Stem cell therapy is applicable for repair and replacement of damaged cells and tissues. Apart from transplanting cells to the body, the stem cell therapy directs them to grow new and healthy tissues. Stem cells in the area of regenerative medicines hold tremendous promise that may help to regenerate the damaged tissues and heal various diseases like multiple sclerosis, heart diseases, Parkinson’s disease, and so on. To prove the safety, efficacy, and for the requirement of a licence for manufacturing and sale, all the stem cell therapies should pass the required criteria and undergo certain examinations of the regulatory agencies. The regulatory authorities review the manufacturing procedures of products to assure its purity and potency. This review summarizes the comparative critical evaluations of existing regulations and developments on the stem cells research in India, USA, EU and Asian regions and also discusses the challenges that have to be overcome and the important points that should be understood to position India as a source of the perspective nation in stem cells around the world.

干细胞疗法适用于修复和替换受损细胞和组织。除了将细胞移植到体内之外，干细胞疗法还指导它们生长新的健康组织。再生医学领域的干细胞具有巨大的前景，可能有助于再生受损的组织并治愈多种疾病，如多发性硬化症，心脏病，帕金森氏病等。为了证明其安全性，有效性以及生产和销售许可证的要求，所有干细胞疗法均应通过要求的标准并接受监管机构的某些检查。监管机构会审查产品的制造程序，以确保其纯度和效力。