Govt drafts SoP to regulate clinical research organizations

New Delhi: The government has framed standard operating procedures (SOPs) for clinical research organizations in the country to ensure safe clinical trials.

Till date, the functions of these organizations were not defined.

With the new regulations in place, the government has now defined their roles, duties and liabilities to monitor them through their registration, approval of licence and renewal, validity period, inspection, and suspension of license if found non-complaint.

India accounts for 3-4% of global clinical trials.

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These SOPs have been framed after consultation with the Drugs and Technical Advisory Committee (DTAB). The government’s aim is to maintain product quality and expedite clinical trials of novel medications and vaccines, and to bring in more transparency.

These new rules, called the New Drugs and Clinical Trials (Amendment) Rules, 2024, come into force 1 April 2025.

They define a clinical research organization “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.”

“The new regulation will now be applicable to all the existing government and private clinical research centres including those organiations that are doing bioavailability or bioequivalence studies. For example, those who are doing research on insulin to determine that this medication helps in weight reduction or not. The regulation brings each and every organization doing clincial reserach work in any form under government purview,” the official added.

“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,” an official added.

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According to the notification, a clinical research organization will now have to make an application to the Central Licencing Authority for the regulator’s approval for the purpose of registration for conducting clinical trials or bioavailability or bioequivalence studies, which means that no clinical research organization will be able to conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects without registration granted by the Central Licencing Authority under these rules.

The registration will remain valid for a period of five years from the date of its grant, unless suspended or cancelled by the Central Licencing Authority.

Furthermore, the regulator may also undertake an inspection of the clinical research organization with or without prior consent, to inspect, search or seize any record, document, investigational product and other related material and replies to queries raised by the inspecting authority in relation to the functioning of the organization.

The government may also suspend or cancel the registration of a clinical research organization if it fails to comply with any provision of the Act and the rules.

Queries sent to the health ministry remained unanswered.