CDSCO certificate is the license that you must have if your business idea is to import drugs or cosmetics and then selling it in India. Without the approval from the Central Drug Standard Control Organization of India, such products can’t be imported, let alone be sold in the country.
The organization has thus implemented testing mechanisms for such products. You take your products through these testing mechanisms. And if the reports say that there is nothing wrong with the drugs or cosmetics, you get the approval for import.
And with that one paragraph, you now know what you need to about CDSCO certificate.
In this article, we are going to do deeper. We are going to explain to you, in simple terms:
- The guidelines from CDSCO that state what kind of products are you allowed to import.
- The process by which you can obtain CDSCO certificate.
- The documentations that you need for the registration process.
- The CDSCO registration consultants that can assist you throughout the procedure.
Let’s begin by discussing the most important topic of them all: the kinds of products that CDSCO allows to import
The CDSCO certificate guidelines stating the products you can import in India
Nothing interacts with our bodies more than the things that we consume. Thus, one must care when consuming chemical substances(drugs) with the body. Wrong chemicals, allergens or materials that are injurious to health can damage the bodies in ways that are too graphic too explain.
But a consumer doesn’t always know what kind of drugs is he consuming – despite what it says on the drug’s labels. That’s why, the Central Drug Standard Control Organizations has to step in to create specific guidelines.
Here are the product registration guidelines CDSCOhas put forth to ensure that whatever drugs our Indians interact with can’t harm them.
- The product should only have limited amount of heavy metals: Heavy metals, despite their nature, have been in use in cosmetic and medicinal products since time immemorial. However, because many falsely believe that “more is better”, the amount of heavy metal is sometimes more than the prescribed limit.
Such carelessness can cause consumers issues such as fatigue, organ failure. In extreme conditions, it can even lead to death. Thus, through an undertaking the CDSCO gets a guarantee from the importers that the heavy metals is only present in such products at a prescribed limit.
- The products should not have high quantity of hexachlorophene: The cosmetics importer has to attach a declaration with his CDSCO certificate application forms that hexachlorophene content in the product is not beyond the prescribed limit. Generally used in topical ointments, hexachlophene is used as a reverse edema at its initial stages.
However, increased exposure of this chemical is known cause issues such as brain swelling, decolouration of skin and other side effects. It’s therefore important that the hexachlophene content in a cosmetic doesn’t extend beyond the right limits.
- The product should be allowed to sold in the native: CDSCO import license can only issued for products that are allowed to be imported. If your intention is to import a product that’s not allowed to be sold in its country of origin, leave the thought of getting the license.
As per the norms of filing the CDSCO form, you also have to attach a free sale certificate. The authority of the product’s native country provides that license if the product can be sold that country. Without a free sale certificate, you won’t get the permission from India’s main drug organization to get the license.
- The product’s label should have all the necessary information: From the country where the product is manufactured to the email ID for customer complaints. From the manufacturing date to the expiry date. From directions to use the product to the ingredients list. Nothing should be missing the product’s label. The customer should have ample of information before choosing to buy that product.
- A different approval is required to import products for personal use: While not a full-fledged license, you’ll need to get approval from the CDSCO to import cosmetics or drugs for personal use. The form you’d need to file for that purpose is CDSCO certificate form 12.
Note: If product’s native country national authority don’t have the concept of a free sale certificate, you would need to obtain an NOC from the same authority. It should state the product can be sold in that country and is fit for export.
Other than limiting the presence of harmful chemicals and only allowing products that can be sold in the country where they are manufactured, CDSCO’s product guidelines also state one important point:
- No animals should be harmed during the testing of product: We live in an enlightened age where compassion is promoted towards all creatures. CDSCO has thus made it mandatory to only allow import of those products whose testing didn’t result in harm to animals.
Other Related Content: Ayush License
The process by which you can obtain the CDSCO certificate
Thankfully, you won’t have to use pen and paper and waste valuable resources to file the application. The process is exclusively online, with some exceptions. Following are the steps of CDSCO certificate process:
- Prepare the documents that are necessary for application filing. You’d realize in the next section that the documents that you need are many. That’s why, we recommend that you create a file of those documents beforehand as it can require days to do so.
- Fill the CDSCO certificate online application available at the Central Drug Standard Control Organization’s website. Upload the documents as you get the prompt upon entering the necessary details.
- Once you filled every detail that the application requires, you’ll have to click the checkbox to declare that the details you’ve entered are correct. And, you understand that CDSCO can hold you liable if any of the details are found to be false.
- After you press of submit after paying the required fee, it will instantly reach the authority.
- The CDSCO will then take its time assessing every little detail of your application.
- If the organizations finds that you’ve correctly filled the application form and attached the right documents, it will send you a notification.
- After receiving the notification, you’ll need to sample of the drug or cosmetics to the CDSCO for reanalysis purposes.
- The CDSCO will then re-analyze these products that you’re looking to import. If they fit every criteria mentioned in the product guideline, CDSCO certificate online registration process will be successful.
And thus, you’ll obtain the CDSCO certificate.
Documentations you need for the CDSCO Certificate registration process
The success of this online registration depends upon the correctness of the documents you’ve submitted. Thus, it’s better to learn about them even before you talk to a consultant. Here is the list of those documents:
- A cover letter mentioning for what purpose you’re filing the application of CDSCO certificate.
- A power of attorney to authorized your Indian representative. They will be responsible for dealing with the complete registration process.
- An undertaking that states that you’ve filed the correct information and you know that you’ll be held liable if the CDSCO finds any information in the application to be false.
- List of ingredients present in the product.
- Label’s put on product’s package.
- Specification of the product
- Manufacturing license of the product issued from the country where it’s manufactured.
- A CDSCO free sale certificate or an NOC from the national authority of product’s country of origin.
- Two duly filled declarations:
- Declaration stating that no tests were done on animals.
- Declaration stating that hexachlorophene and heavy metals are absent / only present under prescribed amount in the product.
The CDSCO Certificate consultants that can assist you with the registration
As you might have gathered, the registration process is not easy. Combining it further with the complexity of the documents might also make you realize the need of a CDSCO consultant by your side. Unsurprisingly, these seasoned professionals already know about the entire process.
They further know which people to strike a conservation with if you need to fast track your application. Whether it’s that, or filing the application, preparing the documents or just any other general assistance, a consultant can provide you full end to end assistance.
Following the product registration guidelines is important if you seek to trade in imported drugs or cosmetics. However, the process of obtaining the registration is complicated, and so are the documents that you need to attach. Thus, whenever you are in need of a CDSCO certificate, bet on a CDSCO consultant to assist you.