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CDSCO

Guide to CRO Registration on SUGAM Portal


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Importer & Manufacturer   |   CDSCO
04 March, 2025
Enforcement Date: 01 April, 2025
Guide to CRO Registration on SUGAM Portal

The document provides a comprehensive guide for Clinical Research Organisations (CROs) to register on the SUGAM Portal. It details the registration process for both new and existing users, including filling out Form CT-07B(Application for Registration Renewal of Clinical Research Organisation), submitting necessary documents, and making payments. The guide also covers steps for profile completion, application submission, and communication with the CDSCO during the processing of the application.


The document serves as a user manual for Clinical Research Organisations (CROs) to register on the SUGAM Portal, an e-Governance solution by the Central Drugs Standard Control Organisation (CDSCO). It outlines the registration process for new users, which involves

  • Signing up on the portal
  • Filling out the registration form
  • Verifying the email address.
    Existing users can request an additional role as a CRO. The guide explains how to complete the user profile, submit Form CT-07B for registration or renewal, and upload necessary documents. It also details the payment process. The fees for registration and renewal of CRO:
  • Fees for registration application is Rs. 500000
  • Fees for renewal application is Rs. 100000
    The document emphasizes the importance of accurate information and provides instructions for final submission and communication with the CDSCO during the application processing.

Applicable For: Importer & Manufacturer
Reference Number: File no. DCG(I/Misc./2025-4 Notification Link

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