CDSCO and TGDCA crack down on illegal medical device production in Serilingampally
TGDCA, in coordination with the CDSCO, raided Bluesemi Research and Development Pvt. Ltd. in Raidurg, Rangareddy district, uncovering unlicensed manufacturing and sale of medical devices.
Hyderabad: The inspecting teams of Telangana Drugs Control Administration (TGDCA) conducted a raid at Bluesemi Research and Development Pvt. Ltd., Raidurg, Serilingampally, Rangareddy district and detected unlicensed manufacturing and sale/distribution of medical devices.
During the raids, which were conducted along with officials from Central Drugs Standard Control Organisation (CDSCO) on Tuesday, the drug inspectors detected unlicensed manufacturing and sale/distribution of the medical device “Patient Monitor (EYVA – Electronic Medical Device)”, claimed to be intended for monitoring human vital parameters.
Stocks worth Rs 4 lakh, which were manufactured and stocked for sale along with the user manuals and sale invoices, were seized during the raid.
Medical devices intended for measuring parameters falling under Risk Class A or Risk Class B categories mandatorily require a medical device manufacturing licence in Form MD-5, issued by the Drugs Control Administration, Telangana, Director General, TGDCA, Shahnawaz Qasim in a press release on Wednesday said.
The seized medical product is classified as a medical device 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, TGDCA said.
