Required Documents for CDSCO Registration in India

August 20, 2022
Registrationwala

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Required Documents for CDSCO Registration in India

Required Documents for CDSCO Registration in India

August 20, 2022

Registrationwala

CDSCO Registration for cosmetic imports includes two levels of assessment. The first is the application and the document assessment, also known as pre-screening. The Central Drug Standard Control Organization scrutinizes your application and documents at this level. The core of its assessment is the correctness of your submitted documents. In this article, we will discuss the required documentation for filing a CDSCO license application in India.

List of Documents for CDSCO application submission

Here, we provide a document list to pre-screen your CDSCO Approval application in India.

Cover Letter

The cover letter should entail the purpose behind applying CDSCO certificate. You must be clear, concise and convincing when drafting this document.

Application Form 42D

Needless to say, you should make no mistake as you enter your details in the application form. For the pre-screening, the details that CDSCO scrutinize is as follows:

Application Sign & Stamp: The Application Form should be signed & stamped by you
Details of the Cosmetic product: As the following:
- Name of the product
- Variant of the product
- Actual manufacturer details
- Categorization of the product
Name of the Authorized Agent: One who is filing the application on your behalf
Name and Address of the factory premises

Fee Challan

You need to provide TR-6 Challan specifying the CDSCO registration fees. The registration fee is USD 1000 for each proposed brand. Don't deposit this document if your challan doesn't have the following:

Bank's Stamp
Name of the Cosmetic
Address of the Manufacturing Site
Processing Fee details

Wholesale/Manufacturing License

The applicant must attach a copy of the valid Wholesale or Manufacturing License for the Indian Origin manufacturer.

Authorization Letter

The company's authorization letter lets the authorized agent collect and submit the documents.

Undertaking of the Authorized Agent

The applicant must provide an undertaking containing the name and designation of the Authorized Agent representing your certification requirements to the CDSCO.

Plant Master File

The applicant must also provide a notarized copy of the plant master file as well as the master file.

Product Registration certificate

The applicant must also provide a copy of the product registration certificate from the country where the cosmetic product is manufactured.

Labels of the Cosmetic Product

Provide the details of the label to be posted on the product's packaging. The label should entail the following:

Name of the Cosmetic Product
Name of the Manufacturer
Ingredients of the Cosmetic Product
Wholesale License Number
Import License Number

If you have any queries regarding filing the required attachments with the CDSCO application, you can connect with one of our CDSCO experts at Registrationwala.