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.