Telangana DCA busts illegal medical device making unit in Ranga Reddy; Rs 4 lakh worth stock seized

Hyderabad: The Drugs Control Administration (DCA), Telangana, has busted an unlicensed medical device manufacturing and distribution unit operating in Raidurg, Serilingampally, Ranga Reddy district.

Stocks worth Rs 4 lakh were seized during a joint raid with Central regulators.

According to an official press note issued by the department, the raid was conducted on February 3 at Bluesemi Research & Development Pvt. Ltd., following credible information about illegal activity.

Unlicensed patient monitors found

Officials found that the firm was engaged in the unlicensed manufacturing and sale/distribution of a medical device identified as ‘Patient Monitor (EYVA – Electronic Medical Device)’, claimed to be intended for monitoring human vital parameters.

During the operation, officers seized large quantities of the devices along with related user manuals and sales invoices. The total value of seized stock was estimated at Rs 4 lakh.

Licence mandatory for risk class A and B devices

DCA stated that medical devices meant for measuring parameters under Risk Class A or Risk Class B categories must be manufactured only under a valid medical device manufacturing licence in Form MD-5, issued by the Drugs Control Administration, Telangana.

The department noted that the seized product falls under the definition of a medical device under the Drugs and Cosmetics Act, 1940 and the Medical Devices Rules, 2017.

As per the rules, such devices must be manufactured under a valid licence and in compliance with Quality Management System requirements for medical devices specified in the Fifth Schedule of the Medical Devices Rules, along with prescribed product standards.

Legal action and public health warning

The DCA said further investigation is underway and action will be taken against all offenders involved as per the law.

The department warned that medical devices manufactured without a licence may not meet required quality standards and may pose risks to public health. It added that manufacturing medical devices without a valid licence is punishable under the Drugs and Cosmetics Act with imprisonment of up to five years.

Public complaint helpline

The Drugs Control Administration has urged the public to report complaints regarding illegal activities related to medicines and suspected unlawful manufacturing of drugs, including narcotic and psychotropic substances, in residential, commercial or industrial areas.

Complaints can be made through the DCA Telangana toll-free number 1800-599-6969, operational from 10:30 am to 5 pm on working days.