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Process of Cosmetics Registration in India

Cosmetic Registration Process in India

May 18, 2026

Introduction

Cosmetic products imported into India for sale must be registered under the Drugs & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945, updated through the Cosmetics Rules, 2020. The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health & Family Welfare, serves as the regulatory authority, with the Drugs Controller General of India (DCGI) acting as the Central Licensing Authority.

Any cosmetic imported into India for sale must be registered before it enters the market.

Background

The Government of India issued Gazette Notification G.S.R. 426(E) dated 19th May 2010, amending the Drugs & Cosmetics Rules, 1945 to introduce registration of imported cosmetics.

The provision was to come into effect from 1st April 2011, but due to challenges anticipated by stakeholders, its implementation was deferred until 31st March 2013.
From April 2013 onward, all imported cosmetics must be registered with the licensing authority defined under Rule 21.
The application is made in Form 42 (old framework) to obtain a registration certificate in Form 43, while under the 2020 Rules the process is through Form COS-1 and Form COS-2.

Important Terminologies

Brand

Means each category of cosmetics as listed in Annexure 1 of the Rules.
Includes all variants such as colour, shades, pack sizes.
Does not mean the trade name of the manufacturer.

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 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 an 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.

Step 4 – 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.

Step 3 – Document Preparation and Submission

Applications are submitted via the SUGAM portal using Form COS-1.

Supporting documents include:

Power of Attorney/Authorization letter from the manufacturer.
Free Sale Certificate or marketing authorization from the country of origin.
Manufacturing license/registration certificate.
Product list with brand names, categories, pack sizes, and variants.
Ingredient list with percentage composition.
Specifications and test methods.
Labels and packaging artwork.
Non-animal testing declaration.

Tip: If the product is already approved in regulated markets like the U.S., EU, Canada, Australia, or Japan, those approvals and Free Sale Certificates can strengthen the application.

Step 4 – Pay the Registration Fee

The statutory fee is USD 250 per brand per manufacturer, payable via Bharatkosh.

Step 5 – CDSCO Review and Queries

After submission, CDSCO may issue queries. The Indian agent must respond with clarifications.

Step 6 – Obtain Registration Certificate in Form 43

After the document submission the CDSCO will get back to the Indian Agent with the 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 7 – Marketing in India & Post-Approval Duties

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.

Timelines

As per Rule 129C:

If the application is complete and the information is in order, the licensing authority shall issue the registration certificate within six months of receiving the application.
In exceptional cases, this period may be extended by up to three additional months, with reasons recorded in writing.
As per a CDSCO circular dated 30th May 2014, the targeted processing timeline is 90 days.

Labeling Compliance

Imported cosmetics must meet Indian labeling rules, including:

Product name, manufacturer’s details, importer’s details.
Batch number, expiry/use-before date.
Ingredient list in standard format.
Registration certificate number (RC No.) on the label.

Conclusion

The process of cosmetics registration in India ensures that only safe and compliant products enter the market. By appointing a reliable Indian agent, preparing complete documentation, understanding key definitions, and following the CDSCO timelines, manufacturers can achieve faster and smoother approvals. Leveraging global approvals from markets like the U.S. or EU can further strengthen the dossier.