Experts see draft national guidelines for stem cell research to stall unproven therapies in India
Bengaluru, August, 2017
Experts see that draft national guidelines for stem cell research could prevent administering unproven cell-based therapies for chronic disease conditions.
The government and the regulatory agencies have played a crucial role in the progress of stem cell research in country and it is the policies introduced by these bodies which are responsible in determining the rate of growth of any field of research and development, said BN Manohar, MD & CEO at Stempeutics Research Pvt. Ltd.
“We see these recent guidelines for stem cell research as an encouraging step from ICMR to curtail unproven stem cell therapy and promote research in the country. It clearly defines the different types of manipulations of the cells and the requirement of GMP facility approved by regulatory authorities before initiating the clinical trial in any indication,” he added.
According to Dr. Caroline Mathen, CEO and Founder, OCT Therapies and Research , the field of regenerative medicine is evolving at a furious pace and the revised guidelines have come at the right time to give us much-needed clarity. However the guidelines need to walk a fine line between encouraging cutting edge research while preventing exploitation and unethical research.
India needs permanent sets of guidelines and only be amended biannually. There is no point in making draft guidelines every year and seek public opinion. This must be stopped immediately since lots of valuable time and money are invested in the same, said Dr Satish Totey, founder, chairman & managing director, Aureostem Research Pvt Ltd.
Most of the time the stem cell field gets a bad name due to a few unethical operators. If the guidelines are going to try and restrict all companies just because of a few unethical ones, then it becomes difficult for those players that stringently follow the guidelines and are stuck for years in an endless gestational R&D phase with no marketing authorisation in sight. Not only does the research aspect become difficult, potential investors are also scared away due to the regulatory landscape. The need of the hour is quick approvals by communication and coordination between the various regulatory and licensing authorities including NAC-SCRT, CDSCO and FDA. There is a real concern that although the intent of the new guidelines is to protect, it may sacrifice research at the altar of safety, added Dr. Mathen.
Although the guidelines are comprehensive and will certainly ensure that patients get reliable and safe stem cell products in India in near future, yet it has controversial section 8 which may give clear escape route to clinicians to push unapproved stem cell therapy, noted. Dr. Totey.