The stent fiasco

It is alarming and a tad worrying when a couple of top stent makers decide to withdraw some products from the country — a move, they say, is in response to the Government’s price control efforts. A stand-off between the Government and industry is not without precedent; price control on medicines is an example. But medical devices have come into the Government’s price net for the first time. And here it would be advisable to learn from the challenges with price control on medicines rather than tread a similar collision course. Caught in the crossfire between two power centres, Government and industry, are hapless patients.

Cardiac stents were the first to be rapped by the National Pharmaceutical Pricing Authority (NPPA). With data from the NPPA revealing exhorbitant distribution margins exercised each time a stent changed hands before it reached the patient at an inflated price, the case for a crackdown was made. And rightly so.

But where the regulator needs to tread with caution is in ensuring that its crackdown does not end up inadvertently stifling supplies and hurting the patient —a fallout red-flagged by no less than a government policy document on medicines. The National Pharmaceuticals Pricing Policy 2012 states: “The emphasis on price control starting at the bulk drug stage itself has, in recent times, resulted in amongst other reasons shifting of manufacture of drugs away from the notified bulk drugs under price control. In fact, only 47 bulk drugs out the of the 74 notified in the First Schedule of the DPCO, 1995 are now under production. This has had a cascading effect on the formulations manufactured from the concerned bulk drugs which in turn has affected the availability of such formulations. The consumer-patient has been adversely affected in the process.”

A similar rationale seems to resonate with medical devices in 2017. In its petition to the NPPA, Abbott said it was withdrawing its dissolvable stent Absorb and another drug-eluting stent, Alpine, as it was unviable to sell them at the reduced prices. (Their prices were brought down from close to ₹2 lakh and ₹1.5 lakh to ₹30,000.) Before Abbott, Medtronic too made a similar submission on its stent Resolute Onyx. And on a similar wicket, though not quite withdrawing its product yet, Boston Scientific made a plea to revise the price on its drug-eluting stents.

The combined impact these withdrawals could have on hospital supplies is disconcerting. After all, unlike medicines where India has the fire power to stave off supply shortages on the back of several reputed drugmakers, the country has yet to reach that level of comfort with medical devices. The NPPA maintains it is monitoring hospitals and the availability of stents. And the six-month diktat on keeping supplies running smoothly was also being ensured. But the air is still far from clear for patients. Local stent makers clarify that higher priced stents do not mean better quality. And multinationals point out that their products make the regulatory cut in multiple developed markets. Add to this confusion global reports on safety concerns involving some stents and a divided house of doctor opinions.

As effective as cardiac stents are, it is true that there has been the use, abuse and misuse of stents. But the Government needs to expand its discussion beyond price control. The health ministry needs to outline guidelines for the use of stents and commission an independent comparative study of Indian and foreign stents to establish what is safe and revolutionary and call the bluff of pretenders. And on prices, NPPA and industry need to discuss methods to bring in good, effective products at affordable prices through better sourcing and financing support for patients.

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