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Cosmetic Regulatory Services

Vaayath > Cosmetic Regulatory Services
We help to sail through the cosmetic licensure and registration process for manufacturers and importers

Cosmetic Regulatory Services

Cosmetic License Consultant – In the new rules, the Government of India has introduced the concept of ‘New Cosmetic’ in similar lines with the concept of ‘New Drug’ as in the case of Drugs. The term ‘New Cosmetic’ as defined in Section 3(r) reads as ‘a cosmetic which contains a novel ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any National or International literature.’ The Rules provide importers of new cosmetics to seek approval by making an application to CLSA in Form COS- 3 before registration of import of new cosmetics into India. The application shall contain the method of test or analysis to be employed for safety evaluation of new cosmetics as specified in the IS 4011: 2018 methods of test for safety evaluation of cosmetics, published by the ‘Bureau of Indian Standards’ as amended from time to time.

The services available for cosmetics licensure and registration are as follows:

For Manufacturers:

  • Application filing including documents preparation for cosmetics licensing
  • Manufacturing layout preparation
  • License renewal

For importers:

For overseas manufacturers and importers, we understand the difficulties and questions arising in the mind as they are venturing into an unknown land with no or little knowledge about the procedures and working culture. The new Cosmetics Rules 2020 has placed the liability of the quality of cosmetics on importers and manufacturers.

An application for registration of a cosmetic product intended to be imported into India shall be made either by the manufacturer itself or by its authorized agent or importer in India or by a subsidiary in India authorized by the manufacturer, through the online portal of the central government in a prescribed form (Form COS-1). Once satisfied, the CLA can issue an import registration certificate in the prescribed form (i.e. Form COS-2) or may deny an application for reasons to be documented in writing within six months of the date of application and remain valid in perpetuity, subject to payment of the retention fee for the registration certificate before the completion of the period of five years from the date of issue, unless, it is suspended or cancelled by the relevant Indian governmental authority.

Services offered to overseas manufacturers and importers are as follows:

  • Authorized Agent/Registration Holder Support
  • Registration Certificate
  • Import License
  • Re-Registration
  • Variations/ Post Approvals/ Amendments
  • Sample testing through approved laboratories

This is to be noted that new cosmetics rules have prohibited the import of cosmetics in following cases:

  • The manufacture, sale, or distribution of the cosmetic in question is prohibited in the country of origin;
  • The ‘Use Before or Use by date’ is less than six months from the date of import;
  • The cosmetic which contains ‘hexachlorophene’ (considered to have harmful effects on humans); and
  • The cosmetic which has been tested on animals after November 12, 2014.
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