National Institute of Medical Statistics under the Indian Council of Medical Research (ICMR) is planning to establish a National Clinical Trial Registry as a one-stop-hub for all clinical trial information in the country. The Department of Science and Technology (DST) has earmarked Rs 2.6 crore from its Pharma Research & Development Support Fund for materializing the project, it is learnt.
The agency would try to collect comprehensive data on all clinical trials that are undertaken in the country. This includes the trials approved by the office of the Drugs Controller General of India and also the small trials that do not require DCGI approval. The move is meant to turn clinical trial operations more transparent.
According to sources, the clinical trial registry would be modelled on the recent WHO guideline on clinical trial registries. The difference between the clinical trial registry that would be prepared by the office of the DCGI and the current one planned by ICMR is that while the former would be complete, the comprehensiveness of the latter would depend upon the inputs provided by the ethics committees across the country. Since there is no mandatory requirement to register their clinical trial with ICMR registry, the flow of inputs may be slow.
The sources felt that the problem would be solved once the Biomedical Research Authority Bill gets approved in the Parliament. The Bill, meant to bring in legislation for regulating and monitoring biomedical research, is yet to be introduced in the Parliament.
The ultimate objective would be to make it mandatory for investigators to register themselves with the National Clinical Trial Registry. The registry would be set up with the support from all related institutions including drug control departments, hospitals ethical committees, etc.