India is expected to have an appropriate strategy in place for stem cell research and therapy as the 24 page draft guidelines prepared by the Indian Council of Medical Research (ICMR) in consultation with a host of experts is in the process of being finalized shortly.
The guidelines have insisted the need for two committees: National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT).
The draft also enumerated the prohibited areas of research like germ line, genetic engineering or reproductive cloning, in- vitro culture of intact human embryo beyond 14 days, transfer of human blastocysts into a human or non-human uterus, research involving implantation of human embryo into uterus after in vitro manipulation at any stage of development in humans or primates and non-autologous donation of any stem cells to a particular individual.
All cord blood banks would have to be registered with the Drug Controller General of India (DCGI) as per the guidelines of blood banks.
In the area of research using Fetal Stem Cells/Placenta, all proposals related to these for research or therapy are permissible. However, pregnancy termination should not be sought with a view to donate fetal tissue in return for possible financial or therapeutic benefits. Also consent for pregnancy termination for fetal material donation for purpose of research or therapy should be sought separately.
Expert says, that as because stem cell are natural cells and not a drug. Therefore a Scientific Body or a Stem Cell Board should regulate the approvals.