Even after several years, the Union Health Ministry's proposal to constitute a National Apex Committee (NAC) for regulating stem cell research and therapy in the country is stuck in the bureaucratic red-tapism. The constitution of NAC is significant as the area of stem cell research is new and is associated with rapid scientific developments and complicated ethical, social and legal issues.
Though the Indian Council for Medical Research (ICMR), part of the Health Ministry, had more than two years ago come out with the 'Guidelines for Stem Cell Research Regulation', prescribing stringent procedures for souring and use of stem cells by research institutions in the country, it is yet to constitute the NAC, thanks to the bureaucratic red-tapism in the ministry.
Even though the senior officials in the union health ministry have been on record saying that the NAC will be constituted very soon, it did not materialise so far. Though the ministry had almost finalised the NAC in October last year with Dr Mammen Chandy of Christian Medical College (CMC), Vellore as its chairman, Dr Chandy's reluctance at the eleventh hour to accept the chairmanship has further delayed the announcement of the NAC, sources said.
Once the Apex Committee is in place, all institutions and investigators, both public and private, carrying out research on human stem cells should be registered with the NAC through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). All institutions involved in any type of stem cell research and therapy shall be registered with the NAC.
The NAC will set standards for safety, quality control, procedures for collection and its schedule, processing or preparation, expansion, differentiation, preservation for storage, removal from storage to assure quality and/or sterility of human tissue, prevention of infectious contamination or cross contamination during processing, carcinogenicity and xenotransplantation.
The NAC will have around 10 members headed by a chairman and will have members from different fields. The chairman will be assisted by deputy chairman, member secretary and nominees from DBT, DST, CSIR, ICMR, DCGI, DAE, and biomedical experts drawn from various disciplines like pharmacology, immunology, cell biology, haematology, genetics, developmental biology, clinical medicine and nursing. There will be a legal expert, social scientist, and a women's representative in the NAC. In addition consultants/experts could be consulted for specific topics and advice.
It will be a multidisciplinary body with a secretariat which will have two main functions: general oversight and policy monitoring function; and to review specific controversial or ethically more sensitive research proposals. The committee will have the responsibility to examine the scientific, technical, ethical, legal and social issues in the area of stem cell based research and therapy.