Critical Analysis of Gaps in the Clinical Establishments Act, 2010: A Policy Implementation Perspective

Abstract

The Clinical Establishments Act (CEA) of 2010 represents India's landmark attempt to standardize healthcare regulation nationwide, yet its implementation has been characterized by significant disparities and systemic challenges. This policy analysis examines eight critical gaps in the CEA's design and implementation, documenting both structural limitations and procedural shortcomings that have hindered its effectiveness. Using an implementation science framework, we analyze how federalism challenges, enforcement limitations, rural provider burdens, absent patient protection mechanisms, and digital integration failures collectively undermine the Act's potential. Our findings reveal that while the CEA provides an important regulatory foundation, its impact is seriously hampered by patchy adoption, weak enforcement mechanisms, disproportionate burdens on smaller providers, and failure to address key dimensions of healthcare quality and access. We propose targeted reforms including tiered standards for different facility types, integrated digital compliance mechanisms, mandatory patient grievance systems, price transparency requirements, and harmonization of overlapping regulations. This analysis provides essential context for understanding regional implementation variations and developing more effective, equitable approaches to healthcare regulation in India's diverse healthcare landscape.