Researchers are injecting stem cells to treat diseases.
With all eyes on the stem cell controversy in South Korea, an Indian physician announced that she had used embryonic stem cells to treat 100 individuals, without ethical oversight from India's regulatory agencies.
Until India has enforceable rules, such violations will continue. Prakash Narain Tandon, Medical Council of India
Geeta Shroff, director of the Delhi-based infertility clinic Nutech Mediworld, said at a press conference on 16 November that her team had injected stem cells to treat heart, nerve and immune disorders and injuries.
The Indian Council of Medical Research, the country's premier biomedical research agency, had in 2003 rejected Shroff's proposal to use stem cells for treating diabetes, citing inadequate details on the source of the cells and study protocol.
In a bizarre turn, Prasanna Hota, secretary of the health ministry, which oversees the ICMR, attended Shroff's press conference and praised her work. “She's a daring soul who's dedicated herself to this work without any government support,” Hota said.
But on 8 December, India's health minister Anbumani Ramadoss told Nature Medicine that his ministry does not support treatment with embryonic stem cells until legal guidelines are in place.
India does not yet have enforceable rules to regulate stem cell research, but both the ICMR and the federal Department of Biotechnology have issued guidelines. The two agencies in March 2005 launched a joint project to draft legislation, due to be finalized by December.
In the meantime, all stem cell work is considered experimental and should therefore comply with ICMR guidelines, notes Vasantha Muthuswamy, ICMR's senior deputy director general. Shroff's work violates the agency's guidelines, says Muthuswamy.
This is not the first time Indian scientists have made stem cell claims. In February 2005, for instance, P. Venugopal, director of the prestigious All India Institute of Medical Sciences, said he had treated 35 heart patients using stem cells from bone marrow. These scientists also did not attain ICMR clearance or publish their results in peer-reviewed journals. In many cases, they cited approval from their institutional ethics committees.
But “who has checked who the members of these committees are?” Muthuswamy asks. “We need a statutory body with adequate powers to punish violators in experiments with humans.”
Maverick claims by some scientists will hurt the credibility of all Indian scientists, warns Prakash Narain Tandon, member of an ethics committee at the Medical Council of India.
Tandon has asked the council to investigate whether Shroff is qualified to conduct stem cell studies and whether the facilities are adequate. “People are misutilizing the liberal environment in the country,” he says. “Until India has enforceable rules, such violations will continue.”
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Padma, T. Unchecked by guidelines, Indian stem cell scientists rush ahead. Nat Med 12, 4 (2006). https://doi.org/10.1038/nm0106-4b