Process of Cosmetics Registration in India
CDSCO Cosmetics Registration Process Guide for India
Introduction
Products falling within the definition of cosmetics that are brought to India for purposes of sale are required to be registered under the provisions of the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945 (as amended by the Cosmetics Rules, 2020). CDSCO is the regulatory body, and DCGI is the Central Licensing Authority.
Background
Gazette Notification No. G.S.R. 426(E), issued by the Government of India, on 19th May 2010, amended the Drugs & Cosmetics Rules, 1945 for importing cosmetics registration.
It was to be implemented from 1st April 2011; however, owing to problems expected to be faced by the stakeholders, its implementation was delayed till 31st March 2013.
After that, all the imported cosmetics will have to be registered with the authority specified under Rule 21.
This can be done using the form number 42 (under old scheme), in order to get registration certificate number 43 (under the old scheme), whereas now it can be done by Form COS-1 and Form COS-2 under 2020 Rules.
Important Terminologies
Brand
Refers to each type of cosmetics as per the categories provided in Annexure 1 of the Rules.
Refers to all variations including color, shades, package size.
Does not refer to the trademark of the company.
Manufacturer
Refers to the person/entity outside India who owns the trade name of the cosmetic brand.
Can manufacture at their own site or at another site under their brand name.
Authorized Agent
A person or entity in India authorized by the manufacturer.
Responsible for all business activities of the manufacturer in India and compliance with the Drugs & Cosmetics Act.
Step 1 Determine Whether Registration Is Required
All cosmetic products that are being imported for their sale in India must get themselves registered with the licensing authority as per Rule 21 of the Drugs & Cosmetics Rules, 1945. The products that require such registration have been mentioned in Annexure 1.
Step 2 Appoint an Authorized Indian Agent
The Indian regulation requires the foreign manufacturer to appoint an Authorized Representative in India, who would work on their behalf in order to facilitate the inspections of the authorities, help in getting their devices approved and registered, and also report any adverse events.
Step 3 Submitting Regulatory Dossier through Form 42
A dossier needs to be compulsorily prepared with all the necessary documentation required to start the process of registration. The application form will have the necessary fee along with the schedule information and undertaking as per D-III schedule.
Step 4 Preparation and Submission of Documentation
The applications can be made through the SUGAM Portal by filling out Form COS-1.
Supporting documents include:
Power of attorney/authorization letter by the manufacturer.
Certificate of Free Sale or marketing authorization issued by the country of origin.
License to manufacture/regulatory approval.
List of products with brand name, category, pack size, and variants.
List of ingredients with percentage composition.
Specifications and testing procedures.
No animal testing certificate.
Tip: If the product has been approved in regulated countries like the United States, European Union, Canada, Australia, and Japan, such approvals and Free Sale Certificates will help your application.
Step 5 Registration Fee Payment
The registration fee is USD 250 for each brand and each manufacturing entity; it has to be paid through Bharatkosh.
Step 6 CDSCO Review & Queries
After submitting your application, CDSCO may ask you questions, which have to be answered by the Indian agent.
Step 7 Obtain Registration Certificate in Form 43
Following the submission of the document, the CDSCO will revert to the Indian Agent through the first query letter. After receiving the replies to the query, the CDSCO will then issue another query letter or will issue the license. Only one registration certificate in Form 43 can be issued to an individual applicant regarding the importation of any number of brands produced in one or several sites by one manufacturer.
Step 8 Marketing in India & Post-Approval Duties
The product shall not be able to get into the market until both the Registration Certificate and the licenses are issued. The Authorized Indian Agent shall report all the changes, any adverse events, any recall from another country etc., as and when they occur.
Timelines
As per Rule 129C:
Provided that the application is complete and the information is accurate, the registration certificate must be issued by the licensing authority within six months from the date of receipt of such application.
In rare instances, this time limit can be extended up to three more months.
According to a notice published by the CDSCO on 30th May 2014, the target time period is 90 days.
Labeling Compliance
The labeling requirements for imported cosmetics include:
Name of product, details of manufacturer, and details of importer.
Batch Number and Expiry/Use before Date.
Ingredients in a standard format.
Certificate of Registration Number (RC No.) in the label.
Conclusion
The entire process of cosmetics registration in India ensures the entry of only those cosmetic products into the market which are safe and in compliance with regulations. With the help of appointing an appropriate Indian agent, preparing all relevant documents, knowing about relevant terms and definitions, and adhering to the timelines set by CDSCO, manufacturers will be able to get quicker approvals.
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