Challenges and prospects for clinical trials in India: A regulatory perspective

Abstract

The purpose of this policy brief is to bring back focus to the debate on clinical research by providing hard data and clarity on issues based on extensive data mining from both secondary and primary sources as well as stakeholder interactions across 4 Indian states and 7 countries across 4 continents. The policy recommendations that follow takes cognizance of the regulatory constraints in low-resource settings, and hence categorized for immediate, medium and long-term implementation to render them actionable.