Maharashtra FDA asks Centre to cap prices of ‘overcharged’ catheters

Mumbai city news: The state FDA Department of Pharmaceuticals asking them to add catheters to National List of Essential Medicines and thereby cap their prices.

Hospitals, distributors, manufacturers and importers of balloon and guiding catheters earn exorbitant profits by forging price tags, revealed a recent Maharashtra food and drugs administration’s (FDA) investigation. Food and Drugs Administration officials wrote to Department of Pharmaceuticals asking them to add catheters to National List of Essential Medicines and thereby cap their prices.

FDA officials conducted the enquiry in phases, starting from cost to patient to landing cost of the product. (HT)

Catheters are medical devices used in angioplasties to clear obstructions or dilate a narrowed canals, ducts or blood vessels. The maximum retail price of balloon catheters ranges from Rs20,000 to Rs28,000 and guiding catheters cost between Rs5,000 and Rs10,500.

“We found that importers, distributors and hospitals earn a huge profit after inflating the MRP by putting false tags. They charge the patients a little less to show they are giving them a discount, when in fact, they are overcharging them,” said Dr Harshdeep Kamble, FDA commissioner.

FDA officials conducted the enquiry in phases, starting from cost to patient to landing cost of the product and what it cost the distributor.

Over 12 hospitals from Mumbai, Vashi, Thane, Aurangabad, Pune and Nagpur were questioned in the probe. The supply chains of six balloon catheter brands and four guiding catheter brands were studied.

“There is an urgent need to bring statutory provisions so that there will be fixed profit margins in the supply chain of catheters based on its import or manufacturing cost. The NPPA may include all types of balloon and guiding catheters and other related medical devices in
NLEM under the drug prices control order since these are
lifesaving drugs and devices,” recommended Dr Kamble in the letter.

Manufacturers and importers earn a profit of between 17% and 120% on balloon catheters and 3% to 154% on guiding catheters . Meanwhile, distributors make anywhere from 20% to 211% on balloon catheters and 64% to 119% on guiding catheters.

Hospitals make a 25% to 472% profit on the sale of balloon catheters and 50%-529% on guiding catheters.

The FDA’s investigation followed a complaint filed by Society for Awareness of Civil Rights. RPY Rao, president of the NGO, said, “The issue surfaced in January when the metrology department pulled up a multinational company involved in importing stents for forging the MRP stickers and confiscated the stock.”

He added that a south Mumbai hospital had also found the anomaly but didn’t take up the matter as they had already charged the patients the inflated rates.

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