• Bengaluru
  • 15 July 2016
  • Features
  • By Ayesha

Have the revised guidelines improved the clinical research environment in India?

Have the revised 2015 guidelines for clinical trials improved the clinical research scenario? How does the future look for Indian clinical research industry?

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The Indian Clinical Research Industry went through a trying phase in 2013 and 2014

The Indian Clinical Research Industry went through a trying phase in 2013 and 2014. However, 2015 saw steps taken by the Indian regulators to mitigate the challenges posed by regulatory uncertainty and address stakeholder concerns through amendments in regulations, new orders and further guidance on existing ones. Have these new guidelines improved the clinical research scenario? How does the future look for Indian clinical research industry? Read on to find out...

Have the revised guidelines improved the environment?
The most significant of these changes were revisions to the compensation guidelines and audio visual recording during clinical trials which were major barriers for sponsors conducting clinical trials in India.
"The compensation guidelines are now more balanced and rational; we are beginning to see more predictable approval timelines with the expansion of the Subject Expert Committees and the expected roll-out of the accreditation process is projected to have a significant impact on the quality of research," Dr Rajashree Devarakonda, Vice President, India and Asia Pacific, Voisin Consulting Life Sciences (VCLS).

She added, "This is a major improvement from the previous guideline and now this brings India back to almost the same level playground as other global counter parts. In addition, CDSCO has launched a new online clinical trial submission system as part of efforts to increase accountability, transparency and efficiency in processing clinical trial applications."

However, it will take time to see the real impact of these changes although there is already begun a reduction in approval timelines.

"The environment is certainly more positive but rebuilding trust and confidence is a long and slow process. What has been extremely encouraging is the inclusive approach adopted by the Indian regulators whereby stakeholder feedback has been actively sought and acted upon in many cases. We now have a regulatory system that is balanced, aligned with global trends and one that addresses our uniqueness as a country and society. This is a significant development," Ms Suneela Thatte, President, ISCR (Indian Society for Clinical Research).

 

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