Healthcare industry divided over Maharashtra FDA's medical device pricing

Industry bodies back greater scrutiny of medical device pricing but differ on how gaps between hospital procurement costs and prices charged to patients should be assessed

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.