CLINICAL TRIALS AND BIOETHICS IN INDIA

Abstract

Since the 1990s, the pharmaceutical industry has been a major contributor to the economic growth of India. India is the world’s largest vaccines producer, and it attracts foreign direct investors who are relocating production capacities and research activities to develop new drugs in India. India, however, suffers from a lack of trust due to repeated scandals over clinical trials. Some of these scandals have led to economic sanctions, such as the withdrawal of hundreds of generic drugs from consumption in Europe in 2015. These measures followed irregularities detected in clinical trials carried out on volunteers. While India has taken steps to reform the bioethical institutions responsible for the control of clinical trials, we show in this contribution that loopholes persist. Two periods can be distinguished. The first period, between the early 2000s and 2013, gathers a significant growth in the number of clinical trials with a growth in bioethical scandals. It led the Indian government, under pressure from the civil society and the Supreme Court, to take action to curb clinical trials and to reform bioethical institutions. The second period, from 2013 to 2021, is characterised by an increase in the number of clinical trials in a context of strengthening the efficiency of bioethical institutions. We show that the increase in clinical trials is mainly due to the implementation of the TRIPs agreements on generic drugs. This development put another pressure on national vigilance authorities which remain undersized with respect to the magnitude of the Indian clinical trials market. It also highlights again the structural frailties of the Indian Federal System.