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
