How to obtain CDSCO Registration in India?

If you’re an importer and your business is to import cosmetic products for the Indian citizens, you need the approval of Central Drug Standard Control Organization (CDSCO). It’s known as CDSCO approval and to obtain it, you need to furnish certain documents and follow certain steps. 

Here, you will know about both of them. 

Documents to acquire CDSCO Registration

Following are the documents you require to obtain CDSCO Certificate in India:

1. Cover letter: In this cover letter, specify the purpose for which you’re applying for the CDSCO approval. 
2. Manufacturer’s authorization: The manufacturer of the cosmetic product must authorize you to act as an importer for it in India. He will facilitate it by issuing you an authorization letter. Provide a copy of that letter to the CDSCO at the time of registration. 
3. Filed Part I of schedule D: The application form of CDSCO has many parts. The part that you must care for is the Part 1. Here, you’re required to enter your personal, organizational and contact details. 
4. List of ingredients: Draft a document where you’ll specify a list of ingredients and their concentration in terms of percentage. 
5. Labels of the proposed product: Provide the label details including the its size and the information you will present of the cosmetic’s package. 
6. Specification and testing methods you have implemented: Provide a list of methods you’ve implemented to test the product. 
7. Pack insert: Pack insert refers to a small document that comes with the package of cosmetic that entails the direction to use and other information about  it. 
8. Manufacturing licenses of the product: Provide the manufacturing license of the product if applicant. If not, provide an undertaking that no manufacturing license is required to product the cosmetic product. 
9. Free Sale certificate: Provide a certificate that proves that the it’s allowed for the product to be sold anywhere in the world. 
10. Declaration of Non animal testing: Sign a declaration that no animals were tested during the product’s production. 
11. Declaration for Hexachlorophene and heavy metal content: Declare that heavy metals and Hexachlorophene content are either absent from the product or are present within the regulatory limitations. 
12. Bharatkosh E-receipt: Provide copy of the e-receipt of application processing fee for CDSCO certificate. 

Process of filing the application

Follow the CDSCO registration process that you must follow:

1. Furnish the documents mentioned in the previous section
2. Now, go to the CDSCO portal and register as a new user
3. Afterwards, login and go your dashboard
4. Then, select the cosmetic import section
5. Choose CDSCO registration application
6. Proceed to fill the part 1 of the application form
7. Once you filled and submitted the online application, take its printout
8. Proceed to attach the printout with the physical copies of the furnished documents
9. Finally, saubmit them with a sample of the cosmetic product to the CDSCO branch office.

After receiving your application, CDSCO will notify you that it has received it. It will then initiate the assessment of your application. If it finds any issues, it will notify you while informing you of the changes you must make to fix those mistakes.

Here, you must rectify the errors and wait for further notifications. After the acceptance of application, the sample of the product goes through testing. 

If the CDSCO finds out after thorough assessment of the product that it meets all the regulatory parameters, you’ll get your CDSCO approval.

Conclusion

You must note that the procedure contains redundant steps considering you couldn’t have uploaded the documents online from the start.

Nevertheless, what you’re reading here in this blog are the precise steps and you need to follow them. Once you obtain the CDSCO certification, it will have a validity period. It’s subjective to the nature of cosmetic product. What does that mean? 

Consult with our Consultants to find out.