The saga of preparing the guidelines for stem cell research and therapy finally ended in November 2007 with their submission to the government by the Department of Biotechnology and the Indian Council of Medical Research. The two bodies began drafting the guidelines separately seven years ago but came together in 2005-06. If the leisurely way they went about preparing the guidelines came in for criticism, the government’s failure to notify them is a cause for serious concern. Stem cell research is a rapidly developing area in medical science. Not a month passes without new discoveries, and potential areas where stem cells can be used to treat certain diseases, being reported. While stem cells are the primary cells that can become any of the approximately 260 specialised cells in the body, stem cell research is still in its infancy. Adult stem cells have been used to treat leukaemia for many years; and a limited number of other diseases in recent years. However, their use in many other diseases still remains in the realm of clinical trials. That is because there is much to be understood before they can be used in regular therapy.
Aside from the many lacunae in our understanding of stem-cell behaviour, the delay in notifying the guidelines may have prompted some doctors to improperly use adult stem cells harvested from a patient or from others as a standard form of therapy for certain diseases. There is a known instance of a Delhi-based doctor who claims to have used stem cells extracted from embryos to treat diseases. In the absence of legislation, the government bodies lack the powers to bring such medical practitioners to book. Follow-up over the long-term is required to assess the outcome of a treatment, and in the absence of any trial or published literature on such work, the success claimed by a doctor cannot be verified. The reality is that the medical community is a long way from using embryonic stem cells for treating diseases. For one thing, it is not known if such treatment puts the patient at great long-term risk. Secondly, any negative fallout from medical misadventures is bound to put a promising science under a cloud. This is why the Indian government should act swiftly and bring in legislation on the issue. The United Kingdom, through its Human Fertilisation and Embryology Authority, has been able to oversee stem cell research. The sound and progressive U.K. system, admired internationally, has prompted Australia and Canada to emulate. It is time India followed suit. It should not go the way of the United States which has no federal regulation in this crucial area.