Misuse of miracle cure feared

NEW DELHI, MARCH 24. The worst fears of both the Indian Council of Medical Research (ICMR) and the Central Department of Biotechnology (DBT) are coming true. Having left a "floating'' draft guideline for Stem Cell Research/Regulation in India, the two organisations have now unofficially washed their hands off the sudden avalanche of applications coming in from small time nursing homes and clinics in the Capital, "informing the regulatory body of them offering and even conducting stem cell therapy".

While top physicians too have expressed their concern at the rapid mushrooming of centres in the Capital offering stem cell therapy, the problem is that while both ICMR and DBT have rough drafts of the guidelines ready, there is nothing "binding'' the medical practitioners to abide by these regulations.

So much so that clinics now "only inform and not take permission to conduct the procedure,'' said an ICMR official.

Warning the general public that what was being offered "may not be the real thing'', ICMR and DBT even in their draft have maintained that "it is strongly recommended that stem cell research and its clinical application should be promoted in the country. However, it is desirable that all new technologies and techniques should be thoroughly examined before approving of any such research and application. There is also a need to have a regulatory body''.

The guidelines, which came into existence in 2002, are yet to become `binding' and in the absence of any regulatory mechanism, accountability, according to experts, has become the big question. "We are receiving a large number of applications from small clinics and nursing homes stating that they want to carry out the therapy and most of the time they only inform a day in advance of the actual process. We have to understand that stem therapy through all the three sources -- adult cell, core blood cell and embryonic cell -- have many concerns currently,'' said the Basic Sciences Division in-charge and Deputy Chief of ICMR, Vasanta Muthuswamy.

"Though permission from ICMR is not mandatory, we need to be kept informed in the absence of any binding regulations in the best interest of the patients. Any one claiming to have the process in place should follow a protocol and get clearances to carry out the process,'' she added.

Understanding the potential of the therapy, the guideline notes: "A speaking order is to be issued by the Ministry of Health and Family Welfare that all proposals involving stem cells of any source should be cleared by a National Apex Committee for cell-based research and therapy and all centres should be registered with this committee.''

While the committee is still awaiting its inception, in the light of the lack of proper laws to prevent misuse, officials now maintain that while rules may still take a while to come by, the best option now for the public is to double check any facility that is offered to them. `Caution,' according to the two departments and top physicians is what patients need to exercise when opting to go to a private clinic offering miracle cure.

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