Yogesh S | Volume 1; Issue 1 (2019) | Mapsci-JRBM-1(1)-001 | Research Article Citation: Yogesh S, Venkatesh MP, Hemanth CK, Bansode M, Mukherjee K, Kaushik D. Overview of Current Regulatory Practices, Challenges and Guidance for Regulation of Stem Cells and Stem Cell Derived Products in India. J Regen Biol Med. 2019;1(1):1-28. DOI: https://doi.org/10.37191/Mapsci-2582-385X-1(1)-001 1 Overview of Current Regulatory Practices, Challenges and Guidance for Regulation of Stem Cells and Stem Cell Derived Products in India Yogesh Shelar 1 , M.P. Venkatesh 1 , C Hemanth Kumar 2 , Manoj Bansode 3 , Kaniska Mukherjee 4 , Kaushik Deb 4* 1 JSS College of Pharmacy, JSS Academy of Higher Education and Research, Karnataka, India 2 E-78, lane No-2, 2nd floor, Pandavnagar, New Delhi, India 3 Saiseva Biotech Pvt Ltd, Curecells Cord Blood Bank, Bhoir colony, Chinchwad, Pune, Maharashtra, India 4 Diponed Biointelligence LLP, #60A Bommasandra Industrial Area, Bengaluru, Karnataka, India * Corresponding Author: Kaushik Deb, DiponedBiointelligence LLP, #60A Bommasandra Industrial Area, 2nd Floor Karnataka Bank Building, Jigani Link Road, Bengaluru, Karnataka, India-560097, Tel: +918027835022 Received Date: 05-06-2019; Accepted Date: 06-12-2019; Published Date:06-21-2019 Copyright © 2019 by Shelar Y, et al. All rights reserved. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Journal of Regenerative Biology and Medicine An Open Access Journal (ISSN-2582-385X) Abstract Stem Cell Science/Regenerative Medicine is perhaps the most important “pillar” out of the four pillars of modern medicine. Use and abuse of the “Stem Cells and Stem Cell derived Products” as therapeutic measure for treatment of several untreatable diseases has come to the fore in recent times. The “stem cells” are drugs as discussed below. In the realm of clinical trials, to be approved by FDA, just as a “drug” undergoes trials, successively via phase I, phase II and phase III trials, likewise stem cells, which are “drugs” per se has to be channelled through the same three phases of clinical trials. There are some evolving regulations in place for regulating stem cell research and its prospective human application in clinical trials which is in place, as per the guidelines of ICSSR 2016. Each and every country, including India has more or less similar rules and regulations which conform to the rules/regulations as proposed by ICSSR and followed by FDA, although many countries has done individual modifications in the same. The role of NAC-SCRT, ICMR, IEC, IC-SCR, DCGI are clearly defined and it has been clearly stated in NGSCR that approval for stem cell application in patients, (Autologous, allogenic, homologous or non-homologous) only within the confines of “clinical trials” and therapy based on Stem Cells and Stem Cell derived Products (SCDP) should be informed in a proper format to the regulatory concern and done through the proper channel.