Cosmetic products which come under the definition of Cosmetics as per Drugs & Cosmetic Act 1940 are regulated in India and need compulsory registration. This compulsory licensing is effective from 1st April,2013. Only Cosmetics products imported into India in bulk for re-packaging and re-processing and 100 percent export to other countries are exempted from this new regulation and will not require registration. Central Drugs Standards Control Organisation (CDSCO) is the central licensing authority of Cosmetics products in India. If you want registration of the cosmetic product in India, you must submit the documents in Form 42 format along with important documents. Registration certificate of a cosmetic product is granted in Form 43. Registration certificate is specific to a product and manufacturing site. If the application and all the documents required for licensing are complete as per Schedule (D III) and Rule 129 C, the regulatory authority will issue Registration Certificate within six months from the date of receipt of an application. However, CDSCO targeted timeline for processing of the application is 90 days as per circular dated 30.05.2014
Manufacturers and importers always have a query- How to register additional products in the already granted or valid Registration Certificate in Form 43?
Importer or manufacturer must apply for endorsement to the existing Registration Certificate. If the cosmetic category is already registered, importer need to provide the necessary cosmetic documents except for fees. Conditions for endorsement are that the additional products are manufactured at the same manufacturing site. Importer needs to pay 2000USD per category needs to be paid. The duration and validity of the registration certificate are valid for three years. Validity of the endorsement issued for these additional products will be the same as of main registration certificate.
The registration certificate needs to be produced by importer or manufacturer whenever licensing authority asks for the same. The manufacturer needs to inform licensing authority in case of any change of any declaration of documents regarding the marketing of the product, product withdrawal or any quality assurance data submitted at the time of registration.
Cosmetics registration in India is a tedious process and requires a lot of processes. It requires a submission of lot of data related to commercial and scientific aspects of the cosmetic product. For hassle-free registration of cosmetic product, call today CliniExperts at +91 7672005050