Telangana DCA, CDSCO Raid Bluesemi R&D, Seize Unlicensed Patient Monitors

New Delhi: In a worrying indication of regulatory violations in the medical devices sector, the Drugs Control Administration (DCA), Telangana, has busted an unlicensed manufacturing and sale operation involving patient monitoring devices at Bluesemi Research and Development, Raidurg, Serilingampally, Ranga Reddy district.

The raid, conducted on February 3, 2026, resulted in the seizure of medical devices worth approximately Rs 4 lakh.

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

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. Huge stocks of the said medical device, worth Rs. 4 lakhs, manufactured and stocked for sale, along with the user manuals and sale invoices, were seized by the officers during the raid.

The device was claimed to be intended for monitoring vital human parameters, placing it squarely within the regulated medical device framework.

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.

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 said products must comply with the prescribed product standards under the Medical Devices Rules, as mandated.

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

According to regulators, medical devices of Risk Class A (Sterile and Measuring) and Risk Class B can only be manufactured under a license issued by the Drugs Control Administration, Telangana, in compliance with the standards prescribed under the Drugs and Cosmetics Act and the Medical Devices Rules.

Medical devices manufactured without a license may not meet quality standards, and these products may pose serious risks to public health.

"Manufacturing medical devices without a license is punishable under the Drugs and Cosmetics Act, with imprisonment of up to five years." the drug regulator highlighted.

Furthermore, the Government of Telangana Drugs Control Administration stated, "The public may report any complaints regarding illegal activities related to medicines, as well as any other suspected manufacturing activities concerning drugs, including narcotic drugs and psychotropic substances, in residential, commercial, or industrial areas through the Drugs Control Administration, Telangana Toll-Free Number 1800-599-6969, operational from 10:30 am to 5:00 pm on all working days."