The Maharashtra Food and Drug Administration (FDA) has started a probe into charges levied by hospitals on catheters and balloons used in angiography for cardiac patients after it came to learn of some irregularities in pricing and use of these devices.
“Now we are looking at other medical devices used in angiography like balloons and catheters. What happens is that these devices are being used multiple times. For example, hospitals would use one catheter on 10 patients and would charge afresh to every patient. Ideally, you can use it one or two times, then discard it,” Harshdeep Kamble, commissioner of the state FDA, said.
The state regulator, which was the first to send a report on overcharging of coronary stents to the health ministry in 2015, is working to bring down overall hospitalisation costs for patients.
On 13 February, the National Pharmaceutical Pricing Authority (NPPA), slashed prices of coronary stents by up to 85%.
Maharashtra FDA is regularly monitoring whether stent manufacturers and hospitals are abiding by NPPA’s order, Kamble said.
After the crackdown on prices of stents, regulators have been looking at pricing, supply and quality of other medical devices.
Maharashtra FDA recently conducted raids across the state and seized orthopaedic implants worth Rs8 crore that were being sold by manufacturers and wholesalers who did not have a valid licence, Kamble said.
“Orthopaedic implants are not regulated as of now, doctors give certain measurements and companies, some of them are local workshops, they design and manufacture it as per the requirements of doctors. They are supposed to have licences but we noticed that many did not have licences,” he said.
The FDA may take legal action against some orthopaedic implants manufactures, Kamble said, adding that the regulator plans to form guidelines for this industry.
The state FDA has been sanctioned Rs135 crore, of which 60% will be provided by the centre and rest by the state government.
This fund will be used to set up laboratories in Nagpur, Pune and Nashik, regional offices in Pune and Nashik, purchase of laboratory equipments, staff addition and enhancing infrastructure at the head office in Mumbai, Kamble said.