Healthcare body seeks regulatory reforms in meeting with Niti Aayog

Nathealth has proposed a digital single-window system to Niti Aayog to ease the healthcare sector's compliance load, citing inefficiencies and duplication across ministries

Healthcare industry body Nathealth on Monday sought regulatory reforms for the hospital, diagnostics, and medical device sectors in a meeting with Niti Aayog, after the planning body had asked for the industry’s suggestions on reducing compliance burdens for healthcare facilities in the country.

 

In a white paper submitted to Niti Aayog, Nathealth said the healthcare industry is currently subject to oversight from 10 to 12 ministries and three tiers of governance at the central, state, and municipal levels.

 

“Multiple discussions have happened with different ministries and bodies in streamlining compliance issues before submitting the white paper,” an official with the industry body said.

 

Calling the segment one of the top three regulated sectors in India, the industry body added that around 24 per cent of regulations applicable to the sector are healthcare-specific.

 

“Twenty-five to thirty per cent of compliance requirements change each year in the healthcare sector, creating operational and system inefficiencies, draining time and resources from patient care, clinical excellence, and innovation,” it said.

 

To tackle this, the industry has sought a digital single-window platform for end-to-end compliance with deemed approvals and well-defined timelines. 

 

This, it said, would help in the harmonisation of regulations across states and departments and ensure clear delineation of roles between central and state authorities.

 

The white paper also identified 85 key compliance challenges across hospitals, diagnostic centres, and medtech companies, of which 44 were flagged as particularly onerous, either due to duplication, lack of clarity, or administrative inefficiency.

 

This includes compliance with multiple quality control orders (QCOs), which may lead to delays in medical device registrations and approvals, along with no defined timelines or guidance on seeking approvals for healthcare professionals (HCPs) travelling for an event.

 

The body also pointed out that there is a lack of standardisation in clinical establishment regulations across states, with little clarity on basic issuance or rejection of lift licences and building height rules.

 

Nathealth President Ameera Shah said that 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.

 

“The white paper reflects the sector’s collective intent to partner with policymakers in strengthening standards through smart, technology-driven solutions,” she added.