With cardiac stent manufacturers failing to submit weekly details of sales and production of the medical devices post-price ceiling, the National Pharmaceutical Pricing Authority (NPPA) on Friday threatened to invoke the Essential Commodities Act for non-compliance of its order.
The country’s drug pricing regulator reminded them to fall in line or face prosecution under relevant provisions of the Essential Commodities Act.
The Department of Pharmaceuticals, under the Chemical and Fertilisers Ministry, had on February 21 directed all the companies manufacturing coronary stents in the country to maintain a record of production/import/supply of the medical gadgets.
They were also asked to submit a weekly report to NPPA and DCGI on coronary stents produced and distributed by them to hospitals.
A NPPA memorandum issued by its Deputy Director Dr R Nihal Pedric said, “It has been found that, the manufactures/importers of coronary stents have not followed the instructions of the Department of Pharmaceuticals so far as no weekly report has been received in NPPA in this regard.
Therefore, all manufactures/importers/marketers of coronary stents are once again directed to follow the direction of the Department of Pharmaceuticals and to submit a weekly report on coronary stents produced and distributed as per the proforma prepared by the authority.”
He also said that the order regarding submission of the details will be valid for six months and NPPA and DCGI will recommend withdrawal or extension as the case may be, two weeks before the expiry of the period.
The NPPA has also directed hospitals/nursing homes/clinics utilising coronary stents to specifically and separately mention the cost of the coronary stent along with its brand name, name of the manufacturer/importer/batch number and other details, if any, in their billing to the patients or their representatives.
The NPPA had notified the ceiling price of coronary stents at Rs 7,260 for bare metal stent and Rs 29,600 for drug-eluting ones.
The regulator has also rejected applications from multinational stent makers Abbott and Medtronic to withdraw their stents from the Indian market over commercial viability concerns.