The Union health ministry will soon constitute the much awaited National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) for effectively reviewing and monitoring the stem cell research in the country. 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-SCRT through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).

The constitution of NAC-SCRT is a significant step by the government as the area of stem cell research is new and is associated with rapid scientific developments and complicated ethical, social and legal issues. So, it requires extra care and expertise in scientific and ethical evaluation of research proposals in the area of stem cells.

The constitution of the NAC-SCRT is part of the guidelines for stem cell research regulation announced by Indian Council of Medical Research (ICMR) around a year ago. The government felt the need for a separate mechanism for reviewing and monitoring research and therapy in the field of human stem cells and recommended an apex body at the National level called as NAC-SCRT and the other at the institutional level called IC-SCRT.

The Apex Committee will have sweeping powers in the area of burgeoning stem cell research in the country as all established human stem cell lines from any source, imported or created in India, should be registered with IC-SCRT and NAC-SCRT. Permission for import/procurement from other Indian laboratories shall be obtained from IC-SCRT. The investigator shall ensure that the cell line has been established in accordance with existing guidelines of the country.

Besides, all clinical trials with any stem cells shall have prior approval of
IC-SCRT, Institutional Ethics Committee (IEC) and Drug Controller General of India (DCGI) for marketable product; and shall be registered with the NAC-SCRT; except that International Collaboration shall also have prior approval of NAC-SCRT and respective funding agency as per its procedure / or Health Ministry's screening committee (HMSC).

Clinical trials with cells processed as per National GTP / GMP guidelines (minimally manipulated or manipulated with alteration in functionality or genetic characteristics) may be carried out with prior approval of IC-SCRT/ IEC/DCGI as applicable. All clinical trials on stem cells shall be registered with NAC-SCRT through IC-SCRT.

The research in stem cells holds much promise for improving human health by control of degenerative diseases and restoration of damage to organs by various injuries. But in its wake, it raises several ethical and social issues such as destruction of human embryos to create human embryonic stem (hES) cell lines, potential for introducing commodification in human tissues and organs with inherent barriers of access to socio-economically deprived and possible use of technology for germ-line engineering and reproductive cloning. To strike a balance, the research in this field needs to be regulated and that is where the constitution of the apex committee is significant.