Permission To Import / Manufacture New Cosmetics in India – COS 12 & COS 3


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    Get CliniExperts professional assistance to import or manufacture new cosmetic products/ingredients in India as per Cosmetic Ruled, 2020.

    Permission To Import Manufacture New Cosmetics– Overview


    The Central Drugs Standard Control Organisation (CDSCO) is the Indian regulatory body that issues import licenses for cosmetic items. The Cosmetic Rules, 2020 state that if a cosmetic product contains a novel ingredient, approval to import or manufacture it must be sought.   Before registering a new cosmetic in India, the applicant must seek prior approval in Form COS-3 from the Central Licensing Authority by filing an application (in offline form) in Form COS-12 with the required fee and documents as specified in Chapter V of the Cosmetics Rules, 2020.

    What is COS 12 and COS 3

    Form Names

    Form COS-12:

    This form is used to submit an application to the central licensing authority to import new cosmetics.

    Form COS-3:

    The CDSCO grants license to import and manufacture new cosmetics in India through this form.

    Who Can Apply?


    Indian Agent on the behalf of foreign manufacturer/Local Cosmetic Manufacturer having valid manufacturing license in Form 32/32A or COS-8/9


    How To Apply?

    Applicant have to submit the application to the Central Licensing Authority in COS-12 along with the requisite fee and the data on safety and effectiveness of cosmetics. 
    If the central licensing authority, after review of application if satisfied that the cosmetic if permitted to be manufactured or imported shall be safe and effective for use in the country, may issue a permission in Form COS-3.

    Fee Involved

    A fee of 500 USD is applicable to obtain a license for the import and manufacture of cosmetic products containing novel ingredients in India.

    Validity

    The license's validity has yet to be specified in the rule.

    Important Documents

    The following documents are necessary for successful application for import license of new cosmetic products:

    Duly filled application in Form COS-12 Safety and efficacy data of the cosmetics Required fee

    Timeline to get Form COS 3 from Central Drugs Standard Control Organisation

    Timeline to get the license not specified in rule yet. Application in Form COS-12, data on safety and effectiveness of cosmetic and requisite fee

    Essential Tips

    To obtain an import license for new cosmetics in India, an applicant must ensure the following:

    It is necessary that the application is duly signed and stamped.


    The data on safety should come from published research articles.


    All product and formulation information should be consistent throughout all papers.


    The applicant must also gather information on the novel ingredients used. In addition, the novel ingredient’s safety must also be demonstrated to the regulatory agencies.

    Expert Advise

    The use of a novel component in the formulation should be safe.

    It is necessary that the importer has information about the ingredients being utilized and their safety prior to finalizing a manufacturer.

    Frequently Asked Questions

    What is New Cosmetic?

    A cosmetic which contain novel ingredient which has not been used anywhere in the world or is not recognized for use in cosmetics in any National and International literature.

    Is prior permission required for import or manufacture of New Cosmetics in India?

    Yes. Prior permission from the Central Licensing Authority is required for import or manufacture of New Cosmetics in India.

    What is procedure for prior permission for import or manufacture of New Cosmetics in India?

    The applicant shall obtain a prior permission in Form COS-3, by making an application (in offline mode) in Form COS-12 along with requisite fee and documents as provided in Chapter V of the Cosmetics Rules, 2020, from Central Licensing Authority before registration of import of new cosmetic in India

    What is procedure for import or manufacture of New Cosmetics in India?

    An application for import and manufacture under Chapter III and under Chapter IV respectively, of the Cosmetics Rules, 2020 shall be made to the Central Licensing Authority or the State Licensing Authority, as the case may be, along with the prior permission obtained in Form COS-3 from the Central Licensing Authority.

    What is the fee for grant of permission for new cosmetics?

    $500

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