How Civil Society Organisations Changed the Regulation of Clinical Trials in India

Science As Culture
Salla SariolaGerard Porter

Abstract

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5-6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceuti...Continue Reading

References

Jul 1, 1999·Journal of Health Politics, Policy and Law·C A Nathanson
Mar 19, 2004·Sociology of Health & Illness·Phil BrownRebecca Gasior Altman
Sep 24, 2004·Lancet·Jennifer Prah Ruger
Apr 22, 2005·The New England Journal of Medicine·Samiran Nundy, Chandra M Gulhati
Dec 6, 2014·Social Science & Medicine·Salla SariolaRoger Jeffery
Jul 12, 2017·Developing World Bioethics·Gerard Porter

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