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India is stepping up efforts to prevent the growth of an illegal and unregulated trade in human embryos, worried that this could result from the recent worldwide increase in interest in embryonic stem cell research.

The move has been prompted by concern that foreign scientists could turn increasingly to India for supplies of human embryos, particularly researchers in the United States and parts of Europe where the creation of such embryos for research purposes is banned, but the commercial potential of such research is significant.

In order to address the potential problems, the country’s leading body for medical research — which is also responsible for medical ethics — the Indian Council of Medical Research (ICMR), has set up a committee to draft rules defining how human embryos can be used in research.

“Our aim is to prevent the violation of human ethics, to streamline collaboration [with foreign partners] in this field, and thwart possible commercialisation [of the field],” says Vasantha Muthuswami, deputy director general of ICMR and an expert on bioethics.

At a meeting in New Delhi on 10 September 2001, the new committee decided that its rules should be made legally enforceable. “The rules will be in place in four weeks,” committee chairman Martanda Sankaran Valiathan said in an interview. He added that the committee was not seeking to place hurdles in front of research, but “to ensure that the research is properly regulated, and that trading in embryos is prevented.”

Human embryonic stem cells are retrieved from five-day-old human embryos and can develop into the many different cells found in the body. Since the isolation of stem cell lines was first achieved in 1998, they have attracted intense interest from biomedical researchers worldwide, who hope to use these cells to produce replacement tissue to treat medical conditions such as diabetes and spinal injuries, as well as Parkinson’s disease and other degenerative diseases.

Muthuswami, who anticipates a significant export trade in embryos from India, says that the commercialisation of embryos is a real possibility, as the country has the right characteristics to become an ‘embryo surplus’ nation. For example, abortion is legal, and there is no ban on the use of embryos for research.

In addition, there are an estimated 200-250 infertility clinics in the private sector. These are largely unregulated and offer a wide variety of in-vitro fertilization procedures for childless couples. “It is very likely that these clinics are left with hundreds of unused embryos,” says Muthuswami.

She adds that ICMR’s main concern is that, in a poor country such as India, the recent advances in stem cell research could lead to an illegal trade in human embryos similar to that which already exists with human kidneys for transplant operations.

“Once the demand for embryos increases, we cannot rule out the possibility of unscrupulous infertility clinics exploiting weaker sections of the population to create embryos specially for trade,” she continues.

Muthuswami expects the race in embryonic stem cell research to gather momentum because of the potential commercial spin-offs a few years from now. “Germany does not allow its scientists to create embryos for research, but it allows them to do research with embryos obtained from outside,” she points out.

To combat this ICMR, together with the National Academy of Medical Sciences, has drawn up a set of rules covering the conduct of clinics offering Medically Assisted Reproductive Technologies (MART). A draft was circulated to operators of MART clinics at a conference in Bangalore on 16 September 2001.

Under these rules, a national authority would be created for accrediting and regulating clinics. As far as the use of surplus embryos is concerned, the clinics will be required to follow the rules framed by the ICMR committee under Martanda Sankaran Valiathan.

Virender Kumar Vinayak, a senior official in the Department of Biotechnology (DBT) says that, under the new guidelines, transfer of embryos or embryonic cell lines to researchers abroad would be subject to clearance by a national bioethics committee. Proper consent from the donor of the embryo, and a commitment from the recipient to share with the donor any profits arising from the embryo’s use, would be required.

Vinayak says that demand for human embryos is also likely to grow rapidly within India itself. The National Center for Biological Sciences in Bangalore, and the Reliance Life Sciences, a private company in Mumbai (formerly Bombay), both already claim to possess embryonic stem cell lines.

And at least three more institutions — the National Center for Cell Science in Pune, Bharat Biotech International, a private company in Hyderabad and the Indian Institute of Science (IISc) in Bangalore — are hoping to join the stem cell bandwagon in the next few months.

© SciDev.Net 2001
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