Maharashtra FDA Commissioner Tukaram Mundhe Writes To NPPA, Flags 2,841% Margin On IV Set, Seeks Action To Rationalise Medical Device Prices

Mumbai, September 16, 2026: A Maharashtra FDA market survey has found substantial differences between the procurement costs and printed maximum retail prices (MRPs) of commonly used medical consumables, with reported margins reaching 2,841.17 per cent in one case.

FDA Commissioner Tukaram Mundhe has written to the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (NPPA), seeking a review of the findings and regulatory intervention to rationalise prices of essential medical devices.

The Maharashtra State Price Monitoring Resource Unit (MSPMRU), functioning under the FDA, conducted the survey across four categories of devices commonly used in inpatient treatment — IV sets, syringes and needles, nebulisers and oxygen masks, and miscellaneous consumables.

The survey found wide price differences across hospital consumables. An IV infusion set, used to administer fluids and medicines, was bought for Rs 11.05 but carried an MRP of Rs 325, reflecting a reported margin of 2,841.17 per cent.

Lyvofusion and Polymed IV sets bought for Rs 11.50 and Rs 10.50 had MRPs of Rs 252 and Rs 187, with margins of 2,091 per cent and 1,680.95 per cent, respectively.

Price Gaps In Medical Consumables

A 10-ml syringe, used to administer medicines, cost Rs 6.75 but had an MRP of Rs 57.20, showing a 747.4 per cent margin. Among respiratory-care products, a Nebplus nebuliser bought for Rs 40 was priced at Rs 715, a 1,687.5 per cent margin, while an Aero Confort kit costing Rs 62.50 had an MRP of Rs 662, with a 959.2 per cent margin.

Among other consumables, a catheter costing Rs 29.41 was listed at Rs 310, showing a 955 per cent margin. A disposable mask bought for Rs 197.50 had an MRP of Rs 500, reflecting a 153.16 per cent margin.

The FDA said such large differences between trade procurement costs and MRPs could increase patients' out-of-pocket expenditure, particularly for consumables routinely required during hospitalisation, where patients have limited bargaining power.

FDA Flags Pricing Policy Gap

The regulator has also highlighted a pricing-policy gap. While scheduled medicines are subject to price controls under the Drugs (Prices Control) Order, 2013 (DPCO), several medical devices do not have comparable statutory price controls.

Mundhe has sought an inter-agency review by the Department of Pharmaceuticals, NPPA and other concerned authorities. The FDA has proposed measures including rationalisation or capping of trade margins, guidelines on permissible price differentials, and stronger price monitoring of essential medical devices.

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The survey details have been submitted as an evidence-based policy input, with the FDA seeking consideration of the listed inpatient medical devices for inclusion under the DPCO framework and fixation of rational MRPs.

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