Your Regulatory partner for Cosmetic in India
Comprehensive regulatory services for cosmetics 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 in India
Central Drug 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 Import of cosmetic in India
No cosmetic product can be imported without a registration certificate granted by the Central Licensing Authority (CLA).
Documents required for import of cosmetic product
The following documents are required with Application Form COS-1 as per described second schedule of Cosmetic Rules,2020.
- Name and address of manufacturing premises to be registered
- Contact details of manufacturer
- Name and address of the authorized importer or distributor or agent in India.
- 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
- 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.
- Specifications and testing method for testing of the cosmetic
- Manner of labelling as per the Cosmetics Rules, 2020
- Package inserts
- Undertaking given in the second schedule of Cosmetics rules, 2020.
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
Why Artixio
Regional team expertise in navigating registration of cosmetic in India
Globally recognized professional with history of successful product launches & life cycle compliance
In accordance with evolving regulatory requirements, supported by gap assessment
Expert Regional Regulatory Teams in 120+ Countries
Customer centric and flexible services
KPI based, continual process excellence
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 |
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