Industry experts respond to Maharashtra FDA review of medical device pricing

The Maharashtra Food and Drug Administration (FDA) has sought a review of pricing of hospital consumables and medical devices after a survey found gaps between procurement prices and printed maximum retail prices (MRPs).

The survey was conducted in July across hospitals in the Mumbai Metropolitan Region, Pune and Chhatrapati Sambhajinagar. The FDA submitted its findings to the National Pharmaceutical Pricing Authority (NPPA) in the first week of August.

Maharashtra FDA Commissioner Tukaram Mundhe subsequently recommended a review of the findings and guidelines on the permissible gap between trade procurement prices and declared MRPs to the Department of Pharmaceuticals and the NPPA.

The FDA has clarified that it does not have jurisdiction over hospital bills and that its role was to bring the pricing issue to the notice of the NPPA, which has the authority to regulate prices under the relevant framework.

The Centre has now sought a report from the NPPA on the price discrepancies flagged by the Maharashtra FDA.

Siddhartha Bhattacharya, Secretary General, NATHEALTH 

Patient safety, clinical outcomes and transparency must remain at the centre of healthcare delivery. At the same time, it is important to distinguish between a simple commodity consumable and a complex medical technology that has to be made safely and reliably available at the point of care.

For sophisticated medical devices and consumables, the hospital is not merely a reseller. Before a technology reaches the patient, the hospital may undertake clinical evaluation and selection, maintain multiple configurations and emergency inventory, ensure sterile-chain integrity and traceability, provide trained clinical and biomedical teams, manage expiry and obsolescence risks, maintain specialised infrastructure, safe disposal and assume responsibility for quality, safety and outcomes while ensuring compliance to all safety regulations. 

Therefore, the procurement price of a device cannot automatically be equated with its true cost of delivery to the patient. Equally, extraordinarily high margins on routine, commoditised consumables deserve scrutiny and should not be justified by costs associated with sophisticated technologies. We therefore need an evidence-based and differentiated framework that distinguishes basic consumables from clinically differentiated and high-complexity medical technologies. The policy objective should not simply be to focus on a fixed markup; it should be to determine what constitutes a fair and transparent patient price after recognising the legitimate cost and value involved in making the technology clinically available and integrate it as part of an overall package that is reimbursed either by patient or insurance. 

The right question is not only, ‘What did the hospital buy the device for?’ but also, ‘What did it take to make that technology safely, immediately and effectively available to the patient?’

Affordability, transparency, innovation, quality and sustainability are not competing objectives. A well-designed regulatory framework must protect all five as they add up to patient’s best interest

Association of Indian Medical Device Industry (AiMeD)

The Association of Indian Medical Device Industry (AiMeD) welcomes the timely intervention of Tukaram Mundhe, FDA Maharashtra, in highlighting the markups on essential medical devices such as IV sets, syringes and cannulas. His survey showing margins as high as 2,841 per cent underscores what AiMeD has consistently cautioned: the current regulatory framework under the Drugs (Prices Control) Order, 2013 is inadequate for medical devices.

Patients, who cannot bargain or choose devices, are left vulnerable to inflated MRPs, while ethical manufacturers and importers are forced to either play within a distorted system or exit the market. This situation penalises both consumers and responsible suppliers, eroding trust and competitiveness.

Rajiv Nath, Forum Coordinator, AiMeD, said, “AiMeD strongly supports Mundhe’s call for review—patients deserve fair prices, not 2,800 per cent markups, and ethical manufacturers deserve a level playing field and a fair opportunity to provide affordable, fair priced medical devices.”

AiMeD has long advocated for a Fair Pricing Policy tailored to medical devices, with transparent trade-margin caps based on ex-factory or landed import prices. Such a system would ensure affordability for patients, encourage ethical competition and strengthen the “Make in India” vision.

The association urged regulators and policymakers to act on Mundhe’s call by instituting structured price monitoring and margin rationalisation, starting with pilot studies on AiMeD’s proposals as “policy making by evidence”. AiMeD said patients deserve fair prices, not inflated margins, and India deserves a medical device ecosystem that is affordable, ethical and globally competitive.

Further industry comments and statements are being received and will be incorporated as they become available.