Parliamentary Panel Seeks Price Control for More Medical Devices, Including Heart Valves and Pacemakers

A Rajya Sabha parliamentary committee has recommended a significant expansion of India’s price-controlled medical device list, pushing to bring prosthetic heart valves, pacemakers, neurosurgical implants, and advanced cardiac stents under government price regulation. The recommendations, part of the Committee on Petitions’ 164th Report, follow years of examination that began with a single petition over exorbitant cardiac stent prices and has since grown into a sweeping review of how medical devices are priced, regulated, and manufactured across the country.

From Cardiac Stents to a Broader Push

The report traces back to a 2015 petition filed by a Delhi resident seeking an efficient mechanism to check exorbitant prices of cardiac stents and other medical devices. The committee, chaired by MP Narain Dass Gupta, first focused narrowly on stents, and the results were significant: the National Pharmaceutical Pricing Authority went on to cut cardiac stent prices by up to 85 percent and knee implant prices by up to 70 percent, delivering an estimated ₹5,900 crore in annual public savings.

Having closed that chapter, the committee resumed its broader examination of the original petition in 2021, holding discussions with the health ministry, the Department of Pharmaceuticals, the NPPA, the Drug Controller General of India, and industry bodies including CII, ASSOCHAM, and FICCI, along with hospitals, device manufacturers, and other stakeholders across the country.

Why the Savings Haven’t Fully Reached Patients

Despite those earlier price cuts, the committee found that overall procedure costs for patients have barely moved. The reason: unregulated procedural charges, everything billed around the device itself, now account for 60 to 70 percent of total treatment costs. Capping the price of the device alone, the committee concluded, does little if hospitals can simply recover the difference through other line items on the bill.

The committee also flagged a related problem with the current price-control mechanism itself: when manufacturers are found to have overcharged, recovered amounts go back to the government treasury rather than being reimbursed to the patients who were actually overcharged, a gap the committee said undermines the entire point of the enforcement.

The New List of Devices Up for Price Control

The committee’s central recommendation is a substantial expansion of India’s price-regulated device list to include prosthetic heart valves (both mechanical and bio-prosthetic), pacemakers across single-chamber, dual-chamber, and CRT variants, neurosurgical implants such as aneurysm clips, PEEK cages, and 3D mesh, and advanced stents including aortic stents, flow diverters, and neurocoiling devices, alongside other unregulated Class C and Class D life-saving devices.

That recommendation was informed directly by patient-level cost data: in cardiac surgery, patients currently bear roughly 40 percent of valve costs and up to 70 percent of aortic stent costs out of pocket, according to figures the committee reviewed, costs the panel said place these procedures out of reach for many families without formal price ceilings in place.

The Insurance Gap: AB-PMJAY Coverage Cuts

Layered on top of pricing concerns is a shrinking insurance safety net. The committee noted with concern that Ayushman Bharat-PMJAY coverage for cardiac catheterization has been reduced from 100 percent to 50 percent, leaving patients to absorb a much larger share of costs directly. It has recommended the government review and raise insurance package coverage, particularly for cardiac catheterization, cardiac surgery, neurosurgery, and interventional radiology, and revise package rates regularly to reflect actual treatment costs rather than outdated estimates.

A Push for a Separate Medical Devices Law

Beyond pricing, the committee renewed its call for a dedicated legal framework for medical devices, separate from pharmaceutical regulation, modeled on how FSSAI governs food safety independently. The panel argued that applying pharmaceutical-style price controls to complex, high-end medical equipment and software creates unintended consequences, squeezed profit margins that in some cases have pushed advanced devices out of the Indian market entirely, discouraging both production and investment in the sector.

The committee also recommended decriminalizing minor procedural lapses under a future Medical Devices Act, replacing criminal prosecution with a graded penalty system, arguing that fear of criminal liability for technical non-compliance currently discourages innovation among device developers and manufacturers.

Models the Committee Wants Replicated Nationwide

Several existing low-cost healthcare delivery models drew explicit praise. HLL Lifecare’s AMRIT Pharmacy network, which sells medical devices and medicines at 15 percent below average market prices on just a 5 percent margin, currently operates 207 stores; the committee wants it expanded to all central government hospitals, AIIMS campuses, and major state hospitals nationwide.

The committee also singled out Sri Jayadeva Institute of Cardiology in Bengaluru, where procedures are priced at actual cost with no margin at all, running 30 to 40 percent cheaper than private hospitals while still serving the majority of patients from low-income backgrounds. It recommended adopting that zero-margin model as standard practice across government hospitals and medical colleges nationally.

Reducing Import Dependency

A recurring theme throughout the report is India’s heavy reliance on imported medical technology: 70 to 80 percent of components in high-end devices are still imported, according to the committee’s findings. To address that, it recommended raising import duties on many device categories from the current 5-7.5 percent range to 10-15 percent, providing targeted financial support to domestic manufacturers competing against subsidized Chinese imports, and mandating that domestic content in government procurement rise gradually from 40 percent to 75 percent over five years.

The committee also praised the Andhra Pradesh MedTech Zone, built in just 342 days and now home to more than 100 companies, which during the pandemic produced over 100 ventilators, 500 oxygen concentrators, and a million RT-PCR test kits daily. It recommended replicating that model in at least ten additional states with existing pharmaceutical or biotechnology ecosystems.

A Faster Path to Market

Looking to balance tighter pricing with faster innovation, the committee proposed a “deemed approval” pathway that would let medical devices already certified by globally recognized regulators, such as the US FDA or Europe’s CE marking, receive an interim Indian marketing license within 30 to 45 days through a National Single Window System, rather than repeating a full local approval cycle from scratch. The committee framed the measure as necessary to support India’s stated ambition of building a $50 billion medical device market by 2030.

What Comes Next

Taken together, the committee’s 31 recommendations sketch out a strategy built on three fronts simultaneously: tightening price controls on a wider range of high-value devices, building domestic manufacturing capacity to reduce reliance on imports, and streamlining regulatory approval to keep pace with global innovation. Whether the government adopts these recommendations in full will determine if patients actually see the kind of relief the committee’s stent price cuts already demonstrated is possible, or whether, as the panel itself warned, savings on paper continue to get absorbed elsewhere in the hospital bill.