Dombivli stockist under FDA scanner for catheter

A stockist from Dombivli is under the scanner of the Food and Drug Administration (FDA) for stocking guiding catheters, that are used during angioplasty procedures, without proper documentation.

When FDA inspected the premises of Parshavnath stockist they found two batches of guiding catheters.

"The stockist told us that he had purchased them from Era Life Sciences in New Delhi. But Era said they had not sold this stockist the product. The catheters belonged to Johnson & Johnson. The company, too, said that of the two confiscated batches, one was never manufactured by them," said a source at FDA.

Another FDA official explained that there could be several irregularities in this case. "A patient could have been charged for the catheter which was never used for his operation and it could be an attempt to resell it in another city. They could also have either illegally been imported or procured without proper billing," the official said.

On Wednesday the FDA sent a report to the National Pharmaceutical and Pricing Authority (NPPA) asking them to reign in the prices of the catheter. Profit margin earned by the hospital for a balloon catheter is between 24 to 472 per cent, and for guiding catheter was between 50 and 529 per cent.

At the moment the stockist has been booked under section 18 C of the Drugs and Cosmetic Act, 1940 that deals with the manufacture, sale or distribution of any drug or class of drugs not of standard quality.