The Healthcare Federation of India (NATHEALTH) has asked the NITI Aayog to look into the compliance challenges faced by hospitals, diagnostic centres, and MedTech companies. In a “white paper” presented to the government’s think tank on Monday, NATHEALTH has outlined 12 high-impact bottlenecks that have to be prioritised for action.
Overlapping Regulations
While recommending a complete overhaul of the fragmented and resource-intensive compliance landscape, the whitepaper said that healthcare industry is one of the top three regulated sectors in India – besides BFSI and mining – with various authorities regulating the sector. For example, 24% of central-level regulations are specific to just healthcare, which is far more than other sectors. Moreover, 25-30% of these compliance requirements undergo changes each year, thereby placing a huge regulatory burden on the industry.
“The healthcare sector is subject to a complex and ever-evolving network of regulations spanning 10-12 ministries and three tiers of governance (central, state, and municipal). Nearly 60% of regulations applicable to the healthcare industry are decentralised that lead to complexity of compliance due to lack of standardisation,” said Himanshu Baid, vice president of NATHEALTH.
Single-Window System, Regulatory Clarity Urged
The paper has laid out short-, medium- and long-term recommendations to make India’s regulatory ecosystem more cost-efficient, innovation-ready, and patient-centric. This includes a digital single-window platform, deemed approvals with well-defined timelines, harmonisation of regulations across states and departments and clear delineation of roles between central and state authorities.
Ameera Shah, executive chairperson of Metropolis Healthcare said that with around 70% of medical conditions relying on diagnostic test results, there’s a need to standardise the Clinical Establishments Act. “Under the existing rules, the height of hospital buildings is capped which limits their capacity to add floors and beds. Many healthcare providers are committed to regulatory accountability, however there is a clear need for streamlined, time-efficient processes that support better outcomes,” she said.
The paper noted that the multiplicity of regulators and enforcement agencies coupled with dated regulations is draining time and resources of the industry from patient care, and innovation. “Over the past two years, the medical devices sector is facing a supply chain disruption since the government has mandated the foreign raw material suppliers to comply for the Indian standards. As a result, many of these component and raw material suppliers are reluctant to supply to India which is affecting the domestic manufacturers of medical devices,” said Baid.