The low translational efficiency of animal models to humans, and the development of new-age methodologies that are human-cell based, is fuelling a paradigm change across the globe. In this perspectives paper, we discuss the current state of research, funding, and regulation in these 21st century technologies, including organoids and organ-on-chip in India. Recently, a road-map was drawn by Indian Council for Medical Research (ICMR) regarding alternatives to animals in research in India and it also held a special session in January 2018 to discuss latest developments in new human-relevant model systems. We document the regulatory and research landscape in this field in India. We also discuss the challenges present in this field which include lack of training and skills to handle embryonic or induced pluripotent stem cell (iPSC) lines, funding limitations, lack of domestic production of reagents leading to elevated costs, and lack of infrastructure, such as microfabrication facilities. In the end, we provide recommendations to enable innovation and application of human-relevant methodologies to develop India as a key player in this arena globally.

中文翻译：

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印度需要为人类相关研究制定框架：迈向更好的疾病模型和药物发现

动物模型对人类的低转化效率，以及以人类细胞为基础的新时代方法的发展，正在推动全球范式的变革。在这篇观点论文中，我们讨论了这些 21 世纪技术的研究、资金和监管的现状，包括印度的类器官和器官芯片。最近，印度医学研究委员会 (ICMR) 绘制了一份关于印度研究中动物替代品的路线图，并于 2018 年 1 月召开了一次特别会议，讨论与人类相关的新模型系统的最新发展。我们记录了印度该领域的监管和研究格局。我们还讨论了该领域存在的挑战，包括缺乏处理胚胎或诱导多能干细胞 (iPSC) 系的培训和技能，资金限制、缺乏试剂的国内生产导致成本上升以及缺乏基础设施，例如微加工设施。最后，我们提供建议，以实现与人类相关的方法的创新和应用，以将印度发展为全球该领域的关键参与者。