4 min readMar 26, 2026 07:23 AM IST
First published on: Mar 26, 2026 at 07:23 AM IST
India may regulate the price of medicines and stents but a major chunk of healthcare costs still remains unchecked — and patients are paying the price. A parliamentary panel has now flagged critical gaps in how medical devices and diagnostic services are regulated, warning that outdated policies, weak price controls and limited insurance coverage are quietly driving up out-of-pocket expenses across the country.
Need for separate framework
A parliamentary standing committee has recommended the creation of a dedicated regulatory framework for medical devices, cautioning that the existing system, designed along pharmaceutical lines, is ill-suited to the sector and may have unintended economic consequences.
In its report on pricing of cardiac stents and other medical devices, the panel argued for a structure similar to that of the Food Safety and Standards Authority of India (FSSAI), which independently regulates food safety. The committee noted that the current medical device rules do not adequately account for the complexity of high-end equipment, effectively subsuming them under a pharmaceutical framework and discouraging investment in the sector.
No cap on diagnostics
The committee drew particular attention to the absence of price regulation in diagnostic, scanning and imaging services. It urged the Department of Pharmaceuticals and the health ministry to formulate a uniform pricing policy, observing that diagnostic costs form a substantial component of overall treatment expenditure.
While some states have periodically capped the cost of specific tests — such as RT-PCR during the pandemic — there is no national mechanism governing pricing in this segment, leaving patients exposed to widely varying charges.
Insurance gaps add to burden
The panel also pointed to gaps in public provisioning and insurance coverage that compel patients to spend on medical devices despite being enrolled under government schemes. Submissions from the Sher-i-Kashmir Institute of Medical Sciences indicated that high-end devices are often unavailable through subsidised channels, while reimbursement rates under Ayushman Bharat remain outdated.
The scheme, it noted, covers only a part of procedures such as cardiac catheterisation, leaving patients to bear a significant share of costs. Expenses for valves and aortic stents, in particular, remain high due to low package rates, while several advanced devices continue to be largely self-financed.
The committee has recommended that package rates under AB-PMJAY be reviewed and revised periodically to reflect prevailing market realities, especially for high-value procedures such as cardiac surgery, neurosurgery and interventional radiology.
Push for industry reforms
On the regulatory front, the panel endorsed long-pending industry demands, including the introduction of a graded penalty system in place of criminal provisions for minor procedural lapses, and an increase in import duties on select devices to support domestic manufacturers competing with low-cost imports.
It also called for streamlining licensing timelines, reducing the financial burden of clinical trials, and introducing a “deemed approval” pathway for devices already cleared by established global regulators. Such products, the committee suggested, could be granted interim marketing approval within a defined timeframe, subject to compliance with local safety and labelling norms.
Consumer interest and stalled projects
The committee further expressed concern that recoveries from companies found overcharging are routed to the government exchequer rather than passed on to affected consumers. It stressed the need for stricter enforcement to prevent overpricing at source so that patients benefit directly.
While reiterating the importance of boosting domestic manufacturing, the panel flagged delays in key infrastructure projects, noting that several Mediparks — including a large facility proposed in Tamil Nadu — remain non-operational.
The committee drew particular attention to the absence of price regulation in diagnostic, scanning and imaging services. (File Photo) 
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