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NPPA to revisit its notification on fixing ceiling prices of coronary stents

pharmabiz 2017-11-13 08:00:00

As it is almost an year since the National Pharmaceutical Pricing Authority (NPPA) capped the prices of coronary stents in the country, the national drug price regulator is now all set to revisit its notification dated February 13, 2017 fixing the ceiling prices of stents which drew sharp criticism from the manufacturers.

The NPPA has now asked all the domestic stent manufacturers and importers to submit any representation or suggestion on this issue positively by December 31, 2017.

In one of its most controversial decisions in the recent times, the NPPA had fixed the ceiling prices of coronary stents through its notification No.SO 412(E) dated February 13, 2017 which was valid for one year.  The decision needs to be revisited in the month of January-February, 2018. In this regard, the NPPA has already received some representations from different quarters with regard to pricing and other related issues.

As per the notification, the NPPA had fixed the ceiling price of drug eluting stents (DES) and bioresorbable stents at Rs.29,600 and that of bare metal stents at Rs. 7,260. The prices were effective from February 14, 2017.

Earlier, the Department of Pharmaceuticals (DoP) appointed a core committee to look into the issue of bringing coronary stents under price control as a large number of health groups and doctors advocating for ethical healthcare have been seeking urgent intervention of the central government to end the nexus between hospitals, doctors and the industry that was resulting in exorbitant prices of life-saving coronary stents.

The committee examined the issues relating to the essentiality of coronary stents and in its report in April 2016 observed that there is very high incidence of coronary artery disease (CAD) in India associated with high morbidity and mortality; and that CAD has become a major public health problem; and that Percutaneous Coronary Intervention (PCI) procedure requiring coronary stent implantation is an important treatment modality for the management of CAD, and hence coronary stents are ‘essential’ for public health.

In the light of the findings of the committee and its recommendation, the NPPA carried out an exhaustive exercise of consultation with stakeholders for fixing the ceiling price of coronary stents on 4th January 2017, 5th January 2017 and 6th January 2017. The drug regulator considered all available information and data on prices of coronary stents in its 40th authority meeting held on 23rd January 2017. During deliberations, it was found that huge unethical markups are charged at each stage in the supply chain of coronary stents resulting in irrational, restrictive and exorbitant prices in a failed market system driven by information asymmetry between the patient and doctors pushing patients to financial misery and whereas under such extraordinary circumstances, there is an urgent necessity, in public interest, to fix ceiling price of coronary stents to bring respite to patients.

Eventually, the NPPA in its authority meeting held on February 13, 2017, after duly examining in detail and considering all available information/data and all relevant options for price fixation of coronary stents, under present extraordinary circumstances of a failed and exploitative market system, decided that it is immediately necessary to fix ceiling prices of coronary stents, in order to protect public interest.