Opinion Address this blockage

Even before the price control move was instituted, only 40 per cent of the stents used in the country were indigenously manufactured; the rest were imported. With prices of imported stents and Indian stents now being the same, doctors and patients could prefer the imported devices.

stent, stent prices, stent price rate, india stents, indian express news, stent industry india

K M Cherian

Ajeet Arul Kumar

July 27, 2017 12:15 AM IST First published on: Jul 27, 2017 at 12:15 AM IST

Stent pricing, NPPA, NPPA stents, Angioplasty, Heart stents, Stent pricing, Cardiologists, Indian Express

Even before the price control move was instituted, only 40 per cent of the stents used in the country were indigenously manufactured; the rest were imported (Illustration: C R Sasikumar)

In February, the National Pharmaceutical Pricing Authority slashed prices of stents by up to 85 per cent. The news was welcomed by public and the media alike. Who could complain? Thousands of patients who couldn’t afford stents can now afford the devices at a fraction of the cost. In the five months since the price control announcement, robust media coverage and government measures have ensured that all hospitals have complied with the order. The consumer (in this case, the patient), it seems, is the biggest winner. But as the dust is settling, several issues and unintended ramifications are becoming apparent.

Stents are tiny metal tubes coated with medication, which are inserted into clogged arteries to keep them flowing well. These metal tubes have revolutionised modern cardiology. The devices save thousands of lives globally, every year. Emergency angioplasty is the treatment of choice during an acute heart attack, wherein the clot is crushed with a balloon and a stent is placed. It improves the chance of the patient surviving by almost 30 per cent when compared to clot dissolving medication (thrombolysis). However, in India, emergency angioplasty was carried out in less than 10 per cent of patients mainly because of the cost involved in the procedure and the lack of access to stents. Bringing the devices under price control will enable more patients to make use of this life-saving procedure.

However, capping the prices of stents has had an unexpected outcome: Preference for stenting even in cases when it is not the best treatment. Senior cardiologists and surgeons at the Frontier Lifeline Hospital, who discuss every patient’s case in their multidisciplinary meetings, have noticed a disturbing increase in multi-vessel stenting. With cheaper stents and a fall in procedure costs, many more patients are opting for angioplasty. Several studies across the globe have shown that in patients with multiple blocks in all three vessels, open heart surgery is a better procedure than the use of multiple stents. However, with lower stent prices, ill-informed patients often choose multi-vessel angioplasty as it is cheaper (even with three stents) than open heart surgery. What they don’t realise is that even the latest drug-eluting stents get clogged in about 5 per cent of cases. With the increasing use of the tiny metal tubes, the chances of a stent blocking with consequent damage to the heart muscle will only increase.

Another issue that has been discussed by many cardiologists and stent manufacturers is the availability of latest generation stents. In April, major international stent companies had filed for withdrawing their latest products from the Indian market. Discussions are still going on between major manufacturers and the government about the withdrawal of already available stents. If the logjam continues, newer and innovative stent technology will never be introduced in India.

Research on indigenous stents has become a victim of the government’s ambitious plan. Stent manufacturers typically spend millions of dollars on research before they can make the device and commercialise it. Some of the profit from sales is pumped back into research. Abruptly reducing stent prices will have adverse effects on the development of improved stents. International companies may be able to offset their losses with profits in other markets, and from profits from other products. But in India, before innovating, manufacturing and marketing a stent, a company has to go through several regulatory hurdles. The process involves testing on animals, trials on humans and finally, controlled studies. This can sometimes take as long as five years and financial institutions, including banks, do not have any provision that allows them to accord special status to funding such research.

Even before the price control move was instituted, only 40 per cent of the stents used in the country were indigenously manufactured; the rest were imported. With prices of imported stents and Indian stents now being the same, doctors and patients could prefer the imported devices. If the situation continues, the financial viability of Indian stent manufacturers could be hit. This will have a bearing on their capacity to do quality research. Lack of government funding for clinical research in India only aggravates the issue.

Ultimately, lack of indigenous research and development will make the country dependent on imported stents. But that is not all. As future generation stents come into clinical use, multinational companies may choose not to release their latest products in India because of the country’s price control regime. In fact, such an alarming scenario might pertain not only to stent technology but also to research and marketing of other implantable devices.

We could end up with a situation where hospitals in the country would have older generation stents. Patients hoping to have advanced stents may have to travel abroad — of course, only a few will manage to do so. Medical tourism also will be hit as it will become apparent that Indian hospitals do not have the latest generation stents. With time, paradoxically, patients who were the intended benefactors of this price control measure may actually turn out to be losers.

The best long-term solution is to encourage and support Indian stent manufacturers and medical device research so that we do no need to depend on imported stents. All aspects involving medical device development(clinical research, animal testing, human trials) must be fast-tracked and should be as transparent as possible. There must be a system to make sure that the latest medical devices, including stents, are priced differently.

Once such a level of competency is achieved, India could actually export stents making Prime Minister Narendra Modi’s Make in India viable for medical devices.