FDA shuts JJ Mahanagar Blood Bank in Byculla and seals Badlapur facility
The Maharashtra Food and Drug Administration (FDA) on Friday issued an immediate "stop work" order for the state's largest blood bank, the JJ Mahanagar Blood Bank located within the JJ Hospital complex in Byculla, Mumbai. Simultaneously, authorities sealed a private facility, the Maya Blood Centre, in Badlapur after a joint inspection revealed severe safety violations.
The crackdown followed a three-day joint inspection conducted from June 22 to June 24 by the FDA and the Central Drugs Standard Control Organisation (CDSCO). The inspection uncovered multiple violations of the Drugs and Cosmetics Act and Rules governing blood banks, prompting officials to issue show-cause notices to both facilities.
At the JJ Mahanagar Blood Bank, which collects over 20,000 units of blood annually, inspectors discovered critical deficiencies in the storage and handling of blood and blood components. The team also found defective equipment, improper disposal of blood bags, and inadequate sterilization in the blood component production unit.
At the Maya Blood Centre in Badlapur, inspectors found missing records of blood collected during donation camps and gaps in blood bag traceability. The private facility also suffered from a shortage of technical staff, poorly calibrated equipment, inadequate quality testing, and irregular biomedical waste management.
FDA Commissioner Tukaram Mundhe stated that the identified deficiencies compromised the quality, safety, and efficacy of blood and blood products. He noted that these lapses could pose a direct risk to patients and undermine public confidence in the voluntary blood donation system.
The suspension of operations comes at a critical time, as the demand for blood typically rises during the monsoon season due to an increase in diseases like dengue and malaria. While a senior physician cautioned that the prolonged closure of the state's largest blood bank could strain local blood supplies, FDA authorities maintained that allowing the facility to function under such conditions would seriously jeopardize patient safety.
The JJ Mahanagar Blood Bank was established in 2009 by the state public health department to assist economically weaker patients. It operates under the State Blood Transfusion Council (SBTC), which outsourced its operations to a non-profit organization. According to an FDA official, the non-profit failed to maintain statutory standards. Further action against both centres will be determined after they respond to the show-cause notices.
