled by the Central Licensing Authority.

Fee Involved

As per the Third Schedule of Cosmetics Rules, 2020, a fee of 1000 US dollars or its equivalent in Indian Rupees is to be paid for grant or retention of Import Registration Certificate for each category of cosmetics, a fee of 500 US dollars for the registration of each manufacturing site, a fee of 50 US dollars for the registration of each variant, and a fee of 1000 US dollars for grant or retention of Registration Certificate for an additional category of Cosmetic is required to be paid along with the Form COS-1 application.

Important Documents

The following documents are mandated by the Central Licensing Authority to be submitted along with the Form COS-1 :-

Duly filled, signed, and stamped online-generated application in Form COS-1 by the authorized Indian Agent/Importer.
The Covering Letter mentioning the detailed information of all documents and the purpose (Fresh or Endorsement Application).
Authorisation from the manufacturer as per First Schedule of Cosmetic Rules 2020, including the complete details which need to be authenticated in India either by a Magistrate of First Class or by the Indian Embassy in the country of origin or by an equivalent authority through apostille.
Information and undertaking filled as specified in Part-I of Second Schedule of Cosmetic Rules, 2020.
List of composition or ingredients along with concentration, function, and CSA no.
Labels of proposed cosmetic products as per Chapter VI of the Cosmetics Rules, 2020.
Specification of the proposed cosmetic products will be as per BIS standards in the Ninth Schedule of the Cosmetics Rules, 2020.
Pack inserts (if any).
Authenticated copy of manufacturing licenses or registration/marketing authorization in respect of applied products issued by Regulatory authority from country of origin. In the absence of manufacturing licenses, an undertaking from the manufacturer shall be submitted.
Free Sale Certificate issued by the National Regulatory Authority of the country of origin for the applied products. In the case of other authorities like a chamber of commerce, it would require further attestation from the Indian Embassy or Apostillation.
Undertaking for non-animal testing.
Undertaking for Heavy Metal Testing and BIS compliance for perfume.
Fee receipt of the registration.

Timeline to get from

Days

Essential Tips

Taking care of these important things will help align your goals for seamless and successful application preparation and submission :-

Make sure the names of the products and manufacturers or importers and addresses of manufacturers are the same and consistent across all documents. Any change in the spellings could lead to great loss.
Ensure all documents or transcriptions are translated into English.
Check the validity or expiration of all legal documents.
Verify the specifications of the cosmetic product are per the Ninth Schedule.

Expert Advise

To avoid potential issues during the application process, applicants should keep the following in mind:

Compliance with Regulations: Ensure all documents and products comply with the Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020.
Accurate Documentation: All documents should be accurate and complete.

Frequently Asked Questions

What is cosmetic?

As per the Drugs and Cosmetics Act, of 1940, a cosmetic is defined 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 a cosmetic.” Any article falling in the definition of cosmetic is obligated to be registered before import into the country under the rules by the Central Licensing Authority appointed by the Central Government as per rule 12(1) of the Cosmetic Rules, 2020.

What are the essential qualifications for importing cosmetics into India?

For a successful Import Registration Certificate, simply importing cosmetics into India, the applicant must be registered with the Central Drugs Standards Control Organization (CDSCO). This is done by applying for an Import Registration Certificate through Form COS-1 and obtaining a Registration Certificate as Form COS-2.

How can you check the status of your application for an Import Registration Certificate?

Visit the CDSCO SUGAM Portal, and log in to your account. Check for the status in Submitted Applications to view the status of your application.

Can cosmetic products with valid Import Registration Certificates be imported through any designated ports in India?

Yes, with a valid and duly signed Import Registration Certificate, you can import your cosmetics through any port in India.

Do we need to provide free sale certificates for all variants of the cosmetic products intended to be imported?

Yes, free sale certificates for all variants of cosmetic products are required to be submitted.