NPPA to revisit its notification on fixing ceiling prices of coronary stents
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Ramesh Shankar, Mumbai
November 14 , 2017
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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.
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