Vijayawada DCA Seizes Rs 20 Lakh Worth of Illegal Medical Devices

Vijayawada: Drugs Control Administration (DCA) officials have seized a large quantity of high-density polyethylene cans containing concentrated acidic solutions, along with packages of sodium bicarbonate and sodium chloride intended for bicarbonate haemodialysis solutions, as well as raw materials, manufacturing, and testing equipment, all valued at Rs 20 lakh. The seizure took place late Tuesday night at the premises of Korra Sunith, proprietor of M/s Biotech Formulations, located at New Auto Nagar in Penamaluru mandal, Krishna district.

According to the DCA authorities, these medical devices were being manufactured and sold in large quantities to various hospitals across the state in violation of Section 18(c) of the Drugs and Cosmetics Act, 1940, in conjunction with the Medical Devices Rules, 2017. The accused had only obtained a temporary registration valid until October 2023 and a test licence, but lacked a valid medical devices manufacturing licence. The seized devices, critical for dialysis and in direct contact with blood, were being produced in unhygienic conditions, within premises covered by asbestos sheets and without the oversight of qualified technical staff.

Authorities have sent two products for analysis and informed the Sixth Metropolitan Magistrate Court in the city about the seizure on Wednesday.