Subsequent to directive to the state drug controllers for auditing hospitals on price capping exercise of cardiac stents post February 14, 2017 notification, drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) is in the process of fast-tracking 300 cases of cardiac stents overcharging in hospitals based on anomalies in medical bills.

“We have observed that in 200 to 300 cases of cardiac stent overcharging, violations were in the form of not mentioning the stent price in the medical bill and billing it as angioplasty charges or cath lab charges, not mentioning brand name and company of the stents in the medical bills and also not mentioning clearly also the batch number and expiry dates of the stents thus misleading the patients and fleecing the patients in a major way,” explained NPPA chairman Bhupendra Singh.  

This comes at a time when cardiac stent manufacturers have raised concern around ensuring consistent supply of latest generation stents on ground of commercial unviability and applied to the drug pricing regulator for its redressal.

While rejecting pleas of Abbott and Medtronic for withdrawing high-end stents from the market, the NPPA has provided an escape clause that the companies can seek regulatory approval to revise prices as per the provisions of the Drug Price Control Order (DPCO) if they can prove superiority of these stents over others.

Abbott had sought permission to withdraw its ‘alpine drug eluting’ stent and ‘absorb dissolving’ stent, while Medtronic had also sought to withdraw its Onyx Zotarolimus eluting stents. Another major multinational stent maker Boston Scientific has already filed an application with NPPA to let it sell some stents in India at “special prices” higher than the mandated ceiling prices.

“The issues that companies raising now are the same issues raised before and they can seek price revision based on certain conditions as per the law of land. There is a legal provision under which there is a method of examining the case and we will do it on case to case basis if it comes to us,” informed Singh.

“Medtronic’s application for the withdrawal of Resolute Onyx was not accepted by the NPPA on the basis of incomplete paperwork. We intend to resubmit the application, and until it is re-submitted and approved we will continue to supply the Resolute Onyx stent in India. All decisions to withdraw or introduce products to the market are made only after taking into consideration all guidelines and norms set by the government and applicable legal and regulatory requirements,” Medtronic said in an email statement.

On 21 February, the government had invoked an emergency clause under the Drug Price Control Order, citing public interest, and asked stent makers to maintain supplies of their products for six months. In a notification on April 26, 2017 the NPPA said during this period no such request from the companies to withdraw their products could be entertained.