CDSCO Introduces Online Registration for Clinical Research Organizations

In anticipation of the mandated registration of clinical research organizations (CROs) starting next month, the Central Drug Regulator has set up the Sugam portal to facilitate online registration of the enterprises.

The online registration process for CROs is already operational, according to the Central Drugs Standard Control Organization (CDSCO). Applications for registration must be made via the Sugam portal and include the required set of documentation.

New users can go to the site, register, and choose "Clinical Research Organization" as their registration objective. After that, they must complete out the registration form. The user manual from the drug regulator for online registration of CROs states that the email ID for further communication will be verified, after which the competent authority at CDSCO will review the account request and grant approval accordingly. After the CDSCO approves the account, applicants can use the portal by logging in.

Through their user profiles, current Sugam portal users can seek an extra role. 'Clinical Research Organisation' is the role that applicants can choose, and they can fill out the form with personal information. As part of the procedure, the CDSCO has also provided a comprehensive user manual for the CROs to utilize while paying the registration and renewal fees online.

It should be mentioned that in September 2024, the Ministry of Health and Family Welfare (MoHFW) released a final notification outlining clinical research organizations and requiring their registration in order to function under the 2019 New Drugs and Clinical Trials Regulations (NDCTR). The revised regulations will take effect on April 1, 2025.