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Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?

Tiwari, Shashank S.; Raman, Sujatha

Authors

Shashank S. Tiwari

Sujatha Raman



Abstract

Stem cell treatments are being offered in Indian clinics although preclinical evidence of their efficacy and safety is lacking. This is attributed to a governance vacuum created by the lack of legally binding research guidelines. By contrast, this paper highlights jurisdictional ambiguities arising from trying to regulate stem cell therapy under the auspices of research guidelines when treatments are offered in a private market disconnected from clinical trials. While statutory laws have been strengthened in 2014, prospects for their implementation remain weak, given embedded challenges of putting healthcare laws and professional codes into practice. Finally, attending to the capacities of consumer law and civil society activism to remedy the problem of unregulated treatments, the paper finds that the very definition of a governance vacuum needs to be reframed to clarify whose rights to health care are threatened by the proliferation of commercial treatments and individualized negligence-based remedies for grievances.

Journal Article Type Article
Publication Date Jan 1, 2014
Journal New Genetics and Society
Print ISSN 1463-6778
Electronic ISSN 1469-9915
Publisher Taylor & Francis (Routledge)
Peer Reviewed Peer Reviewed
Volume 33
Issue 4
APA6 Citation Tiwari, S. S., & Raman, S. (2014). Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?. New Genetics and Society, 33(4), doi:10.1080/14636778.2014.970269
DOI https://doi.org/10.1080/14636778.2014.970269
Keywords stem cell therapy, India, STS and biomedical governance
Publisher URL http://www.tandfonline.com/doi/abs/10.1080/14636778.2014.970269
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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