After more than a decade of research on the use of stem cell technology for treating  deadly human diseases, no breakthrough has been achieved in commercial applications of this science worldwide. What has been happening so far is occasional claims of curing of certain diseases by some medical institutions or individual doctors in different countries. Stem cells are self renewable and essentially the building blocks of human body that can form into 200 different cell types. In most countries, stem cell technology is used to slow down or stop further deterioration of body cells caused by the deadly diseases. In India, researchers and doctors are working mainly in clinical applications of stem cells in ophthalmology, cardiology, diabetes, and spinal cord repair. There are more than 40 research institutes, hospitals and firms involved in stem cell research in the country. And the Central government has recognized stem cell use  as a niche area of medical research and initiated the process of promoting it by allocating funds for infrastructure development and operational activities. Although stem cell technology holds out huge potential as a science, it raises many ethical, legal and policy issues which are of concern to the government and the public. And that calls for a regulatory framework to promote and develop this as a responsible science. But, no nation has notified a set of rules including India to regulate this sector so far.

In India, the Central government has been trying to introduce a set of rules for regulating this medical technology since last seven years. In 2007, the Department of Biotechnology (DBT) and Indian Council of Medical Research (ICMR) jointly formulated the National Guidelines of Stem Cell Research and Therapy. Subsequent to that, the health ministry had set up a National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) and an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) to regulate and oversee the activities of this sector. Institutions and investigators carrying out research on human stem cells must be registered with NAC-SCRT through IC-SCRT. This is the first step towards streamlining the stem cell research in the country. As the guidelines could be finalised after the formation of NAC, it felt that there is a need to review and revise the guidelines as several developments had taken place during the period since the ICMR issued the draft guidelines. The union health ministry thus issued a guidance document for regulatory approvals of stem cell and cell based products (SCCPs) with  a road map for regulation of stem cells and other cell based research in the country. A significant change incorporated in the revised document is that guidance cover only stem cell research, both basic and translational, and not therapy. That would mean any stem cell use in patients must 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. Stem cells are still not a part of standard of medical care in India or elsewhere. With this clear cut definition, use of stem cells in patients outside an approved clinical trial may be considered as a malpractice. The very objective of this safety clause is to protect patients receiving unproven stem cell therapies from irresponsible institutions and doctors.