CDSCO-Cosmetic Approvals
Vincular simplifies CDSCO cosmetic approvals by handling documentation, filing, and end-to-end compliance.
Central Drugs Standard Control Organisation (CDSCO)
The Central Drugs Standard Control Organisation (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. The Cosmetic & Medical products are covered under CDSCO, with specific documentation and processes for each category.
Every cosmetic product intended for import into India must be registered with the CDSCO through a well-defined process under the Cosmetics Rules, 2020.
What is Considered a Cosmetic?
As defined by CDSCO, a cosmetic is any product that is rubbed, poured, sprinkled, sprayed on, introduced into, or otherwise applied to the human body or any part of it for cleansing, beautifying, promoting attractiveness, or altering appearance. This also includes any article intended for use as a component of such a product.
Forms Used in the Registration Process
Import of cosmetics is regulated under the Cosmetics Rules, 2020, part of the Drugs and Cosmetics Act
Form COS-1
The application form used to apply for a Registration Certificate for importing cosmetics into India under the Cosmetics Rules, 2020.
Form COS
The certificate issued after approval, allowing the import of cosmetics into the Indian market.
Regulated Product Categories under Cosmetics Rules, 2020
80 regulated cosmetic product categories organized by type
Skin & Face Care Products
Skin Cleansing & Hygiene Products
Hair Removal Products
Deodorants & Antiperspirants
Make-up Products
Hair Care Products
Shaving Products
Perfumes & Fragrances
Sun Care & Tanning
Oral Care Products
Nail Care Products
Who Can Apply for Cosmetic Import Registration?
Under the Cosmetics Rules, 2020, the following entities are eligible to apply
Authorised Agent
Any authorised agent of the manufacturer in India
Other Importer
Any other importer in India
Foreign Manufacturer
A foreign manufacturer having a registered office in India
Subsidiary
A subsidiary of the manufacturer in India
Application Submitted Under CDSCO for Cosmetic Imports
FRESH (Form COS-1)
Application for a new Import Registration Certificate for cosmetics under the Cosmetics Rules, 2020.
ENDORSEMENT
Addition of new products under an existing Import Registration Certificate.
Key Application Components
Manufacturing Site:
Details of the foreign manufacturing site where the cosmetic product is made.
Import Certificate:
The certificate granted by CDSCO allows the import of the approved cosmetic products.
New Cosmetics:
Any cosmetic product not previously marketed in India and requiring approval under Rule 13.
Registration Number (COS-4):
A unique Import Registration Number is issued upon approval of the COS-1 application.
CDSCO Fee Structure for Cosmetic Import Registration
As per the Cosmetics Rules, 2020, the CDSCO fee is payable in USD
| S. No. | Process | Description | Govt. Fee (USD) |
|---|---|---|---|
| 1 | GRANT | Registration certificate for each category of cosmetics | $1000 |
| 2 | ENDORSEMENT | Additional category under the existing registration certificate | $1000 |
| 3 | VARIANT | For each product variant under a registered category | $50 |
| 4 | MANUFACTURING SITE | For each foreign manufacturing site | $500 |
| 5 | NEW COSMETIC | Permission to import new cosmetic products (not marketed in India before) | $500 |
| 6 | REISSUANCE OF CERTIFICATE | Duplicate copy of the registration certificate (if lost, defaced, or damaged) | $200 |
| 7 | INSPECTION | Inspection of each overseas manufacturing site by the Indian regulatory authority | $5000 |
Documents Required for COS-1 Application
To apply for an Import Registration Certificate under the Cosmetics Rules, 2020
List of Ingredients / Composition
Complete list of ingredients with their concentrations (w/w or w/v basis).
Free Sale Certificate
Issued by the regulatory authority of the country of origin, confirming that the product is freely sold there.
Application in Form COS-1
Duly filled and signed application form for cosmetic import registration.
Label Artwork
Final product label including details such as product name, manufacturer, importer's name and address, batch number, MRP, expiry date, etc.
Manufacturing License
License or equivalent document from the country of origin, proving the manufacturer is authorised to produce cosmetics.
Key Regulatory Guidelines
Validity
The Registration Certificate is valid for 5 years from the date of issuance.
Language Requirement
All documents submitted must be in English.
License Maintenance
All licenses provided to the authorities must be valid and periodically renewed.
Certificate Presentation
The Registration Certificate must be produced on demand by the authorised importer, distributor, or agent whenever requested by the Licensing or Regulatory Authority.
Amendments for Changes
In the event of any change in the name or address of either the registered certificate holder or the overseas manufacturer, an amendment application must be submitted through the Central Government's online portal within 60 days of the change. Prior approval from the Central Licensing Authority is mandatory for such changes.