List of documents for cosmetics
The market is flooded with various cosmetics and personal care products. Consumers get confused which product has quality and worth buying. However, to ensure the safety of cosmetics products Ministry of Health and Family Welfare brought regulations for licensing of cosmetics in India. Central Drugs Standard Control Organisation (CDSCO) of Ministry of Health and Family Welfare is the central regulatory licensing authority for registration of cosmetics products. Cosmetics which are imported and sold in India requires compulsory licensing in India. Only if the product is imported to India for re-packaging;100% export and not sold in the Indian market there is no need of registration.
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.
- Provide information on the product – The marketing status of the product in India and the period it has been selling in the Indian market.
In short, the following documents are required to be submitted:
- Covering letter
- Form 42
- Treasury Challan
- Power of Attorney by the manufacturer
- Schedule D (III)
- 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.
- 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.
If the product is imported for research and development like clinical trials, population studies, shelf life studies and post marketing consumer studies, then registration certificate is not required. In this case, the importer must take a No Objection Certificate (NOC) from CDSCO(HQ). A Registration Certificate is generally valid for a period of three years from the date of its issue if not suspended or cancelled.