‘New Drugs’ Approvals in India: An Institutional Perspective

Abstract

The approval mechanism for new drugs in India has in recent years been a subject of scrutiny and controversy in both the public sphere and academics. Frequent rollbacks in the guidelines have attracted criticisms from the industry as well. All this happens at a time, when the country aspires to catch up and keep pace with the fast-changing global regulatory norms. This article draws upon the scholarships on regulatory science and institutional theories to understand the regulatory processes of new drugs approval in India. Both strands of scholarships highlight the multidisciplinary, context-specific character of regulatory knowledge. We find that Indian regulation-making process relies heavily on regulatory knowledge built up elsewhere, potentially limiting the scope of generating its own, context-specific, regulatory knowledge through learning and capacity building. Inadequate level of deliberations in the decision-making process, dearth of documentation and a lack of connections with the larger institutional settings appear to be two other features of it. All this might explain the reasons for frequent changes, and lack of continuity, in regulation for new drugs approval in the country in recent years.