Demythologising the 'Liberalisation' of Clinical Trial Regulations in India: A Practitioner's Perspective
Brijesh Regal, Science, Technology and Society, 2018, 23(3): 1–22.
Abstract: Recent history of clinical trials in India has been mired in avoidable controversies. Negative public perception and consequent reactions by government and judiciary have led to a virtual blockade of clinical trials in the country. This article dispassionately analyses the fiascos that happened in the past few years, describes how folklore disseminated by media, civil society and experts created a myth about 'liberalisation' of regulations and presents facts about regulatory amendments. The causes of recent non-compliances are discussed and real fault-lines are identified. The article posits that territorial laws must remain harmonised with contemporary international standards for regulating global activities like clinical trials. Fixing what was not broken has already caused substantial harm and Indian regulators have done well by reversing the unnecessary tinkering recommended by some quasi-experts. Professional self-regulation along with implementation of existing regulations are proposed as the best solutions for gaining India's place on the global clinical trials' growth curve.