Hyderabad: The Drugs Control Administration, Telangana officials, acting on credible information, conducted a raid at Mediblue Healthcare company located at the Medical Devices Park, Sultanpur, Sangareddy district, on Tuesday, and detected unlicensed manufacturing of medical devices.
During the raid, DCA officers detected the unlicensed manufacturing of Risk Class B Medical Devices, including Dialysis Kits (Sterile EO), Sterile Surgical Gowns, and Sterile Eye Drapes. Huge stocks of these medical devices were manufactured and stocked for sale.
“Risk Class B medical devices, including Dialysis Kits (Sterile EO), Sterile Surgical Gowns, and Sterile Eye Drapes, mandatorily require a medical device manufacturing licence in Form MD-5, issued by the Drugs Control Administration, Telangana. DCA officials seized stocks worth Rs. 1.70 lakhs during the raid. The company did not obtain a licence,” said the DCA officials.
The said products are classified as Medical Devices under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, and must mandatorily be manufactured under a ‘Medical Devices Manufacturing Licence,’ issued under the said Act, adhering strictly to the Quality Management System requirements for medical devices as outlined in the Fifth Schedule of the Medical Devices Rules, 2017.
Further investigation will be conducted, and action will be taken in accordance with the law against all offenders involved, added the officials.
