Implementation of regulations and policies have been taking very long time especially when it comes to cell based therapies. It takes undue delay of around 6 to 9 month for initiating the trial in any site after CDSCO approved the trial protocol, said BN Manohar, MD & CEO, Stempeutics Research Pvt. Ltd.
Take for instance the latest national draft guidelines where there are no approved indications for stem cell therapy other than the Haematopoietic stem cell transplantation (HSCT) for conditions stated in the annexure of the draft document. Mononuclear stem cell (MNC) for homologous use for unapproved indications and for non – homologous use will require CDSCO approval. These strong steps will help to curtail unapproved stem cell therapy and also HSCT for unapproved indications. This is a positive step for the country, Manohar told Pharmabiz.
Research has been categorized as permissible, restrictive and prohibitive areas of study. The prohibitive area includes research related to human germ line gene therapy and reproductive cloning amongst others. What we observe is that these guidelines have not changed from the previous published rules and are as per the international norms.
More over guidelines have no legal power as no action can be taken against clinics/hospitals who are conducting unauthorized stem cell transplantation in different unapproved indications. These guidelines should be converted to legislation so that necessary actions can be taken against unproven stem cell therapies being done in India. This will also help in improving India’s image in the global arena.
Another issue is presence of multiple committee approvals before one can conduct clinical trials in the country. For conducting a multi-centric clinical trial one have to take approval from CDSCO for the trial protocol. Thereafter, each hospital/site for the conduct of the trial has to give approval on the DCGI approved protocol by its IC-SCR (Institutional committee of stem cell research) and IEC (Institutional ethics committee).
If one is using specific cell types like iPSc/ESCs cells than NAC-SCRT (National apex committee of stem cell research and therapy) has to accord approval for the study. There is unwarranted holdup of around 6 to 9 month for start the human study in any site after CDSCO has approved the trial protocol, he stated.
The only possible solution for this would be the harmonization of the different regulatory bodies under one banner so that a clear-cut path can be developed for the submission and approval of proposals. This would not only ensure clarity, but would also hasten the transition of a therapy from bench to bedside. In addition to this, the regulatory bodies must have regular debates and meetings with basic researchers, clinicians and industrialists, so as to educate them about the various policies being introduced and also to gain their perspectives, said the Stempeutics chief.