Architecture of drug regulation in India : what are the barriers to regulatory reform?

Abstract

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 the authors 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.

Citation

Jeffery, R.; Santhosh, M.R. Architecture of drug regulation in India : what are the barriers to regulatory reform? Journal of health studies (2009) 2: 13-32.

Architecture of drug regulation in India : what are the barriers to regulatory reform?

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