5th March, 2025

The Ministry of Health and Family Welfare, Government of India, has taken a significant step to streamline and enhance the registration process for Clinical Research Organizations (CRO) by mandating online registration through the SUGAM portal. This initiative, formalized under G.S.R. 581(E) dated September 19, 2024 which will be effective from April 1, 2025.

Understanding the New Registration Requirement

The Central Drugs Standard Control Organization (CDSCO) has announced that all CROs must register via the SUGAM portal. The move aims to ensure transparency, efficiency, and ease of access in the regulatory framework governing clinical research in India. This digital approach will replace previous manual procedures, thereby reducing paperwork and enhancing regulatory compliance.

Key Highlights of the Notification

  • Mandatory Registration: Effective from April 1, 2025, all CRO’s must register through the SUGAM portal.
  • User-Friendly Interface: The portal provides a simplified and user-friendly interface for submission and tracking of registration applications.
  • Comprehensive Checklist: Applications must include all prescribed documents as per the checklist provided on the portal.

Benefits of Online Registration via SUGAM Portal

  1. Efficiency: Accelerates the approval process by reducing manual interventions.
  2. Transparency: Facilitates real-time tracking of application status for CROs.
  3. Standardization: Ensures uniform compliance with regulatory norms.
  4. Accessibility: Enables remote submission and management of documents, simplifying the process for CROs across the country.

Steps for CRO Registration on SUGAM Portal

  1. Visit the Portal: Go to www.cdscoonline.gov.in.
  2. Create an Account: Register your organization and obtain login credentials.
  3. Submit Application: Complete the registration form with requisite details and upload the necessary documents as per the checklist.
  4. Track Status: Monitor your application status through the portal dashboard.

How Vaayath can help?

With extensive experience in regulatory affairs, Vaayath excels at managing the entire registration process on the SUGAM portal — from initial registration to the final approval stage. Their expertise ensures that all documentation is accurately prepared and submitted, compliance requirements are met efficiently, and the entire process is smooth and hassle-free for Clinical Research Organizations (CROs).

By leveraging Vaayath support, CROs can focus more on research and less on regulatory complexities.

For more details click on the official Circular