The Central Drugs Standard Control Organization (CDSCO) has announced the launch of online registration for Clinical Research Organizations (CROs) through the SUGAM portal. This initiative follows the Ministry of Health and Family Welfare’s notification making CRO registration mandatory from April 1, 2025. This notice was issued on March 4, 2025.
It may be recalled that as per the Ministry of Health and Family Welfare’s G.S.R. 581(E) notification dated September 19, 2024, all Clinical Research Organizations operating in India are required to register with the CDSCO effective April 1, 2025.
Online Registration via SUGAM Portal
To facilitate the registration process, the CDSCO has made the online registration module functional on the SUGAM portal.
Online Submissions Only: All applications for CRO registration must now be submitted exclusively through the SUGAM portal.
Document Checklist: Applicants are required to submit their applications along with a prescribed checklist of documents.
The move to online registration aims to:
- Streamline the registration process for CROs.
- Enhance transparency and efficiency in regulatory oversight.
- Ensure compliance with the mandatory registration requirements.
- Provide a central location for the CDSCO to maintain records.
The mandatory registration of CROs is a significant step towards ensuring the quality and integrity of clinical research conducted in India. This measure will contribute to:
- Improving the standards of clinical trials.
- Protecting the rights and safety of clinical trial participants.
- Enhancing the credibility of clinical research data.
CROs are strongly advised to familiarize themselves with the registration process and submit their applications through the SUGAM portal before the April 1, 2025, deadline.
