India's FDA Chief Highlights Massive Medical Device Price Disparities

India's drug regulator has raised serious concerns about the wide disparity between the cost price and declared maximum retail price (MRP) of medical devices, calling for immediate government action to curb what appears to be widespread overpricing.

According to findings presented by the regulator's chief, the price gaps are staggering. An intravenous set procured for ₹11.05 carried a declared MRP of ₹325, while an infusion set acquired for ₹11 was listed at an MRP of ₹201. These figures suggest markups of over 2,800 per cent and 1,800 per cent respectively, raising questions about consumer protection and healthcare affordability across the nation.

The regulator has appealed to the central government to intervene in the pricing mechanism for medical devices, which remain largely unregulated compared to pharmaceutical drugs. The issue threatens to exacerbate healthcare costs for patients and hospitals, particularly in rural and economically disadvantaged regions where such devices form essential components of treatment protocols.

The findings underscore growing concerns about price regulation in India's medical device sector, which has expanded substantially with rising demand for diagnostic and therapeutic equipment. Healthcare experts and patient advocacy groups have long flagged the absence of effective price controls as a barrier to equitable access to quality medical care across the country's diverse populations.