NATHEALTH seeks regulatory reforms, flags heavy compliance burden
New Delhi: Healthcare industry body NATHEALTH has sought regulatory reforms for the sector, saying it is currently subject to 10-12 ministries and three tiers of governance at the central, state and municipal levels.
The healthcare industry body, in collaboration with EY India, has prepared a whitepaper on the issue which has been submitted to the NITI Aayog.
According to the PTI report, 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.
"India's healthcare sector is subject to a complex and ever-evolving network of regulations spanning 10–12 ministries and three tiers of governance," the industry body stated.
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The whitepaper presents a practical, future-facing roadmap for regulatory reform, grounded in extensive engagement with healthcare stakeholders across the country, it added.
It noted that 25–30 per cent of compliance requirements change each year in the healthcare sector.
This creates substantial operational and system inefficiencies, draining time and resources from patient care, clinical excellence, and innovation, it added.
"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," NATHEALTH stated.
The industry seeks a digital single-window platform for end-to-end compliance, deemed approvals with well-defined timelines, harmonisation of regulations across states and departments and clear delineation of roles between central and state authorities, it added.
"As the sector scales, it is essential to have regulatory frameworks that are agile, forward-looking, and aligned with the needs of patient-centred care," NATHEALTH President Ameera Shah said, reports PTI.
