NPPA struggles to get pricing data from medical devices firms

Efforts by the National Pharmaceutical Pricing Authority (NPPA) to get pricing data on medical devices has met with little success although a recent study by the Maharashtra Food and Drug Authority has found that the prices of imported medical devices can be effectively brought down to check local prices.

NPPA's instructions to companies to provide data about medical devices - notified as 'Drugs' under the Drug Price Control Order, 2013 - manufactured, imported or marketed by them has yielded only partial responses from a majority of the companies.

''All companies whose names are mentioned in the annexures are requested to take urgent action within 7 days of issue of this letter and furnish the complete updated information as indicated in the annexures,'' NPPA's notification, issued two weeks earlier, states.

However, of the 25 companies that the NPPA had sought information from, only six have responded with a complete data set.

Also, most of the responses received from the companies either did not conform to the required format, or did not have the soft copy of the data sought, or had certain data missing from key segments.

Meanwhile, an FDA study, based on an extensive survey covering hospitals in Pune, Nashik and Mumbai, has found that it is possible to bring imported cardiac stents and drug eluting stents (DES) under price control.

In a report to the NPPA, the FDA has cited case studies wherein the margins of these products can be brought down by up to 30 per cent or more to make it affordable at the point of care.

NPPA officials said they are still waiting for complete responses despite repeated reminders. ''We are compiling data on the information we have received so far and are looking at our next step,'' said an official.

This comes at a time when the government is in advanced stages of framing a policy on medical devices as part of its mandate to make medical devices affordable through an effective and rationale pricing policy.

While medical devices, including DES, have been notified as drugs under the Drugs and Cosmetics Act, 1940, the union health ministry has recently accepted the recommendations of an expert panel constituted to examine the issues relating to the essentiality of coronary stents and has decided to include coronary stents in the National List of Essential Medicines (NLEM) with immediate effect.

FDA study has found that importers, distributors and hospitals are fixing the MRP of medical devices arbitrarily which is then passed on to the gullible patients. It was observed that the maximum retail price (MRP) of imported DES is at least two to three times higher and patients are given no option to bargain at the hospitals surveyed across Maharashtra.

The MRP of 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.

Also, it was noted that the cost of DES is immediately recovered from the patients although payments to the distributors are made after a period of 60 to 120 days. Distributors make payments of applicable taxes of the sale transactions to the state government only within 51 days.

While MRP is mandatory on everything manufactured in India, many devices are imported and escape this stipulation. In most hospitals, if two devices are more or less equal, the choice of which one is used depends on which fetches the hospital a bigger cut.

The health ministry had earlier constituted a core committee under the chairmanship of Dr VM Katoch, former secretary, Department of Health Research and director general, ICMR for reviewing and revising the NLEM, 2011 in the context of the contemporary knowledge of the use of therapeutic products.