January 15, 2016 4:18:31 am
With revised estimates for rest of the financial year starting to come in, the Department of Health Research (DHR) has seen a 25 per cent reduction in funds at its disposal. In Union Budget 2015-16, the department was allocated Rs 1,000 crore by the government. However, now it has been told it will get only Rs 750 crore.
The DHR secretary, meanwhile, claimed that fund crunch and tougher clinical trials norms were adversely impacting critical research. “Finances are crucial to conduct world class research. Field studies too are cost intensive, requiring investment in manpower technology etc. Budget cuts across the board in the last few years has affected research. In the 12th five-year plan, DHR was allocated Rs 10,000 crore but only 50 per cent of that has been released so far.
That’s why research is not on track… stringent clinical trial norms have affected academics more than industry. That’s why we are in talks with Drug Controller General of India (DCGI) so that trials not aimed at registration of a new drug should not require approval from the drug controller,” said Soumya Swaminathan, secretary, department of health research.
The department is trying to work out a middle path with the drug controller’s office so that academic trials are exempted from some of the tougher clauses related to clinical trials. As per the plan, trials that do not result in the registration of a new product may not need mandatory approval from DCGI, though they would still require clearance from institutional ethics committees.
Norms for compensation, too, would be made less stringent, though deaths and injuries would have to be compensated as per existing norms. Swaminathan added that without revision in trial conditions, research on diseases like TB and malaria, which affect Indians far more than any other country in the world, will inevitably suffer.
DHR has also come out with fresh norms for conducting research in children and is also working on another set of guidelines for research among the tribal population. Despite constraints, Swaminathan added, DHR is working on several projects including one where it is anchoring an ambitious plan for phased elimination of malaria, and for launching an acute cardiac event registry with 12 nodal registries from where data is to be collated.
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