Cosmetic is defined under section 3(aaa) of the Drugs and Cosmetics Act, 1940 as, any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance, and includes any article intended for use as a component of cosmetic.

State License ~ Central License

Under the provisions of Drugs and Cosmetics Act, 1940 and Rules made there under, the manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments, while the import of cosmetics is regulated under a system of registration by the Central Licensing Authority appointed by the Central Government.

The Drugs Controller General (India) functions as the Central Licensing Authority who grants the Import Registration Certificate and regulates the import of cosmetics into India.

Any article falling within the definition of cosmetic is required to be registered along with pack size, variant(s) and manufacturing premises before its import into the country.

Those who manufacture cosmetics in India are required to take State Cosmetics License and those who import cosmetics into India are required to take Central Cosmetics License.

• A

  State License - Manufacturing of Cosmetics

  1. Covering Letter.
  2. Application in Form COS-12.
  3. Particulars of New Cosmetics such as name of the cosmetics, category of cosmetics/intended use, composition of product, test protocol/test method of raw materials and finished product and specification of the raw materials and finished product along with certificate analysis.
  4. Assessment of the safety for human health of the finished product, its ingredients, their chemical structure and level of exposure.
  5. Existing data on undesirable effects on human health resulting from use of the cosmetic product.
  6. Supporting data for the claimed benefits of cosmetic product should be made available to justify the nature of its effect.
  7. Specimen copy of the product label and carton ie. package insert and promotional literature.
  8. Whether the preparation of the proposed cosmetic is approved and marketed in other major countries if yes details of the same.
  9. Any other data generated on safety, effectiveness and quality parameters.
  10. Other documents such as undertaking from the manufacturer stating compliance of all raw materials or pigments used, heavy metals and hexachlorophene contents in products with Bureau of Indian Standards and the Cosmetics Rules, 2020 and details of GST Number.
• B

  Central License - Import of Cosmetics

  1. Covering Letter mentioning the purpose of application.
  2. Application in Form COS-1.
  3. Authorization from the manufacturer (duly authenticated).
  4. Information and undertaking required to be furnished by the manufacturer or his authorized importer or distributor or agent with the application form for import registration certificate.
  5. Filled in Part-I of Second Schedule D.
  6. List of Ingredients along with its percentage contents.
  7. Labels of proposed products.
  8. Specifications and testing methods.
  9. Pack insert.
  10. Manufacturing Licenses/undertaking for no provision of manufacturing license in the country.
  11. Free Sale Certificate (duly authenticated).
  12. Non Animal Testing Declaration.
  13. Declaration for Heavy Metal and Hexachlorophene content.
  14. Other documents (If any).
  15. Original Bharatkosh e-receipt for fee paid.

Below is the step by step registration process for Cosmetics License in India.

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