Cosmetic Manufacturing License In India

Cosmetic Manufacturing License In India

The manufacture of cosmetics means the preparation of cosmetic products which may be used for personal care or for the cosmetic treatment of humans. A cosmetic manufacturing license is required for manufacturing cosmetics in India.

The Central Drugs Standard Control Organization (CDSCO), Government of India has framed The Drugs and Cosmetics Rules 1945 under which manufacturers are required to obtain a license from the Drug Controller General of India (DCGI). A Cosmetic Manufacturing License In India is required for the manufacture, possession, and sale of cosmetics in India.

What is Cosmetic Manufacturing License?

Cosmetic manufacturing is the process of making cosmetic products. The cosmetic manufacturing license is the authorization issued by the government which allows to manufacture, store and sell the cosmetic products in India.

Cosmetic Registration in India: A Step-by-Step Guide

  1. Step 1: Determine if your product needs to be registered. Under Rule 21 of the Drugs&Cosmetic Rules, 1945, all cosmetic items imported for sale in India must be registered with the licensing authority. Annexure 1 contains a list of products that must be licensed.
  2. Step 2: Select an Indian agent who is authorized to represent you: Foreign producers must have an Authorized Representative in India who will act as a point of contact for inspection authorities, assist in the device approvals and registration process, and report vigilance/adverse activities on their behalf.
  3. Step 3-Submit a Regulatory Dossier using Form 42: To start the registration process, Must have the required list of documents. The specified fee, as well as the information and undertaking in Schedule D III. Must be submitted with an application for the issuance of a registration certificate.
  4. Step 4: Obtain a Certificate of Registration in Form 43: After receiving the documents, the CDSCO will provide the Indian Agent with the first query letter. The CDSCO will either issue a subsequent query letter or grant a license after receiving the responses to the question. A registration certificate in Form 43 may be issued to a particular application for the import of any number of brands manufactured by a single manufacturer at one or more locations.

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Requirements for documentation

  1. Application letter with a cover letter from the applicant
  2. Form No. 42
  3. Treasury Challan
  4. Appointment of an attorney
  5. Schedule D III
  6. An original or a copy of the label is required.
  7. If applicable, a Free Sale Certificate (FSC), a Marketing Authorization Letter, or a Manufacturing License
  8. Specification and testing process for the product.
  9. List of countries that have received Market Authorization, Import Permission, or Registration.
  10. Soft copies of the brand, product, and manufacturer information

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