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How Civil Society Organisations Changed the Regulation of Clinical Trials in India Edinburgh Research Explorer How civil society organisations changed regulation of clinical trials in India Citation for published version: Sariola, S, Jeffery, R, Jesani, A & Porter, G 2019, 'How civil society organisations changed regulation of clinical trials in India', Science as Culture, vol. 28, no. 2, pp. 200-222. https://doi.org/10.1080/09505431.2018.1493449 Digital Object Identifier (DOI): 10.1080/09505431.2018.1493449 Link: Link to publication record in Edinburgh Research Explorer Document Version: Publisher's PDF, also known as Version of record Published In: Science as Culture Publisher Rights Statement: © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons. org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. General rights Copyright for the publications made accessible via the Edinburgh Research Explorer is retained by the author(s) and / or other copyright owners and it is a condition of accessing these publications that users recognise and abide by the legal requirements associated with these rights. Take down policy The University of Edinburgh has made every reasonable effort to ensure that Edinburgh Research Explorer content complies with UK legislation. If you believe that the public display of this file breaches copyright please contact [email protected] providing details, and we will remove access to the work immediately and investigate your claim. Download date: 30. Sep. 2021 Science as Culture ISSN: 0950-5431 (Print) 1470-1189 (Online) Journal homepage: http://www.tandfonline.com/loi/csac20 How Civil Society Organisations Changed the Regulation of Clinical Trials in India Salla Sariola, Roger Jeffery, Amar Jesani & Gerard Porter To cite this article: Salla Sariola, Roger Jeffery, Amar Jesani & Gerard Porter (2018): How Civil Society Organisations Changed the Regulation of Clinical Trials in India, Science as Culture, DOI: 10.1080/09505431.2018.1493449 To link to this article: https://doi.org/10.1080/09505431.2018.1493449 © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group Published online: 13 Jul 2018. Submit your article to this journal Article views: 9 View Crossmark data Full Terms & Conditions of access and use can be found at http://www.tandfonline.com/action/journalInformation?journalCode=csac20 SCIENCE AS CULTURE https://doi.org/10.1080/09505431.2018.1493449 How Civil Society Organisations Changed the Regulation of Clinical Trials in India Salla Sariolaa,b, Roger Jefferyc, Amar Jesanid and Gerard Portere aEthox Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK; bSociology, University of Turku, Turku, Finland; cSchool of Social and Political Science, University of Edinburgh, Edinburgh, UK; dIndependent Researcher and Teacher (Bioethics, Public Health); eSchool of Law, University of Edinburgh, Edinburgh, UK ABSTRACT KEYWORDS In 2005 India changed its pharmaceutical and innovation India; regulation; civil society policy that facilitated a dramatic increase in international organisations; clinical trials; clinical trials involving study sites in India. This policy shift bioethics; social justice 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 pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research. Introduction As part of the world-wide offshoring or globalisation of clinical trials that dates from the 1990s, there has been a dramatic expansion of global clinical trials and CONTACT Salla Sariola salla.sariola@utu.fi Ethox Centre, Nuffield Department of Population Health, Uni- versity of Oxford, Old Road Campus, Oxford, OX3 7LF, UK; Sociology, University of Turku, Assistentinkatu 7, 20014Turku, Finland © 2018 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons. org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 2 S. SARIOLA ET AL. international contract research organisations (CROs) in India. The number of trials with Indian sites grew especially after 2005. That year, following the signing of the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) in 1995, India brought its domestic patent laws into line with WTO requirements. This allowed foreign sponsors to test new drugs in India without fear of copying. In 2005, India revised its pharmaceutical legislation to match the international ICH Good Clinical Practice (GCP) Guidelines – which standardises the conduct of randomised control trials (RCTs) globally and was drawn up by the pharmaceutical industry (Abraham, 2010; Cooper and Waldby, 2014) – to enable global phase II and III clinical trials to take place within the country. Removing restrictions on global trials was part of a national programme designed to attract trials and encourage Indian pharmaceuticals companies to shift their Research and Development (R&D) from being almost entirely based on ‘reverse-engineering’ of existing molecules to carrying out innovative research on new molecules. Supporters of clinical trials described benefits for India in terms of foreign exchange earnings and Indian involvement in advanced scientific activities. Those promoting India as a trial destination also made bold and, in the event, exaggerated claims about the likely scale of trial activity in India. The market research firm Frost and Sullivan (2012), for example, estimated that Indian clinical trials business was worth USD $485 million (£282 million) in 2010–2011 and would pass the $1 billion (£594 million) mark by 2016. Local and international promoters within the pharmaceutical sector stressed lower expenses for sponsors because of: low Indian salaries; the existence of a large pool of potential trial participants; and the availability of English-speaking staff. Carrying out trials could also offer sponsoring companies an opportunity to build market access by establishing networks of friendly key physicians. Opti- mistic estimates of the current and future size of the industry helped it to lever- age assistance from the Government of India: direct funding, its support for schemes involving collaboration between industry and academia, sharing state institutions’ infrastructures, and through deregulation itself, for example (Kale and Little, 2007, pp. 605–606). The changes brought into play a plethora of new actors in the field of clinical research. Kaushik Sunder Rajan has described India’s emergent CROs, inter- national sponsors, clinical hospital sites etc. as a form of capacity building through which India joined the global pharmaceutical industry (Sunder Rajan, 2010). Sariola et al. (2015) call this process ‘Big-Pharmaceuticalisation,’ pointing to how the pharmaceutical industry is impacting on how, where and on whom drugs are tested, and changing local industries towards global collaborative and methodological models. Civil society groups and voices within mass media contested the economic policy leading to the increase of international clinical trials in India from the start. As the number of global trials increased in India (see Table 1), such SCIENCEASCULTURE 3 Table 1. Approvals of trials by CDSCO between 2007 and 2017. Note: All values taken from the running number of the trials approved for that year. Source: All sources from the CDSCO website for approved clinical trials, accessed 15 September 2016. 2007–2012: http://www.cdsco.nic.in/writereaddata/DCG(I)%20approved%20clinical%20trial%20registered%20in% 20ctri%20website%20(Jan.2013).pdf 2013: http://www.cdsco.nic.in/Forms/list.aspx?lid = 1884 2014: http://www.cdsco.nic.in/Forms/list.aspx?lid = 1883 2015: http://www.cdsco.nic.in/forms/list.aspx?lid = 2093andId = 11 2016 and 2017: http://www.cdsco.nic.in/forms/list.aspx?lid = 2173&Id = 11 Note on the Source: In 2010, the number of approvals by the CDSCO dropped before regulatory restrictions came into force, which
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