Coronary stents sold to patients at exorbitant rates, reveals probe

A six-month-long investigation conducted by Maharashtra’s Food and Drug Administration (FDA) has revealed that life-saving coronary stents are sold to patients at exorbitant rates. Also, hospitals do not allow patients to choose from differently-priced stents available in the market.

A stent is a tube which is used during angioplasty (operation to unblock clogged arteries). FDA’s investigation has shown that imported stents costing Rs 40,000 are sold to patients at Rs 1.25 lakh. In the case of another company, stents costing Rs 25,000 are being sold at Rs 1.5 lakh.

Though Indian-made stents are also available, the investigation was specific to only imported ones. The huge profit is shared among importers, distributers, hospitals and in some cases, doctors.

“Stents are mostly used in emergency situations. Patients’ families do not have the time to enquire about rates and end up paying whatever is being asked,” Maharashtra’s FDA Commissioner Harshadeep Kamble, who led the investigation, said.

The FDA conducted the investigation, the report of which was submitted last Thursday. Probe was conducted against a major medical devices company which deals in cardiac stents, six distributors and seven hospitals in Mumbai, Pune and Nashik regions.

The probe was conducted following complaints by non-governmental organisations (NGOs) which alleged that stents were overpriced.

Huge profit margins

The FDA found that the profit earned by various stakeholders from selling stents often amount to 300-700 per cent. On an average, the profit margin of importing companies, distributors and hospitals remains anything between 120-125 per cent each. The maximum retail price is set high from the very beginning.

However, despite the findings, no legal action can be taken against anyone involved as currently there is no mechanism to regulate the pricing of stents, Kamble added.

Refusing to reveal the names of the companies and the hospitals involved, he said, “We have submitted our findings to the National Pharmaceutical Pricing Authority (NPPA). We have asked NPPA to include stents in the list of essential drugs which will enable it to regulate its prices.”

Cardiac stents fall under the category of medical devices and are labelled as “drugs” under the Drugs and Cosmetics Act, 1940.

Reasonable pricing needed

According to Kamble, stents should be sold at reasonable prices and the profit margin should be kept as low as possible.

“All the three stakeholders can charge up to 20 per cent extra. Thus, stents imported at Rs 40,000 will cost Rs 64,000 to patients.”

Nearly 350,000 stents are sold every year in Maharashtra alone. If the average price of one stent is Rs 1.25 lakh, then it is an industry of over Rs 400 crore, FDA officials told Down To Earth.

“Even if we can save 40 per cent after price regulation, it will go a long way in improving public healthcare,” Kamble said.

Another FDA official said that during investigation, the agency came across certain cases where doctors recommended stents of a particular company to hospitals. “We found doctors lobbying for a particular company and being paid high prices for it. I think hospitals and their staff benefit the most from the existing system,” he said. The official added that catheterisation laboratories in hospitals are funded by stent importers and distributors.

“Establishing such a lab costs around Rs 1-1.5 crore. Companies often pay for them and expect hospitals to buy stents exclusively from them. It is a huge racket and needs strong regulation in place,” the FDA official said.

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