Express Pharma

A brighter future for clinical research in India


Leading upto International Clinical Trials Day, which falls on May 20, Suneela Thatte, President, Indian Society for Clinical Research (ISCR), is hopeful that new orders and revised guidelines will herald a renewed wave of progress in India’s clinical research scenario

The last three years saw a drop in clinical research being done in India on account of regulatory uncertainty, judicial and social activism and some media sensationalism. This made the clinical research fraternity apprehensive and concerned over how this would translate into delayed access to new therapies for Indian patients. Over the last year and a half, the Ministry of Health and Family Welfare has taken steps to address the challenges posed by regulatory uncertainty and take on board concerns voiced by stakeholder. Regulations were amended and further guidance was given on existing ones. These were significant movements forward and a reiteration of the regulator’s commitment to clinical research in the country.

The changes that began in 2014 now need to be sustained. The inclusive approach adopted by Indian regulators in which multi-stakeholder feedback has been actively sought and acted upon in many cases, must continue. We need to build on an emerging regulatory system that is balanced, aligned with global trends and one that addresses our uniqueness as a country and society. These developments send out a strong signal to th