Over the last decade, stem cell research has emerged as a new hope to humanity for the treatment of several life threatening diseases like leukaemia, anaemia, bone marrow cancer, tumours, inherited diseases affecting the immune system and metabolic disorders. Stem cells are self renewable and essentially the building blocks of human body that can form over 200 cell types. Stem cell therapy in India is only catching up as is the case in most of the developed countries with very few successful cases. In fact, in most countries, stem cell therapy is used to slow down or stop further deterioration of body cells caused by the deadly diseases. The great advantage for developing this science in India is the huge population base with genetic versatility and its huge patient demand. Moreover, India is well positioned to emerge as a significant player in the global stem cell research and clinical application with its vibrant biopharmaceutical companies, a large intellectual pool of scientific talent and a mature information technology industry. Currently, Indian researchers and doctors are working mainly in the clinical application 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 government has recognized stem cell research as niche area and initiated the process of promoting it by allocating funds for infrastructure development and operational activities.
With such a huge growth potential, stem cell research raises many ethical, legal, scientific and policy issues that are of concern to the policy makers and public at large. It is in the background of these factors, the government has been trying to introduce a set of comprehensive rules for regulating this new segment in medical technology. 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 to lay down general principles on ethics of stem cell research and therapy. These guidelines are expected to address both ethical and scientific concerns to encourage responsible practices in the area of stem cell research and therapy. For marketable products, clearance from Drug Controller General of India is necessary since stem cells are akin to biological drugs. It has set standards for the collection, processing and storage of cells intended for clinical use. As per the guidelines, the health ministry has also 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. Now, after four years of issuing the guidelines for stem cell research, government is not able to lay down the rules for this critical sector of medical research. ICMR is still holding its public consultation with various stakeholders to evolve a consensus on the document. In key policy making matters like this, it is important to have a sense of urgency amongst the government departments like DBT and bodies like ICMR.