Registration Guidelines, 2013

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We, COSMETICS REGISTRATION (INDIA) are a consultancy subsidiary of ARHAM CONSULTANTS (INDIA) PTY, New Delhi and are focused on the regulatory compliance of Cosmetics Imports Registration in India.

Guidelines for Cosmetics Import Registration, 2013 :

After much amendments, this is the latest set of guidelines for executing the Registration of Cosmetics in India.

Guidelines for Cosmetics Import Registration [As on 2nd January 2013]

A: Purpose

GOI, Government of India has made provision for registration of cosmetic products being imported into the country as part of amendment to the Drugs and Cosmetics Rules, 1945, under the Gazette Notification G.S.R 426[E], as on 19th May 2010.

Initially, the provision was to be observed officially from 1st April, 2011. However, due to stakeholders concerns and implementation issues, its effective date was later deferred till 31st March, 2013.

GOI, Government of India has issued following guidelines and requirements for facilitating the aforesaid notification and the subsequent grant of RC - ‘Registration Certificate’.

The guidelines are not to be interpreted as exhaustive and are subject to the implementation issues, changes or modifications that may be made if considered necessary by the Licensing Authority.

Clarifications/ Guidelines
  • 1. As per Rule 21 of the Drugs & Cosmetics Rules, 1945, every cosmetic product, being imported for sale in India, needs to be registered with the licensing authority
  • 2. The Import registration has to be applied in Form-42 Proforma along with the required and relevant documents and should be presented to the Cosmetics Division Incharge, Office of the Drugs Controller General of India, Central Drugs Standards Control Organization, FDA Bhawan, Kotla Road, New Delhi- 110002, India
  • 3. The Manufacturer, who has a registered office in India, any Subsidiary of the manufacturer or the Authorized Representative/ Agent of the manufacturer or the importer can apply for the Import Registration of Cosmetics.
  • 4. The Cosmetic ‘Brand’, as referred under the Act, means each of the cosmetic products which are being mentioned under the 3rd column of the list [see Annexure list].
  • 5. A ‘Brand’ will give umbrella cover to all the different variants of the product i.e. pack sizes, shades, color etc.
  • 6. A ‘Brand’ doesn’t imply the trade-name of the manufacturer or of any of the manufacturer’s cosmetics.
  • 7. The term ‘manufacturer’ implies an entity or a person in a country (other than India) who is the owner of the brand / trade name of the cosmetic product for which the registration is sought; one who manufactures the cosmetic product at his owned manufacturing site; one who manufactures the cosmetic product at another manufacturer’s site but under his brand / trade name.
  • 8. The ‘Authorized Agent’ is an entity or the person who is authorized by the manufacturer to conduct regulatory activities / registration of cosmetic products being imported into the country as part of amendment to the Drugs and Cosmetics Rules, 1945
  • 9. ‘Subsidiary’ is a term allocated to a business entity in India that is under ownership of the manufacturer
  • 10. ‘Other importer’ signifies any entity or person which/ who proposes to import the cosmetic brand in India, other than the manufacturer, his subsidiary or its authorized representative
  • 11. The registration application should come along with the specified registration fee and an undertaking under Schedule D-III.
  • 12. Only one application needs to be submitted under form-42 for one or more number of the cosmetic brands, being manufactured at one or more manufacturing sites, but for a single manufacturer [under whose name the registration is sought].
  • 13. A Registration Certificate would be issued under form-43 for the applicant for importing any number of brands, being manufactured at more than one locations, but for a single manufacturer [under whose name the registration is sought].
  • 14. The Registration application should be submitted along with the specified fees of U.S. $250 or its similar value in Indian rupee, for each brand of cosmetics as listed in the 3rd column [see Annexure list].
  • 15. In case, registrations are sought for the same brand but for different manufacturers, then separate application forms need to be filled for each of the manufacturers and the registration fees will need to be paid separately.
  • 16. In case, the applicant wishes to add more brands to its existing list of registered category as shown in the 3rd column of the annexure, then a separate application has to be made and no further fee would be charged. The permission on product registration would be acknowledged on the existing RC ‘Registration Certificate’ in the already approved category.
  • 17. The power vested by the manufacturer in the Indian Authorized Representative would be documented on the ‘Power of Attorney’. It is mandatory that the Power of Attorney is authenticated or executed in the presence of a Class-I Magistrate or an equivalent authority in the manufacturer’s country of origin; or the document gets attested by the Embassy of India in the said country; or an Apostle from one of the member countries of Hague convention is also acceptable.
  • Note: the original copy of the document should be sent along with the application for the product’s registration.

