Four years after the Centre capped the price on cardiac stents, the dice of price regulation continues to roll. The National Pharmaceutical Pricing Authority (NPPA) has asked the producers of 24 “non-scheduled” medical devices to submit their price-related information in three weeks. The products include intra-ocular lenses, heart valves, orthopaedic implants, organ preservative solution, surgical dressings, and blood component bags, to list a few.

MRP data

The manufacturers have been asked to submit their MRP (maximum retail price) data as on January 1, 2018, 2019, 2020 and 2021.

The manufacturers of four other products — blood pressure monitoring machines, glucometers, digital thermometers and nebulisers — need to submit data as on January 1, 2021.

At present,medical devices are regulated as drugs under the Drugs and Cosmetics Act, and industry representatives believe the data collection is the first step towards exercising price control on critical products.

A section of local producers, though, are unhappy with the MRP-centric approach to monitoring devices, a system that will perpetuate the flawed approach that is already in place for drugs, they point out.

“We are not against regulation, but the approach should be to take the landed-price of imported products (first point of sale) and ex-factory price of locally-made ones,” says Rajiv Nath, Forum Coordinator of AiMeD (Association of Indian Medical Device Industry). This will help weed out the irrationally high trade margins that bulk-up the MRP, the price paid by the patient, he points out. It is common place “to artificially inflate MRP to satisfy excessive margin needs of the healthcare provider / retailer, which is not only harmful to consumers but also to ethical manufacturers who lose out on competitiveness if they are unable to satisfy needs of their buyers,” he alleges. The system of allowing an annual price increase of not more than 10 per cent, similar to drugs, is also flawed, he added, calling for a more dynamic system of price monitoring for medical devices.

The NPPA’s data-gathering exercise, before it capped prices on cardiac stents, had revealed exorbitant margins to over a 1,000 per cent across various levels. And the price cap brought it down many fold to about ₹7,000-odd for bare metal stents and about ₹30,000 for drug-eluting stents.

NPPA data

In 2017, similar data was taken by the NPPA on 19 products, for the years between 2014 and 2017. After price caps were put on cardiac stents, a move that stirred the entire medical device industry, public health workers expected more to follow, including on intra-ocular lenses. But the pace appeared to slow downafter orthopaedic knee implants were also brought under price control after stents. Prices have not been capped on any other devices, they point out, hopeful that the latest exercise will end in bringing about a more reasonable pricing for patients.

Related Topics
comment COMMENT NOW