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CDSCO Certificate Registration in India

Overview of CDSCO Registration

The Drugs and Cosmetics Rules, 1945, and the Drugs and Cosmetics Act, 1940, control and regulate the sale, manufacture, import, distribution, and other aspects of drug-related activities in India. According to the aforementioned Act and Regulations, any chemical that meets the criteria for a drug must be registered prior to being imported outside of the nation. The Central Drug Standard Control Organization, or CDSCO, is the organization that grants CDSCO Registration in accordance with national laws and regulations. It is a National Regulatory Authority, and every drug clinical trial requires the CDSCO's permission in order to proceed. It established the guidelines for medications and monitored their quality.

What is the Role of CDSCO?

The Central Drugs Standard Control Organization (also known as CDSCO) is the national regulatory body in India for pharmaceuticals, medical devices, and cosmetics. Operating under the auspices of the Ministry of Family Welfare & Health, the Directorate General of Health Services, and the Government of India, it is a highly influential institution in India.

The Central Drugs Standard Control Organization will now be able to assess all medical devices, including implants and contraception, according to a proposal unveiled by the Indian government. Licenses for some specialized categories of important pharmaceuticals, such blood and blood products, IV fluids, vaccines, and sera, are granted by CDSCO in collaboration with state authorities.

Research and development are undoubtedly conducted in relation to pharmaceuticals and cosmetics by any organization engaged in their import, export, or manufacture. This is done in order to assess the medications' and cosmetics' BE (bioequivalency) and BA (bioavailability). They just need to submit one registration, known as the CDSCO Registration, for all of this. The CDSCO website can be used to secure this registration.

What is the importance of CDSCO Registration?

The Central Drugs Standard Control Organization's (CDSCO) registration procedure is essential for ensuring the efficacy and quality of medicines, cosmetics, and medical devices. It verifies that these items are safe for use by the general public and ensures that no animals were harmed during manufacture.

Types of CDSCO Certifications

The types of CDSCO registration or certifications are mentioned below:

Pharmaceutical Manufacturing License

This license is required for businesses that produce pharmaceuticals. It guarantees that the production unit abide by all applicable rules and specifications.

Registration Certificate

A pharmaceutical registration certificate is granted following a comprehensive assessment of all available data pertaining to the safety, effectiveness, and formulation of the product. It is essential for marketing and sales of products in India.

Clinical Trial Approval

CDSCO must provide permission to organizations carrying out clinical studies for new medications. This puts participant safety first and guarantees that the studies adhere to ethical and scientific norms.

Import License

Businesses must apply to CDSCO for an import license in order to import medications or medical equipment into India. This guarantees that the imported goods fulfill the required quality criteria that CDSCO has set for certain items.

Registration of Medical Devices

CDSCO issues medical device registrations in order to ensure that they meet safety and quality standards. Throughout the registration process, details on the device's design, intended use, and manufacturing process must be supplied.

Good Manufacturing Practice (GMP) Certificate

Manufacturing facilities that follow the guidelines set out for the production of medicines are granted GMP certification. It denotes adherence to controls and quality assurance procedures.

COPP

A Certificate of Pharmaceutical Product (COPP), which attests to the product's approval for sale in the destination country, is exported with pharmaceutical items.

What are the Advantages of CDSCO Registration?

A license holder in the Indian pharmaceutical, medical device, or cosmetic industries might profit greatly from having a CDSCO registration in a number of ways listed below:

Market Access

In order to market and sell medicines, medical equipment, and cosmetics in India, one must first register with the CDSCO. It ensures regulatory criteria are met by giving the items the legal permission to be sold.

Legal Compliance

The license holder's adherence to the laws and regulations governing India's pharmaceutical and healthcare industries is ensured by their CDSCO registration. This lessens the chance that non-compliance may result in penalties and legal issues.

Quality Assurance

Through regulatory monitoring, which includes audits and inspections, the good manufacturing Practice (GMP) laws, which are implemented by CDSCO, aid in maintaining high manufacturing standards.

Conformity with Standards

The CDSCO establishes and upholds strict guidelines for the effectiveness, safety, and quality of medical supplies. A CDSCO registration boosts customer trust by proving that the product and its production methods adhere to certain defined criteria.

Consumer Trust

The CDSCO registration acts as a regulatory authority's seal of approval, promoting consumer trust. They can feel reassured knowing that the product has undergone safety and efficacy testing prior to being on sale.

International Trade

CDSCO registration, in particular the Certificate of Pharmaceutical Product (COPP), is frequently necessary for regulatory clearance in the importing country for businesses involved in the export of pharmaceuticals or medical equipment.

Who can apply for CDSCO Registration?

