Drug Controller General of India granted permission for conducting clinical trials for a stem cell based therapy to the Bangalore based Stempeutics Research in March this year. The research company, belonging to Manipal Group, is developing a range of therapies using adult mesenchymal stem cells derived from the bone marrow of healthy donors. The trials are expected to test mesenchymal stem cells in patients with critical limb ischemia or with acute myocardial infarction. A multidisciplinary team of eminent scientists, clinicians and officials from the DCGI and Indian Council for Medical Research after careful consideration of the ethical and scientific aspects approved the protocol. Stempeutics has already commenced phase I / phase II trials and phase III is expected to be completed by March 2011. Based on the results of the clinical studies, Stempeutics plans to launch the first stem cell based drug in the country by the end of 2011 for these critical ailments. Reliance Life Sciences, another company working on regenerative medicine has completed clinical trials using mesenchymal stem cells from patient's own bone marrow for myocardial infarction. Reliance Life is also developing a wide range of autologous and allogenic cell therapies and tissue engineered products to establish itself in the regenerative medicine business. Whatever progress so far made in India in stem cell research is based more on adult stem cells derived from bone marrow and not by using embryonic stem cells. It is possible that this trend only will continue considering the ethical issues involved in the use of embryonic stem cells. Even in the case of adult stem cells, conflicting views are being expressed over the use of autologous and allogenic cells for treatment by the scientific community. Such developments and debates can lead to more confusion in the country as there is no clear policy regulating stem cell research. At the same time, over a dozen organizations are seriously involved in this research and claims of magical therapies are being raised from some quarters. Laying down a set of rules for this branch of medical research is, therefore, extremely urgent considering the possibility of its misuse by unscrupulous organizations. The Central government had set up a high level committee to frame a policy for genomic research including stem cell technology seven years ago. A draft guideline for stem cell research was then prepared by Indian Council of Medical Research and it is with the government. As per the draft, the Union health ministry was to constitute 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 this sector. Institutions and investigators carrying out research on human stem cells must be registered with NAC-SCRT through IC-SCRT. All research studies and clinical trials will have to obtain the prior approval of IC-SCRT for permissive research and NAC-SCRT for restricted research. The proposed regulatory framework for the sector seems to be adequate enough to oversee the activities of institutions operating now. What is important is to make the system functional without any further delay.