After around three years of debates and deliberations, the Indian Council of Medical Research (ICMR) and the Department of Biotechnology have released 24 pages of guidelines clearly spelling out the do’s and dont’s of stem cell research and therapy in the country.While foetal and adult stem cells (cells from the cord blood, bone marrow, peripheral blood, and teeth and bones cells) can be used for in-vitro studies, embryonic cells have been listed under restricted areas of research. Genetic engineering (germ line), or reproductive cloning, has been completely prohibited. Implanting manipulated human embryo or using a human embryo in animals have also been disallowed. The two departments have also suggested an elaborate mechanism of review and monitoring. The guidelines propose setting up of a national apex committee for stem cell research at the central level as well as an institutional committee for research and therapy. ‘‘The area of stem cell research being new and rapidly growing, the complicated ethical, social, and legal issues need extra care and scientific expertise for monitoring,’’ said Dr Vasanta Muthuswami, Senior Deputy Director General at ICMR. The guidelines set specific norms for research institutions and individuals, like:• All institutions and investigators carrying out research on human stem cells should be registered with the NAC through the institutional committee.• All research studies using human stem cells should have prior approval of the institutional committee for permitted areas of research and from the national level committee for restricted areas of research.• All cell lines created should be registered with NAC.• All clinical trials with stem cells should have prior approval of the institutional committee and the Drug Controller General of India.‘‘Creation of an embryo for any research or therapy will require proper approval by the government. Now you can’t have everybody doing embryonic research in the country,’’ said Dr Muthuswami.The guidelines have been put on the ICMR websites. ‘‘We will invite comments and their will be a public debate about the guidelines till September. After that it can be transformed into a Bill or incorporated into the current laws,’’ said Dr Muthuswami.Stages in stem cell research1960s: Research begins on stem cells taken from adult tissues.1981: First mouse embryonic stem cell line established. 2003: Britain becomes the first country to issue research licenses for human embryonic cloning to create stem cells. 2004: South Korean scientists clone 30 human embryos. 2005: Dr Hwang and team in South Korea develop stem cells tailored to match individual patients, but the project id shrouded in controversy.2005: Scientists grow new human embryonic stem cell lines in culture free of animal cells.2005: Adult stem cell research in India makes news. AIIMS does pilot study for cardiac diseases. Controversy follows when a small time clinic in Delhi declares successful treatment in 100 patients. Government orders probe.
