Indian Council of Medical Research public database not ‘permanent’
India’s apex health research agency has said a public database it created 15 years ago to register all clinical studies in the country and enhance transparency in research is not its “permanent activity”, evoking disbelief among researchers.
The claim made by the Indian Council of Medical Research (ICMR) to the Central Administrative Tribunal (CAT) that the Clinical Trials Registry India (CTRI) is “not a perennial or permanent project” contradicts its own documents that have represented the register as “a perennial activity”.
Seven CTRI staff members working on renewable contracts for over a decade have petitioned Delhi High Court seeking judicial intervention to nudge the ICMR into implementing its own plans and changing the CTRI’s status from a project into a permanent activity.
The staff members had last month also petitioned the CAT — a quasi-judicial body that examines service-related issues — seeking their absorption into the ICMR as permanent staff.
The ICMR’s counter reply, submitted to the CAT on June 1, has surprised many researchers, including some who have served on panels to guide the CTRI’s activities. They said they cannot imagine any circumstances under which the ICMR might shut down or give up the CTRI.
Since its launch in July 2007, the CTRI — a free public digital platform for registration of clinical trials managed by the ICMR’s National Institute of Medical Statistics (NIMS) — has catalogued more than 44,000 clinical trials and studies, including over 1,400 trials involving research on Covid-19.
India’s drug regulations make it mandatory for any entity — academic, medical or industry — wishing to conduct regulatory clinical trials on patients or healthy volunteers in India to register the trial on the CTRI. The registry is one of 17 worldwide recognised by the World Health Organisation.
“I’m astonished that something so important is being managed as a project,” said Gayatri Saberwal, a faculty scientist and dean at the Institute of Bioinformatics and Applied Biotechnology, Bangalore, who has studied features of the 17 major public registries worldwide.
In research circles, a project is time-bound — the funds and other resources typically stop in two, three or five years. And the staff recruited for the project need to find other jobs.
The ICMR did launch and operate the CTRI as a project — with 70 per cent funding from the Union science ministry and 30 per cent from the ICMR — from 2006-07 to 2012. After that, the ICMR fully took over the project.
Scientists outside the ICMR familiar with the CTRI’s evolution say it was always intended to be established by the ICMR as a permanent activity but for reasons unclear this has not happened.
Queries sent by this newspaper to the ICMR and the NIMS seeking their perspectives on why the CTRI had continued in project mode have not evoked responses.
A senior ICMR official declined comment saying the issue was being heard by the CAT and Delhi High Court.
In its counter reply to the CAT, the ICMR said the CTRI project “cannot be treated as permanent or perennial”.
In a rejoinder to the counter reply, the petitioners have submitted ICMR documents that they say establish the ICMR’s intention to make the CTRI permanent and absorb the existing staff.
“The CTRI should be a source of great pride for the ICMR and for India,” said Gagandeep Kang, a professor of clinical microbiology at the Christian Medical College, Vellore, who was the chair of an expert panel that reviewed the CTRI’s activities for several years.
She said the database served “an essential function” to increase transparency and accountability on studies on human volunteers.
“Establishing the CTRI as a permanent structure was always the intention,” Kang said.
The ICMR had written to the Union health ministry in October 2011, proposing to make the CTRI “a regular activity” at the NIMS and seeking approval for 10 posts.
But the CTRI staff members — two scientists and five data entry operators recruited between 2006 and 2011 — weren’t “regularised” and continued to work on contracts that were renewed every six months or every year.
Documents submitted by the petitioners to the CAT and Delhi High Court show that the ICMR has in the past been sensitive to the need to absorb the existing CTRI staff members.
At a May 28, 2018, meeting, NIMS director M. Vishnu Vardhan Rao briefed ICMR director-general Balram Bhargava about the existing contractual workforce at the CTRI and the administrative issues relating to their appointment to permanent posts.
Bhargava suggested that the NIMS explore administrative routes towards that objective and assured Rao of his support for what he called “this programme of national importance”, according to minutes of the meeting submitted by the petitioners.
In May 2021, Rao wrote to Bhargava that the CTRI project had been initiated “with the understanding that once the registry was established, it would become a perennial activity of ICMR and the existing staff would be absorbed into it”.
Rao’s note also said that “considering the highly specialised… nature of the work in the CTRI, there is a need to accord five-year extension to the trained CTRI scientists and staff who have been working on the project for many years now in a reliable and consistent manner”.
The note requested that the CTRI staff members be granted extension from July 1, 2021, to June 30, 2026. Instead, they received one-year extensions that will expire on June 30 this year, the staff members have said in their petition to the CAT.
The petitioners have also told the CAT that the ICMR has “started deputing other permanent staff to the project” and has been asking the petitioners to help the new staff “understand the functioning of CTRI”.
“This is not an appropriate way to handle this,” Kang said. “The existing staff members have acquired unique sets of skills — this can’t be done by just anybody through outsourcing.”
Saberwal, who has criticised some aspects of the CTRI’s database in the past and has led studies to analyse clinical trial registries worldwide, said the CTRI needed to be strengthened through more resources. Instead, she said, the move to remove its existing staff might handicap the database even more.