In a major crackdown that has raised serious concerns over patient safety, officials in Telangana busted an unlicensed medical device manufacturing unit operating at the Medical Devices Park in Sangareddy district, seizing illegal stock worth about Rs 1.70 lakh.
The Drugs Control Administration (DCA), Telangana, raided Mediblue Healthcare at Sultanpur on December 23 and found that the company was manufacturing and storing Risk Class B medical devices without the mandatory licence. The seized products were intended for sale, officials said.
During the inspection, authorities discovered the unlicensed manufacture of dialysis kits (sterile EO), sterile surgical gowns and sterile eye drapes. These medical devices are used directly on patients, and any compromise in quality could lead to infections, treatment failure or serious complications, officials said.
Under existing norms, Risk Class B medical devices must be manufactured only under a valid manufacturing licence and in accordance with strict quality management system rules under the Medical Devices Rules, and Devices made without a licence may not meet quality standards and can harm patients, putting public health at serious risk.
