The New Drugs and Clinical Trial (NDCT) Rules, 2019 have brought changes in the Indian clinical trial regulations. However, the regulatory environment on the ground needs to adapt further to ensure India gets a higher share of global clinical trials. In an e-mailed interview with Sohini Das, Indian Society for Clinical Research (ISCR) President Sanish Davis outlines the problems and the possible solutions. Edited excerpts:
India now has a 3-4 per cent share of global clinical trials. The US has 23-24 per cent. What are the reasons for India’s low share?
Global clinical trials are run in 25-30 core countries.