Amidst reports from cardiologists and hospitals that manufacturers have withdrawn the latest generation of cardiac stents from city hospitals in the name of re-labelling, NPPA chairman Bhupendra Singh has clarified that manufacturers in a meet recently have assured the drug pricing regulator in writing that proper and consistent supply of latest generation of stents would be made available at the point of care.
Cardiologists rue that bioabsorbable vascular scaffold (BVS)-the fourth generation and the latest in the series is practically unavailable as of now. Distributors have taken it away for relabeling new prices with an assurance to return them to hospitals.
There is also a fear amongst the cardiologists that some of the major MNCs might totally withdraw the latest generation of stents from the Indian market post the price capping exercise of the drug pricing regulator and launch their products in other markets.
In an attempt to dispel ongoing rumours on inconsistent supply of stents at the point of care, Bhupendra Singh said, “Manufacturers have assured us that that stocks will be replenished in the inventories and no withdrawals shall take place. It has been verified that there are sufficient stocks in place and manufacturers are bound to ensure its supplies in a timely manner.”
While some Indian drug makers feel that the indigenously made drug eluting stents can help overcome the current crisis of shortages due to withdrawals on account of relabelling, the government have further clarified that relabelling was not required.
NPPA had put a cap on the prices of bare metal stents - the basic category - at Rs.7,260 and that of more advanced drug-eluting and bioresorbable stents at Rs.29,600. The authority made the move as patients often ended up paying 700 per cent more than the manufacturing cost. The latest version of the drug eluting stents (DES) too has been whisked away from most centres. Both these categories of stents used to be sold for more than Rs.1.5 lakh to Rs.2 lakh before their price was fixed at Rs.29,600.
Cardiac surgeons in the city say centres had to postpone angioplasties because of confusion at the stentmakers' and suppliers' end. An average of over 12,000 angioplasties are carried out in the Mumbai Metropolitan Region every year. Certain hospitals are only left with locally-manufactured stents. The technology available to patients now is the first and second generation of DES that arrived more than two years ago.
Maharashtra Food and Drug Administration (FDA) has also stepped in to carry out an informal survey on compliance of price capping at hospitals and availability of implants. Maharashtra FDA became one of the first state-level bodies to enforce the price regulation of stents, stating any attempt at creating a shortage with be dealt with strongly.
India’s drug pricing regulator has also restricted the margin on cardiac stents for hospitals and distributors to 8 per cent in a move expected to curb profiteering at the expense of heart patients.
The decision elicited a positive response from some domestic stent makers, which had feared they would be forced to beat down prices of stents to satisfy distributors and hospitals seeking to maintain high margins after price controls were imposed. NPPA clarified that hospitals and distributors together have to share a total margin of 8 per cent from the ceiling price of cardiac stents - a steep drop from the margins on the devices before they came under price control.