FDA Maharashtra Suspends Operations Of Two Blood Centres Over Serious Regulatory Violations
· Free Press Journal
Mumbai: In a major regulatory action to safeguard public health, the Food and Drug Administration (FDA), Maharashtra, has ordered the immediate suspension of all operations at Sir J.J. Metropolitan Blood Centre, Mumbai, and Maya Blood Centre, Badlapur (Thane) after a joint inspection uncovered serious violations of blood banking regulations.
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The action follows a joint inspection conducted by officials of the FDA Maharashtra and the Central Drugs Standard Control Organisation (CDSCO) between June 22 and 24, 2026. The inspection found multiple violations of the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945, particularly the provisions of Schedule F, Part XII-B, which governs the operation of blood centres.
At Sir J.J. Metropolitan Blood Centre which is located inside the J J Hospital in Byculla, inspectors found deficiencies in the storage and inventory management of blood and blood components, improper handling of reactive and expired blood bags, inadequate biomedical waste disposal practices, failure of the quality management system, malfunctioning equipment, and lack of essential sterilization controls in the blood component preparation unit. Patients of J J Hospital used to get blood and components from this blood bank.
Maya Blood Centre Lacked Traceability and Technical Staff
At Maya Blood Centre, Badlapur, the inspection revealed missing records for the transportation of blood collected through donation camps, deficiencies in blood bag traceability, absence of a Blood Transfusion Officer and other mandatory technical staff, expired equipment validation, lack of quality control testing, irregularities in biomedical waste management, and the absence of required approvals and documentation for blood donation camps.
According to the joint inspection team, these deficiencies could compromise the safety, quality, purity and efficacy of blood and blood components, posing potential risks to both blood donors and patients. The authorities also expressed concern that such lapses undermine transparency and public confidence in the voluntary blood donation system.
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Acting in the interest of public health and patient safety, the FDA Licensing Authority has directed both blood centres to immediately cease all activities until further orders, including blood collection, blood component preparation, testing, storage, distribution, sale, and the organisation of blood donation camps.
FDA Commissioner Tukaram Mundhe said that blood is a life-saving resource and maintaining the highest standards of quality, safety and transparency in its collection, processing and distribution is non-negotiable. He warned that the FDA would not tolerate negligence or regulatory violations affecting patient safety and directed all blood banks in Maharashtra to strictly comply with statutory requirements, failing which stringent action would follow.
The FDA said regulatory proceedings under the Drugs Rules, 1945, have been initiated against both blood centres.
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