Cosmetics Registration in India


About Cosmetics Regulation

Cosmetics is amongst the most widely used product range in our day to day life. From head to toe we use endless such products ranging from Skin, Hair & Scalp, Nail & Cuticle, Oral Hygiene etc. Keeping the interest of the end consumers, cosmetics are regulated under the overarching regulation Drug and Cosmetic Act 1940 & Rules 1945 (amended up to Dec.31st 2016) & the Bureau of Indian Standards (BIS) issued standards for ingredient usage in cosmetics.

  1. For Indian Manufacturer:
    • License on form 32 is issued for manufacture/ sale distribute of cosmetics. (Form no 31).
    • License on form 32-A is issued for loan license for manufacture/ sale distribute of cosmetics. (Form no. 31-A)
    • License on form 37 is issued for grant or renewal of approval for carrying out tests on Drugs/ cosmetics or raw material used in the manufacture thereof on behalf of licenses for Manufacture for sale of drugs/cosmetics. (Form no. 36

    To manufacture any of these products, a license has to be obtained from a Licensing Authority appointed by the State Government. The manufacturer has to ensure that the production is done in the presence of a competent and qualified technical staff (Production Chemist and Analytical Chemist/ QC Chemist) and at least one of the staff persons should possess the following educational requirements:

    • holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948),or
    • is registered under the Pharmacy Act, 1948 (8 of 1948), or
    • has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it. 

    Before granting or refusing the license, the Licensing Authority is required to order inspection of the whole premises where the operations are to be carried out. The inspectors are appointed under the Act. They are then required to submit a detailed report to the Licensing Authority which can then decide whether to grant the license or not.

  2. For Impoters
    • Applicant should be an Indian entity:

      • The Manufacturer himself having registered office in India.
      • The Authorised Agent of the Manufacturer
      • The Subsidiary of the Manufacturer
      • Any other importer

    • A "Manufacturer" here means a person or entity in a Country other than India who owns the trade name of the brand of the cosmetic product for which registration has been applied for and who / which manufactures such product at his / its own manufacturing site or at a site owned by another manufacturer in the trade name of his / its brand.

    • Validity of Registration Certificate: 3 years from date of issue

    • Timeline:

      • Application preparation 1 week: depending upon response from Customer
      • After applicant filing 6 -10 weeks: Under normal circumstances CDSCO processing time varies depending on the ongoing backlog of processing of the application. The notified/published timeline by the Government under the Drugs & Cosmetics Act is 6 months.

    • Registration Cases:

      • Import Registration Certificate (RC): Applicant to submit Form42 alongwith requisite supporting documents to CDSCO and if application is found as per requirement then CDSCO will issue Import Registration Certificate RC (Form 43).
      • Endorsement: Under issued RC, applicant can apply for adding Product categories, Product Variant, Manufacturing facility by means of endorsement with requisite application documents submission to CDSCO.
      • Re-registration/Renewal: For those product categories where applicant wish to renew the registration certificate before the expiry of it’s issued validity, Renewal needs to be applied 6 months prior to the expiry of RC by submitting requisite application documents to CDSCO.

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