Telangana DCA busts unlicensed MedTech unit at Medical Devices Park, Sultanpur; stocks worth Rs 1.70L seized

Hyderabad: Telangana Drugs Control Administration (DCA) busted an unlicensed MedTech manufacturing unit being operated at Mediblue Healthcare Pvt. Ltd in the Medical Devices Park at Sultanpur in Sangareddy district.

The officials also seized stocks worth Rs 1.70 lakh during a raid conducted on December 23.

Raid based on credible information

Acting on specific inputs, DCA officials conducted a surprise inspection at the facility located at Plot No. M-59, where they detected large-scale unlicensed manufacturing and stocking of medical devices intended for sale.

Risk Class-B medical devices found

During the raid, officers found the company manufacturing Risk Class-B medical devices without mandatory approvals. The seized products included Dialysis Kits (Sterile EO), Sterile Surgical Gowns, and Sterile Eye Drapes.

Officials noted that these devices were produced and stored for commercial distribution without obtaining the requisite licence.

Licence mandatory under law

As per the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, Risk Class-B medical devices must be manufactured only under a valid Medical Device Manufacturing Licence (Form MD-5) issued by the DCA.

Such manufacturing units are also required to strictly adhere to Quality Management System norms prescribed under the Fifth Schedule of the Medical Devices Rules, besides complying with notified product standards.

Public health risks and legal action

DCA officials warned that medical devices manufactured without a licence may not meet prescribed quality standards and could pose serious risks to public health.

Manufacturing medical devices without authorisation is a punishable offence under the Drugs and Cosmetics Act, carrying imprisonment of up to five years.

Probe to continue

Authorities said further investigation is underway and stringent action will be taken against all those involved, in accordance with the law.

Public asked to report illegal activities

The DCA has urged the public to report any information or complaints related to illegal manufacturing or sale of drugs and medical devices, including narcotic drugs and psychotropic substances, through its toll-free helpline 1800-599-6969, operational from 10.30 am to 5 pm on all working days.