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Architecture of Drug Regulation in India: What are the Barriers to Regulatory Reform?
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The regulation of pharmaceuticals in India is generally seen to be in need
of reform, and has been the subject of many official commissions since 1995. Most
commentators agree that the state should intervene to prevent untrammelled market
forces leading to citizens’ suffering, because adequate information about the costs
and benefits of different pharmaceuticals is inaccessible to most users. But in India,
a wide range of stakeholders must be considered before changes can be made to
the regulatory framework. In addition, many international agencies influence these
processes. Efforts to enhance India’s capability to regulate medicines sold within the
country come into conflict with other processes that tend to locate responsibility and
power elsewhere, whether in the hands of global institutions or with other governments.
In this paper we discuss the extent to which the barriers to regulatory reform can be
understood as ‘industry capture’ by reviewing the constitution, focus and effects of the
main pharmaceuticals task forces, commissions and committees established in India
since 1995.
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by Roger Jeffery, Santhosh M.R. | Vol.2, No.1,2,3, -2009-Tracing Pharmaceuticals in South Asia: Drugs, Doctors and Public Policy
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