The government based its decision on a sub-committee report that recommended putting all types of stents, including the latest biodegradable stents, onto the list.
“The sub-committee has submitted its report to the government and after examination of the report, the government of India has accepted the recommendations of the sub-committee," a notification issued in the name K.L. Sharma, joint secretary, ministry of health and family welfare (MoHFW) said.
“The government of India further decided that the recommendations of the sub-committee with regard to the inclusion of the coronary stents in the NLEM 2015 will be operational with immediate effect," the notification added.
The sub-committee of expert cardiologists was constituted by MoHFW – in October 2015 under the chairmanship of Prof. Y.K. Gupta, head, department of pharmacology, All India Institute of Medical Sciences (AIIMS) to examine the issues relating to the essentiality of coronary stents and recommend whether the coronary stents should be included in the NLEM.
The committee held broad deliberations with different stakeholders, including stent manufacturers and patient groups, before recommending inclusion of coronary stents in the NLEM. It took into account the high burden of coronary heart disease in the country and the enormous need of percutaneous coronary intervention or angioplasty with stent.
Medicines and devices listed in the NLEM must be sold at the price fixed by National Pharmaceutical Pricing Authority (NPPA), while those in the non-scheduled list are allowed a maximum annual price hike of 10%.
Drugs outside price control can be sold at prices set by the manufacturer.
The medical devices industry said the inclusion of stents in the NLEM and the consequent price cap could stop manufacturers from introducing technologically advanced stents in India.
“The quality of products and clinical outcomes do not seem to have been given a priority," said the Advanced Medical Technology Association (AdvaMed), an international lobby group for the medical devices industry in a statement.
“Singular focus on capping prices of stents by way of their inclusion in NLEM will not help improve access to medical devices for patients, as it will not impact the overall procedure cost and limit the introduction of innovative products," Advamed added.
“The government’s move to include stents in the National list of essential medicines is contradictory to its recent efforts to press forward with legislation that would create separate and appropriate legislations for medical devices," said Himanshu Baid, chairman of the Confederation of Indian Industry (CII) Medical Technology Division.
Baid said in response to the government’s call, CII members have already submitted their proposals for voluntary price reduction to the health ministry and other departments enabling access of “value stent" at CGHS prices below ₹ 25,000 to all patients and many companies have already reduced prices of their good quality stents as proposed in by the CII.
“A price control on the nascent medical devices sector at this stage does not bode well in creating a conducive environment for FDI, realizing Make in India or investment in R&D, both of which are required for growth of this sector," Baid added.
A stent is a tiny expandable metal scaffold to open up narrowed or weakened arteries to prevent chest pains and reduce chances of a cardiac arrest. The procedure of placing the stent in an artery is called angioplasty. The cost of angioplasty is around ₹ 200,000-250,000 on average in a private hospital, depending on the complexity of the case, number of stents and types used. A bare metal stent on average costs about ₹ 10,000- ₹ 20,000, while a drug eluting stent (DES) ranges between ₹ 25,000- ₹ 80,000.
According to the sub-committee report around 25% of deaths in India is attributed to Cardiovascular disease (CVD) Coronary artery disease (CAD) is the commonest CVD accounting for 90-95% of all CVD cases and deaths.
In India, only about 3 out of 1000 coronary heart disease needy patients are treated with angioplasty compared to 32 in the US. As per the National Interventional Council (NIC) Registry data in 2015 a total of 3,53,346 angioplasties were performed and 4,73,000 stents were implanted in India.
“Hence there is an obvious and enormous need of PCI (or angioplasty) in India which is unmet as of now," the sub-committee contended in its reported.
About 60% of the market for stents is shared by multinational companies such as Abbott, Medtronics, Meril Lifesciences and Boston Scientific.
India’s coronary stents market was valued at $481 million in 2015, and is expected to reach $531 million in revenues by 2016-end.