Cosmetic Registration and Approval (Form 42, 43)

Cosmetic Registration and Approval (Form 42, 43)

As defined under Rule 21 of Drugs & Cosmetics Rules, 1945, all cosmetic products imported for sale in India need to be registered with licensing authority.

The application for Registration of Import of Cosmetics can be made by-

  1. The Manufacturer himself having registered office in India
  2. The Authorized Agent of the Manufacturer
  3. The Subsidiary of the Manufacturer
  4. Any other importer

The application for registration (Form-42) with required documents, are submitted to Drugs Controller General (I), CDSCO, New Delhi. This application is accompanied by the fee specified along with information and undertaking in Schedule D-III. A single application is made in Form 42 for any number of brands manufactured at one or more locations by a single manufacturer (legal).

The Registration Certificate (Form 43) may be obtained in approximately three months, whereas the validity of the registration is for three years.

In the Guidelines on Registration of Import of Cosmetics, cosmetics are categorized as per Column 3 of Brand of Cosmetic products. Cosmetic product categorization is important as government charges for cosmetic registration application based on each category and variant. According to new regulations, the government fee is 2000 USD per category and 50 USD per variant.

To take cosmetics registration in India, you must provide the following information to CDSCO:

  • Details of the manufacturer and manufacturing premises – Name and address of the manufacturer and manufacturing facilities along with contact numbers and email addresses; name, address and contact details of the of the applicant; and a short profile of the manufacturer’s business in the domestic as well as global market.
  • Proof of payment of registration fee.
  • Details of the cosmetics – Brand names of the cosmetics along with their category, variants and pack sizes to be imported for sale in India; particulars of the manufacturing licenses/Registration/marketing authorization; list of countries where a grant of import permission of the cosmetic product has been given.
  • Product Information – Names of the ingredients, specification and testing method of the product, specimen of the label, and if any package inserts.

In short, the following documents are required to be submitted:

  • Covering letter: The purpose of the application has to be mentioned clearly. This document is provided by the importer.
  • Form 42: This is generated online after payment of the government fee and signed and stamped copy of the same must be provided by the importer
  • Challan: Document indicating the fee paid in support of the application in INR and also includes some details of the applicant.
  • Power of Attorney by the manufacturer: is a document that indicates the legal relationship between the manufacturer and importer and lists out the products, the categories being registered and the pack sizes to be imported.
  • Schedule D (III): Gives the details of the manufacturer and manufacturing premises
  • Original or a copy of the Label of the product.
  • Free Sale Certificate (FSC)/Marketing Authorization letter/Manufacturing License for all variants need to be submitted: lists the products and is a declaration that the enlisted products are freely sold in the country of origin
  • Product specification and testing protocol of the product.
  • The list of countries where Market Authorization or import permission or Registration was granted.
  • Package inserts of the product.
  • Soft copies of the information about the brands, products, and manufacturer of the product.

CliniExperts can smoothen the process and help you obtain the Cosmetic Registration.

For more details on our services contact us.

Reference

1. The Drugs and Cosmetics Act, 1940 and Rules 1945. Available at- https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
. Accessed on – 21st May 2016.
2. The Drugs and Cosmetics Rules, 1945. Available at- https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf
, Accessed on – 21st May 2016.

Call Now