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

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...

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Main Authors: Tiwari, Shashank S., Raman, Sujatha
Format: Article
Published: Taylor & Francis 2014
Subjects:
Online Access:https://eprints.nottingham.ac.uk/34702/
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author Tiwari, Shashank S.
Raman, Sujatha
author_facet Tiwari, Shashank S.
Raman, Sujatha
author_sort Tiwari, Shashank S.
building Nottingham Research Data Repository
collection Online Access
description 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.
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spelling nottingham-347022020-05-04T20:17:53Z https://eprints.nottingham.ac.uk/34702/ Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity? Tiwari, Shashank S. Raman, Sujatha 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. Taylor & Francis 2014 Article PeerReviewed Tiwari, Shashank S. and Raman, Sujatha (2014) Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity? New Genetics and Society, 33 (4). pp. 413-433. ISSN 1469-9915 stem cell therapy India STS and biomedical governance http://www.tandfonline.com/doi/abs/10.1080/14636778.2014.970269 doi:10.1080/14636778.2014.970269 doi:10.1080/14636778.2014.970269
spellingShingle stem cell therapy
India
STS and biomedical governance
Tiwari, Shashank S.
Raman, Sujatha
Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?
title Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?
title_full Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?
title_fullStr Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?
title_full_unstemmed Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?
title_short Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity?
title_sort governing stem cell therapy in india: regulatory vacuum or jurisdictional ambiguity?
topic stem cell therapy
India
STS and biomedical governance
url https://eprints.nottingham.ac.uk/34702/
https://eprints.nottingham.ac.uk/34702/
https://eprints.nottingham.ac.uk/34702/