Officials found large quantities of the monitors manufactured and stocked for sale without a valid licence. User manuals and sale invoices were also seized.
HYDERABAD: The Drugs Control Administration (DCA), Telangana, has busted the unlicensed manufacture and sale of medical devices at Bluesemi Research and Development, Raidurg, Serilingampally, Ranga Reddy district. Stocks worth about ₹4 lakh were seized during a raid conducted on February 3, 2026.
Acting on credible information, DCA officials, along with officers from the Central Drugs Standard Control Organisation (CDSCO), carried out a surprise inspection and detected the illegal manufacture and distribution of a medical device named Patient Monitor (EYVA – Electronic Medical Device), claimed to be used for monitoring human vital parameters.
Officials found large quantities of the monitors manufactured and stocked for sale without a valid licence. User manuals and sale invoices were also seized.
According to the DCA, medical devices falling under Risk Class A (sterile and measuring) and Risk Class B categories mandatorily require a manufacturing licence in Form MD-5, issued by the Drugs Control Administration. The seized product is classified as a medical device under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
Authorities stressed that such devices must be manufactured only under a valid licence and in strict compliance with Quality Management System requirements prescribed under the Fifth Schedule of the Medical Devices Rules, 2017. Products must also meet prescribed standards under the rules.
The DCA warned that medical devices manufactured without a licence may not meet quality standards and could pose serious risks to public health. Manufacturing without the required licence is a punishable offence under the Drugs and Cosmetics Act, carrying imprisonment of up to five years.
Officials said further investigation is underway and strict legal action will be taken against all those involved in the illegal activity.
