New Delhi: The government’s decision to bring under price control coronary stents—tiny tubes placed inside the heart’s blood vessels to keep the passages open—is in bureaucratic limbo.
Although four months have passed since the inclusion of stents in the National List of Essential Medicines (NLEM), the department of pharmaceuticals (DoP) has failed to issue the notification that would allow the National Pharmaceutical Pricing Authority (NPPA) to fix a price ceiling for stents included in the list.
The Union health ministry, following the recommendations of an expert sub-committee, notified the decision to include coronary stents under the NLEM in July.
According to the law, medicines and devices listed in the NLEM must be sold at the price fixed by NPPA, while those in the non-scheduled list are allowed a maximum annual price hike of 10%. However, the NPPA can only fix the price of a drug or device once DoP issues a notification.
“We have asked about the impending notification but we have no idea about why DoP has not issued the notification yet," an official from the NPPA said, requesting anonymity.
A bare metal stent costs Rs10,000-20,000. Drug-eluting stents, which are inserted into diseased coronary arteries and release drugs to prevent cell proliferation, make up almost 95% of the market and cost Rs30,000-80,000, while the price of a dissolvable stent in India is Rs2-3 lakh.
Almost 60% of the stents market is shared by multinational firms such as Abbott Laboratories, Medtronic, Meril Lifesciences Pvt . Ltd and Boston Scientific Corp. Stent manufacturers selling their wares with exorbitant mark-ups of between 100%-300% is the norm, according to industry experts. Vigorous lobbying has been going on to block the government’s move, experts said.
“All that the DoP needs to do is issue the notification but it has been sitting on its decision for over four months now. The foreign stent device manufacturers have inundated the Prime Minister’s Office, NITI Aayog and the respective ministries with their representations. The greater the delay by the department of pharmaceuticals in issuing the notification, the better off stent manufacturers and hospitals will be as they can overcharge and simply get away with it," said an industry official.
Mails sent to the DoP secretary Jai Priye Prakash about the reasons behind the delay in issuing the notification went unanswered. “I don’t talk to the media," Prakash said.
Domestic stent manufacturing group Association of Indian Medical Devices Industry (AIMED) said it has raised these concerns with the group of secretaries as well as Prakash. “We have raised the issue with the government almost two weeks back but we did not get any response as to what is the reason behind the delay. We tabled our concerns about how this is impacting patients but we are yet to understand why the notification has not been issued by the DoP," said Rajiv Nath, forum coordinator, AIMED.
India’s coronary stents market was valued at $481 million in 2015, and is expected to reach $531 million in revenues by 2016-end.
The medical devices industry has been fighting the impending price cap on stents as it would imply reduced margins, and has pushed for differential pricing of price stents.
The industry lobby representing foreign stent manufacturers has argued that the price cap on stents does not equal a cap on treatment, and that treatment costs at hospitals could arbitrarily be raised by hospitals to offset the diminished margins on stent prices incurred.
“Apart from reducing options for patients, this price ceiling on stent also discourages innovation and foreign companies bringing newer technologies to India and competing because it will be financially unviable to do so," Himanshu Baid, chairman of the medical technology division at the Confederation of Indian Industry had told Mint earlier.