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MAKING OF STEM CELL RULES
P A francis | Wednesday, July 18, 2012, 08:00 Hrs  [IST]

Research on the use of stem cells for treating human diseases started more than a decade ago worldwide. This new pursuit commenced at a time when research by international drug companies for finding new chemical entities actually started slowing down. Now, even after ten years of research into this highly challenging area, scientists world over could not come out with a safe stem cell technology which is commercially workable. Stem cells are self renewable and essentially the building blocks of human body that can form into 200 different cell types. Although stem cell research holds out huge potential as a science, it raises many ethical, legal and policy issues that are of concern to the policy makers and the public. An elaborate set of regulations are necessary to promote and develop this as a responsible science. But, no nation has come out with a set of rules to govern this sector so far. Stem cell research is also catching up in India as is the case with most of the developed countries. In most countries, stem cell therapy is used to slow down or stop further deterioration of body cells caused by the deadly diseases. In India, researchers and doctors are working mainly in the clinical applications of stem cells in ophthalmology, cardiology, diabetes, and spinal cord repair. There are more than 40 research institutes, hospitals and firms involved in stem cell research in the country. And the government has recognized stem cell research as niche area and initiated the process of promoting it by allocating funds for infrastructure development and operational activities. The Central government has been trying to introduce a set of comprehensive rules for regulating this new segment in medical technology since last five years. In 2007, the Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR) jointly formulated the National Guidelines of Stem Cell Research and Therapy. As per the guidelines, the health ministry has also set up a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) to regulate and oversee the activities of this sector. Institutions and investigators carrying out research on human stem cells must be registered with NAC-SCRT through IC-SCRT. This is the first step towards streamlining the stem cell  research in the country but the whole process is yet to begin. The health ministry could not yet decide to notify the rules for stem cell research based on the guidelines after more than five years. The guidelines need not be followed by the institutes and individuals who are engaged in this activity as they are not mandatory. In the absence of a set of rules, there is always a danger of a spurt in unethical and illegal activities in the name of stem cell research.

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