Medical devices have come in for scrutiny from the National Pharmaceutical Pricing Authority (NPPA) after certain life-saving products such as cardiac stents and cardiac drug-eluting stents showed wide fluctuations in prices.

The NPPA has sought price details from several medical device makers on products that they sell in India. All device manufacturers are supposed to regularly submit price details to help NPPA ensure that steep price increases do not take place.

In its show-cause notice to the companies, NPPA said: “As a result of this lapse (of not submitting price details) on the part of a majority of the manufacturers, including importers and marketers, the consumer stands highly vulnerable to being overcharged, which severely undermines public interest.”

Companies have been asked to furnish price details on stents first, following which they are required to do the same with about 20 devices, including catheters, intra-ocular lenses, heart valves, orthpaedic implants and bone cement. The coronary stent market in India is estimated at over ₹2,000 crore, while the total medical devices industry is pegged at ₹30,000 crore.

Currently, the Centre does not control prices of these devices, but under the Drug Prices Control Order, the NPPA has the right to monitor the prices of these devices, manufacturers of which are not allowed to increase prices over 10 per cent annually.

A senior NPPA official said following the notice, most manufacturers have furnished details, even as a few smaller ones are yet to do so. “We have asked them to furnish details of price revision in the last two years, along with other details. Wherever we find companies have increased prices by more than 10 per cent, we will bring it down and recover that money,” the official said.

The government may be looking at bringing cardiac stents under the National List of Essential Medicines (NLEM), where prices will be fixed by the NPPA. The list was being revisited by a committee set up by the Union Health Ministry. A senior member of the committee said it has taken into consideration the prices of life-saving devices, such as stents.

Currently, birth-control devices such as IUDs and condoms are under price control.

While not commenting on whether or not the committee will recommend the inclusion of stents under NLEM, a Health Ministry official said: “There is a case for including these devices under the NLEM. Many companies are selling stents at two to three times of the imported price.”

Himanshu Baid, Managing Director, Polymed, said: “Maximum retail prices of these devices certainly need to be rationalised and the margins in the supply chain — of distributors, dealers, retailers and also hospitals — need to be looked at to achieve that.”

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