Update on Cosmetics Import & Registration Guidelines in India

09/10/2015

Update on Cosmetics Import & Registration Guidelines in India 

SJES051015 Dated 09th October 2015

Updated Guidelines on Registration of Import of Cosmetics in India

Please read the updated guidelines on the Registration of Import of Cosmetics which will come in effect from 01/04/2013 as briefed below-

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.

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.

Who can apply for Registration of Import of Cosmetics / who can be an importer :

(i) The Manufacturer himself having registered office in India.
(ii) The Authorized Agent of the Manufacturer
(iii) The Subsidiary of the Manufacturer
(iv) Any other importer.

Brand Registration:

A “Brand” for the purpose of these rules will mean each category of cosmetic products.
A “Brand” will include all variants of a product e.g. colour, shades, pack sizes, etc.
A “Brand” will not mean the trade name of any product of a manufacturer or the manufacturer himself / itself.

Brand Registration 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.

Regulations Pertaining to an Authorized Agent:

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

(a) 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
(b) Attested by the Indian Embassy of the said Country.
or
(c) 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 Authorized 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 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 Authorized agent stated in the Power of Attorney should correlate with the Form 42.
    • It should be valid for the period of said Registration Certificate.

Labels & Changes Guideline:
1. The label of imported cosmetics will bear the registration certificate number of the brand and name and address of the registration certificate holder.
2. Stickering of labels containing the registration certificate number of the brand and the name and address of the registration certificate holder may be allowed to be carried out after import at a suitable declared place approved by the Licensing Authority on an application made to the Licensing Authority.
3. The Label should also bear the name and address of the manufacturer and name of the country where the product has been manufactured. If the product has not been manufactured in a factory owned by the manufacturer, the name and address of the actual manufacturer or the name of the country where it has actually been manufactured as “Made in …….. (name of country)” should be there on the label.
4. In case of any change in product specification, ingredients, variant etc. after grant of Registration Certificate, the applicant will inform about those changes to the Licensing Authority by submitting revised Schedule D III at least 30 days before the date of import.

Documents Needed for Regn.:

  1. Covering letter by the applicant
    2. Form 42
    3. Treasury Challan
    4. Power of Attorney
    5. Schedule D III
    6. Original or a copy of the Label.
    7. Free Sale Certificate (FSC)/Marketing Authorization letter/Manufacturing License, if any
    8. Product specification and testing protocol.
    9. List of countries where Market Authorization or import permission or registration was granted.
    10. Pack insert, if any
    11. Soft copies of the information about the brands, products and manufacturer
  2. Heavy Metals Test report and Declaration from the manufacturer

Registration Exemption:

  1. Cosmetic products which are imported into India as bulk for repackaging for 100% export to other countries will not require registration certificate. In such cases the importer has to obtain necessary permission from CDSCO HQ. Importer must give written undertaking that these products are not released for domestic sale.
    2. For Import of cosmetics for R&D purposes like packaging trials, consumer studies, shelf life studies and transport studies, registration certificate is not required. In such cases the importer has to obtain necessary permission from CDSCO HQ. Importer must give written undertaking that these products are not released for domestic sale.

SOURCE: GOVT. OF INDIA, Ministry of Health & Family Welfare

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