Mumbai: The Maharashtra Food and Drug Administration (FDA) on Friday issued an immediate “stop work” order for the state’s largest blood bank — JJ Mahanagar Blood Bank, located within the JJ Hospital complex in Byculla — for serious blood safety violations. A private facility, Maya Blood Centre in Badlapur, has also been sealed.Although demand for blood typically rises during the monsoon because of diseases such as dengue and malaria, authorities said allowing the Mahanagar Blood Bank — collects over 20,000 units annually — to function would endanger patients given the extent of lapses.A joint inspection by the FDA and the Central Drugs Standard Control Organisation (CDSCO) between June 22 and 24 found multiple violations of the Drugs and Cosmetics Act and Rules governing blood banks. “Our inspection uncovered serious violations that could jeopardise patient safety,” said a senior FDA official. Show-cause notices have been issued to both centres.At the Mahanagar Blood Bank, inspectors found deficiencies in the storage and handling of blood and blood components. “We also found improper disposal of blood bags, defective equipment and inadequate sterilisation in the blood component production unit,” said officials.At Maya Blood Centre, inspectors found missing records of blood collected during donation camps, gaps in blood bag traceability, shortage of technical staff, poorly calibrated equipment, inadequate quality testing and irregular biomedical waste management.FDA Commissioner Tukaram Mundhe said the deficiencies compromised the quality, safety and efficacy of blood and blood products. “This could not only pose a risk to patients but also undermine confidence in the voluntary blood donation system,” he said.A senior physician, however, cautioned that the prolonged closure of the state’s largest blood bank could strain supplies during the monsoon. “Scientific storage is non-negotiable, but compliance must be restored quickly as demand for blood and blood components will rise,” the doctor said.Public health activists maintained that the FDA action addresses only part of the problem. “The real issue is corruption,” one activist alleged. “Six units of blood dispatched from JJ Mahanagar Blood Bank to Ulhasnagar Civil Hospital never reached their destination. Where did they go?” State Blood Transfusion Council (SBTC) has also initiated an inquiry, but its director, Dr Suhas Mohnalkar, was unavailable for comment. A doctor familiar with govt blood bank operations also questioned discrepancies between the number of blood bags procured and those accounted for.Established in 2009 by the state public health department to help economically weaker patients, the Mahanagar Blood Bank functions under the SBTC, though it is not attached to JJ Hospital (apart from sharing its campus). An FDA official said the SBTC outsourced its operations to a non-profit organisation that failed to maintain statutory standards. Further action will depend on the blood banks’ replies to the show-cause notices.
