Burdened by over 29,000 compliances, healthcare sector seeks government intervention

study

Pointing to over 29,000 annual compliances, the healthcare industry has sought government intervention to look into the “labyrinthine regulatory environment”, which it says hampers efficiency and innovation.

According to a whitepaper issued by the industry body NATHEALTH and consulting firm EY India, pan-India organisation are faced with more than 29,000 “compliance tasks” every year and a patchwork of overlapping rules across ministries and states.

The report identifies fragmented oversight, duplicative licensing and outdated regulations as key bottlenecks stifling efficiency, delaying innovation, and diverting resources from patient care.

NATHEALTH president Ameera Shah, also executive chairperson of Metropolis Healthcare Ltd, stressed the need for agile, patient-centric regulation. “Digital-first approaches will be instrumental in making healthcare delivery more efficient, transparent, and future-ready,” she said.

The sector, one of the most heavily regulated in the country, faces a 25–30 percent annual churn in compliance requirements, with nearly 60 percent of rules decentralised across jurisdictions, says the report, submitted to NITI Aayog.

Over 1,400 compliance tasks pertain to licences, approvals and registrations to be obtained by the healthcare sector. Hospitals, diagnostic labs, and MedTech firms report delays in approvals, lack of standardisation, and administrative overload.

The report outlines a roadmap for improved compliance architecture across hospitals, diagnostic centres and MedTech firms.

It identifies 85 key challenges, with 44 flagged as particularly burdensome due to duplication, ambiguity, and inefficiency.

NATHEALTH and EY have proposed a digital single-window platform for compliance, deemed approvals with defined timelines and harmonisation of regulations across jurisdictions.

They also recommends self-certification, digitisation of records, and collaborative policymaking with industry stakeholders.

Compliance challenges

The report highlighted issues for hospitals like dual licensing for blood bank, which requires both central and state approvals, lift licence delays, multiple practitioner registrations, height restrictions for hospital buildings that are hampering capacity expansion, among others.

Diagnostic facilities face non-acceptance of digital signatures, inconsistent ultrasound device approvals under the Pre-Conception and Pre-Natal Diagnostic Techniques (PCPNDT) Act. MedTech problems include Bureau of Indian Standards (BIS) certification delays, multiple licensing authorities, and lack of guidance for HCP travel approvals.

For the short term, they recommend digital signatures and centralising practitioner registrations. Medium-term goals involve transparency in approval timelines and decriminalising non-safety-related compliance.

Long-term reforms could include a National Single Window System (NSWS) and unifying state-level requirements.

The whitepaper aligns with the government’s push for Ease of Doing Business and digital transformation, aiming to create a high-performing, technology-enabled healthcare system that delivers value across the board.