The 'National Guidelines for Stem Cell Research', issued recently by the Union health ministry, has omitted the word 'Therapy' from the title of the Guidelines to emphasize the fact that stem cells are still not a part of standard of care and hence there can be no guidelines for therapy until its efficacy is proven.
The drafting committee of the Guidelines felt that the guidelines are intended to cover only stem cell research, both basic and translational, and not therapy. It has been made clear in these Guidelines that any stem cell use in patients, other than that for hematopoietic stem cell reconstitution for approved indications, is investigational at present.
Accordingly, any stem cell use in patients must only be done within the purview of an approved and monitored clinical trial with the intent to advance science and medicine, and not offering it as therapy. In accordance with this stringent definition, every use of stem cells in patients outside an approved clinical trial shall be considered as malpractice.
The committee also felt that this clear definition will serve to curb the malpractice of stem cell “therapy” being offered as a new tool for curing untreatable diseases.
Earlier in the year 2007, the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) had jointly released the draft 'Guidelines for Stem Cell Research and Therapy', which has now been revised by an expert drafting committee to reflect new scientific and clinical findings that have significantly changed the scope of stem cell research and possible translation. The committee has now dropped the word 'Therapy' as it felt that the stem cells are still not a part of standard of care and hence there can be no guidelines for therapy until its efficacy is proven.
However, the present guidelines have retained the earlier classification of stem cell research into three categories, namely Permitted, Restricted and Prohibited categories.
The Union health ministry has recently issued the 'National guidelines for stem cell research' to provide ethical and scientific directions to scientists and clinicians working in the field of stem cell research in the country.