Draft Guidelines for Stem Cell Research in India

Draft Guidelines for Stem Cell Research in India Thursday, 08 November 2007 After five years of consultation, a panel of Indian experts has at last devised a set of guidelines to regulate stem cell research and its use in India. The Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) will submit the final guidelines to the Union Health Ministry on November 8. The guidelines on stem cell research and its use will be enforced after the government gives its consent. The committee has decided that human cloning should not be allowed in India. The regulations say that embryonic stem cell research can be executed, but the donor’s consent will be mandatory. All cord blood banks would have to be registered with the Drug Controller-General of India (DCGI). Research or therapy using foetal stem cells / placenta will be allowed but those who fail to follow the rules will face a heavy penalty, in the form of monetary fine as well as jail term. The road map also specifies that termination of pregnancy can’t be attempted for donating foetal tissue for any possible financial or therapeutic profit. The medical person entrusted with the care of the woman planning to undergo termination of pregnancy and the person who will use the foetal material can’t be the same. The identity of the donor and the recipient will have to be kept secret. Two committees are being planned to oversee and regulate the area: A National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). They will analyze the scientific, technical, ethical, legal and social issues in embryonic stem cell research. All institutions and investigators carrying out research on human stem cells must be registered with NACSCRT through IC-SCRT. All research studies and clinical trials will have to obtain the prior approval of IC-SCRT for permissive research and NACSCRT for restricted research. At the same time India’s first Clinical Research Facility (CRF) for Stem Cells and Regenerative Medicine (CRF) will open in Hyderabad by the Centre for Cellular and Molecular Biology (CCMB) along with Nizam’s Institute of Medical Sciences. It will be completed by the year 2009. Union Minister for Science & Technology Kapil Sibal laid the foundation stone for the project last week, on a five-acre site at Uppal at CCMB. He said that the DBT in association with ICMR had formulated draft guidelines for stem cell research and placed them for public debate. Sibal also said that more than 40 institutions and hospitals in country are involved in different aspects of embryonic and adult stem cell research. Many programmes are unveiled to encourage the basic researchers, clinicians and industry to come together to share information. Sibal said a Bill in Parliament will soon be introduced to provide incentives and/or up to 30 per cent of the license fee’s as royalty to scientists to encourage them for their research. Sibal said, “We do not have many experts hence the need for having a public debate on the issue, with a view to incorporating divergent points.” See also: India’s First Institute of Regenerative Medicine ......... ZenMaster

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