Maharashtra FDA Shuts Down Two Blood Banks Over Serious Violations

by

Deependra Singh

Maharashtra FDA Shuts Down Two Blood Banks Over Serious Violations

Mumbai, June 26: The Maharashtra Food and Drug Administration (FDA) has ordered the immediate closure of the Sir JJ Municipal Blood Bank in Mumbai and the Maya Blood Center in Badlapur due to serious irregularities in blood collection and distribution. This action follows a joint inspection conducted by state FDA officials and the Central Drugs Standard Control Organization from June 22 to June 24, 2026.

During the inspection, significant deficiencies were identified at the Sir JJ Municipal Blood Bank regarding the storage and control of blood and blood components. The authorities noted negligence in maintaining reactive and expired blood units, inadequate disposal of bio-hazardous materials, flaws in the quality management system, poor maintenance of equipment, and a lack of necessary sterilization controls. These issues were deemed a serious threat to patient safety, prompting further investigations at other facilities that also failed to meet safety standards.

At the Maya Blood Center in Badlapur, inspectors found no records of blood transportation from donation camps. Additionally, there were shortcomings in blood bag traceability, absence of transfusion officers and essential technical staff, expired equipment certifications, neglect of quality control tests, mismanagement of biomedical waste, and lack of necessary permits and records for blood donation camps.

Given these grave deficiencies, the FDA has instructed both institutions to cease all activities related to blood collection, component preparation, testing, storage, distribution, sales, and organizing blood donation camps until further notice. Both facilities have also been issued show-cause notices, and legal proceedings under the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 have been initiated against them.

Maharashtra FDA Commissioner Tukaram Munde emphasized the administration’s commitment to ensuring safe, high-quality, and transparent blood services. He made it clear that any negligence or violation of regulations related to patient and donor safety would not be tolerated under any circumstances.

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