NATHEALTH – Healthcare Federation of India, in collaboration with EY India, has released a whitepaper titled Streamlining Compliance in the Indian Healthcare Sector. Submitted to NITI Aayog, the paper outlines a roadmap for regulatory reform, based on stakeholder engagement across hospitals, diagnostic centres and MedTech firms.
The whitepaper recommends simplifying the country’s fragmented and resource-intensive compliance system. It aligns its proposals with national priorities such as Ease of Doing Business, digital governance, and improved healthcare access. The central focus is on how harmonised regulations and digital tools can reduce administrative burden and support sector-wide growth.
The Indian healthcare sector is currently governed by multiple layers of regulation spread across 10–12 ministries and three tiers of governance – central, state, and municipal. NATHEALTH’s benchmarking analysis reveals that healthcare ranks among the top three sectors in compliance intensity, alongside BFSI, mining, and IT. A single healthcare facility may handle hundreds of compliance-related tasks annually, many of which are repetitive or ambiguous.
According to the whitepaper:
- 25–30 per cent of compliance requirements change each year
- 24 per cent of central-level regulations are specific to healthcare
These conditions lead to operational inefficiencies that affect time allocation, resource use, and the delivery of patient care.
To address these issues, NATHEALTH collaborated with EY India and stakeholders over two years to design a digital single-window platform. This tool would allow online tracking, unified documentation, and faster regulatory submissions. The platform aims to increase transparency, predictability and speed across compliance workflows.
The whitepaper outlines 85 compliance-related challenges specific to hospitals, diagnostic centres, and MedTech firms. Of these, 44 were marked by the industry as especially burdensome due to duplication, vagueness, or procedural delays.
Twelve high-impact bottlenecks have been prioritised for intervention. The recommendations include:
- A digital single-window platform for compliance management
- Deemed approvals within fixed timelines
- Harmonisation of regulations across jurisdictions
- Clearer roles for central and state authorities
Segment-specific issues detailed in the whitepaper include:
- Diagnostics: Issues related to clinical establishment registration, differences between physical and digital signatures, PNDT Act compliance, and dual record-keeping.
- MedTech: Requirements related to BIS certification, labelling standards, marketing codes, and licensing under the Medical Device Rules.
- Hospitals: Challenges involving blood bank licensing, overlapping registration of practitioners, building code adherence, and fire safety NOCs.
Ameera Shah, President, NATHEALTH and Promoter & Executive Chairperson of Metropolis Healthcare, said, “In healthcare, patient safety and quality are non-negotiable. As the sector scales, it’s essential to have regulatory frameworks that are agile, forward-looking, and aligned with the needs of patient-centred care. Many healthcare providers are committed to regulatory accountability, however there is a clear need for streamlined, time-efficient processes that support better outcomes. This whitepaper reflects the sector’s collective intent to partner with policymakers in strengthening standards through smart, technology-driven solutions. We are encouraged by the positive response this issue has received and believe that digital-first approaches will be instrumental in making healthcare delivery more efficient, transparent, and future-ready.”
The whitepaper provides short-, medium-, and long-term strategies aimed at making India’s healthcare compliance landscape more cost-effective and capable of supporting innovation. NATHEALTH and EY India propose digitisation, centralisation, and simplification as key steps to building a modern, efficient regulatory framework that serves patients, healthcare providers, and the wider economy.
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