Cosmetics Registration in
Central Drugs Standard Control Organization – Directorate General of Health Services
Link for RA:
Drugs & Cosmetic Act, 1940 & the Cosmetics Rules, 2020.
Who can register :
- The Authorized Agent of the Manufacturer
- The Subsidiary of the Manufacturer
Data to be communicated :
An authorisation must be submitted with an application for an import registration certificate.
- Executed and validated before a First Class Magistrate in India or a comparable authority in the country of origin, or attested by the Indian Embassy in the stated nation, or Apostilled from Hague convention member countries.
- Name and complete address of the manufacturer & its manufacturing premises as per Form COS-1.
- Name and complete address of the approved Indian Agent as per Form COS-1.
- Name of the Cosmetic product, Variants (if any), and name and full address of the product’s manufacturing premises.
- The product should be classified according to the Fourth Schedule of the Cosmetics Rules, 2020.
- Both the approved Indian Agent and the manufacturer have signed, stamped, and dated the document with the name and designation of the signatory.
Application in Form COS-1
- Original application in Form COS-1, duly filled, signed, and stamped by the authorised Indian Agent/Manufacturer.
- The cosmetic product’s name, variations (if any), pack size (in Indian Metric System), and manufacturing location must all be recorded. The product should be classified according to the Fourth Schedule of the Cosmetics Rules, 2020.
- Authorized Agent’s full name and address in India.
- Manufacturer’s full name and address, as well as its manufacturing facilities.
- All details on Form COS-1 must match those in the Authorisation and Part-I of the Second Schedule.
Timeframe and fees:
The fee of Registration Certificate for each category of cosmetics – 1000 USD
Registration of each manufacturing site – 500 USD
Each variant – 50 USD
The Registration Certificate fee for an additional category of Cosmetic is paid along with the application in Form COS-1 – 1000 USD.
- Authenticated copy of manufacturing licenses/registrations/marketing authorisations issued by the Regulatory Authority in the country of origin for the applied products.
- If manufacturing licenses/marketing authorisation is not available in the country of origin, the producer must make an undertaking to get them.
Original free sale certificates issued by the National Regulatory Authority or other competent associations/organisations from the major manufacturer’s or actual manufacturer’s place of origin can be considered.
Along with the application in Form COS-1, the company must certify that the applied cosmetic products to be imported into the nation have not been tested on animals.