No Government extension order for running Clinical Trial Registry

New Delhi: The Clinical Trial Registry of India (CTRI), the Government of India's platform where anyone conducting a clinical trial is required to pre-register before enrolling any research participants, and its staff members have been functioning without a government extension. 

No official order extending the CTRI beyond June 30, 2022, has been mandated by the government. The current staff of CTRI has also not been given an extension. However, registrations for over 1,060 clinical trials from July 1 till August 5 have taken place despite the non-extension of their services. 

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The government has been fighting against the demand for regularization made by the staff who have been running CTRI for the last 16 years. CTRI receives hundreds of applications for clinical trials, and the Times of India reports that trials worth crores of rupees could stop if the registry becomes non-functional. 

The Clinical Trials Registry- India (CTRI), located at the ICMR's National Institute of Medical Statistics is a free and online public record system for registration of clinical trials being conducted in India and was launched on 20th July 2007. Initiated as a voluntary measure, on 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI). It is a completely paperless online repository of data from more than 45,000 registered clinical trials. 

The CTRI is publicly accessible and searchable and is maintained by data entry operators, a few scientists, and statisticians. However, the CTRI has been running in project mode with regular extensions instead of being given permanent status. However, the Drug Controller General of India made it mandatory to register all clinical trials from September 15, 2009. And a 2013 amendment in the Drugs and Cosmetics Rules 1945 also made it mandatory for clinical trials to be registered with CTRI before enrolling the first participant in any study. Various biomedical journal editors also mandate trial registration as a precondition for considering the publication of trial results and so do several ethics committees. 

The employees had filed a case at the Delhi High Court demanding the regularisation of their services and making the registry a permanent feature of NIIMS. However, the government responded that the CTRI was not a permanent feature of NIMS, which comes under ICMR, and that it was a project "extended from time to time". 

The government further observed that the CTRI was fully supported by ICMR with funds coming from the health ministry. The NIMS affidavit stated that making a project a permanent one or not is an executive function and therefore a policy decision, asking further if the court would like to intervene at all under the circumstances. 

According to the official correspondence attached to the petition, ICMR had committed to ensuring the continuity of the project after the pilot years and the commitment was to make CTRI a regular activity of NIMS and to create posts in the institute for CTRI. The registration of clinical trials is referred to as a "perennial activity"  as per the ICMR correspondence. 

In May last year, the NIMS director M Vishnu Vardhana Rao wrote a letter to the ICMR DG, which observed, "Considering the highly specialized and time-bound nature of the work in CTRI, there is a need to accord five-year extension to the trained CTRI scientists and staff who have been working in the project for many years now in a reliable and consistent manner." It further stated, "During the pandemic, including the lockdown phase, the CTRI staff continued to work 24/7, all days of the week to enable COVID studies to be registered at the earliest (often on the same day), providing hand holding as per need of the hour." 

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