Karnataka drugs control dept all set for monitoring stent prices across hospitals in state
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Nandita Vijay, Bengaluru
February 25 , 2017
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Karnataka drugs control department has decided to closely monitor the
coronary stent pricing in all the hospitals in the state. Its
enforcement team will make surprise inspections to hospitals to review
the billing and ensure the stents are priced as per the Drug Prices
Control Order (DPCO), 2013.
There is no specific cell to monitor
stent pricing and all officers in the drugs control department will now
need to take up this responsibility. “We will keep a close watch on the
price charged by the hospitals. This will be for the two stents. These
are the Bare Metal Stents (BMS), with new pricing of Rs.7,260 and Drug Eluting stents (DES), costing at Rs.29,600”, BT Khanapure, Karnataka Drugs Controller, told Pharmabiz.
“Even
though we have not received any communication from DCGI on this, we
need to abide this going by the Government of India notification on the
same”, he added.
“We have 63 inspectors and all of them will be
on the job. In addition, it will also include all senior officers in the
drugs control department”, said Karnataka drugs controller Khanapure.
The
National Pharmaceutical Pricing Authority has 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 will be effective from its notification on February 14, 2017.
Last
week Union minister for chemicals & fertilizers and Parliamentary
Affairs, Shri Ananthkumar said in Bengaluru the notification for fixing
the ceiling prices of coronary stents, would bring down the cost by
about 85 per cent.
The move by the government is decisive action
on the unethical margins charged at each stage in the supply chain of
coronary stents, noted the Minister.
Violations or deviations by
manufacturers and hospitals from the defined norm will attract
cancellation of respective licenses and will be subject to criminal
charge. The excess cost charged will have to be returned to the buyer at
an interest rate of 15 per cent, said minister Kumar.
According
to Dr. BR Jagashetty, former National Adviser (Drugs Control) to MoHFW
& CDSCO and former Karnataka drugs controller, there is no need for a
separate cell to monitor the pricing of the stents.
Vide S.O No.
1468 (E) dated. 6.10.2005, cardiac stents and drug eluting stents have
been included and considered as ‘drugs’ under Section 3 (b) (iv) of
Drugs and Cosmetics Act, 1940. Later the Government of India in the
Ministry of Health and Family Welfare included coronary stents in the
National List of Essential Medicines2015 by notification No
X-11035/344/2015-DFQC dated July 19, 2016 and then in the Ministry of
Chemicals and Fertilizers, Department of Pharmaceuticals, by
notification No. S.O. 4100 (E) dated December 21, 2016 has incorporated
coronary stents at serial no. 31 of Schedule I of the DPCO, 2013 and
therefore, Coronary Stents are ‘scheduled formulations’ under the
provisions of this order. Considering all facts & in view of
extraordinary circumstances, under paragraph 19 of the DPCO, 2013, vide
S.O. No. 412(E) dated February 13, 2017 the Government of India, in
public interest, notified the ceiling prices, exclusive of local tax
applicable, if any, for Coronary Stents.
“Therefore, whichever
authority has been empowered to monitor the prices of drugs in the
country will have to monitor the prices of stents also. As far as
Karnataka is concerned, the state drugs control department is mandated
to verify and observe the prices of stents also unless some other
authority has been empowered in this regard,” said Dr. Jagashetty.
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