KOCHI: With National Pharmaceutical Pricing Authority (NPPA) declaring on Thursday that it was working on fixing ceiling prices of stents, the stage is set for moves for cost control in the highly unregulated sector. The decision of the regulator comes close on the heels of the department of pharmaceuticals notifying coronary stents as Schedule-I drug under the Drug Price Control Order (DPCO) 2013. The decision of the department on Wednesday came months after the Union ministry of health and family welfare, in July, included them in the National List of Essential Medicines (NLEM). In the notification, DoP has put ‘bare metal stents and drug-eluting stents (DES), which include metallic, DES and bioresorbable vascular scaffold (BVS)/biodegradable stents" in the Schedule I of DPCO 2013.
However, medical and legal experts say there is still a long way to go in enforcing price control in stents. “The current formula to fix the ceiling price of medicines within the national list of essential medicines would not impact in the case of stents. Currently, the fixation of ceiling price is done on the basis of the simple average of prices of all the brands having one percent share in the market plus the retail margin. This will not work in the case of stents because of two reasons. First, not every manufacturer currently prints MRP. Second, those who print MRP, print it very high between Rs 70,000 to Rs 1,50,000. Therefore applying the current DPCO formula will not result in the ceiling of price at affordable level,” said legal expert K. M. Gopakumar.
“Moreover foreign stent manufacturers are lobbying for the creation of different categories of DES and fix different ceiling prices. This would defeat the purpose of price control by giving a long rope to hospitals and companies to continue their business as usual. Further, there is no evidence based on clinical trials to approve of the different categorisation of DES.” A cardiologist at Kozhikode Government Medical College, Dr Mohanan K. S., while agreeing with these arguments, said that if the prices of stents were lowered a lot of patients who have put off stent implantation would be able to go for it. India's stent market is estimated to be worth around Rs 3,000 crore annually.
