Department of Pharmaceutical Regulatory Affairs and Pharmaceutics, NGSM Institute of Pharmaceutical Sciences, NITTE Deemed to be University, Paneer, Mangalore 575018, Karnataka, India.
Curr Stem Cell Res Ther. 2020;15(6):492-508. doi: 10.2174/1574888X15666200402134750.
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的细胞和组织。除了将细胞移植到体内，干细胞疗法还可以指导它们生长出新的健康组织。再生医学领域的干细胞具有巨大的潜力，可以帮助再生受损组织并治疗各种疾病，如多发性硬化症、心脏病、帕金森病等。为了证明安全性、有效性以及制造和销售许可证的要求，所有干细胞疗法都应通过所需的标准，并接受监管机构的某些检查。监管机构审查产品的制造程序，以确保其纯度和效力。本文总结了印度、美国、欧盟和亚洲地区现有的干细胞研究监管规定和发展情况的比较性关键评估，并讨论了印度必须克服的挑战和应该理解的要点，以使其成为全球干细胞研究的潜在国家。
