The union health ministry has issued the 'National Guidelines for Stem Cell Research' which will provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country. These guidelines were jointly prepared by the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT).
The guiding philosophy of the new guidelines is to promote scientific and ethical stem cell research while preventing premature commercialization and potential exploitation of vulnerable patients.
The guidelines reiterate that the general principles of biomedical research involving human participants shall also be applicable to all human stem cell research. The guidelines have been prepared to ensure that research with human stem cells is conducted in a responsible and ethical manner and complies with all regulatory requirements pertaining to biomedical research in general and of stem cell research in particular.
These guidelines apply to all stakeholders including individual researchers, organizations, sponsors, oversight/regulatory committees and any others associated with both basic and clinical research on all types of human stem cells and their derivatives. However, these guidelines do not apply to research using non-human stem cells or tissues. Further, they do not regulate the use of haematopoietic stem cells for treatment of various haematological, immunological and metabolic disorders which has already been established as a standard of medical care.
As per the guidelines, research is prohibited in research related to human germ line gene therapy and reproductive cloning; in vitro culture of intact human embryos, regardless of the method of their derivation, beyond 14 days of fertilization or formation of primitive streak, whichever is earlier; clinical trials involving transfer of xenogeneic cells into a human host (any clinical research on Xenogeneic-Human hybrids is also prohibited); research involving implantation of human embryos (generated by any means) into uterus after in vitro manipulation, at any stage of development, in humans or primates; and breeding of animals in which any type of human stem cells have been introduced at any stage of development, and are likely to contribute to gonadal cells.
The guidelines on stem cell research, still in its nascent stage, is of utmost importance as some clinicians have started exploiting hapless patients by offering unproven stem cell treatments prematurely. Such fraudulent practices had to be stopped urgently, while ensuring that scientifically designed and responsible research on stem cells is not hindered. It was under this background that the ICMR and DBT jointly released Guidelines for Stem Cell Research and Therapy, way back in 2007, which has now been revised to reflect new scientific and clinical findings that have significantly changed the scope of stem cell research and possible translation.
The present guidelines have retained the earlier classification of stem cell research into three categories, namely Permitted, Restricted and Prohibited categories; an additional layer of oversight, besides the Institutional Ethics Committee (IEC), in the form of Institutional Committee for Stem Cell Research (IC-SCR) and National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) has been introduced. This mechanism of additional review has been accepted by the scientific community in the country and the required NAC-SCRT has become operational. The role and functioning of these committees is being streamlined.