Drug pricing regulator National Pharmaceutical Pricing Authority (NPPA) will soon hold a meeting with medical device manufacturers on helping them to accomplish filing of online data on coronary stents and medical devices in a complete manner in the Integrated Pharmaceutical Database Management System (IPDMS) towards maintaining DPCO compliance and to detect possible circumvention of price caps.
This is subsequent to its exercise of capping prices of drug eluting stents (DES) and Bioresorbable Vascular Scaffold (BVS) stents with effect from February 14, 2017 in the wake of unethical markups in each stage of the supply chain.
“We have adapted the drugs format into devices format and the meeting with manufacturers on February 22, 2017 is meant to get a final view and feedback on what brands and categories can be incorporated towards developing a complete online database as per IPDMS,”NPPA chairman Bhupendra Singh explained.
He further added NPPA is also seeking billing data from insurance companies, hospitals, nursing homes, clinics performing cardiac procedures, medical facilities, including retailers and dealers of stents to ensure benefits of price cap are passed on to the patients and no artificial shortage is created.
This comes at a time when the government is in advanced stages of framing a separate well defined rules on medical devices as part of its mandate to make medical devices affordable through an effective and rationale pricing policy.
The Union health ministry had recently accepted the recommendations of an expert panel constituted to examine the issues relating to the essentiality of coronary stents followed with the inclusion coronary stents in the National List of Essential Medicines (NLEM).
Based on an extensive survey covering hospitals in Pune, Nashik and Mumbai, the Maharashtra Food and Drug Administration (FDA) has also suggested to the drug pricing regulator 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.
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 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.