The ethics and governance of stem cell clinical research in India

India is rapidly becoming established as a major player in the stem cell sector. However, concerns have been raised about the use of unproven stem cell therapies and the exploitation of parents for cord blood banking. This study aims to explore the nature of stem cell activities, how key stakeholders generate expectations around them and frame the ethical issues they raise, and why the biomedical governance system is unable to regulate these emerging practices. The study involved a survey, documentary analysis and qualitative interviews with key scientists, clinicians, representatives of firms and policymakers. The thesis observes that, unlike international commentaries which largely focus on embryonic stem cell treatments, in India it is adult and cord blood stem cells which are dominant in research and clinical settings. Expectations are configured on the basis that stem cells have the potential to: solve the problem of organ shortage; help patients with ailments; provide affordable health care; and establish India as a global player. The creation of expectations is ethically problematic given the potential health risks and economic exploitation of both native and international patients. However, the ethically contested activities are justified by clinicians on the basis that the Helsinki Declaration allows to use an experimental therapy; there are many 'desperate patients' demanding these treatments; and adult stem cells are safe. To date, the government of India appears to be unable to prevent these activities. Contrary to suggestions in previous literature and by some informants that new legislation is needed to address the problem, this thesis finds that state-led mechanisms for biomedical governance lack the ability to implement existing oversight measures. This implementation gap is partly because other forms of governance are not strong enough and partly because there are high expectations at state level aimed at establishing India as a global player in the stem cell sector