Mediblue Healthcare caught manufacturing medical devices without licence, stocks worth Rs 1.70 lakhs seized
Telangana: Drugs Control Administration, Telangana, has busted the unlicensed manufacturing of Medical Devices at Mediblue Healthcare and stocks worth Rs. 1.70 lakhs were seized during the raid.
Acting on credible information, the officials conducted a raid at the company located at M- 59, Medical Devices Park, Sultanpur, Sangareddy District, on 23rd December 2025.
During the raid, DCA officers detected the unlicensed manufacturing of Risk Class B Medical Devices, including Dialysis Kits (Sterile EO), Sterile Surgical Gowns, and Sterile Eye Drapes.
Huge stocks of these medical devices, manufactured and stocked for sale, were detected by the officers.
Risk Class B medical devices, including Dialysis Kits (Sterile EO), Sterile Surgical Gowns, and Sterile Eye Drapes, mandatorily require a medical device manufacturing licence in Form MD-5, issued by the Drugs Control Administration, Telangana.
The said products are classified as Medical Devices 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.
Sri T. Praveen Kumar, Drugs Inspector, Bollaram; Sri G. Srikanth, Drugs Inspector, Jinnaram; Sri M. Varaprasad, Drugs Inspector, Pashamylaram; and Sri N. Ravikiran Reddy, Drugs Inspector, Sangareddy, were among the officers who carried out the raid under the supervision of Sri K. Dass, Deputy Director, Nizamabad, and Sri P. Ramu, Assistant Director, Patancheru.
Further investigation will be conducted, and action will be taken in accordance with the law against all offenders involved.
Medical Devices of 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 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.
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