The expert group from stem cell industry in order to get faster clearance, are pushing hard on the committees under the scope of the Drug Controller General of India for their products. DCGI’s final consent are Institutional Ethics Committee (IEC) or Institutional Committee for Stem Cell Research (IC-SCR) and National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). The clearance requires some clinical trials to be done.
Managing Director of Stempeutics Research, Mr. BN Manohar said the government needs to make clearances in a faster phase as the multiple levels of stem cell products are much of time consuming and unwieldy.
The Revise of three level approval process needs to be narrowed down to a single window clearance. On stem cell therapy gaining its base, several things like tissue engineering, induced pluripotent stem cells (IPSC) can be seen exposed along with advances in stem cell therapies that proves to indicate unique regenerative abilities and offering with new solutions for ischemic heart disease to osteoarthritis and Burgers disease treatment.
Assuming the stem cell treatment will repair, regenerate and restore organs that are diagnosed by traumatic injuries. Globally there have several advancements as three products are launched in Korea, Japan has approved the first therapy for graft versus host condition, stem cell therapy for cornea replacement and enzyme deficiency cleared in European Union and few products are under clearance in India too.
Mr. Monohar the moderator of the session listed that in recent years, the area of stem cell research has undergone rapid development ensuring new leads in the treatment of several incurable diseases in a session about Regenerative Medicine.
Dr. Satyen Sanghavi, also the chief scientific officer and executive director, Regenerative Medical Services, Mumbai said that there is an immediate need to strengthen the regulatory framework for faster approvals. It is challenging to educate patients in the country that stem cells therapy is curative and not a disease management product like a drug. Talking about the drug, which should be approved by the Central Drug Standards Control Organization (CDSCO)
The president and CEO, CIRM, Dr. C Randall Mills, articulated that it was necessity to improve stem cell treatment to patients with fruitless needs. The main criteria for stem cell research and therapy are infrastructure, education and training besides regulatory paradigm enabling a level playing field.