Guidelines on Registration of Import of Cosmetics

A: PURPOSE:

1. The Government of India has issued a Gazette Notification G.S.R 426(E) dated 19th May 2010 for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country.
2. The above provision was to come into effect from the 1st April, 2011. But in view of the various possible difficulties apprehended by the stakeholders, its implementation has
   been deferred till the 31st March, 2013.
3. With a view to implementing the provisions of the aforesaid notification and facilitate the registration process for import of cosmetics, the following guidelines / clarifications,
   including general requirements for grant of Registration Certificate, are being provided hereunder:
4. These guidelines are not exhaustive and may be augmented / modified further through additional guidelines or amendments of these rules, if considered necessary.

B: GUIDELINES / CLARIFICATIONS:

1. All cosmetic products that are imported for sale in India need to be registered with the licensing authority as defined under Rule 21 of Drugs & Cosmetics Rules, 1945.
2. An application for registration in Form-42, along with all requisite documents, shall be submitted to Drugs Controller General (I), CDSCO, FDA Bhavan, Kotla Road, New Delhi
   110002.
3. Who can apply for Registration of Import of Cosmetics / who can be an importer:
   
   1. The Manufacturer himself having registered office in India.
   2. The Authorised Agent of the Manufacturer
   3. The Subsidiary of the Manufacturer
   4. Any other importer
4. A "Brand" for the purpose of these rules will mean each category of cosmetic products as mentioned in Column 3 of the list enclosed at Annexure.
5. A "Brand" will include all variants of a product e.g. colour, shades, pack sizes, etc.
6. A "Brand" will not mean the trade name of any product of a manufacturer or the manufacturer himself / itself.
7. A "Manufacturer" means a person or entity in a Country other than India who owns the trade name of the brand of the cosmetic product for which registration has been applied
   for and who / which manufactures such product at his / its own manufacturing site or at a site owned by another manufacturer in the trade name of his / its brand.
8. An "Authorized Agent” means a person or entity in India authorized by the manufacturer. The authorized agent will be responsible for the business activities of the manufacturer in
   India including compliance to the provisions of the Act in all respects.
9. "Subsidiary" means an entity in India owned by the manufacturer.
10. "Any other importer" means any person or entity purporting to import cosmetic products other than the manufacturer, its authorised agent and its subsidiary.
11. An application for issue of a registration certificate will be accompanied by the specified fee along with the information and undertaking in Schedule D-III.
12. A single application may be made in Form 42 for any number of brands manufactured at one or more locations by a single manufacturer.
13. A single registration certificate in Form 43 may be issued to a particular applicant in respect of import of any number of brands manufactured at one or more locations by a single
    manufacturer.
14. Each application will be accompanied by a fee of USD 250 or its equivalent Indian rupees for each Brand viz. each category of cosmetics as mentioned in Column 3 of the list
    enclosed at Annexure.
15. If the applicant seeks to import the same brand belonging to different manufacturers, he needs to submit separate application for each manufacturer and has to pay separate fees therefor.
16. In any existing valid Registration Certificate, if the applicant wants to add any further brand or product of already registered category as mentioned in Column 3 of the Annexure
    for the same manufacturer, separate application will need to be submitted by the importer. But no fee will be charged. In such cases additional product permission will be endorsed
    to the already approved category in a given Registration Certificate.
17. Power of Attorney – The authorization by a manufacturer to his authorized agent in India will be documented by a Power of Attorney. The power of attorney shall be
    
    1. executed and authenticated either in India before First Class Magistrate, or in the country of origin of the manufacturer before such an equivalent authority.

    or

    2. attested by the Indian Embassy of the said Country.

    or

    3. Apostille from Hague convention member countries is also acceptable.

The original of the same will be furnished along with the application for Registration Certificate.

While submitting the Power of Attorney, the following points should be kept in mind: -

• It should be co-jointly signed and stamped by the manufacturer as well as the Authorised agent indicating the name & designation of the authorized signatories.
• It should clearly list the names of all cosmetic products along with their trade names, Brand as per Column 2 of the Annexure and variants (e.g. colour, shades, pack sizes,
  etc). Further, the name of the cosmetics should correlate with those mentioned in the Form 42.
• The names and addresses of the manufacturer as well as the Authorised agent stated in the Power of Attorney should correlate with the Form 42.
• It should be valid for the period of said Registration Certificate.

ANNEXURE