Gap Analysis of Clinical Establishment Act Implementation in India and Assam: A Retrospective Study

Background: The Clinical Establishment Act (CEA) provides a regulatory framework for healthcare facilities across India, yet its implementation varies significantly between states and across demographic groups. This study investigates implementation disparities in Assam compared to national standards, with particular focus on the role of District Health Societies (DHS) in the registration process and religious demographic factors affecting compliance patterns. Methods in Brief: We conducted a mixed-methods retrospective study analyzing 2,187 private healthcare establishments and 1,450 pharmacies across 33 districts in Assam from 2018-2023. Administrative data from official registration records was supplemented with a structured survey of 500 establishments across 10 representative districts. Statistical analysis included chi-square tests, multivariate logistic regression, propensity score matching, and hierarchical linear modeling to identify factors associated with registration compliance. Results in Brief: Assam's CEA implementation rate (52.3%, 95% CI: 50.7-53.9%) lagged significantly behind the national average (68.2%, 95% CI: 67.4-69.0%; p<0.001). Only 54.5% of districts had properly registered DHS before registering other establishments. Registration compliance was significantly higher among Muslim-owned establishments (78.4%) compared to Hindu-owned establishments (64.7%, p<0.001), with even greater disparities among pharmacies (56.8% vs. 31.5%, p<0.001). Districts with properly sequenced DHS registration demonstrated 27.1% higher CEA registration rates (68.3% vs. 41.2%, p<0.001). These disparities persisted after controlling for geographical location, establishment size, years of operation, and socioeconomic factors. Conclusion in Brief: This study reveals critical implementation gaps in Assam's execution of the CEA, with significant implications for healthcare regulatory policy. The findings demonstrate that both structural factors (DHS registration sequence, administrative capacity) and social determinants (religious demographics, geographical location) significantly influence regulatory compliance. Addressing these disparities requires a multi-level approach that strengthens institutional foundations, creates context-specific compliance pathways, and employs targeted interventions for underrepresented groups.