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FDA tells pharma body to regulate prices of cardiac stents

Charging the importers and distributors of cardiac stent of making over 100 per cent profit, Maharashtra's Food and Drug Administration (FDA) today said it has asked the National Pharmaceutical Pricing Authority to regulate its "high prices".

"It has come to FDA's notice that demand for cardiac stents has increased considerably and also the fact that cardiac stents are being exorbitantly priced," FDA Commissioner Harshadeep Kamble said here today.

Cardiac stent
Representational picture

"There were complaints from the public and also from non-governmental organisations (NGOs) regarding overpricing and overcharging of cardiac stents to needy patients," the senior IAS official said.

Based on its inputs, Maharashtra FDA's Vigilance Branch conducted a detailed probe against a major importing company dealing in cardiac stents.

The probe included investigation of six distributors and also involved seven hospitals in Mumbai, Pune and Nasik division, Kamble said.

The enquiry was conducted to know the cost to the importing company, also cost to the distributors, hospitals and cost to the patients vis-a-vis maximum retail price (MRP) of the cardiac stents, he said.

The study revealed that the MRP itself is exaggerated and to the tune of more than 300 to 700 per cent of the actual cost of importing cardiac stents by the importing company, Kamble said.

The profit margin earned by the importing company with respect to its distributors on an average is about 120 per cent and the average profit margin earned by distributors to the hospital is about 125 per cent, he said.

The profit margin earned by hospitals is also about 25 per cent, he said.

Due to such an exorbitantly high MRP, it is clear that importing companies, distributors and hospitals mint huge profits while patients suffer by paying such huge prices, he said.

Since these types of heart related operations are emergency surgeries related to patients' lives, they are left with no choice but to pay high costs, he said.

"Considering all the above facts, I have recommended the NPPA to regulate prices of cardiac stents under the Essential Commodities Act, so that their exorbitant prices can be brought down considerably to help poor patients," he said.

The Maharashtra FDA's main recommendation is that prices of cardiac stents must be brought under the National List of Essential Medicines as well as Drugs Price Control Order, since these are life saving drugs.

"There has to be a fixed profit margin for importing companies, distributors and hospitals. Also, cardiac stents must be brought under National List of Essential Medicines as well as Drugs Price Control Order since these are life saving drugs," he said.

Appropriate directions should be issued in public interest so that reasonable and uniform prices of cardiac stents are maintained throughout India, he said.

Cardiac stents which fall under the medical devices category, are 'drugs' as defined under Drugs and Cosmetics Act, 1940. Therefore, the NPPA can issue these directions, he said.

Maharashtra FDA Minister Girish Bapat is also taking up this issue with the Union Health Minister to expedite this process, he said.

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