Capping may hit innovations, imports

The National Pharmaceutical Pricing Authority’s (NPPA) decision to cap prices of coronary stents might have brought cheer to patients, but fear looms large whether new innovations would hit the Indian market in the future or not. While the domestic industry manufactures mostly the basic and mid-range stents, the country is largely dependent on the imported variety for high-end stents.

Cardiologists and distributors fear that the price cap might stop foreign manufacturers from exporting the best of their innovations to India citing low margins.

A day after the NPPA capped prices, the Department of Pharmaceuticals came under severe criticism as manufacturers began withdrawing high-end stents from the market on the pretext of relabelling them. This forced the ministry to issue a notification warning manufacturers and distributors not to withdraw the existing stock from hospitals. They were also asked to maintain the same supply as they did for the last three years, for one more year. This might address the issue in the short-term, but the medical fraternity is a worried lot about the long-term implications. Experts are asking: “What if, after the one year, they stop supply of high-end stents? Also, does this mean a block on the arrival of new stents?”

Though a meeting was held before the prices were regulated, stakeholders feel their opinion has not been considered. AdvaMed, a trade association of medical device manufacturers, had expressed similar concerns. It said the notification on new prices “completely disregarded representations on the need to differentiate stents based on their technological differences.” AdvaMed also feared that the new pricing could potentially block innovations and limit access to world-class medical care and options to deserving patients.

 The decision, it said, disregarded the evolution of coronary stents over the last four decades, and blocking innovation might set our healthcare sector back by at least a decade, when there were far lesser options for Indian patients. This may also result in a loss for the medical tourism sector. Besides, Indian patients might be forced to go to neighbouring countries just to avail quality stents.

Similarly, the Cardiological Society of India had put forth several recommendations before the Ministry of Chemicals and Fertilisers. Anticipating that stent manufacturers might not launch new innovations in the Indian market, they had recommended a differential capping based on the performance of the stents. Instead of having just two categories, the Society had sought that stents be categorised under multiple categories and be capped. A member expressed that such crucial recommendations have not been considered by the government.

Alternatively, cardiologists propose that having a cap based on the landing cost of these stents would encourage distributors to procure stents with the latest technology and distribute them with minimal profit.

According to a senior cardiologist in Bengaluru, India depends on new products emerging out of research, particularly for the high-end stents. Doctors are sceptical whether such unscientific price cap on stents would mean a compromise on patient’s safety and loss of life. The need for stents varies from patient to patient. While the basic bare metal stent would not do much harm to some, it could lead to complications for others.

Hospitals, both government and private, have been recommending high-end drug eluting stents for complex cases with other co-morbid conditions to avoid the need for a re-stenosis procedure. The cost of the stent is dependent on the efficiency of the microscopic layer of polymer that coats the metallic structure. High quality absorbable polymer is used in stents that are imported into the country.

For example, in the case of a patient with diabetes, the chances of re-narrowing the walls of the blood vessels is higher compared to others. In such cases, implanting high-end stents would minimise the risk of a second heart attack, say cardiologists. Such care should be taken for patients with previous bypass surgeries as well. India has 60 million diabetics and another 60 million are pre-diabetic. Both need high-end stents to ensure long-term relief. The bare metal stents or mid-range stents would also up the risk of stent thrombosis, a condition where clots are formed inside the wall of the stent blocking the artery further. Companies in the US and Europe have been manufacturing stents which address this issue.

“In India, these stents are supplied to hospitals based on a demand and procure model. These are among the new innovations. If these are capped along with the other stents, stent manufacturers abroad might not even send it to India. As it is a new product in the market, it would come with higher price as companies need to meet their research and development costs,” said a senior cardiologist.