Maha FDA asks DCGI to include balloon catheters and guiding catheters under NLEM
The Maharashtra Food and Drug Administration
(FDA) has urged the Drug Controller General of India (DCGI) and the National
Pharmaceutical Pricing Authority (NPPA) to include balloon catheters and
guiding catheters under National List of Essential Medicines (NLEM) as was done
for coronary stents. The Maharashtra FDA has submitted a study report to the
DCGI in this regard.
While a coronary stent is a small metal mesh tube that is
surgically embedded in blocked coronary arteries, various accessories like
balloon catheter and guiding catheters are used during the procedure to ease
the pathway for flow of blood.
Following complaints received by the drug pricing watchdog
NPPA that hospitals had increased the prices of balloons and catheters after
the capping of stent prices in February 2017, a government constituted panel
had recommended that the accessories also be classified as essential drugs,
bringing them under price control.
Says a senior FDA official, “Recommendations from Maharashtra
FDA has been sent. At present the matter is under consideration of the NLEM
committee.”
The NPPA had earlier requested the ministry to classify
balloons and cardiac catheters as drugs and include them in the NLEM. This
would ensure that the benefits of stent price reduction could be passed on to
the people. Former NPPA chairman Bhupinder Singh had written a letter to health
secretary CK Mishra in this regard.
In the letter, NPPA stated that “it had been found that after
the price control of cardiac stents, several hospitals have increased the
various procedure charges in order to compensate for their losses. NPPA has
also found some specific complaints that several hospitals have increased the
prices of balloons and the cardiac catheters which have not been included in
NLEM, 2015.
In some cases, the cost of balloons and catheters have been
charged at a much higher level than the cost of stent itself. This situation
needs immediate intervention by ministry of health by declaring balloons,
cardiac catheters, covered stents and peripheral stents as drugs and also to be
notified under NLEM, 2015.
It is learnt that the standard practice followed in hospitals
is that consumables like guide wire and balloon are not covered by the cost of
the stent. So they are billed separately. During an angioplasty procedure, a
number of different peripherals are used like guiding catheters, balloons,
inflators and stents.
As of today, 23 categories of medical devices are regulated
which cover around 400 medical devices amongst the 5,000 odd unregulated
medical devices in the country.
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