Healthcare industry divided over Maharashtra FDA's medical device pric

17 Sep 2026 | Press Release | Business Standard
Healthcare industry divided over Maharashtra FDA's medical device pric

The healthcare industry has voiced differing views on recommendations by the Maharashtra Food and Drug Administration (FDA) on medical device pricing, with industry bodies calling for greater transparency and scrutiny while differing on how the gap between procurement costs and prices charged to patients should be assessed.

The debate follows Maharashtra FDA Commissioner Tukaram Mundhe’s call for a review of medical device pricing after a state survey found wide gaps between hospital procurement prices and MRPs of some devices and consumables. The survey reportedly found mark-ups running into several times the procurement price in some cases.

The Medical Technology Association of India (MTaI) has backed Mundhe’s recommendations to rationalise margins, undertake an inter-agency review and establish clear guidelines on the permissible difference between trade procurement costs and declared maximum retail prices (MRPs).

Pavan Choudary, chairman, MTaI, said the recommendations were in line with the association’s position since 2016 and the principle of Trade Margin Rationalisation (TMR). MTaI cited the National Pharmaceutical Pricing Authority’s decision during the Covid-19 pandemic to cap trade margins on oxygen concentrators, pulse oximeters, blood pressure monitors, nebulisers and glucometers as a precedent for such an approach. 

Nathealth, meanwhile, has called for a differentiated framework that distinguishes between routine consumables and complex medical technologies. Siddhartha Bhattacharya, secretary general, Nathealth, said a hospital’s procurement price cannot automatically be equated with the cost of delivering a medical technology to a patient, as hospitals incur costs related to clinical evaluation, emergency inventory, sterile-chain integrity, trained personnel, specialised infrastructure, traceability and safety compliance.

At the same time, Nathealth said unusually high margins on routine, commoditised consumables should be scrutinised and cannot be justified on the basis of costs associated with sophisticated technologies.

The Association of Healthcare Providers of India (AHPI) has urged a fact-based assessment, saying the regulatory framework governing medical products needs to be considered before drawing conclusions from differences between procurement prices and prices charged to patients.

Girdhar Gyani, director general, AHPI, said hospitals do not determine the MRP printed on medicines and medical products. According to AHPI, MRPs are determined by manufacturers and medicines are subject to applicable regulation by the National Pharmaceutical Pricing Authority (NPPA). It also said prices of non-scheduled medical devices are regulated by the central government, with annual price increases capped at 10 per cent under the applicable framework.

AHPI also pointed to the government’s powers to regulate prices of medical devices in extraordinary circumstances and in the public interest. It cited the 2017 price cap on knee implants, which are non-scheduled devices, as an example of such intervention under the Drugs (Prices Control) Order, 2013.

The association said the distinction between procurement price and MRP was important because hospitals do not set the latter. It cautioned that attributing the gap between the two to hospitals, or suggesting coordination between hospitals and manufacturers, would require evidence of coordinated pricing.

AHPI also referred to Competition Commission of India proceedings relating to 12 Delhi hospitals, saying the CCI’s May 21, 2026, orders examined allegations concerning pricing of medicines, medical devices and consumables and noted that hospitals are legally permitted to sell medical products up to the manufacturer-notified MRP.