Based on an extensive survey covering hospitals in Pune, Nashik and Mumbai, the Maharashtra Food and Drug Administration (FDA) has recently suggested to the drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) to bring imported cardiac stents and drug eluting stents (DES) under price control. For this, the FDA has cited case studies wherein the margins of these products can be brought down significantly even by 30 per cent or more to make it affordable at the point of care.  

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 but 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 has suggested through its study to the NPPA 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 from the studies that the Maximum Retail Price (MRP) of the imported DES is at least two to three times higher and patients are given no option to bargain at the hospitals surveyed across Maharashtra.

It has been observed that 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. Besides this, the cost of 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.

Moreover, 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.