The Indian government has drafted Standard Operating Procedures (SOPs) to regulate Clinical Research Organizations (CROs) in the country, aiming to ensure the safety, quality, and transparency of clinical trials. These new regulations, formalized under the New Drugs and Clinical Trials (Amendment) Rules, 2024, are set to take effect on April 1, 2025.
Defining Roles and Responsibilities
Previously, the functions of CROs in India were not clearly defined. The new SOPs address this gap by outlining the roles, duties, and liabilities of these organizations. This includes monitoring CROs through registration, license approval and renewal, validity periods, inspections, and potential license suspension for non-compliance.
According to the notification, a CRO is defined as "the sponsor or a body, commercial or academic or of other category, owned by an individual or an organization 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."
Registration and Oversight
Under the new rules, CROs must apply to the Central Licensing Authority for registration to conduct clinical trials or bioavailability/bioequivalence studies. This means that no CRO can conduct clinical trials or bioavailability/bioequivalence studies of new drugs or investigational new drugs on human subjects without registration granted by the Central Licensing Authority.
The registration will be valid for five years from the date of grant, unless suspended or cancelled by the Central Licensing Authority. The regulator may also inspect CROs, with or without prior consent, to examine records, documents, investigational products, and related materials. The government retains the right to suspend or cancel a CRO's registration for non-compliance with the Act and its rules.
Impact and Scope
India currently accounts for 3-4% of global clinical trials. These SOPs have been developed after consultation with the Drugs and Technical Advisory Committee (DTAB). The government's objective is to maintain product quality, accelerate clinical trials of novel medications and vaccines, and enhance transparency in the clinical research process.
"The new regulation will now be applicable to all the existing government and private clinical research centres including those organizations that are doing bioavailability or bioequivalence studies... The regulation brings each and every organization doing clinical research work in any form under government purview," an official stated.
"Now, we will be able to have a repository in place which are into clinical research work apart from the main clinical research organization and sponsors," the official added. This centralized repository aims to improve oversight and coordination within the clinical research landscape.
