Clinical research stakeholders welcome positive steps, hope for better regulations

During the recent deliberations on prevailing scenario, the various industry and academic experts have called for greater stakeholder collaboration in an evolving regulatory environment


Besides welcoming various positive developments, the optimism for a better future for clinical research in India and patient access to more effective medicines was the overwhelming sentiment expressed at the 9th Annual Conference of the Indian Society for Clinical Research (ISCR) held recently at Mumbai.

Over 400 clinical research professionals from across the stakeholder spectrum were drawn together to discuss and deliberate on the theme ‘Clinical Research in India: Patients First and Research for India' and what more needs to be done to create a more enabling environment for the conduct of clinical research in the country.

Ms Suneela Thatte, president, ISCR in her welcome address said, "We have seen a series of developments and order relating to clinical research in the country which has to a great extent helped bring balance in the regulatory environment.

The compensation guidelines are more balanced and rational; we are beginning to see more predictable approval timelines with the expansion of the Subject Expert Committees; the expected roll-out of the accreditation process is projected to have a significant impact on the quality of research. We now have a regulatory system that is balanced, aligned with global trends and innovation and addresses our uniqueness as a country and society. This is a significant development, something that we at ISCR hope to build upon in 2016. It now extremely important not to lose sight of quality and compliance as the clinical research industry enters into the growth phase."

A message was read on behalf of Dr K L Sharma, joint secretary, Ministry of Health and Family Welfare who could not join the conference, "The government of India understands the importance of clinical research in India and the industry concerns have been addressed substantially...In areas where we need improvement, the Government is willing to engage with industry stakeholders and academic or research institutions to work out solutions. We are committed to leverage the resources in the public and private sector to ensure cutting edge research in drug related areas," he said.

Previous 1 3 Next

Leave a Reply Sign in

Notify me of follow-up comments via e-mail address

Post Comment

Survey Box

National Health Policy

Is National Health Policy 2017 helpful for patients?

Send this article by email