The irregular pricing of cardiac stents have finally made the Food and Drugs Administration to act. The FDA authorities on Tuesday wrote a letter to the National Pharmaecutical Pricing Authority to regulate the high prices of cardiac stents.
The irregular pricing of cardiac stents have finally made the Food and Drugs Administration to act. The FDA authorities on Tuesday wrote a letter to the National Pharmaecutical Pricing Authority to regulate the high prices of cardiac stents.
According to the statement issued by FDA, it has got several complaints from the public and NGOs regarding the overpricing of cardiac stents. "Based on the complaints, our vigilance branch had conducted a detailed enquiry. It was headed by joint commissioner (vigilance) MM Pawar," said Dr Harshadeep Kamble, FDA commissioner.
Kamble said that the enquiry was conducted against major companies importing cardiac stents. He informed that a detailed investigation of six distributors and seven hospitals in Mumbai, Pune and Nashik division was done. "It was found that the MRP itself is exaggerated and it was more than 300-700% of the actual cost of the stents. The enquiry team also found that the profit margin earned by the importing company with respect to its distributors on an average is about 120%," said Kamble.
The enquiry committee found that the average profit margin earned by distributors is about 125%. "Even the profit margin earned by the hospitals is about 125%. Due to such a exorbitant MRP, it was clear that the importing company, distributor and hospitals, are minting huge profits at the expense of patients," Kamble said.
Since angioplasty, the interventional heart procedure, is a life-saving emergency procedure, the administration has submitted its report to NPAA and urged it to take required steps to regulate the prices.
"Prices of the cardiac stents need to be regulated under Essential Commodities Act. We have asked the NPPA to list cardiac stents under national list of essential medicines under the drugs price control order as it is a life-saving drugs. We have also asked the NPPA to fix the profit margin for importing companies, distributors and hospitals."
In 2011 too, the state's FDA had written to the Drug Controller of India that life-saving medical devices like stents, pacemakers, orthopedic implants among other things, should be included in the Drug Price Control Order (DPCO). In 2014, the NPPA had sought pricing data from the manufacturers, importers and distributors of cardiac stents, drug-eluting stents and orthopaedic implants.
Dr Prafulla Kerkar, head of cardiology department at KEM Hospital, said, "It is a welcome move and will benefit many patients." Kerkar, who was part of the pricing of the stents for Rajiv Gandhi Jeevandayee Yojna, a state insurance policy, said, "For RGJY, we get a stent manufactured by MNC which is US FDA and drug regulatory body of Europe approved. The stent price for us under the scheme is approximately Rs25,000. Same stent is available in certain private hospitals at four times the price we get."
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