    The Power of Attorney should be stamped and signed jointly by the Authorized Agent and the Manufacturer with a clear description of the identity and the designation of the signatories

    The application form should mention clearly the name of the cosmetic product, brand name, trade name and its variants i.e. pack sizes, shades and color, on the 2nd column of the Annexure. Also, the name of the cosmetic product should be the same on the Annexure and the form-42. The same applies for the name and the address of the Authorized Representative / Agent and the Manufacturer on form-42 and the Power of Attorney.

    The Power of Attorney should remains in force for the same period as that of the RC ‘Registration Certificate’.

  • 18. Post issuance of the ‘Registration Certificate’, if there is any change on the product’s specifications such as variant, composition, labeling contents etc then the same should be informed for amendment by the Licensing Authority by a revised schedule D-III, 30 days prior to the import of the product.
  • 19. The label on the imported cosmetic product has to carry the number of RC ‘Registration Certificate’ and the name and address of the RC holder
  • 20. Stickering i.e. the formal procedure on labeling the number of RC ‘Registration Certificate’ and the name and address of the RC holder, would be allowed only once the import is done at a suitable place, as declared or approved by the Licensing authority on the application form.
  • 21. It is mandatory that the label carries the name and the complete address of the manufacturer; the country of origin where the product has been made may be mentioned; if the manufacturer got it manufactured at some other site, not owned by him.
  • 22. Subsequent approval of the RC ‘Registration Certificate’ would require the following documents
  • Form-42

    Covering letter

    Power of Attorney

    Treasury Challan

    Schedule DIII

    Label – original and a copy

    FSC ‘Free Sale Certificate’ / Manufacturing License / Marketing Authorization Letter

    Specifications of the Cosmetics and the Protocol / Test Results on the same

    The list of countries where the manufacturer already has grant for Import Permission or Market Authorization

    Pack Insert

    Electronic details of the brand, cosmetic product and the manufacturer

    Product samples for testing and appraisal

  • 23. In case the document is in language other than English, then the translated version of the same has to be provided in English language
  • 24. In case the country of origin doesn’t have the provision for manufacturing license, than the importer needs to substantiate this through an affidavit
  • 25. RC ‘Registration Certificate’ is not a pre-requisite in case the import of the cosmetic products is in bulk for re-packaging and it is subsequently being exported 100% to any other country. This however requires a written permission by the CDSCO [Central Drugs Standard Control Organization] and a written declaration by the importer that the products are not for domestic sale.
  • 26. Also, a ‘Registration Certificate’ is not a pre-requisite for cosmetic products being imported for R&D purpose, studies on shelf-life, consumer studies and packaging trials. This however requires a written permission by the CDSCO [Central Drugs Standard Control Organization] and a written declaration by the importer that the products are not for domestic sale.
Annexure
Cosmetics-Registration-in-Indiacom-Brands-of-Cosmetics-Guidelines
Disclaimer:

All the information on various aspects of Cosmetics Registration process and regulations in India is the personal interpretation of the author as gathered from various online & offline source materials. None of the information on this site, in part or whole, is claimed to be an authoritative opinion or summary extract of any law or regulations ; readers are requested to validate the information from their own informed sources and act so on their own wise decision.

Resources:

The Drug & Cosmetics Act, 1940

Drug Controller of India, Ministry of Health, Government of India

Ministry of Finance, Government of India

Reserve Bank of India