Registration of Imported Cosmetics in India

A Gazette Notification G.S.R 426(E) dated 19th May 2010 has been issued by the Government of India for amending the Drugs & Cosmetics Rules, 1945 providing for registration of import of cosmetics into the Country. This 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 was deferred till the 31st March, 2013.

All cosmetic products that are imported for sale in India now need to be registered with the Central Drugs Standard Control Organisation (CDSCO) which has been appointed as the licensing authority for the purpose of these rules. This new 'registration' requirement is primarily to regulate indiscriminate import of beauty and personal care products by traders with no accountability for contents and no mechanism to fix responsibility in case a consumer is not satisfied with the quality. The new regulation is an attempt to check the sale of sub-standard cosmetic products and also to harmonise import requirements with products manufactured in India.

What is the Registration Procedure?

The trade mark owner, who has no manufacturing unit in India but intends to sell his goods by way of import through their appointed importers/distributors/marketers in India, is now required to obtain registration certificate to continue with their marketing activities in India. An application for registration on Form-42, along with all requisite documents needs to be submitted to Drugs Controller General (I), CDSCO, FDA office in New Delhi.

How should one apply?

An application for the issue of a Registration Certificate for cosmetics intended to be imported into India need to be made on a specified form, i.e. Form 42 either by:

1. The manufacturer himself having registered office in India or

2. by his authorised agent or

3. importer in India or

4. by the subsidiary in India authorised by the manufacturer

Further, the documents to be provided along with the application include:

1. A request letter by the applicant on the letterhead of the importer or the authorised agent applying for the registration duly stamped and signed by the authorised person.

2. Form 42 – This requires details such as the location of the actual manufacturing sites of the products. A single application can cover many brands (read Trademarks/brand names), many variants; many pack sizes and different manufacturing units corresponding to the products applied.

3. Proof of payment of requisite fee: Original treasury challan indicating the payment of registration fee of USD 250 or its equivalent in Indian rupees for each 'brand' of cosmetic product.

4. Power of Attorney (if the application is being submitted by an authorised agent of the manufacturer. This document needs to be notarised and apostilled or legalised by the Indian embassy in that country)

5. Schedule D III (details of the cosmetic products to be imported including the chemical and safety data)

6. Original or a copy of the Label and art works thereof (this will contain the details of the actual manufacturer and in cases where the manufacturer is not the brand name owner, the label will at least state, 'manufactured in XYZ country')

7. Free Sale Certificate (FSC)/Marketing Authorisation

8. Manufacturing License (and attested English translation if not in English), if any: If there are multiple manufacturers for a single product, all manufacturers need to provide these documents

9. Product specifications and testing protocols: details of ingredients used, quality data etc.

10. List of countries where Market Authorisation or import permission or registration has been granted

11. Package inserts, if any (copies of any leaflets, product specification data that goes inside the packaging has to be provided. No specific requirement has been listed, it is suggested to provide information about the potential side effects/allergic reactions and other safety concerns and remedies available)

12. Copies of the information about the brands, products and manufacturer

What is the timelines for processing of application?

Within six months from the date of submission of the application form and submission of the required documents (especially details required with schedule D III), the registration certificate will be issued.

What is the validity of the registration certificate?

Registration certificate for import of cosmetics is valid for a period of three years from the date of its issuance.

With a view to implementing the provisions of the aforesaid notification and facilitate the registration process for import of cosmetics, there are various guidelines/clarifications and requirements for the grant of Registration Certificate.

Reference:

1. The drugs and cosmetics act and rules. The Ministry of Health and Family Welfare. The Government of India. Available on- http://www.iracm.com/wp-content/uploads/2013/01/act-on-the-drugs-and-cosmetics-1940-3505.pdf. Accessed on 13thApril 2015.

2. Guidelines on Registration of Import of Cosmetics. Available on-http://cdsco.nic.in/writereaddata/Guidelines%20on%20Registration%20of%20Import%20of%20Cosmetics.pdf. Accessed on 15th April 2015.