As per new amendment of New Drugs and Clinical Trials, Clinical Research Organisations cannot conduct any clinical trial or bioavailability studies without permission from Central Licencing Authority.
As per new amendment, application for registration of Clinical Research Organisation for the purpose of conducting clinical trial or bioavailability or bioequivalence study with the Central Licencing Authority shall be made to the said authority in Form CT-07B.
New amendment said, "No Clinical Research Organisation shall conduct any clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug in human subjects except in accordance with the registration granted by the Central Licencing Authority under these rules."
The Clinical Research Organisation registered by the Central Licencing Authority under rule 38C in Form CT-07C, shall allow any officer authorized by the Central Licencing Authority, who may be accompanied by an officer authorized by the State Licencing Authority, to enter the premises of the Clinical Research Organisation with or without prior consent, to inspect, search or seize, any record, document, investigational product and other related material and reply to queries raised by the inspecting authority in relation to functioning of the organisation.
These rules may be called the New Drugs and Clinical Trials Amendment Rules, 2022
