Cosmetics Regulatory Affairs Services in India

Support for cosmetics companies with regulatory affairs, compliance requirements, ingredient checks, and product approval processes in India.

Cosmetics

Cosmetic Products Regulatory Consultant in India

Artixio’s regulatory team provides comprehensive regulatory services throughout the cosmetic product lifecycle. Our regulatory expert has decades of experience and offers effective strategies to expedite product launch and seamless management of cosmetics in India.

Cosmetic Regulations by CDSCO in India

Regulatory process is different for products made in India and products imported from other countries. Manufacturing licenses are handled by the State Licensing Authorities, while CDSCO handles the central requirements for imported cosmetics.

Central Drugs Standard Control Organization (CDSCO) regulates cosmetic products strictly and is responsible for setting standards, guidelines and ensuring implementation for safe cosmetic use. Drug and Cosmetic act 1940 and Rules 1945 is the main regulatory provision.

Under Drug and Cosmetic act 1940, Ministry of Health and Family Welfare notified Cosmetic rules 2020, providing a comprehensive regulatory framework for manufacturing, import and distribution of cosmetics in India.

Registration Process for Cosmetics in India

Pre-Registration	Registration	Post-Registration
Product & category assessment Ingredient compliance check Regulatory pathway identification Label & claim review Document preparation Manufacturing site assessment	Prepare application Submit required documents File through applicable regulatory portal Respond to regulatory queries Address deficiencies, if any	Obtain applicable license/registration Maintain regulatory records Manage product/label changes Product additions & amendments Ongoing compliance monitoring Renewal / retention, where applicable
⬅ Cosmetics Registration in India: Key Steps ➡

Documents Required for Cosmetic Products in India

The documents required depend on whether the cosmetic product is manufactured in India or imported from another country.

Documents Required for Cosmetic Manufacturing in India

Name and address of manufacturing premises to be registered
Application in Form COS-5 for a manufacturing licence
Form COS-6 for a loan licence, where applicable
Contact details of manufacturer
A brief profile of the manufacturer's business activity
Names of cosmetics along with their brands name
Category of Cosmetic as per cosmetic rules, 2020
Specifications and testing method for testing of the cosmetic
Manner of labelling as per the Cosmetics Rules, 2020
Package inserts

Documents Required for Cosmetic Import Registration in India

Name and address of the authorized importer or distributor or agent in India.
Form COS-1 application
Copy of manufacturing license, free sale distribution certificate issued by competent authority of country of origin.
List of countries where marketing authorization or import permission for cosmetics has been granted.
Undertaking given in the second schedule of Cosmetics rules, 2020.
Product category, Ingredient list with percentages

Artixio’s Services for Cosmetic Products in India

End-to-end guidance registration of cosmetic
Appointing Indian authorizes agent
Support for account generation on online portal
Coordination in submission of application to CLA.
Strategic regulatory support throughout product lifecycle

Registration Process for Import of Cosmetics in India

No cosmetic product can be imported without a registration certificate granted by the Central Licensing Authority (CLA).

Complete RA Services for Market Entry in India

Why Choose Artixio for Cosmetics Regulatory Services in India?

FAQs

What is the process of importing and manufacturing new Cosmetics in India?

As per, Cosmetic Rules 2020, prior permission is required for the import and manufacturing of new cosmetics with additional requirements specified in Chapter V. Permission application for Import and Manufacturing must be submitted in Form COS-3 and Form COS-12 respectively.

What is the validity of the import license certificate of cosmetics?

The registration certificate granted by the Central Licensing Authority will be valid for 5 years from the date of issuance of license retention fee must be paid from time to time.

Which cosmetic products are not allowed to be imported in India?

Chapter III of Cosmetic Rules 2020, following cosmetics are prohibited from import in India-

No cosmetics should be imported in India, which are prohibited for manufacture, sale, and distribution in the country of origin.
No cosmetics should be imported that contain hexachlorophene.
No cosmetics shall be imported if the “Use Before” or “Use By” date shown on the label, wrapper, or container of the cosmetic is later than six months from the date of import.

What are the fees required to be paid for registration application for import and manufacturing?

Fees required to be paid are described in the third schedule of Cosmetic Rules 2020.

Sr. No.	Purpose	Fees
1	Fee for the grant or retention of registration certificate for each category of cosmetic	$1000
2	Fee for the grant or retention of registration certificate for additional category of cosmetic	$1000
3	Fee for each variant of cosmetic for the grant or retention of registration certificate	$50
4	Fee for inspection of each overseas manufacturing site of cosmetics	$5000
5	Fee for grant of license in Form COS-8 for manufacture of cosmetics for sale or distribution up to ten items of each category of cosmetics	INR 10000
6	Fee for grant of license in Form COS-8 for manufacture of cosmetics for sale or distribution of each additional item of the category of cosmetic	INR 500