Telangana DCA busts unlicensed medical device manufacturing unit; dialysis kits, sterile eye drapes found at site

Officials from Telangana Drugs Control Administration (DCA) conducted a raid on Mediblue Healthcare Private Limited at the Medical Devices Park in Sultanpur of Sangareddy district, on Tuesday (December 23, 2025) and detected the unlicensed manufacture of medical devices.

During the inspection, the DCA officers found that the company was manufacturing Risk Class B medical devices without obtaining the mandatory manufacturing licence. The products identified included Dialysis Kits (Sterile EO), Sterile Surgical Gowns and Sterile Eye Drapes. Large quantities of these devices, which had been manufactured and stocked for sale, were found at the premises.

Risk Class B medical devices are low-to-moderate risk healthcare products that come into direct contact with patients and therefore require strict quality control. Under the Medical Devices Rules, 2017, they must be manufactured only with a valid licence from the Drugs Control Administration, as defects can pose risks to patient safety. As the unit was operating without the required approval, stocks valued at ₹1.70 lakh were seized during the raid.

DCA officials stated that further investigation is underway and that action will be taken against all those involved, in accordance with the law. “Manufacturing medical devices without the requisite licence is a punishable offence under the Drugs and Cosmetics Act, carrying a penalty of imprisonment of up to 5 years,” as per a press release.