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CDSCO Certificate: Understand the requirements before applying

CDSCO certificate is a requirement that the government has made mandatory for anyone who wants to either import drugs, medical devices or cosmetics in India. As India’s primary authority of watching over chemicals, drugs and related products, the Central Drug Standard Control Board has the power to ask for specific requirements before it can issue any license.

In this article, we are going beyond the CDSCO certification process. We are digging deep into the requirements that a cosmetics importers need to fulfil before getting CDSCO’s approval.

Importance of understanding the requirements  of CDSCO certification

Simply put, if you don’t adhere to the requirements, you’re not going to get CDSCO certificate. The stringent product registration guidelines set by CDSCO consist of these requirements because:

  • The governments wants for the products that come into the country to be free of any adulteration.
  • The government wants that these products to be produced in an ethical manner.
  • The government wants these products to be same for an Indian citizen’s consumption.

Each and every stringent law that the government has put in place is to make sure that no harm comes to the people. However, because sometimes adulterated products make their way into the country, the government has to impose restrictions by adding more requirements.

As an importer, your brand’s image depends on your product. Understanding these mandatory requirements is important for you because:

  1. Product with no adulteration will enhance your reputation.
  2. Products that are ethically produced will tickle the conscience of the people.
  3. Product’s that are safe for consumption have more customers.

Bottom line is, understanding the requirements leads to better products that leads to more reputation for your brand and more customers for your business.

A cover letter to the product

The governments wants the applicants of the CDSCO import license to be confident. If you’re confident enough to put your intention into words, the government considers you diligent enough to follow all the product guidelines. Thus, the very first requirement that you need fulfil is  a cover letter. Through it, your goal is to:

  1. Convince the CDSCO to grant you the license.
  2. Exude confidence in your services so that the government doesn’t consider you a fraud.
  3. Provide complete details of the services you provide in a concise and easy to understand manner.

A power of attorney to authorize CDSCO registration consultants

No one in the right mind wants to go through the pains of dealing with the CDSCO on their own. The wiser among you will try to find a CDSCO registration consultant for help. However, you can’t just ask for help and then provide them with nothing that they need to help you. A power of attorney assigns them the power to file your application. You need to draft it keeping the following details in mind:

  • The details of the manufacturer should be present.
  • No information of the authorized agent  – CDSCO consultant – should be left out.
  • Details of the product should be complete.
  • The power of attorney should mention its own validity period.  

An undertaking that speaks out your intentions

Licenses like vno license and below every application of any business license or registration, there is an undertaking line. As per the line, you have to declare that all the information you have provided is correct. In case you have falsified any detail, making such a declaration is considered a criminal offense. However, the punishment is still limited to rejection of the CDSCO application forms.

List of ingredients present in the cosmetic product

You need to provide a document listing every ingredient used to make the product. By analyzing this along with the CDSCO form for cosmetic import, the organization would try to determine whether the ingredients are present at right levels or not.

Labels on the product

The product label has been a topic of contention in many circles. But, it’s the most simple one. A label of a product should contain the name of the product, the details of the manufacturer, the registration certificate number of the product, and other information as directed by the requirements of CDSCO online application.

Testing method implemented to test the effectiveness and other factors of the product

Every cosmetic product should go to mandatory testing before it’s put on sale or is imported in India. The original manufacturer have to provide the details of that test along with a complete report detailing the:

  1. Environment within with the test took place
  2. The parameters that were considered
  3. The duration of these tests
  4. The number of iterations in which the tests were done.

Cosmetic products manufacturing license

The original manufacturer is only allowed to expert his cosmetic products in India if it has the manufacturing license for it. It would also work as another document that states that product can be sold in regions other than their country of origin.

Free sale certificate

It’s a document that states that the product can be sold in other countries. In the absence of a free sale certificate, you can present the manufacturing license of the product.

A declaration stating that the product wasn’t tested on animals

CDSCO online registration rules state that the products to be imported should be the ones that weren’t tested on innocent animals. You have to make a declaration of the same.

A declaration stating that the product doesn’t contain any heavy metals

Heavy metals might be regarded as exotic when it comes to Ayurveda, but when it comes to cosmetics, they are considered damaging to the body. Thus, you have to make a declaration that the cosmetic products that you’re looking to import is free of any heavy metal.

Conclusion

Understanding these requirements of CDSCO certificate will let you penetrate the meaning of the license. Also, if you want to obtain the license quickly, knowing about the requirements will give you a head start.

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