The Drugs Control Administration (DCA) of Telangana has uncovered an unlicensed medical device manufacturing and distribution operation in the Ranga Reddy district, leading to the seizure of products and supporting materials valued at Rs 4 lakh. The action was taken after officials received credible information about illegal activity at a facility in Raidurg, Serilingampally.

During the raid on February 3, authorities from the Telangana DCA, acting alongside inspectors from the Central Drugs Standard Control Organisation, found that the company was manufacturing and selling patient monitors without a valid licence. The devices, identified as “Patient Monitor (EYVA – Electronic Medical Device)”, are intended to track human vital parameters. A significant stock of the devices, together with user manuals and sales invoices, was seized during the operation.

Under Indian regulations, medical devices that measure physiological parameters and fall under Risk Class A or Risk Class B categories must be produced under a valid medical device manufacturing licence, known as Form MD-5, issued by the relevant state authority. Such devices are regulated under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017, and must comply with prescribed quality management system requirements and product standards.

Officials emphasised that manufacturing or selling medical devices without the required licence not only violates statutory requirements but may also pose risks to public health. The DCA noted that further investigations are underway, and legal action will be pursued against all individuals and entities involved in the unlicensed activity.

The operation highlights ongoing enforcement efforts by regulatory authorities in Telangana to ensure compliance with medical device laws, protect patient safety and uphold industry standards. In recent months, the DCA has undertaken a range of actions to clamp down on illegal drug and device manufacturing, strengthening monitoring and compliance across the state’s healthcare supply chain.