In a significant crackdown on the illegal production of medical equipment, the Drugs Control Administration (DCA) of Telangana raided the premises of Bluesemi Research & Development Pvt. Ltd in Raidurg, Serilingampally.
Acting on credible intelligence, DCA officials, in collaboration with the Central Drugs Standard Control Organization (CDSCO), executed the operation on Tuesday, February 3. The raid targeted the unauthorized manufacturing and distribution of medical devices within the Ranga Reddy district.
During the operation, authorities uncovered the unlicensed production of a device marketed as the ‘Patient Monitor (EYVA – Electronic Medical Device)’. This product was being sold under the claim that it could monitor vital human parameters. Upon inspection, officials seized a substantial inventory of the devices, alongside user manuals and sale invoices, with the total value of the confiscated goods estimated at Rs. 4 lakhs.
The DCA clarified that medical devices intended for measuring human physiological parameters fall under Risk Class A or Risk Class B categories. According to the Medical Devices Rules of 2017, such products mandatorily require a manufacturing license in Form MD-5. This license is issued specifically by the state's drugs control administration to ensure that the equipment meets stringent safety and operational guidelines. Under the Drugs and Cosmetics Act of 1940, these products must adhere to a strict Quality Management System as outlined in the Fifth Schedule of the Medical Devices Rules.
By bypassing the licensing process, the company allegedly failed to demonstrate that its products comply with the prescribed national standards. Such compliance is essential to ensure that medical readings provided by these devices are accurate and reliable for clinical or home use. The raid was conducted by a specialized team including drug inspectors D. Swetha Bindu and K. Anvesh, along with M. Vikram from the CDSCO Hyderabad Zone.
The operation was carried out under the direct supervision of Anjum Abida, Deputy Director-II, and K. Anil Kumar, Assistant Director of Serilingampally. Following the seizure, officials confirmed that a comprehensive investigation is underway to identify all parties involved in the illegal operation.
Shahnawas Quasim, director general of the DCA, emphasized the grave public health risks associated with unlicensed medical devices. Equipment manufactured without regulatory oversight may fail to meet quality benchmarks, potentially leading to inaccurate health data and endangering lives. Quasim noted that the DCA remains vigilant in its mission to protect the public from substandard or fraudulent medical technologies entering the market. The DG further warned that manufacturing medical devices without a valid license is a serious criminal offense. Under the Drugs and Cosmetics Act, those found guilty of such violations face severe legal consequences, including imprisonment for up to five years. The department has stated that strict action will be taken against the offenders to deter similar unauthorized activities in the future. |