Mind the gap: Investigating the role of collective action in the evolution of Indian medical device regulation.

Using the Indian medical device sector as a case study, this research examines the evolution of regulatory frameworks by analysing the conditions and processes through which regulatory environments for a technology-based industry come about. It also attempts to unpack the complex relationships between industrial capabilities in healthcare technology and human health, and the role of regulation in facilitating more inclusive healthcare and development in emerging countries. In doing so, the paper explains the ways in which an absence of collective action can severely inhibit the development of appropriate technological regulation and industry growth, particularly in the context of developing countries. It shows that contestation, conflict and coalitions as a key mechanism through which different stakeholders influence, enable and/or disable institutional change. These findings have significant implications for other developing countries which are struggling with the development of healthcare technology regulatory policy that is appropriate to local societal context and needs. • Investigates a neglected but highly relevant issue in the healthcare policy: Evolution of Medical device regulations in developing countries. • Shows the role and significance of collective action in shaping regulatory policies in developing countries. • Reveals contestation and conflict act as key mechanisms through which different stakeholders influence, enable and/or disable institutional change. • Argues developing countries should create regulations that will ensure safety, efficacy and quality parameters suitable to the local context. [ABSTRACT FROM AUTHOR]