New Delhi: NATHEALTH – Healthcare Federation of India, in collaboration with EY India, has released a whitepaper titled “Streamlining Compliance in the Indian Healthcare Sector.”
Formally submitted to NITI Aayog, the whitepaper presents a practical, future-facing roadmap for regulatory reform, grounded in extensive engagement with healthcare stakeholders across the country.
The whitepaper makes a compelling case for a sector-wide overhaul of India’s fragmented and resource-intensive compliance landscape. It presents a positive, industry-backed vision that aligns with the government’s priorities on Ease of Doing Business, digital transformation, and healthcare access focusing on how simplified, harmonised regulation can drive quality, innovation, and growth.
India’s healthcare sector is subject to a complex and ever-evolving network of regulations spanning 10–12 ministries and three tiers of governance (central, state, and municipal). NATHEALTH has benchmarked healthcare’s regulatory intensity against other industries including BFSI, mining and IT, where healthcare emerges among the top three sectors in terms of compliance burden. A single facility is required to manage hundreds of tasks annually, many of which are duplicative or unclear.
Notably, 25–30% of compliance requirements change each year and 24% of central-level regulations are specific to healthcare, far more than most other sectors. This creates substantial operational and system inefficiencies, draining time and resources from patient care, clinical excellence, and innovation.
To directly address these challenges, NATHEALTH has worked closely with industry over two years to identify compliance bottlenecks and the concept of a digital single-window platform with EY. The platform allows for online tracking, unified documentation and faster submissions bringing predictability, transparency and speed to regulatory workflows.
Key Findings and Solutions
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The whitepaper identifies 85 key compliance challenges across hospitals, diagnostic centres, and MedTech companies. Of these, 44 were flagged by industry as particularly onerous, either due to duplication, lack of clarity, or administrative inefficiency
A focused set of 12 high-impact bottlenecks have been prioritised for action. Recommendations include:
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A digital single-window platform for end-to-end compliance
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Deemed approvals with well-defined timelines
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Harmonisation of regulations across states and departments
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Clear delineation of roles between central and state authorities
Segment-Specific Challenges Highlighted in the Whitepaper:
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Diagnostics: Clinical Establishment registration, physical vs. digital signatures on reports, PNDT Act compliance, dual maintenance of physical and electronic records
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MedTech: BIS certifications, labelling norms, marketing codes, and licensing under Medical Device Rules
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Hospitals: Blood bank licensing, practitioner registration overlaps, building codes and Fire Officer’s NOCs
