NATHEALTH, in collaboration with EY India, has submitted a white paper to NITI Aayog urging comprehensive regulatory reforms in the Indian healthcare sector. The industry currently operates under a complex web of regulations involving 10–12 different ministries and three layers of governance central, state and municipal making it one of the most heavily regulated sectors in the country.
The white paper highlights that approximately 24% of all regulations healthcare organizations face are specific to the sector, with 25–30% of compliance requirements changing every year. This creates a highly unstable regulatory environment that diverts resources away from patient care and hampers innovation and efficiency.
Among the 85 key compliance challenges identified, 44 were noted as especially burdensome due to duplication, ambiguity, or inefficiency. Common issues include repeated licensing renewals, inconsistent enforcement of rules, delays in medical device approvals due to multiple Quality Control Orders and varied local-level regulations such as those governing building heights and lift licenses. There is also no clear policy for approving travel by healthcare professionals for industry events.
To address these issues, NATHEALTH has recommended the creation of a digital single-window compliance platform. This system would offer end-to-end regulatory management, include deemed approvals and enforce clear timelines, helping harmonize regulations across jurisdictions and reduce duplication.
The paper also emphasizes the need for regular, structured engagement between policymakers and industry stakeholders. NATHEALTH believes this collaboration can help shape future-ready regulations that are technology-driven, responsive to the sector’s rapid growth and focused on patient-centric care. The proposed reforms aim to ease bureaucratic burdens, attract investment and improve healthcare delivery across India.
