Abstract
Stem cell treatments offered in Indian clinics have been controversial since they are based on procedures that have yet to be certified by standard research protocols. Proposals for regulating such practices have emphasised the role of statutory laws, assuming that once put in place, these have the capacity to automatically compel behaviour in expected ways. This chapter draws on social studies of law, governance and biomedicine to argue that the task of governing stem cell treatments in India has been complicated by difficulties in pinning down the object to be regulated as well as ambiguities in jurisdictional boundaries. Early efforts to respond to the controversy over unproven treatments took the form of guidelines for research. However, since those who were offering treatments did not consider themselves to be doing research, they did not perceive the guidelines to be applying to them. Since then, legislative changes proposing to regulate stem cells under the category of drugs have raised hopes for addressing this challenge. But since gaps between legislation and enforcement are common, the chapter examines the potential of more decentralised modes of governance (through regulation of the medical profession and practice, consumer legislation and civil society action), finding that significant hurdles do still remain. In conclusion, we argue that the case of stem cell governance must be understood within the broader picture of inequalities in access to health care in India.
Parts of this chapter were previously published in the following article: Tiwari SS, Raman S (2014) Governing stem cell therapy in India: regulatory vacuum or jurisdictional ambiguity? New Genetics and Society, 33(4), 413–433. Material from that article is reprinted with permission from Taylor & Francis.
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Acknowledgements
This chapter draws from and reworks material from a paper previously published by the authors in the journal New Genetics and Society (DOI:10.1080/14636778.2014.970269). The fieldwork reported here was supported by a Wellcome Trust Developing Countries Doctoral Studentship (grant number: WT087867MA) awarded to Shashank Tiwari. The Trust is not responsible for views expressed in this paper. The authors would like to thank Pranav Desai for support and feedback during the course of the project.
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Tiwari, S.S., Martin, P., Raman, S. (2017). Governing the Stem Cell Sector in India. In: Pham, P., Rosemann, A. (eds) Safety, Ethics and Regulations. Stem Cells in Clinical Applications. Springer, Cham. https://doi.org/10.1007/978-3-319-59165-0_11
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