3 months ago
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A portion manufacturing aesculapian devices — marketed arsenic a ‘Patient Monitor (EYVA – Electronic Medical Device)’ and claimed to way quality captious parameters — has been seized by the Telangana Drugs Control Administration (DCA) aft officials recovered the devices were manufactured and sold without a valid licence successful Hyderabad’s Raidurg area.
Acting connected information, the DCA officials, on with officers of the Central Drugs Standard Control Organisation (CDSCO) Hyderabad Zone, conducted a raid connected Tuesday (February 3, 2026) astatine Bluesemi Research and Development Private Limited. During the inspection, they detected the unlicensed manufacture and merchantability of the diligent monitoring device. Stocks worthy ₹4 lakh, which were manufactured and stocked for sale, were seized from the premises. User manuals and merchantability invoices were besides seized arsenic portion of the operation.
The officials said further probe is nether mode and enactment volition beryllium initiated against those liable successful accordance with the law.
The officials warned that manufacturing aesculapian devices without a valid licence is simply a punishable offence nether the Drugs and Cosmetics Act, carrying imprisonment of up to 5 years.
The DCA stated that nether the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, aesculapian devices intended for measuring parameters falling nether Risk Class A oregon Risk Class B categories indispensable beryllium manufactured nether a valid licence successful Form MD-5 issued by the Telangana Drugs Control Administration. Such devices are besides required to comply with the Quality Management System requirements laid down successful the Fifth Schedule of the Medical Devices Rules and conscionable the prescribed merchandise standards.
