New Delhi: The government is likely to regulate the prices of accessories used for implanting stents to treat patients with weak or narrow arteries. The move, which follows the regulation of stent prices, is set to be opposed by the pharma industry.

Prices of essential accessories like cardiac guiding catheters, guide wire and balloons used in the procedure may be reduced in line with a recommendation by an expert panel on coronary stents.

The panel recommended that the accessories be classified as essential drugs, bringing them under price controls.

The panel was consulted by the ministry of health following complaints received by the drug pricing watchdog, the National Pharmaceuticals Pricing Authority (NPPA), that hospitals had increased the prices of balloons and catheters after the capping of stent prices in February.

The NPPA requested the ministry to classify balloons and cardiac catheters as drugs and include them in the National List of Essential medicines (NLEM), 2015. This would ensure that “the benefits of stent price reduction could be passed on to the people" read a letter by written by NPPA chairman Bhupinder Singh to health secretary C.K. Mishra.

According to the letter, reviewed by Mint, NPPA stated that “it had been found that after the price control of cardiac stents several hospitals have increased the various procedure charges in order to compensate for their losses. NPPA has also found some specific complaints that several hospitals have increased the prices of balloons and the cardiac catheters which have not been included in NLEM, 2015. In some cases, the cost of ballons and catheters have been charged at a much higher level than the cost of stent itself. This situation needs immediate intervention by ministry of health by declaring balloons, cardiac catheters, covered stents and peripheral stents as drugs and also to be notified under NLEM, 2015".

A coronary stent is a small metal mesh tube that is surgically embedded in blocked coronary arteries. To ease the pathway for flow of blood, various accessories like balloon catheter and guide wire are used during the procedure.

Private hospitals said the standard practice is that consumables like guide wire and balloon are not covered by the cost of the stent. So they are billed separately.

Doctors said bringing accessories used during the stenting procedure under price regulation will be impractical.

“During an angioplasty procedure, a number of different peripherals are used like guide catheters, balloons, indeflators and stents. While stents can be considered under one category, the other peripherals cannot be clubbed together in a single category," said Nishith Chandra, director and interventional cardiologist at Fortis Escorts Heart Institute. “Each component comes at a different price. Bringing these different, but essential components of stenting procedure under a single umbrella with a view to cap their price would be impractical and cause lot of chaos and uncertainty."

Currently, only 14 medical devices are classified as drugs under Section 3 of the Drugs and Cosmetics Act.

Interestingly, NPPA has also urged the health ministry to develop a “standard treatment protocol" in consultation with Cardiological Society of India and Medical Council of India to mitigate the fear of “unnecessary angioplasties, multiple stenting and angioplasty cases getting converted into bypass surgeries".

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