A brief look into the CDSCO guidelines

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If you’re applying for a license to import drugs or cosmetics from a foreign land, it’s important for you to know about the CDSCO guidelines.

However, the guidelines to get CDSCO certificate are quite complicated, filled with legal jargon and overall unpleasant to read. So, we understand that why many are apprehensive to know about this necessary certification.

That being said, it’s the reason we have created this article. Through it, we have made the complex issue of CDCSO registration process into a simple matter using simple words. Read to take a brief look into the CDSCO guidelines to a level that you understand.

What India wants as per the product registration guidelines of the CDSCO?

CDSCO or Central Drug Standard Control Organizations’ is India’s primary authority to watch over all the imported drugs and cosmetics. As per the guidelines, India wants that:

  1. The products that are imported should not have any toxicity in them.
  2. The imported products should have been ethically produced.
  3. The imported products should not have been tested on animals.

To filter those products that follow the guidelines from the ones who don’t, this Authority has come up with CDSCO application forms. There are applications forms for import of:

  1. Medical Equipments
  2. Drugs for Personal use
  3. Drugs for sale
  4. Surgical devices
  5. And even cosmetics.

Guidelines specific to CDSCO import license for cosmetics

The products associated with drugs or medical domains require the license. However, when it comes down to it, the most important one among it is for the import of cosmetic products. Thus, let’s now take a brief look into how to acquire the CDSCO certificate for importing cosmetic products:

  1. First, you’re required to create a file. In that file you’ll put all the documents required for CDSCO certification for import of cosmetic products.
  2. Through online mode, you’re then required to file the application and submit it to primary CDSCO body.
  3. Anticipate that you can be asked to give additional documents or can face objections of one nature or another. That’s why, get in touch with CDSCO registration consultants from the start so that you can do a pre-emptive strike – leaving no option for CDSCO but to only accept your application.
  4. Once your application is accepted, the Central Drug Standard control authority will mail you the article through the email.

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Covering the most challenging aspect of CDSCO online registration

Filing the CDSCO online application is not the most challenging aspect of the certification process. It’s the documents that you need to gather. Following is a list of those documents:

  1. A cover letter will be your first document. It will contain some select choice of words to convince the CDSCO to issue you CDSO online registration.
  2. The second document will be the power of attorney. As exporter and importer both are involved with the filing of the application form, they would need an Authorized Indian Representative to file the application. In this case, that AIR would be the CDSCO consultant.
  3. An undertaking in which you’ll declare that everything you’ve put inside the application form is correct.
  4. Labels that you’ve put on the product’s packaging
  5. Specification of how the product is to be used
  6. Testing method that has been implemented on the product prior to it going for sale.
  7. The manufacturing license that the manufacturer of the product has gotten from the country of origin.
  8. A free sale certificate of the product that establishes that the product can be sold freely in any country
  9. An undertaking stating that no animals were tested during the testing process of the product.
  10. Another undertaking attesting that no heavy metals are used during the manufacturing process of the product.

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Now that you have gotten a look into the CDSCO form of license, would you like to proceed with getting the application. If you are, reach out to our experts.

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