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.

中文翻译：

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印度的干细胞治疗管理：监管真空还是管辖权模糊？

印度诊所正在提供干细胞治疗，尽管缺乏其有效性和安全性的临床前证据。这归因于缺乏具有法律约束力的研究指南造成的治理真空。相比之下，本文强调了在与临床试验脱节的私人市场上提供治疗时，在研究指南的支持下试图规范干细胞治疗所引起的管辖权歧义。虽然成文法在 2014 年得到了加强，但鉴于将医疗保健法律和专业准则付诸实践的挑战，其实施前景仍然疲软。最后，关注消费者法和民间社会激进主义在解决不受管制的治疗问题方面的能力，