A multilevel governance framework for regulation of nanomedicine in India

Abstract

AbstractNanomedicine is a novel and challenging field in terms of its governance. It is gradually emerging that the existing regulatory regimes may not be able to accommodate the requirements of nanomedicine without amendments or supportive measures. Further, its multidisciplinary essence poses challenges and indicates a need for an adaptive regulatory framework for governance as well as promotion of innovation system. The best strategy to govern nanomedicine remains highly debatable across the globe. Although, major challenges posed by nanomedicine are universal, some of them are specific to each country, hence, making a jurisdiction-based framework essential to address unique needs of a nation. In India, a clear framework for the regulation of nanomedicine is lacking, as this governance gap has been realized through various studies. Keeping this in view, the authors propose a multi-level national governance system for regulation of nanomedicine in India based on four principles. The hierarchical governance model proposed involves regulatory space, policy regime, sites of governance and lifecycle of nanomedicine. The proposed system is inclusive of its various stakeholders. The system can play a significant role in sustainable growth of nanomedicine in India.