Bridging Brands and Borders

Regulatory Body: Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. Import of cosmetics into India is regulated by the Cosmetics Rules, 2020.

Key Requirements:

Mandatory Registration: All cosmetic products, including skincare and beauty products, must be mandatorily registered with the CDSCO before import into India. This applies to each specific product, including its pack size, variants (e.g., color, shades), and manufacturing premises.

Application Process:

o    Application is made online in Form COS-1 on the CDSCO's SUGAM Portal.

o    The application can be submitted by the manufacturer, their authorized agent, the importer in India, or a subsidiary in India authorized by the manufacturer.

o    A prior registration with the SUGAM portal is required.

Documentation: Comprehensive documentation is required, including:

o    Covering letter.

o    Proof of fee payment (USD 250 or equivalent INR for each brand for each category of cosmetics).

o    Authorization from the manufacturer (duly authenticated).

o    List of ingredients with percentage contents.

o    Labels of proposed products (must be in English or Hindi, clear, and easy to understand).

o    Specifications and testing methods for the cosmetic.

o    Valid manufacturing license issued in the country of export, or an undertaking if no such license exists in the country of origin.

o    Free Sale Certificate (FSC) from the country of origin.

o    Non-animal testing declaration. Cosmetics tested on animals are strictly prohibited for import.

o    Declaration for heavy metal and hexachlorophene content.

Labeling Requirements:

o    Labels must include: product name, manufacturer's details (name, address, principal place of manufacture with pin code), manufacturing and expiry date, batch/lot number, net contents (weight for solids, fluid measure for liquids), list of ingredients in ascending order of concentration, directions for use, warnings/precautions (e.g., "Avoid contact with eyes," "for external use only"), and any required international symbols.

o    No misleading claims are allowed.

Quality and Safety Standards: Cosmetics must comply with the specifications prescribed under the Ninth Schedule of the Cosmetics Rules, 2020, or other applicable standards of quality and safety. If not listed, they must meet the standards of the country of origin.

Shelf Life: Only products with a minimum expiry period of six (06) months from the date of import are permitted.

Prohibited Ingredients: Certain ingredients, like hexachlorophene, are prohibited. Dyes, colors, and pigments must be specified by the Bureau of Indian Standards (BIS) (IS: 4707 Part).

 Validity: The registration certificate is typically valid for three years and must be renewed