Registration
- All cosmetic products imported for sale in India must be registered with the CDSCO (through CDSCO Registration)defined under the Drugs & Cosmetics Rules of 1945.
- An application for registration of a cosmetic must file in Form-42, and all the requisite documents must be submit to Drugs Controller General(I), CDSCO.
- The following entities can apply for the Registration of Import of Cosmetics:
- The manufacturer with a registered office in the country:
- The Authorized Agent of the Manufacturer.
- The Subsidiary of the Manufacturer.
- Any other importer.
Brand definition
A Brand means
- each category of cosmetic products as mentioned in the list enclosed in the Annexure.
- Includes all product variants, e.g., shades, pack sizes, color, etc.
- Does not mean the trade name of any product of a manufacturer or the manufacturer himself/itself.
Entities definition
Manufacturer
A Manufacturer means an entity, which can be an individual or a company of a foreign country that owns the trademark of the cosmetic brand.
Authorized Agent
An Authorized Agent means an entity authorized by a manufacturer to delegate to him in situations. However, The authorized agent will be responsible for the business activities of the manufacturer in India, including compliance with the provisions of the Act in all respects.
Subsidiary
A subsidiary means an entity that the product manufacturer owns for carrying out some specific purpose on behalf of the manufacturer.
Importer
Importer means any person or entity purporting to import cosmetic products other than the manufacturer, authorized agent, and subsidiary.
Application Filing
- Firstly, An application for the issue of a registration certificate will be accompanied by the specified fee and the information and undertaking as prescribed by the CDSCO registration.
- Secondly, A single application can be made in Form 42 for any number of brands manufacture at one or more locations by a single manufacturer.
- At the last, A single registration certificate in Form 43 can issue to a particular applicant regarding the import of any number of brands manufacture at one or more locations by a single manufacturer.
Application Fee
- Each application will be accompanied by a fee of USD 250 or its equivalent Indian rupees for each brand, viz., each category of cosmetics.
- Meanwhile, If the applicant seeks to import the same brand belonging to different manufacturers, he must submit separate applications for each manufacturer and pay separate fees.
- Therefore, In any existing valid Registration Certificate, if the applicant wants to add any further brand or product of the already registered category for the same manufacturer. But no fee will be charged. Additional product permission will be endorsed to the already approved category in a given Registration Certificate.
Power of Attorney
A Power of Attorney (PoA) will document the authorization by a manufacturer to his authorized agent in India. Therefore, the PoA must be
- attested by the Indian Embassy of the said Country or
- Apostille from Hague convention member countries is also acceptable. The original of the same will be furnish along with the application for the Registration Certificate. While submitting the Power of Attorney, the following points keep in mind:-
- It should be co-jointly signed and stamped by the manufacturer and the Authorized agent indicating the name & designation of the authorized signatories.
- It should list the names of all cosmetic products along with their trade names, brand, and variants (e.g., shades, pack sizes, colors, etc.). Further, the name of the cosmetics should correlate with those mentioned in Form 42.
- The names and addresses of the manufacturer and the Authorized agent stated in the Power of Attorney should correlate with Form 42.
- Consequently, It should be valid for the period of said Registration Certificate.
Product Changes
In case of any change in product specification, ingredients, variant, etc., after the grant of the Registration Certificate, the applicant will inform those changes to the Licensing Authority by submitting them at least 30 days before the date of import.
Labeling
- Firstly, The label of the imported product must bear the RNC (Registration Certificate Number) of the manufacturing Brand. It should also include the name and address of the registration certificate holder.
- Secondly, Label sticker’s containing the RCN, name, and address of the certificate can be allow to be affix on the product after the import at a suitable place approve by the Licensing Authority.
- At the last, The name and address of the manufacturer must mention on the label top be affix on the product. If the product has not been manufacture in a factory of the manufacturer, the name and address of the actual manufacturer should be mention on the label.
Required Documentation
The following documents are in need for submission for grant of registration certificate:
- Covering letter by the applicant
- Form 42
- Treasury Challan
- Power of Attorney
- Schedule D III
- Original or a copy of the label.
- Free Sale Certificate (FSC)/Marketing Authorization letter/Manufacturing License, if any
- Product specification and testing protocol.
- Document enlisting countries that granted Market Authorization/Import permission/registration for the product.
- Pack insert, if any.
- Soft copies of the information about the brands, products, and manufacturer
Product instructions
The applicant must provide the translated English version of any document in any other foreign language from a qualified translator.
Export of Imports
In such cases, the importer has to obtain the necessary permission from CDSCO HQ for CDSCO Registration. Importers must give a written undertaking that these products are not release for domestic sale.
Also Read: Facts that One Must Know About AGR Dues in India
Cosmetics for R&D
The registration certificate is not required to import cosmetics for R&D purposes like packaging trials, consumer studies, shelf-life studies, and transport studies. In such cases, the importer has to obtain the necessary permission from CDSCO HQ. Therefore, Importers must give a written undertaking that these products are not release for domestic sale.
We will prepare you for the required application filing to get the CDSCO registration for your import business.
