This article was written by Ananya Bose, a student of Symbiosis Law School, Pune.
Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. This undifferentiated cell of a multi-cellular organism is capable of giving rise to an indefinite number of other cell types from which again different kinds of cells arise by the process of differentiation.
Stem cells can be obtained from basically two kinds of cells, the first being, human embryos and the second being the adult somatic cells. In addition, stem cells may also be isolated from the umbilical cord blood. Much like the bone marrow, cord blood is one of the richest sources of stem cells. Cord blood stem cell research is being conducted for potential future use in the treatment of certain auto-immune disorders, neurological disorders, muscular/cartilage diseases, stroke, etc.
The immense potential that has been shown by stem cells in treatment of diseases traditionally considered “degenerative, incurable and irreversible” such as diabetes, heart disease, spinal cord injuries, Parkinson’s, Alzheimer’s disease has brought them into the spotlight. Research in human developmental biology has led to the discovery of human stem cells including embryonic stem (ES) cells, embryonic germ (EG) cells, and adult stem cells.
In India, several science agencies of the government are promoting SCR. Priority areas for research have been identified by means of thorough discussion in various fora on basic and applied research for specific diseases and various programmes have been supported on embryonic and adult stem cells. In India, several science agencies of the government are promoting SCR. Priority areas for research have been identified by means of thorough discussion in various fora on basic and applied research for specific diseases and various programmes have been supported on embryonic and adult stem cells. Apart from the government, some industry research organizations are also involved in SCR. For example, Reliance Life Science, Mumbai has characterized 10 stem cell lines including two neuronal cell lines, dopamine producing neurons and neurons for patients of stroke. One cell line has been deposited in the National Centre for Cell Science (NCCS), Pune. Their research focus is on ESC; haematopoitic stem cells; treatment of leukaemia; sickle cell anaemia; and skin and tissue engineering. Other centres are located in Vellore, Chennai and Lucknow too.
Ethical Issues In The Stem Cell Research
In India, the relationship between the supply of embryos for stem cell research and the political and cultural context is a complex one .Moreover, as stem cell therapies move into the later stages of development, the field will be confronted with many of the problems that currently plague the conduct of pharmaceutical trials in general. As India becomes a global centre for clinical trials, the question of ethical oversight becomes increasingly difficult to ignore.
The Ethical guidelines for biomedical research on human subjects were published by the Indian Council for Medical Research (ICMR) in 2000. However, their recommendations are non-binding and scandals continue to emerge. At the same time, the Drugs Controller General issued binding regulations on ‘good clinical practices’(GCP) for clinical research in India (2001), based on World Health Organization standards, and it is reported that programs to train clinicians in good clinical practice are proliferating around the country.
The Guidelines propose a system of review and monitoring of the field based on a National Apex Committee (NAC) for Stem Cell Research and Therapy and, at the institutional level, Institutional Committees for Stem Cell Research and Therapy. All research, including clinical trials, would require the prior approval of, and be registered with, the NAC. Prohibited areas of research include reproductive cloning, implantation of a human embryo into the uterus after in vitro manipulation, and transfer of human blastocysts generated by somatic cell nuclear transfer (SCNT) into a human or nonhuman uterus etc.
But since there is no legal backing for the Guidelines, Indian stem cell scientists feel free to consult their own consciences and make their own decisions. In principle, they should abide by the principles of the ICMR’s Ethical guidelines for biomedical research on human subjects published in 2000. However, a 2005 survey by ICMR showed that in the absence of any powers of enforcement only a minority [40 (22%)] of India’s 179 institutional ethics committees followed the principles.
The National Guidelines for Stem Cell Research, 2013, in its Preamble clearly mention that the philosophy to act as a guideline over stem cell research should include promotion of scientific and ethical stem cell research while preventing premature commercialization and potential exploitation of vulnerable patients. As per the National Guidelines for Stem Cell Research (2013), at present, there are no approved indications for stem cell therapy other than the hematopoietic stem cell transplantation (HSCT) for haematological disorders. Use of stem cells for any other purpose outside the domain of clinical trials is to be considered unethical and hence is not permissible. As per the National Guidelines for Stem Cell Research (2013), 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 to review and monitor stem cell research at the institutional as well as National level.
The Indian Council of Medical Research (ICMR) has informed that the research on embryonic stem cell involves creating embryonic stem cell lines, which may lead to commoditization of human tissue and cells with inherent risk of exploitation of individuals, particularly those belonging to underprivileged groups. Another concern is the misuse of the material for germ-line engineering and reproductive cloning. Hence, the research involving embryonic stem cells requires very close monitoring by the local committees.
Intellectual property regimes for stem cell research should set conditions that do not restrict basic research or encumber future product development. It is essential that there be a public that is educated and informed about the ethical and policy issues raised by stem cell research and its applications. Informed public discussion of these issues should be based on an understanding of the science associated with stem cell research, and it should involve a broad cross-section of society. It is essential for citizens to participate in a full and informed manner in public policy deliberations about the development and application of new technologies that are likely to have significant social impact.
- Mudur M. India plans to audit clinical trials. Br Med J. 2005;331:1044. [PMC free article] [PubMed]
- National Guidelines for Stem Cell Research, Indian Council of Medical research, 2013, Available at: http://dbtindia.nic.in/wp-content/uploads/2014/05/national-guidelines-of-stem-cell-research.pdf
- LeRoy Walters, Human Embryonic Stem Cell Research: An Intercultural Perspective, Kennedy Institute of Ethics Journal Vol. 14, No. 1, 3–38 © 2004 by The Johns Hopkins University Press
- Alka Sharma, Stem Cell Research in India: Emerging Scenario and Policy Concerns, Asian Biotechnology and Development Review,2006, 8 No. 3, pp 43-53.