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CDSCO Registration Process

CDSCO Registration Process
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INTRODUCTION

CDSCO stands for (Central Drugs Standard Control Organisation). This organization is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority of India. It envisages uniform implementation of the provisions of the Act and rules made there to ensure the safety, rights, and well-being of the patients by regulating drugs and cosmetics. 

The Drugs & Cosmetics Act,1940 and Rules 1945 have entrusted various responsibilities to central & state regulators for the regulation of drugs & cosmetics CDSCO is constantly thriving to bring out transparency, accountability, and uniformity in its services to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

CDSCO along with state regulators, is jointly responsible for the grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera. Under the Drugs and Cosmetics Act, CDSCO is responsible for the approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country, and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

How to get online CDSCO Registration

This is the steps by which you can online CDSCO Registration:

  1. First you have Identity proof of yours;
  2. Also address proof of the yours;
  3. Then upload the copy of BE or BA Site Registrations as issued by CDSCO in case of BE or BA approved site Registration;
  4. After that undertaking allotted by a Government Authority;
  5. And at the end wholesale License or Manufacturing License in the case of Manufacture or Import of Blood Product registration or Drugs or Test License Registration.

Central Drugs Standard Control Organisation Registration

The CDSCO is responsible for the regulation & approval of New Drugs and Clinical Trials in the country under the Drugs & Cosmetics Rules, 1945 and Drugs & Cosmetics Act, 1940.Any organisation that manufacturers or imports or exports drugs & cosmetics conducts Research & Development activities regarding drugs, imports drugs for the purpose of examining conducts BA (Bioavailability) & BE (Bioequivalence) studies in drugs for export purposes need to obtain CDSCO Registration through its online registration portal.

The CDSCO laid down the standards for Drugs, control over the imported Drugs’ quality, coordination of the activities of SDCO (State Drug Control Organisation) and facilitating expert advice with an outlook of the regularity in the enforcement of the Drugs & Cosmetics Act.

Central Drugs Standard Control Organisation online Registration

CDSCO portal registration is entirely online. So these are the steps for obtaining registration under the CDSCO portal are:

  1. First you have to go to the CDSCO registration portal and click on the ‘Login/Sign Up’ button, which is on the top left-hand side of the portal.
  2. Next, click on the ‘Sign Up Here’ option to apply for registration. This will open the ‘Registration Purpose’ page. Select the ‘Registration Purpose’ from the options in the drop-down box and click on ‘Submit’.
  3. Then The ‘Applicant Registration’ page opens. You have to fill the applicant details form which contains the details such as the ‘Applicant Type’, ‘User Name’, ‘Password’, ‘Name’, ‘Mobile Number’ and ‘Email ID’. Upload the ‘ID Proof Details’ and ‘Undertaking’.
  4. After that fill the ‘Registered Indian Address Form’ which contains details such as the ‘Organisation Name’, ‘Organisation Type’, ‘CIN’, ‘Address’, ‘Contact Number’ and upload the ‘Corporate Address Proof’. After entering all the details on the application, click on the ‘Submit’ button.
  5. Then a confirmation link will be sent to your registered email id to verify the registration. Click on the link sent to your email to activate your account on the CDSCO portal.
  6. At last when you clicked on confirmation link, the application for registration will be sent to the concerned authority (CDSCO Officials) for approval.
  7. After the application is approved, an email of the approval will be sent to your registered email id. In case the application is rejected, a rejection mail will be sent to your registered email id. Once, you receive the email of approval; your registration will be complete.

Documents which are required for Registration Under CDSCO

These are the documents required to be attached along with the registration application on the CDSCO portal are:

• Undertaking issued by a Government Authority

• ID Proof Document

• Copy of BA/BE Site Registration as approved by CDSCO in case of BA/BE Approved sites Registration

• Address Proof Document

• Manufacturing License or Wholesale Licenses in case of Import or Manufacture of Drugs/Blood Product Registration/Test license Registration

Conclusion

As per the cosmetics rule of 2020, every cosmetic product must be registered to ensure that they are safe and fully reliable for every customer. On the other hand, obtaining a cosmetic license is not as simple and easy as it seems like because it requires cooperation with authorities, documentation, scrutiny, and fulfilling CDSCO requirements. That’s why the best thing is to seek expert help so that they can handle the entire process and assist you in obtaining a cosmetic registration certificate.

Evtl India is a one-stop solution for all your compliance requirements. Evtl India helps you to provide a single window for product testing, training, technical certification, auditing, laboratory setup, and technical compliance services to the manufacturer and importer. We provide useful insight and advice at every step of the process required for cosmetic registration.

 


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