FDA moves NPPA to bring down prices of overpriced cardiac stents

Medical devices firms have been directed to submit pricing details after the Food and Drugs Administration (FDA) in Maharashtra wrote a letter to the National Pharmaceutical Pricing Authority (NPPA) on the need to regulate high prices of cardiac stents.

FDA acted following complaints by consumers and doctors who wanted the NPPA to crack down on profiteering in the medical devices industry, particularly cardiac stents.

A recent FDA survey has found that the MRPs of stents are inflated by a staggering 300 to 700 per cent, as distributors, doctors and hospitals add huge profit margins on them.

The survey found that distributors on an average earn about 125 per cent profit. "Even the profit margin earned by the hospitals is about 125 per cent. 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.

The FDA, however, has little power to regulate prices and it has written to the regulator, the National Pharmaceutical Pricing Authority (NPPA), to bring stents under essential medicines and thereby control the prices of these life-saving devices.

A statement issued by the FDA pointed to the several complaints it received 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) M M Pawar," said FDA commissioner Dr Harshadeep Kamble.

Earlier attempts to do so have met with little success. A senior hospital administrator in South Mumbai, however, says the rot runs much deeper - meaning it is an organised affair.

"What the survey has missed out is the involvement of cardiologists in the entire chain. Most senior cardiologists have more say than hospital managements when it comes to buying stents from vendors. In fact, we get a requisition slip once the surgery is over and the stent has been used," he says, adding that any attempt to break the nexus often leads to friction between the doctor and the hospital management.

The practice also extends to orthopaedic implants, ocular lenses and several other devices.

Suresh Shetty, public health minister in the erstwhile Congress government in Maharashtra, had pointed to the rot, saying it was too complex an industry.

"It is a complex Rs800-crore industry, which is completely unregulated," The Times of India quoted him as saying.

Yet, the health ministry during his tenure had managed to offer drug-eluting stents at record low prices of Rs23,000 each under the Rajiv Gandhi Jeevandayee Arogya Yojana (RGJAY), which were sold in the market at Rs90,000 or more.

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."