Pharmabiz
 

DHR proposing regulatory framework to govern research in health sector

Joseph Alexander, New DelhiTuesday, December 13, 2011, 08:00 Hrs  [IST]

The Department of Health Research (DHR) is planning to set up a regulatory mechanism to monitor and govern the research activities in the health sector with a number of crucial bills and legislations expected to be under implementation in the coming years.

“During the last two years, the Department has already developed a National Health Research Policy, Knowledge Management Policy and also prepared a draft Bill on Ethical Issues pertaining to Biomedical Research. Department is also perusing Assisted Reproductive Technology (ART) Bill as well as a Bill on Alternate System of Medicine. During the XII Plan, all these policies are to be implemented. Department proposes to establish an authority as an overarching body to monitor such health research activities. Besides, extracting evidence generation through model projects for improving the research governance in health in India is another key area,” a senior official said.

Further mechanisms are being built to create systems/ administrative structures for recognition of health research institutions and for identification and promotion of affordable technologies for improved diagnosis, treatment and prevention of various relevant diseases, he said.

“The priorities are putting in place appropriate Guidelines, Acts, through appropriate regulatory authorities and structures to evaluate and recommend technologies, programmes, studies etc. for introduction into the public health system; enactment of an Ethics Bill and the establishment of the National Bioethics Authority; and creation of National Health Research Forum for implementing National Health Research Policy,” he said.

Establishment of mechanisms for mapping, accreditation/recognition etc. of health research institutions, and taking up research for establishment of mechanisms for knowledge management for better service, education and research are also on the agenda.

Development of robust ethical systems to promote ethical animal and human research programmes and its implementation was considered as a top priority by Experts. Existing regulatory and related loopholes emerging from the current experience should be plugged and used to develop regulatory framework, sources said.

Outcome of the establishment of such systems and regulation will be reflected in improved ethical standards in biomedical research; proper allocation and utilization of resources for health research; better environment for product development for domestic and international purposes and optimum usage of infrastructure as well, sources added.

 
[Close]