Overview of Current Regulatory Practices, Challenges and Guidance for Regulation of Stem Cells and Stem Cellderived Products in India

Rajneesh Verma¹, Yogesh Shelar², Venkatesh, M. P.² & Manoj Bansode^3*

¹Stem Cells 21 co. Ltd, 2^nd & 7^th fl, Urbis bld, Aetas Residence, Soi Ruamrudee, Bangkok, Thailand
²J.S.S. College of Pharmacy, Sri State Highway 17 Near Fire Station, Shivarathreeshwara Nagar, Mysuru, Karnataka
³Saiseva Biotech Pvt Ltd, CurecellsTM Cord Blood Bank, Kant Helix, Bhoir colony, Chinchwad, Pune, Maharashtra

Dr. Manoj Bansode, Saiseva Biotech Pvt Ltd, CurecellsTM Cord Blood Bank, Kant Helix, Bhoir colony, Chinchwad, Pune, Maharashtra.

Keywords: Stem Cells; Stem Cell Derived Products; Regulation; India

Abstract

Stem cell and cell derived products are included under the category of drug nowadays, as it is involve in treatment of several untreatable diseases. Therefore, in current era of modern medicine the stem cells need to pass through Food and Drug Administration (FDA) regulation of clinical trials to pass as a drug. International Society for Stem Cell Research (ISSCR) regulates clinical trials involved in stem cell research and its prospective human application. Currently every country including India has own regulation for stem cell research and are more or less similar to ICSSR. The role of National Apex Committee for Stem Cell Research and Therapy in India (NAC-SCRT) are clearly stated in NGSCR that approval for stem cell application in patients only within the confines of clinical trials and therapy based on Stem Cells and Stem Cell derived Products (SCCPs) should be informed in a proper format to the regulatory concern and done through the proper channel.
This review article covers the requirement of laboratories and institutes which covered under NGSCR along with requirements for testing and evaluation of stem cells and cell based products in India. The review as a whole may not be comprehensive enough to include all the points in relation to the regulatory domain for approving Stem Cell Derived Product (SCDP) in our country but an attempt has been made to identify the important points keeping in mind that this domain will evolve and rules and regulations will change with the passage of time.

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).