Manufacturers must adhere to official guidelines
The National Pharmaceutical Pricing Authority's (NPPA) effort to make coronary stents accessible to the patients at affordable rates has been incredible. However, the method the regulatory body has adopted to achieve its purpose — by keeping a check on stent prices — has invited the ire of certain manufacturing companies, especially multinational healthcare companies like Abbot and Medtronic, who have time and again cited some reason or the other to stop the supply of cardiac stents. The Government, on the other hand, has adopted a no-holds-barred approach to ensure continued supply of this life-saving device.
This time, the cardiac stent manufacturers' refusal to submit the details of sales and production of the medical devise has led the Government to come down heavily on them. It has warned defiant manufacturers to follow guidelines or face prosecution under relevant provisions of the Essential Commodities Act, if they fail to comply with its order. There's no reason that the manufacturers must resort to such scrambling ways to plug gaps. After all, they are not being asked to supply the device for free or by incurring losses. At best, the Government, while taking care of the interest of both, the manufacturers and the patients, has chalked out a middle-path so that both stand to benefit. Of course, the NPPA has done its calculations well, keeping in mind the profits of manufacturing companies. As it is, before the cap, stent manufacturers had been earning a profit ranging between 270 per cent and about 1,000 per cent. Their more often than not ways to remain profitable has made it clear that they are not willing to do with less profits — the stent business had been a major channel of profiteering.
In fact, the tussle between the stent manufacturers and the NPPA started in February, when the NPPA sought to regulate the prices of stents. Since then, the former has devised innovative ways to remain relevant. They even threatened to withdraw their stents from market and to lower investments by not supplying new variety of stents. At the forefront of this battle have been two global med-tech firms — Abbott and Medtronic — who are the most nervous about the price cap and have even made lobbying efforts to take control of the situation.
The NPPA has, on the other hand thwarted such efforts by rightly resorting to legal mechanisms. Earlier too, in response to manufacturing companies requests under paragraph 21(2) of the Drug Price Control Order, 2013, to allow them to withdraw certain categories of their stents from the market, the Government had rejected their requests by citing paragraph three of the same Act, which allows the Government to direct the manufacturers to increase or continue the production of a notified medical device. It's unfortunate that stent manufacturers are trying to skirt the guidelines of the Government. It would be advisable for them to not opt for a legal battle. After all, the Government has not made unjust guidelines.