India
Maharashtra FDA Commissioner Calls for Review of Medical Device Price Disparities
Maharashtra Food and Drugs Administration Commissioner Tukaram Mundhe has directed the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (NPPA) to examine a state survey that found hospital surgical consumables and medical devices were being sold at markups as high as 2,841% over their procurement prices. In a letter to the NPPA, Mundhe urged a review of the survey findings and proposed capping trade margins and placing essential medical device categories under structured price monitoring. He said the survey revealed an extraordinary disparity between trade procurement prices and printed maximum retail prices (MRP) for items such as IV sets, syringes, nebulizers, oxygen masks and catheters. For example, catheters were procured at ₹29.41 against an MRP of ₹310, while IV infusion sets bought at ₹11.05 were billed to patients at ₹325. The survey covered surgical items used in inpatient departments. Mundhe noted that many of these products fall outside the direct ceiling-price mechanism under the Drugs (Prices Control) Order, 2013 (DPCO), which allows the NPPA to regulate statutory ceiling prices for essential medicines and notified medical devices. The NPPA is investigating whether manufacturers and intermediaries are adding large markups between wholesale procurement prices and the prices ultimately charged to patients. Mundhe emphasized that the pricing disparity requires examination of margins, product quality and other factors, and that the issue is a patient‑protection concern due to the asymmetry of information in healthcare. He added that when a product procured at a low trade price carries an exceptionally high MRP, the patient bears the financial burden.