Structure, organization and knowledge production of the Indian clinical trials industry

In India, the number of clinical trials has been radically transformed in two directions since 2005. In that year, legislation was changed to make it easier for ‘Big Pharma’ to carry out multi-sited trials in India and at the same time as elsewhere in the world. After a period of rapid growth to 500 in 2010, numbers of new trials registered with the Clinical Trials Register-India dropped to 321 in 2011 and 262 in 2012 (Chawan, Gawand and Phatak, 2015). Following a series of adverse reports, the number of approvals in 2013 dropped further to 107 in 2013, to 150 in 2014, 121 in 2015 and 6-7 a month in 2016. The future scale of the global clinical trials industry in India remains unclear.

This chapter reviews the evidence about the scale and significance of these trials, using a theoretical approach derived from the theories of ‘global assemblages’. We set out some of the new social forms that have arisen to service these trials before assessing the growth in clinical trials in India since 2005. The chapter also analyses the ethical implications of clinical trials for India and its public health¬¬. We conclude by considering the implications of the reforms that have been introduced since 2012 as a result of several highly-publicized controversies that highlighted problems in the management of clinical trials.

Our main argument is that the nascent Indian clinical trials industry rapidly adjusted to the opportunities provided by the 2005 reforms, linked to India’s signing of the TRIPs agreement. It exaggerated the potential benefits, but provided sites and supporting infrastructure to encourage trials to go ahead. On the other hand, Indian regulators were slow to come to terms with the challenges of responding to well-co-ordinated global assemblages (Yee 2012). Civil society institutions were able to mobilise a groundswell of opinion against trials, drawing on tropes such as the Indian population being used as ‘guinea pigs’. Despite resistance from the industry, Indian regulations have been tightened, offering some prospect that at least the worst abuses are unlikely to be repeated.We draw on research funded by the UK’s Economic and Social Research Council (ESRC) and its Department for International Development (DfID), carried out between 2010 and 2013. Our detailed understanding of the pharmaceuticals sector and the growth of clinical trials comes also from previous research (SS, RJ) and long-term engagement with issues of medical ethics (AJ) and medical law (GP).