FDA chief Tukaram flags huge price gaps in medical devices, seeks Centre’s intervention

The Maharashtra Food and Drug Administration (FDA) has flagged a wide disparity between procurement costs and maximum retail prices (MRPs) of many medical devices used in hospitals.

The FDA has sought the Centre’s intervention to examine the issue and consider bringing essential devices under price regulation.

A market survey by the Maharashtra State Price Monitoring Resource Unit under the FDA examined intravenous (IV) sets, syringes, nebulisers, oxygen masks, and other consumables available in trade and retail markets, an official said.

The survey report submitted to the Department of Pharmaceuticals stated that the difference between purchase prices and declared MRPs was substantial for several products.

The report cited that an IV set purchased for ₹11.05 had a declared MRP of ₹325, while an infusion set purchased for ₹11 had an MRP of ₹201.

The report said a 10-ml syringe purchased for ₹6.75 had an MRP of ₹57.20, while a hypodermic needle bought for ₹1 had an MRP of ₹3.30.

The survey found similar disparities in nebuliser products. A Nebplus product purchased for ₹40 had an MRP of ₹715, while an adult nebuliser mask kit bought for ₹45 carried an MRP of ₹652, the official said.

The FDA said the findings highlighted the need for greater transparency in the pricing of essential medical devices used during inpatient treatment.

The report said hospitalised patients generally have limited ability to compare prices or negotiate, particularly when such products are required as part of ongoing treatment.

It also pointed to regulatory gaps in the existing pricing framework, saying these could contribute to higher out-of-pocket healthcare expenditure.

The FDA has requested the Department of Pharmaceuticals to examine the findings in consultation with the National Pharmaceutical Pricing Authority and other concerned authorities.

It suggested regulation of trade margins, structured price monitoring of essential medical devices and guidelines on the permissible differential between procurement prices and declared MRPs.

The agency also sought stronger price-monitoring mechanisms at the state and national levels.

The report was submitted to the DoP as an evidence-based policy input, seeking examination of the listed devices for an appropriate price-regulation mechanism, including their possible inclusion in the relevant framework of the Drugs (Prices Control) Order, 2013, the official said.

Maharashtra FDA Commissioner Tukaram Mundhe said, “Healthcare is not a conventional marketplace. A hospitalised patient needing an essential medical device cannot reasonably compare prices or negotiate costs..” This information asymmetry leaves patients vulnerable and can drive up out-of-pocket expenditure, he told PTI.

“In healthcare, information asymmetry cannot become an opportunity for excessive pricing. Essential medical devices must be subject to greater transparency, accountability and appropriate price oversight. This is fundamentally a matter of public health,” Mundhe said.