FDA suspends Badlapur and Mumbai blood centres over safety violations
The Maharashtra Food and Drug Administration (FDA) has ordered the immediate suspension of operations at the Maya Blood Centre in Badlapur, Thane, and the Sir J J Metropolitan Blood Centre in Mumbai. The order, issued on Friday, follows a joint inspection that revealed serious regulatory violations that could compromise the safety and quality of blood supplied to patients.
The joint inspection was conducted by the FDA and the Central Drugs Standard Control Organisation (CDSCO) between June 22 and 24. The action was initiated after the FDA received information about alleged violations in blood collection, processing, and distribution at both facilities.
At the Maya Blood Centre in Badlapur, inspectors uncovered numerous deficiencies under Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945. The violations included the absence of mandatory records for transporting blood collected during donation camps, poor traceability of blood bags, and the absence of a blood transfusion officer and other required technical staff.
Furthermore, the Badlapur facility was found operating with expired equipment calibration, a lack of quality control testing, irregularities in biomedical waste management, and missing mandatory approvals and records for blood donation camps.
Meanwhile, the inspection at the Sir J J Metropolitan Blood Centre in Mumbai revealed deficiencies in storage and control systems, improper handling of reactive and expired blood bags, poor disposal of biohazardous material, a failed quality management system, malfunctioning equipment, and missing sterilisation controls.
Due to these findings, the licensing authority ordered both centres to immediately halt all operations, including blood collection, component preparation, testing, storage, distribution, and the organisation of donation camps. The FDA has also issued show-cause notices to both institutions and initiated regulatory proceedings under the Drugs and Cosmetics Act, 1940.
"The Food and Drug Administration will not tolerate any negligence or violation of rules affecting the health of blood donors and patients," FDA Commissioner Tukaram Mundhe said. He warned all blood banks in the state to strictly comply with the law or face stringent regulatory action.
While major tertiary hospitals with their own licensed blood banks are unlikely to be affected, medical officials noted the suspension could impact smaller nursing homes and patients in Mumbai and its suburbs who rely on external blood centres, particularly those requiring regular transfusions for conditions like thalassaemia.
