- Import of cosmetic products is regulated in India under the provisions of the Drugs & Cosmetic Act 1940 & Rules 1945.The Cosmetic Brand is required to be registered with CDSCO.
- From the perspective of registration import, the product is considered a ‘Brand’. For example –If your face wash comes in 3 variants each having different colour packs and is packaged and sold in 50 ml, 100 ml tubes. All six of them together will comprise a single brand category.
- The content of your product needs to comply with the Bureau of Indian Standards (BIS) and Drugs & Cosmetic Rules, 1945. Specific guidelines are also available for inner and outer labelling, ingredients and colour. (More on labelling in another blog)
- The applicant could be the Manufacturer / subsidiary or his Authorised Agent.
- Application for registration (Form 42) should be submitted in both hard copy and e- format to the Drugs Controller General (India), CDSCO, (cosmetics division), FDA Bhawan, ITO, Kotla Road, Delhi-110002.
- Along with the application, a dossier for Registration as per the guidance documents available at the link: http://cdsco.nic.in/Cosmetics/guidelines on registration of import of cosmetics.htm should be compiled and submitted.
- A fee of 2000 USD [or its equivalent in Indian rupees] per category of cosmetic plus a fee of USD 50 for each variant to be paid along with application. Please note the fee has lately been revised from USD 250 for each brand irrespective of number of variants.
- If the application is complete in all respects, CDSCO shall within six months from issue the Registration certificate (Form 43). However, CDSCO targeted timeline for processing of application is 90 days.
- The certificate is valid for 5 years after which it has to be re –registered.
- Since it is mandatory to print the registration number on the labels, it is illegal sell the products before the number is issued or permission obtained.
Author : Sheela Iyer
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