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In January 2016, India’s Central Drugs Standard Control Organisation (CDSCO) introduced SUGAM, an online portal, for filing applications of various services. The services offered by the SUGAM includes online submissions, review, and grant of NOC/permission.

How to register?

Following are the steps required to register and make submissions on SUGAM:

Step 1: To register on SUGAM, log on “cdscoonline.gov.in” and click on “LOGIN/SIGN UP”.

  • Applicants such as corporate, importers, Indian agents, subsidiaries can register themselves on the portal.
  • Manufacturing units are not allowed to register on the portal directly.
  • Manufacturing units can use the login created by the corporate for SUGAM on their behalf.

Step 2: After clicking on “LOGIN/SIGN UP”, a registration form will pop up that needs to be filled duly by an authorized/responsible person.

  • The Unique corporate ID must be used as the username for the portal.
  • Users are required to upload and submit the ID proof, undertaking and address proof on the portal along with the form.
  • After submitting the application, a confirmation link is sent to the registered email ID.
  • Once the user clicks on this confirmation link, the account gets activated and the application is sent to CDSCO for approval.
  • If approved, an email will be sent to the user else, rejection mail will be sent.

Step 3: To login, users are required to enter the login details on the portal and login.

Types of Applications Allowed to File In The SUGAM

SUGAM allows users to file the following type of applications:

  1. Certificate of Registration – Form 41 for Drugs
  2. Certificate of Registration – Form 41 for Medical Devices
  3. Certificate of Registration – Form 41 for Diagnostic Kit
  4. Certificate of Registration – Cosmetics
  5. License of Import – Form 10 for Drugs
  6. License of Import – Form 10 for Medical Devices
  7. License of Import – Form 10 for Diagnostic Kit
  8. Clinical Trial Test License
  9. BE NOC for Clinical Trial for importing/manufacturing a New Drug
  10. Permission to conduct GCT

Benefits of the SUGAM

  • Applicants can directly apply for all import licenses to the CDSCO
  • Easy tracking of status of submissions
  • Easy query handling
  • Applicants can directly upload documents related to activities of submission

SUGAM is an online e-Governance portal introduced by the government of India to build an in-depth Regulatory framework for the registration processes of the CDSCO. Are you planning any submissions towards the CDSCO? Know more about SUGAM? Reach out to Freyr at sales@freyrsolutions.com.