This blog is briefed about the various steps to be carried out for the Cosmetic Registration process and the documents required.
Step 1 – Determine If Your Product Requires Registration
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 & Cosmetic Rules, 1945. The list of products requiring registration is listed in Annexure 1.
Step 2 – Appoint an Authorized Indian Agent
The regulations in India require that foreign manufacturers have a Authorized Representative in India who will act on their behalf as the point of contact for inspection authorities, assist in device approvals and registration process and vigilance/adverse event reporting. To Learn More – Contact Us.
Step 3 – Submit the Regulatory Dossier under Form 42
A dossier has to be prepared with the required list of documents to start the registration process. 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.
Document Requirements
- 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.
- List of countries where Market Authorization or import permission or registration was granted.
- Pack insert, if any
- Soft copies of the information about the brands, products and manufacturer
Each application will be accompanied by a fee of USD 250 or its equivalent Indian rupees for each Brand viz. each category of cosmetic as mentioned in Column 3 of the list enclosed at Annexure.
Labeling Requirements:
- The label of imported cosmetic will bear the registration certificate number of the brand and name and address of the registration certificate holder.
- 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.
- 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
- Importers of registered Cosmetic products are currently allowed to incorporate India- specific requirements like name and address of importer, import License Number on imported Cosmetic products post landing in India at customs warehouse or place approved by the Central Drugs Standard Control Organization (CDSCO) prior to release into market.
For Medical Device Labeling Requirements – Labeling Requirements for Registration of Medical Devices in India.
Ban On Animal Testing On Imported Cosmetics
At the time of clearance of the consignment at the port office, an undertaking issued from the manufacturer stating that the cosmetic has not been tested on animals on 12.11.2014 or after the date is required to be submitted to the concerned port office.(as per circular, file no. 18- 12/2013-DC/part file dated 03.02.2015)
Step 4 – Obtain Registration Certificate in Form 43
After the document submission the CDSCO will get back to the Indian Agent with first query letter. Upon receiving the answers for the query the CDSCO will either issue a subsequent query letter or grant license. 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.
Step 5 – Marketing in India
The product can enter the Indian market only when the registration certificate and licenses are issued. The Authorized Indian Agent should report any change, adverse events, recalls in other countries etc to the CDSCO as and when they happen.