After announcing the price cap on stents three days ago, the National Pharmaceutical Pricing Authority (NPPA) on Thursday stated that some companies are now trying to create artificial shortage of stents in market and state drug controllers should use their search and seizure powers — provided under Drug Price Control Order (DPCO) 2013 — to deal with it.
“It has also been informed to the NPPA that some manufacturers /importers/distributors are trying to create artificial shortage of stents. NPPA has advised all state governments and state drug controllers to proceed under Para 30 of the DPCO, 2013, if required,” the pricing regulator noted on Thursday in one of its office memorandum. Under Para 30 of the DPCO 2013, any designated officer of the government — state or the Centre — can enter any premises and search or seize stents anywhere in the trade channel in order to fully implement the NPPA’s order.
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The NPPA on Monday capped the prices of coronary stents to provide relief to cardiac patients. A stent is a tiny expandable metal scaffold to open up narrowed or blocked arteries. The ceiling price of bare metal stents has been fixed at Rs7,260 per piece and that of drug-eluting stents and biodegradable stents has been fixed at Rs 29,600 per piece.
Meanwhile, the department of pharmaceuticals (DoP), which has also received some reports about shortage of coronary stents in hospitals, wrote separate letters on Thursday to the health secretary, NPPA chairman and the Drug Controller General of India (DCGI). The NPPA works under the DoP.
In its letter to the NPPA chairman, the DoP noted that it might take necessary action under Paragraph 21 of DPCO 2013 to “ensure adequate availability of coronary stents at the earliest”. If any stent manufacturer intends to discontinue any scheduled formulation from the market, Paragraph 21 of the DPCO 2013 states that it has to issue a public notice and also intimate the regulator at least six months before.
The NPPA on Thursday tweeted that it has written to all chief secretaries of the states to ensure “compliance of stents price capping, its availability and uninterrupted cardiac care services”. Moreover, the regulator has also asked the stent manufacturers to provide a report on “price revision compliance along with evidence” by March 1.
“The manufacturers recalling or re-labelling or re-stickering on the label of container or pack of released stocks in the market prior to date of notification (February 13, 2017), shall ensure that adequate stocks are maintained to avoid shortage of such coronary stents. However, it does not mean that revised prices get deferred for the stock in circulation. The price change takes place with immediate effect,” the NPPA stated.