Fears that India's booming assisted-fertility industry could become a source of human embryonic stem (ES) cells have prompted the country's medical authorities to propose a ban on the export of all human embryonic material.
The Indian Council of Medical Research (ICMR), a government-funded body that coordinates biomedical research, last week released new draft guidelines aimed at preventing the misuse of human embryos stored at the hundreds of unregulated fertility clinics that have sprung up in India over the past ten years. The new rules will prohibit the export of any part of an embryo, and stipulate that couples may only donate, and not sell, embryos to researchers inside India.
T. C. Anandkumar, research director of the Hope Fertility Clinic in Bangalore and a former ICMR director, was involved in drafting the guidelines. He says that the council has reacted to fears that restrictive embryo-research regulation in Europe and the United States could force scientists to look abroad for embryonic material. Some Indian clinics say that they have already been approached by Western researchers wishing to obtain human ES cells.
Whether European and US researchers would want to risk the bad publicity associated with obtaining stem cells from an unregulated clinic in a developing country is unclear. Germany allows research to be carried out only on imported ES cells, but these must be obtained from certain approved cell lines. And US researchers, who are free to obtain stem cells from fertility clinics as long their work is not federally funded, say that they have no problem in obtaining embryonic material.
The new guidelines could, however, cause problems for Indian researchers. “Prohibiting the transfer of embryos could virtually prevent us from collaborating with foreign agencies,” says Mitradas Panicker, a neurobiologist at the National Centre for Biological Sciences in Bangalore, one of two Indian laboratories that the US National Institutes of Health lists as providing ES-cell lines with which federally funded researchers are permitted to work (see Nature 412, 665; 200110.1038/35089187). Panicker says that collaborations with US scientists would suffer “if the guidelines failed to make a distinction between selling embryos for money and transferring them for research”.
The owner of the other ES cells on the NIH list, Reliance Life Science in Mumbai, faces similar problems. The company says that it has developed a cell line that differentiates into insulin-producing pancreatic cells that could be used to treat diabetes, and is ready to begin animal trials. “We have several foreign collaborations planned with our cell lines, but as the guidelines stand today we cannot do any collaborative research,” says Satish Totey, the company's head of ES-cell research.
The guidelines may yet be refined before a final version is presented to the government. The National Accreditation Authority, a new body that is currently being set up to administer the guidelines, says that it will consider suggested amendments from the scientific community until the end of December.
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Legal and Ethical Approaches to Stem Cell and Cloning Research: A Comparative Analysis of Policies in Latin America, Asia, and Africa
The Journal of Law, Medicine & Ethics (2004)