The CDSCO web portal is open for registration to the following candidates:

  • Importers
  • Indian Representatives
  • Foreign Businesses with Indian Subsidiaries
  • Companies

Note: Manufacturing units are not able to sign up for the portal directly. To access the site, a company must establish login credentials for the production unit.

What is the purpose of CDSCO Registration in India?

According to the norms and regulations, CDSCO registration is required for a variety of reasons, some of which are listed below:

  • To complete the Dual Use No Objection Certificate for the merchants; the Test License.
  • With the intention of completing the Blood Bank Registration process in order to become a Blood Bank.
  • Moreover, in order to obtain a Cosmetics Registration.
  • BA, or bioavailability, or bioequivalency, authorized locations.
  • For the manufacture and import of pharmaceuticals; the formation of research and development organizations; the registration of ethics committees.
  • A certificate of no objection for export related to a certain zone.
  • The process of registering blood products, which is referred to as blood product registration.

What are the documents required for CDSCO Registration?

Even though obtaining a CDSCO Registration is an online procedure, it is not feasible to obtain this registration without uploading specific papers. The following is a list of documents that are required for CDSCO registration:

  • Identity proof of the applicant who needs CDSCO Registration.
  • Address proof of the applicant.
  • Upload a copy of the site registration for BE or BA.
  • Undertaking granted by a government authority for the registration of tests, drugs, or medical devices.
  • Manufacturing license in the event that the company manufactures medical devices and imports blood products.

What are the steps for CDSCO registration?

The CDSCO registration can take place online, and you will be required to follow the below mentioned process:

Step 1: Visit the CDSCO registration page and select the "Login/Sign Up" option located at the top left of the page.

Step 2: Then, to apply for registration, choose the "Sign Up Here" option. The "Registration" page will open as a result. Click "Submit" after choosing "Registration" from the drop-down menu.

Step 3: The page labeled "Applicant Registration" appears. Complete the application details form, which asks for information about the applicant type, user name, password, name, mobile number, and email address. Upload the "Undertaking" and "ID Proof Details." Enter the information requested in the "Registered Indian Address Form," including the "Organisation Name," "Organisation Type," "CIN," "Address," and "Contact Number," and attach the "Corporate Address Proof." Click "Submit" once you've filled out the application completely.

Step 4: To complete the registration, a confirmation link will be emailed to the email address you registered with. To activate your account on the CDSCO portal, click the link that was supplied to you by email.

Step 5: The registration application will be forwarded to the relevant authorities (CDSCO Officials) for approval as soon as the confirmation link is clicked.

Step 6: The CDSCO shall examine the application upon receiving, and ascertain the safety and efficacy of the medication or medical device for the purpose for which it is intended. In order to conduct an evaluation, it may be necessary to go over all pertinent data, visit the site, and confer with subject-matter specialists.

Step 7: The CDSCO may authorize the medication or medical device for sale and distribution in India based on the review. Alternatively, if it determines that the medication or medical device does not fulfill the necessary safety and effectiveness requirements, it may reject the application.

Why Choose PSR Compliance for CDSCO Registration?

CDSCO is an organization that manages and oversees the Medical Devices market's operations by providing CDSCO registration. There are several procedures associated with this registration process that must be completed, even if it is an online process. As a result, professional assistance is usually advised when obtaining this license because even a minor error may result in time and financial loss.

We have competent team members available to address any questions you may have about the CDSCO Registration. PSR Compliance can guarantee that your registration process will be smooth and on time.

 Frequently Asked Questions

Q1- Which license shall I take for selling medical devices in India?

The primary regulating agency for the Indian pharmaceutical and medical device industry is the Central Drugs Standard Control Organization (CDSCO). Medical device sales in India are under the jurisdiction of the State Food and Drug Administration (State FDA). Any medical device sold in India must have a wholesale drug license form MD 20 B/21 B or a registration certificate form MD 41/42.

Q2- Who approves medical devices in India?

Medical devices and IVDs are regulated by the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO), a division of the Ministry of Health and Family Welfare.

Q3- Is it mandatory to take CDSCO registration?

Starting on October 1, 2022, items classified as class A and class B are required to get CDSCO certification; products classified as class C and class D will require certification starting on October 1, 2023. Products falling to Class A (measuring and sterile), Class B, Class C, and Class D require a CDSCO license.

Q4- What is BA and BE?

The corresponding quantity of medicine that enters the intrinsic circulation and has the capacity to exert an active effect on the body is known as its bioavailability, or BA. On the other hand, BE, or bioequivalence refers to two medications whose purpose is to give equal amounts of the same medication.

Q5- How long is CDSCO registration valid for?

A CDSCO registration certificate is valid for three years from the date of issuance, unless it is suspended or canceled earlier.