All cosmetic products imported for sale in India must be registered with the CDSCO Guidelines Authority as per Rule 21 of the Drugs & Cosmetics Act of 1945. The applicant must apply for registration in Form-42. They must submit the requisite documents to the Drugs Controller General of India. The applicant must destine the application to the address: CDSCO, FDA Bhavan, Kotla Road, New Delhi 110002.
Who can be a CDSCO-registered Cosmetic Importer in India?
The following entities can apply for the Registration of the Import of Cosmetics in India:
- Manufacturer of Cosmetic with a registered office in India
- Authorized Agent of the Cosmetic Manufacturer
- Subsidiary of the Cosmetic Manufacturer
- Other Cosmetic Importers
Meaning of a Cosmetic Brand
Here, a cosmetic Brand or a Brand means each category of cosmetic products as mentioned in the columns enclosed in the Act’s Annexure. A Brand includes all product variants such as color, shades, pack sizes, etc. Also, Brand does not mean the trade name of any manufacturer’s product or the manufacturer himself.
Who is a CDSCO-approved Cosmetic Manufacturer?
A Manufacturer is a person or entity in a nation other than India who owns the trade name of the cosmetic product Brand for which registration has been applied. He can manufacture such cosmetic products at his own manufacturing site. The manufacturer can also produce the cosmetic at a site owned by another manufacturer. But it must be in the trade name of his cosmetic Brand.
Also Read: Import License
Authorized Agent of a Manufacturer
Subsidiary here means an entity owned by the manufacturer. An authorized agent is a person or entity in India certified by a cosmetic manufacturer. The authorized agent is responsible for the business activities of the cosmetic manufacturer in India. It includes compliance with the Cosmetic Act’s provisions in all respects.
Here, CDSCO Guidelines-approved Importer means any entity purporting to import cosmetic products other than the manufacturer and its subsidiary.
CDSCO Application Procedure & Fee
An application for the issue of a CDSCO registration certificate must accompany the specified fee along with the information and undertaking as mentioned in the D3 Schedule of the Drugs & Cosmetics Act. Also, the applicant must make a single application in Form 42 for any brands it tends to manufacture at one or more locations by itself.
The Authority will then issue the applicant’s single registration certificate in Form 43. It will be in respect of the Import of brands manufactured at one or more locations by the Cosmetic manufacturer.
CDSCO Licensing Fee
Each application must accompany a fee of USD 250 or its equivalent Indian rupees for each Brand. It must be for each category of cosmetics as the Act mentions in the third column of the enclosed list in the cosmetic annexure.
If the CDSCO applicant seeks to import a similar Brand belonging to different cosmetic manufacturers, then he must submit a separate CDSCO registration application for each manufacturer and pay separate licensing fees.
Multiple Brands for single Cosmetic
For any existing CDSCO Registration Certificate, if the applicant wants to add any different brand or cosmetic product of an already registered category, then he must file a separate application to the Authority. In such cases, the Authority will endorse additional product permission to the already approved class in an existing CDSCO Guidelines. But no fee will be charged.