Published Paper Details:

ABSTRACT Background: Regulatory bodies are essential to ensuring safety, quality, and ethical practices in healthcare. In India, despite a complex array of oversight institutions, overlapping roles, fragmented mandates, and regulatory gaps persist. This study performs a comparative, evidence-based review of key international and Indian healthcare regulatory bodies to identify strengths, inefficiencies, and actionable opportunities for systemic reform. Methods: This narrative review follows SANRA guidelines and employs a structured methodological framework. Data were sourced from 2018 to 2024 using peer-reviewed journals (PubMed, Scopus, Google Scholar), official publications of global institutions (WHO [1], ISO [2], IAEA), Indian agencies (NMC [3], AERB [5], BIS [4]), and policy documents from government portals. Thematic analysis was conducted across four dimensions: jurisdictional scope, functional responsibilities, digital integration, and implementation challenges. Stringent inclusion and exclusion criteria were applied to ensure quality. Results: India's regulatory ecosystem remains fragmented, characterized by bureaucratic inertia, limited digital interoperability, and inconsistent enforcement. In contrast, international models exhibit centralized oversight, advanced digital governance, and real-time data sharing. Case examples from the AERB [5], NMC [3], and BIS [4] highlight gaps in compliance and operational efficiency. The Ayushman Bharat Digital Mission (ABDM [6]) represents a promising step forward, despite implementation barriers. Conclusion: India must transition to a unified, evidence-based regulatory framework aligned with global best practices. Key reforms include the creation of a National Regulatory Convergence Commission (NRCC), mandatory digital licensing and audits, and AI-driven compliance monitoring. These strategies can enhance transparency, improve healthcare service quality, and strengthen public trust.