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Health ministry notifies Rules to register CROs under NDCTR, 2019
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Gireesh Babu, New Delhi
September 25 , 2024
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The Union health ministry has issued final notification defining the clinical research organisations (CROs) and mandating registration for the organisations to operate under the New Drugs and Clinical Trials Rules (NDCTR), 2019. The amended rules will come into force from April 1, 2025.
The New Drugs and Clinical Trials (Amendment) Rules, 2024, notified on September 19, defines CROs 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."
Adding a new chapter VA to the NDCTR on CROs, it stipulates that no clinical research organisation shall 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 (CLA) under these rules.
The CROs shall apply with the CLA for registration for conduction such studies, accompanied by a fee of Rs. 5 lakh, along with documents and other required information, as per the ninth schedule added to the NDCTR through the new notification, for operating in the country. The registration will be valid for five years from the date of its grant, unless suspended or cancelled prior to this.
The CLA may grant registration within a period of 45 working days if satisfied with the information furnished along with the application. If not satisfied, it may reject the application with reasons to be recorded in writing, within the same timeframe. The authority may inform the applicant to rectify any deficiency identified prior to approval, not later than 45 days working days from the date of receipt of the application.
In case of rejection of application, the applicant may request the CLA to reconsider the application within a period of 60 days from the date of rejection of application on payment of fee of Rs. 1 lakh. If still aggrieved by the decision of the CLA, the organisation can file an appeal within 45 days from the date of such decision before the Central government.
The Central government may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose of the appeal within a period of 60 days from the date of receipt of the appeal.
The CROs shall allow any officer authorised by the CLA, who may be accompanied by an officer authorised by the State Licensing Authority, to enter its premises 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.
If the CRO fail to comply with the provisions of the Act and the Rules, the CLA may, after giving an opportunity to show cause and affording an opportunity of being heard, shall take actions including warning in writing, reject the results of the clinical trial or BA/BE study, suspend or cancel registration for certain period, or debar the organisation to conduct any study in future for a period considered appropriate by the Authority. The CRO can approach the central government with an appeal within 60 days from the date of receipt of such orders.
The notification also amends the Sixth Schedule of the Rules to include application form for registration and renewal of registration for CROs, and the form under which the CLA would issue the approval.
The newly added ninth schedule details the requirements for registration of CROs. The Schedule include requirements such as the CROs shall have adequate facilities, resources, qualified and trained staff for handling any oversight of clinical trials and bioavailability or bioequivalence studies and such staff shall be trained regularly to update their skills; they shall ensure that the trials and bioavailability or bioequivalence studies are adequately monitored and the trial or study related responsibilities transferred to it, partially or fully, by the sponsor are discharged effectively and efficiently; and shall implement quality assurance and quality control as per standard operating procedures designed for the purpose and such standard operating procedures (SOPs) shall be well documented.
It shall maintain complete data, documentations and other related records accurately including checking and ensuring that the essential documents required for the conduct of the trail are maintained properly by the investigators. All documentation and communication shall be dated, filed and preserved safely for a period of five years after completion of such study or for at least two years after the expiration date of the batch of the new drug or investigational new drug studied, whichever is later, it added.
The draft notification was issued on May 11, 2023, inviting objections and suggestions from the stakeholders. The Ministry, in its final notification, said that the objections and suggestions received from the public have been considered by the Central government.
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