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

Gerard Porter; Amar Jesani; Salla Sariola; Roger Jeffery

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

Gerard Porter
Amar Jesani
Salla Sariola
Roger Jeffery
Katso/Avaa
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Routledge
doi:10.1080/09505431.2018.1493449
URI
https://www.tandfonline.com/doi/full/10.1080/09505431.2018.1493449?scroll=top≠edAccess=true
Näytä kaikki kuvailutiedot
Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2021042719545
Tiivistelmä

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
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.

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