Telangana DCA raids firm for unlicensed medical devices, seizes Rs 4L stock

Telangana's Drugs Control Administration raided Bluesemi Research in Hyderabad, busting the unlicensed manufacturing of medical devices. Officials seized stocks of a "Patient Monitor" device, valued at Rs 4 lakh, during the joint operation with CDSCO.

Drugs Control Administration, Telangana, busted the unlicensed manufacturing and sale/distribution of medical devices at Bluesemi Research and Development Pvt Ltd., Raidurg, Serilingampally, Ranga Reddy district. Stocks worth Rs 4 lakhs were seized during the raid, a Drug Control official from Telangana state said.

"Drugs Control Administration, Telangana officials, acting on credible information, conducted a raid on February 3, 2026 at Bluesemi Research & Development Pvt. Ltd., located in Raidurg, Serilingampally, Ranga Reddy District, Telangana, along with officials of the CDSCO, and detected unlicensed manufacturing and sale/distribution of medical devices," Drug Control official said.

Details of the Seized Medical Device

During the raid, DCA officers detected the unlicensed manufacturing and sale/distribution of the medical device "Patient Monitor (EYVA - Electronic Medical Device)", claimed to be intended for monitoring human vital parameters. A large stock of the medical device, valued at Rs 4 lakh and manufactured and stocked for sale, along with the user manuals and sale invoices, was seized by the officers during the raid.

Violation of Manufacturing Norms

Medical Devices intended for measuring parameters in Risk Class A or Risk Class B categories must hold a medical device manufacturing licence in Form MD-5, issued by the Drugs Control Administration, Telangana.

The said 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. Additionally, the products must comply with the prescribed product standards under the Medical Devices Rules.

D Swetha Bindu Drugs Inspector Gandipet; K Anvesh Drugs Inspector Shabad, of the Drugs Control Administration, Telangana; and M Vikram, Drugs Inspector, CDSCO, Hyderabad Zone, were among the officers who carried out the raid under the supervision of Anjum Abida, Deputy Director-II, and K. Anil Kumar, Assistant Director, Serilingampally.

Further investigation will be conducted, and action will be taken in accordance with the law against all offenders involved. (ANI)

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