Abstract

Biobanks are an international phenomenon today and promise solutions to hitherto unanswered questions in biomedical research. However, though India may benefit from biobanking activities and output, the regulatory landscape for biobanks remains woefully inadequate. The Guidelines of the Indian Council of Medical Research, which prescribe the conditions for the operation of biobanks, do not adequately address the concerns that emerge in view of the socio-politico-economic backdrop peculiar to the Indian situation. The lack of awareness and understanding of the implications of bioethical issues and requirements on the part of research participants, and inadequate engagement with these issues and requirements on the part of interested personnel could exacerbate growing concerns over effective scientific and ethical management of biobanks, especially commercial ones that have emerged. The role of the State is to be highlighted here as facilitator of such research, mindful of the developmental and health-related needs of the Indian people, regulator of such research, ensuring ethical and regulatory requirements are met, and enabler of access to the productive outcomes of such research, keeping in mind the principles of egalitarian distribution of common resources for the good of all.