The demand for such a category originated from the stent-makers themselves, who withdrew their top-end stents after the price cut

The national drug price regulator, which slashed the price of cardiac stents by up to 80% nearly a year ago, has asked the heath ministry to consider creating a new category of high-end stents.

The demand for such a category originated from the stent-makers themselves, who withdrew their top-end stents after the price cut. Manufacturers hope such a category will help them launch new premium stents.

In a 9 January letter, the National Pharmaceutical Pricing Authority (NPPA) chairman Bhupendra Singh asked Union health secretary Preeti Sudan to call an urgent meeting of the cardiac stents core committee for the National List of Essential Medicines (NLEM) to “re-consider” the issue and review if all drug-eluting stents (DES) are equal, or if a new category is required. Mint has seen a copy of the letter.

“NPPA received several representations from the stent importers (MNCs) urging the need for a new sub-category of stents within DES to include ‘new generation’ stents with added features. In this context, I would request you that ministry of health and family welfare may like to convene an urgent meeting of NLEM core committee on cardiac stents to re-consider the issue and if necessary, whether all DES stents in the market are equal or there is a need for adding a sub category under DES to take care of new generations of stents,” reads the letter.

Following the recommendations of the core committee, the health ministry on 19 July 2016 included coronary stents in NLEM. The stents were classified into two categories: Bare Metal stents (BMS) and Drug Eluting Stents (DES). According to the core committee, it did not find it necessary to create a separate category for certain categories of stents as it found that there was no “scientific and statistically, proven data to validate the therapeutic superiority of these stents”. On 21 December 2016, stents were included under Schedule 1 drugs. Subsequently, the NPPA capped prices of both categories of stents on 13 February, 2017 which is valid for one year.

In its letter, the NPPA asked the health ministry to communicate its decision by 31 January, following which the authority will revisit the issue. Last year’s price cap is valid for one year ending 13 February, meaning NPPA has to settle price revision discussions before February 2018.

In November, following representations from multinational stent-makers, NPPA sought their views. Earlier in November, the US-based Abbott Laboratories said it would not introduce its latest stent Xience Sierra in India. In September, it had received permission to withdraw its premium Xience Alpine metallic stents as well as its dissolving stents. Boston Scientific Corp. is also considering withdrawing its high-end stents, Mint reported on 20 September.

Probir Das, chairman of industry lobby group Ficci’s medical devices forum and the Healthcare Federation of India’s Medical Technology Forum, vouched for a superior category. “To preserve access of Indian patients and doctors, it will be ideal if they made a superior category either out of price control, or covered by margin rationalization, or at the very least a higher price point,” he said.

Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMed), said: “We agree that any stent produced with a claimed superior technology backed by clinical evidence of proven superiority would be worthy of differential pricing. However, we disagree with some importer manufacturers trying to seek differential pricing just because their product is US FDA approved and to be considered superior to others”. The stent price cap was discussed at the 26 October US-India Trade Policy Forum in Washington DC.

In September, US trade representative (USTR) Robert E. Lighthizer wrote to commerce minister Suresh Prabhu and the prime minister’s principal secretary Nripendra Misra that the policy had created serious problems for US stent makers in India. He also urged India not to extend caps to other devices. The matter was also discussed during Prime Minister Narendra Modi’s visit to Washington in June.

In September, American medical device makers asked USTR to suspend or withdraw India’s benefits under the Generalized System of Preferences (GSP) to counter India’s decision to fix retail prices of various medical devices. Under GSP, Indian exports to the US enjoy lower import tariffs compared to those imposed on non-GSP exporters.