The Union Health Ministry has notified the New Drugs and Clinical Trials (Amendment) Rules, 2024 (“Amendment Rules”), introducing mandatory registration for Clinical Research Organizations under the New Drugs and Clinical Trials Rules, 2019. This requirement will gain effect from 1st of April, 2025.
The Amendment Rules define Clinical Research Organisations as “the sponsor or a body, commercial or academic or of other category, owned by an individual or an organisation having status of legal entity by whatsoever name called, to which the sponsor may delegate or transfer in writing, some or all of the tasks, duties or obligations regarding clinical trial or bioavailability or bioequivalence study.”
In order to conduct clinical trials or bioavailability / bioequivalence studies of new drugs or investigational new drugs involving human subjects, Clinical Research Organisations are required to submit an application in Form CT-07B to the Central Licensing Authority (“Authority”) for registration to conduct clinical trial or bioavailability or bioequivalence study, along with fees of Rs. five lakhs (5,00,000) and supporting documents prescribed in the Ninth Schedule.
The Authority may grant registration in Form CT-07C within a period of 45 working days (if satisfied) or reject the application (with reasons in writing). Further, the Authority may inform regarding rectification of deficiency in the application. In the event application is rejected, the applicant may request the Authority to reconsider the application within a period of sixty (60) days from the date of rejection of application, upon payment of additional fee of Rs. one (1) lakh. The registration will be valid for a period of five years from the date of grant.
A Copy of the Notification is linked below for your ease of reference.
Source: Central Drugs Control Standards Organization
