RESUMO
Hundreds of clinics in India offer unproven stem cell therapies despite having remarkably stringent guidelines and regulations for fraudulent advertisements and clinical practice. We discuss the challenges with current regulations, how a recently proposed amendment may further legitimize unproven stem cell therapies, and discuss paths forward in a global context.
Assuntos
Transplante de Células-Tronco/legislação & jurisprudência , Transplante de Células-Tronco/normas , Humanos , Índia , Células-Tronco/citologia , Células-Tronco/metabolismoRESUMO
The government of India has heavily promoted research and development in regenerative medicine together with domestic innovation and business development initiatives. Together, these promise a revolution in healthcare and public empowerment in India. Several national and transnational linkages have emerged to develop innovative capacity, most prominently in stem cell and cord blood banking, as well as in gene therapy, tissue engineering, biomaterials and 3D printing. However, challenges remain of achieving regulatory oversight, viable outputs and equitable impacts. Governance of private cord blood banking, nanomaterials and 3D bioprinting requires more attention. A robust social contract is also needed in healthcare more generally, so that participation in research and innovation in regenerative medicine is backed up by treatments widely accessible to all.
Assuntos
Invenções/tendências , Medicina Regenerativa/legislação & jurisprudência , Medicina Regenerativa/tendências , Controle Social Formal , Bioimpressão , Terapia Genética , Humanos , Índia , Impressão TridimensionalRESUMO
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.
