2016 will see India on global clinical research map: Experts

The Indian Society for Clinical Research President Suneela Thatte believes “2016 will be the year that will put India on the global clinical research map.”

Post the regulatory reforms that came into play in mid-2015, “Given where we are in terms of the clinical research landscape — the scale that we could offer — in terms of destination, medical expertise or hospital infrastructure, we were working at a much lower scale. However, that situation has been addressed to a large extent, because regulations have been balanced with all stakeholders being taken into consideration,” she said.

Of the hurdles in the clinical research environment in India, compensation guidelines and approval mechanism, inclusive of the review process are the significant game changers, she opined. As per compensation guidelines, prior to the reform, all participants within a clinical trial had to be provided with medical management for even unrelated medical conditions.

Now, however, medical management is restricted to causally-related conditions. “India bears a fifth of the global disease burden, however, India’s participation in global trials is as low as 1.4 per cent. That bridging of that gap has been initiated this year,” she said.
Having regained interest from global players as well as academic institutions, India is on the path of recovery. This should translate into growth for clinical research in India.

“National Institutes of Health (NIH), one of the major players who had earlier pulled out of India, has once again shown interest in conducting global trials in India,” she added.

Steps in the direction were also seen at the 16th edition of ‘Bangalore India Bio 2016’, on Tuesday. Jon Mowles, UKTI Life Science Sector Specialist, who is leading the British delegation here, said “UK science is world-class, offering industry an opportunity to partner with globally recognised pioneers and innovators. Some 25 percent of the drugs in the UK are made in India and I am looking forward to meeting with Indian experts and discuss how we can Make Tomorrow’s Medicine together.” The UK has brought in the strongest overseas presence to the conclave with over 20 companies participating.