/ Séminaire Santé mondiale : savoirs, dispositifs, politiques
Roger Jeffery : “Clinical Trials in India : Ethics, Scandals and Regulation in a Globalised Assemblage”15 octobre 2015, de 14 h à 17 h, à l’EHESS, salle 015, RdC, bât. Le France, 190-198 av de France 75013 Paris
Roger Jeffery, Edinburgh India Institute, University of Edinburgh, Royaume-Uni
In India, the amount of activity that falls under the general heading of ’clinical trials’ has been radically transformed since 2005. Legislation that year made it easier for ’Big Pharma’ to carry out multi-sited trials in India at the same time as elsewhere in the world. While the Indian generics pharmaceuticals industry, and the nas-cent contract research organisations, were well prepared for the changes introduced by India signing up to the TRIPS element when joining the World Trade Organisation in 1995, its regulators have been much slower to come to terms with the ethical, political and public health implications of this change. After a period of rapid growth to 2011, the number of new trials registered in India dropped sharply, even before a series of scandals and Parliamentary and Supreme Court interventions tightened the regulatory approvals process. It remains to be seen if it will be possible to resume the previous rates of growth. This presentation will provide a brief overview of theories of ’global assemblages’, and will set out some of the new social forms that have arisen to service these trials. It will then describe and analyse the growth in clinical trials in India since 2005 and the emergent critiques of ethical practices. It will conclude by considering the implications of the reforms that have been introduced since 2012 as a result of heightened external surveillance of the regulation and management of clinical trials in India.