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

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 channeled 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. All laboratories and institutes coming under the umbrella of NGSCR should have GMP, GLP and GCP compliant. Appropriate clean room classification shall be followed for stem cell isolation, culturing or manipulation in their respective lab/institutes. The safety and efficacy concerns regarding animal and human applications, uniformity in batch production, strengthening of scientific knowhow should definitely be in line with the cutting edge technological advancements globally. Conformity with international guidelines, and peer reviewed publications are a must for getting approval for clinical trials and marketing options. The review as a whole may not be comprehensive enough to include all the points in relation to the regulatory domain for approving 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.