New Delhi: The medical device industry has backed Maharashtra Food and Drug Administration (FDA) Commissioner Tukaram Mundhe’s call for a review of national device pricing rules.
The support from the Association of Indian Medical Device Industry (AiMeD), which represents 1,000 member companies, follows a Maharashtra state study that found private hospitals were charging patients for surgical consumables at a markup of 2,841% over their purchase price. Mint reported on Tuesday.
Mundhe has written to the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority (NPPA), urging regulators to cap trade margins or bring major device categories under structured price monitoring. Similar concerns were raised by FDA commissioners in Punjab, Rajasthan and Tamil Nadu.
The price discrepancies relate to surgical products and medical devices that are not covered by the direct price cap mechanism of the Drug Price Control Order (DPCO) 2013.
This development assumes significance given that the government estimates that the Indian medical device market is worth around $18 billion.
“We urge regulators and policymakers to respond to Mr. Mundhe’s call by instituting structured price monitoring and margin rationalization, starting with some pilot studies of AiMeDs proposals as evidence-based policy development,” AiMeD said in a statement late Tuesday. “Patients deserve fair prices, not inflated profits, and India deserves a medical device ecosystem that is affordable, ethical and globally competitive,” it added.
A study of private hospital bills conducted by the Maharashtra State Price Monitoring Resource Unit (MSPMRU) across four categories of consumables showed a huge discrepancy between trade procurement costs and the stated maximum retail prices (MRP). The biggest gap occurred in standard infusion sets, which hospitals purchased at ₹11.05 and billed patients on ₹325 – markup 2841%. Other IV sets were purchased from ₹11.50 and the count is ₹252.
Similar gaps have been found in other routine clinical materials. We bought a 10 ml syringe. ₹6.75 was invoiced for ₹57.20, and bought hypodermic needles for about ₹1 were sold for ₹3.30. For respiratory support, you can use a store-bought adult nebulizer mask kit ₹40 had a printed retail price ₹715, and another set of nebulizer masks purchased for ₹45 was invoiced for ₹652.
Among the various surgical supplies is an IV cannula extension line purchased for ₹22.50 was sold at ₹424, balloon catheters purchased in ₹29.41 issued an invoice for ₹310, as well as bacterial-viral HEPA filters purchased for ₹50.68 were valued at ₹473.
“Based on our findings on the ground, I have sent a survey to the Department of Pharmacy and NPPA requesting appropriate intervention; including rationalization of trade margins, structured price monitoring and, where warranted, bringing essential medical devices under an effective price regulation system,” Mundhe said. Mint. “Health care pricing should be transparent, rational and fair. Information asymmetries should never become a source of avoidable financial burden for the patient.”
AiMeD also said that the pricing structure impacts patients, manufacturers and importers. “Patients who are unable to bargain or choose devices remain vulnerable to inflated MRPs, while ethical manufacturers and importers are forced to either play within a distorted system or exit the market. This situation penalizes both consumers and responsible suppliers, undermining trust and competitiveness,” the association said.