Against the backdrop of overpricing of cardiac and drug-eluting stents by manufacturers and importers across the state, Maharashtra Food and Drug Administration (FDA) has sent a set of recommendations recently to the National Pharmaceutical Pricing Authority (NPPA) to bring it under price control.
Medical devices including drug eluting stents (DES) are notified as drugs under the Drugs and Cosmetics Act, 1940 but is not included under the Drug Price Control Order (DPCO). Therefore, prices of medical devices like stents cannot be monitored and controlled as of today.
State FDA has found that prices of such medical devices notified as "drugs" have increased significantly in the recent past based on the studies carried out across the state.
Studies have revealed that manufacturers in connivance with importers, distributors and hospitals are fixing the maximum retail price (MRP) of medical devices like drug eluting stent arbitrarily which is then passed on to the gullible patients.
It was also observed that the MRP of the imported drug eluting stents are exorbitantly high and patients have no option to bargain in such a scenario. FDA, therefore, has also recommended that in order to monitor and control the prices of medical device, the term medical device should be included under the new DPCO regime.
The MRP of a DES is fixed by the importing company. As the manufacturers of these devices are located overseas, it is difficult to study the manufacturing cost and export prices of these devices. Besides this, the startling fact is that the cost of a medical device like DES is immediately recovered from the patients but payments to the distributors are made after a period of 60 to 120 days. The payments of applicable taxes of the concerned sale transactions, to the state government are made only within 51 days by the distributors.
The study showed that in one such case of profiteering, DES imported at a price of Rs. 40,710 and having MRP of Rs. 1,50,000 was sold to a Mumbai based distributor at a price of Rs. 73, 440. The said distributor sold this stent to a leading private hospital at a price of Rs. 1,13,400 and the patient ended up paying a price of Rs. 1,19,070.
It was observed that patients were being forced to pay double or even triple the price for medical devices at hospitals. As most of these are not available in the open market, patients can't check prices and are held hostage by the hospitals, which force them to buy at the price they quote. However, experts opine that having an MRP has not prevented profiteering in medicines, with the MRP being fixed high enough to accommodate commissions since there is no limit on what the MRP can be.
Alarmed by unusual spikes in prices of cardiac stents and drug-eluting stents, NPPA had also sought pricing data from manufacturers, importers and distributors of these devices.
NPPA has also reminded the companies that since such medical devices are under non-scheduled drug category, their prices can be increased only up to 10 per cent of MRP annually. Those who have charged beyond this have to reduce it to the level of 10 per cent of MRP for the next 12 months.
Further, Para 25 of DPCO, 2013 provides that every manufacturer /importer shall issue a price list and supplementary price list in Form V to the dealer, State Drugs Controller and the Government from time to time.