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 last date for ascertaining constructive comments from the general public and experts ended on June 30. From July 3, both ICMR and DBT will begin to assess the public comments on the guidelines and decide if certain additions or deletions are required , stated sources.

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 former comprising 12 to 15 members would examine the scientific, technical, ethical, legal and social issues involving human embryonic stem cell research. The latter is required to submit monthly reports to the national committee. All scientific proposals involving stem cell research will have to be cleared by the national and institutional committees.

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.


With regard to research using Umbilical Cord Blood Stem Cells, 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.

Further the guidelines also insisted the investigators and the institutions undertaking stem cell research should adhere to the standards.

Appreciating many of the points in the guidelines, Dr Ramananda S Nadig, COO, Stempeutics, Manipal Health Systems said that it calls for a debate to bring in clarity in the areas of adult stem cell use in therapeutics. There is also a need for the guidelines to deal with regulation relating to quality assurance and purity of stem cells.
Regulations are needed in embryonic and adult stem cell use. Not only that being a new biological entity and approvals for stem cell therapy cannot be sought from the DCGI. This is because stem cell are natural cells and not a drug. Therefore a Scientific Body or a Stem Cell Board should regulate the approvals, he added.