The Indian Council of Medical Research (ICMR) has come out with a draft proposal to constitute a National Apex Committee (NAC) for regulating stem cell research and therapy in the country.
The NAC has been envisaged with representatives from various government agencies like Department of Biotechnology, Department of Science and Technology, Council for Scientific and Industrial Research, Central Drugs Standard Control Organisation and the Department of Atomic Energy. Mammalian cell based research and therapy, both in the public as well as private sectors, is expected to come under the regulatory control of NAC.
As per the draft guidelines circulated by ICMR, the NAC is meant to be in control of all proposals involving stem cells of any source undertaken in the country. All such research centres would have to be registered with this committee. The Committee will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of cell based research and therapy.
The ICMR also proposes the setting up of a central monitoring committee - a sub-committee of the NAC - for carrying out inspections and site visits in such centres.
All proposals either from public or private sector for research or therapy should be placed before NAC for clearance after recommendation through appropriate scientific peer review mechanism. These proposals should also be cleared by the Institutional Ethics Committee before submitting to NAC.
Research on stem cells includes both basic and applied aspects. Currently this technology has potential for therapy through regeneration of tissues or implantation of cell and tissues in nervous system diseases e.g. Parkinson's disease, Alzheimer's, multiple sclerosis, spinal cord etc., cardiac infarction, bone and cartilage diseases, cancer and immune diseases, diabetes etc. and burns.
The framework of NAC, as suggested by ICMR, includes nominees from all concerned government departments. It also calls for co-opting biomedical experts like pharmacologist - clinical, cell biologist, clinician, haematology/genetics etc. Inclusion of legal expert, social scientist and women's representative has also been suggested.