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Parliamentary panel asks ICMR to work with pharma industry to regain trust on clinical trials

Gireesh Babu, New Delhi
Tuesday, April 12, 2022, 08:00 Hrs  [IST]

The Indian Council of Medical Research (ICMR) should work together with the pharmaceutical industry in the country to regain the trust of the general public on clinical trials and authentic collection of patient data, by engaging them more transparently, said a group of parliamentarians who have looked into the activities of Department of Health Research (DHR) and the budgetary allocation to the health research under the Union Budget 2022-23.

The Members of Parliament, under the chairmanship of Prof Ram Gopal Yadav, in a recently submitted report of the Department-Related Parliamentary Standing Committee (DRSC) on health and family welfare, has observed the challenges faced by the ICMR in operationalising clinical trials in India during the Covid-19 pandemic.

It has also appreciated ICMR for developing a pan-India clinical trial network (Indian Clinical Trial and Education Network -INTENT) which will provide a single, ready platform for conducting rapid but good quality randomized clinical trials.

“The Committee, however, believes that there is a general lack of public confidence in the healthcare/pharmaceutical industry and the Committee apprehends that slackening public confidence might pose a hurdle in conducting clinical trials,” it said. It recommended ICMR to work in cohesion with the pharmaceutical industry to regain trust of the general public by engaging more transparently.

“The ICMR should also make more efforts to educate and inform patients and the society at large about the benefits of engaging in clinical research and allowing authentic collection of patient data,” it added.

ICMR has informed the Committee the challenges it faced in operationalising clinical trials in India during the Covid-19 pandemic, such as that the health care workers were already overloaded with the Covid-19 test and treatment and setting aside time for quality conduct of trials was difficult.

The patients, once discharged, were reluctant to revisit the hospital. Any follow-up had to be done virtually. Collection of samples like convalescent plasma was difficult and required motivation and counselling of potential donors. All training and monitoring of study sites had to be done virtually due to restricted movement.

In order to facilitate result-oriented trials to combat future challenges, ICMR has initiated a pan-India clinical trial network - INTENT which will provide a single, ready platform for conducting rapid but good quality randomized clinical trials. Capacity building of researchers and improving public awareness regarding medical research are some of the other objectives of this network.

The Committee also recommends ICMR to establish one BSL-IV lab in each of the four zones and the DHR to launch more mobile laboratories as such mobile units could be of great help during outbreaks particularly in rural and remote areas.

It has also recommended the DHR-ICMR to formulate regulations and national policy for oversight of dual-use research- which refers to experiments that are conducted for peaceful purposes but can be modified or altered to cause harm. DHR/ICMR should conduct training and develop strict and exhaustive guidelines on bio-safety and bio-security.

In its 135th report, the Committee also observed that the BE 2022-23 allocation to ICMR, government's premier health research organization and the agency steering the research response to pandemic Covid-19, is Rs. 2,198 crore which is a meagre increase from Rs. 2,133.07 crore, as per the revised estimate for 2021- 22.

“Considering the pivotal role of Indian Council of Medical Research in the field of bio-medical and health research in India, the Committee is deeply concerned to note the large gap in funding of ICMR when compared with health research institutions of countries like US, UK, France and China. What worries the Committee more is that the allocation of funds to ICMR and subsequent utilization of funds by ICMR has always been less than the projected demand, even in the Covid-years, where the need for adequate funds and optimal utilization was call of the hour,” it opined.

“The Committee believes that the budgetary allocation to ICMR in 2022-23, is grossly inadequate keeping in view the mandate of the ICMR. However, the Committee is also aware that the utilization trends of ICMR over the years don’t present a justified reason for increase of funds. The Committee, therefore, recommends ICMR to improve the absorption capacity of its scheme implementing agencies,” it added.

It also recommended ICMR to provide more money for research projects, joint-research projects with national and international bodies, establish network of labs for diagnosis of communicable and non-communicable diseases, extensively fund research projects, provide trainings/international exposure to researchers, develop programmes to encourage youth to take up research, scheme to develop inclination towards health-research in students of higher-secondary and senior secondary. Appropriate expenditure as per originally conceived plan by ICMR-DHR would make a good case for seeking higher budgetary allocation at the RE stage and BE 2023-24 as it is well established that only through the in-depth health research, the country can be saved from the life-threatening non communicable and communicable diseases.

ICMR should conduct an external evaluation wherein the Council is compared to other competitors on parameters like, trends in budgetary allocation and utilization, comparison between public and private investment, utilization avenues and research work undertaken, health research infrastructure and its development, numbers of scientific professionals and clinical researchers, patents filed, number of fellowships and grant for research and future outlook.

Analysing the data from the 2016 evaluation the Committee observes that there is a wide gap in funding between health research institutions of countries like US, UK, Australia, China and Brazil and ICMR. The Committee further noted that just the number of papers published cannot be a sufficient indicator for performance, as the quality of research, its significance in public health and its viability are far more important factors in performance analysis.


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