Cosmetic Industry is a blooming industry in India with a huge market for cosmetic and personal care products. Especially, with the start of online marketing cosmetic industry went through a paradigm shift. India is an attractive place for global brands making/planning an entry an entry.
Cosmetics Regulation in India protects consumers and makes sure that all cosmetic products on the Indian market are safe. Importing of cosmetic products in India requires registration certificate from Ministry of Health and Family Welfare as defined under Rule 21 of Drugs and cosmetics rule, 1945.
To obtain necessary clearances for selling Cosmetics in India, Registration Certificate is required from the Central Drugs Standard Control Organization (CDSCO). Using this license, import activities can be performed. Morulaa Health Tech provides assistance in applying Cosmetic Registration Certificate, Master importer (Customs Clearance, Supply Chain and Logistics), analysis and testing of cosmetics. In addition, we also assist manufacturers in setting up e-commerce portal for the sales of cosmetic product in India.
Procedure for Issue of Cosmetic Registration Certificate:
- The manufacturer or by his authorized channel in India or by the subsidiary in India authorized by the manufacturer.
- The application form must be submitted to the office of the DCGI under Indian Ministry of Health and Family Welfare, New Delhi (Both as a hard Copy and Soft Copy)
- The application must be submitted
Form – 42
along with a cover letter
Challan
Power of Attorney
Schedule DIII
Original or copy of a label
FSC/Marketing Authorization letter/Manufacturing License (if any)
Product specification and testing protocol
List of countries where Market Authorization or Import Permission or Registration has been granted
Pack insert ( if any)
Soft copies of the information about the brands, products and manufacturer.
- Receipt of the application form
- The Drug Controller General office will issue an acknowledgement i.e. copy of duly stamped cover letter.
- Registration fee
USD250 or equivalent per imported product
Fee is to be deposited in designated branches of the Bank of Baroda
- Waiting period before issue of registration certificate
- Drug Controller General’s office would issue a registration certificate within six months from the date of submission of application.
- Validity period of the registration certificate
- The registration certificate would be valid for three years.
- A single application and a registration certificate in Form 43 may be issued for import of one or more than one cosmetics manufactured by the same manufacturer only if the cosmetics are manufactured at one factory or more than one factory functioning combined as a single manufacturing unit.
- A Registration Certificate is sooner suspended or cancelled shall be valid for 3 years from the date of its issue only if application for a new Registration Certificate is made within 6 months before the expiry of the said certificate, the existing Registration Certificate shall continue to remain until orders are passed on the application.
- No cosmetic shall be imported with the specifications mentioned in schedule S and schedule Q or any other standards of quality, safety and other provisions under the rules. If cosmetic is not included under schedule S then it shall meet with specifications under the rules and standards applicable to it in the country of origin.
- Registration certificate is not required for Import of cosmetics for Research and development (R&D) purposes like packaging trials, consumer studies, shelf life and transport studies. In such cases the importer has to get necessary permission from CDSCO(HEAD QUARTERS). Importer must give written statement that these products are not released for domestic sale.