The Maharashtra Food and Drug Administration (FDA) on Friday ordered the immediate suspension of operations at Sir J J Metropolitan Blood Centre in Mumbai and Maya Blood Centre in Thane’s Badlapur, following serious violations of blood bank regulations that could compromise the safety and quality of blood supplied to patients.
The action follows a joint inspection conducted with the Central Drugs Standard Control Organisation (CDSCO) between June 22 and 24, after the FDA received information about alleged violations in blood collection, processing and distribution at the two facilities.
“The Food and Drug Administration will not tolerate any negligence or violation of rules affecting the health of blood donors and patients. All blood banks in the state must strictly comply with the law, failing which stringent regulatory action will follow. We are committed to ensuring that citizens receive safe blood,” FDA Commissioner Tukaram Mundhe said.
Multiple violations
According to the FDA, inspectors found multiple violations of Schedule F, Part XII-B of the Drugs and Cosmetics Rules, 1945, which prescribes mandatory standards for licensing and operating blood banks, including requirements for staffing, donor screening, testing, storage, quality control and record-keeping in India.
Blood is a life-saving substance, and the highest standards of quality, safety and transparency must be maintained in its collection, processing and distribution, Mundhe said.
At the Sir J J Metropolitan Blood Centre, inspectors found deficiencies in the storage and control systems for blood and blood components, improper handling of reactive and expired blood bags, shortcomings in the disposal of biohazardous material, failure of the quality management system, malfunctioning equipment, and the absence of essential sterilisation controls in the blood component preparation section.
“The inspection at Maya Blood Centre in Badlapur revealed the absence of mandatory records relating to the transportation of blood collected during blood donation camps, deficiencies in the traceability of blood bags, the absence of a blood transfusion officer and other required technical staff, expired equipment calibration, lack of quality control testing, irregularities in biomedical waste management, and the absence of mandatory approvals and records for blood donation camps,” FDA officers said.
Putting quality, efficacy of blood at risk
The FDA said the inspection team concluded that these deficiencies could adversely affect the safety, quality, purity and efficacy of blood and blood components, potentially putting both blood donors and recipients at risk. The violations also raised concerns over the transparency of voluntary blood donation and blood distribution systems, it said.
In view of the findings, the licensing authority has ordered both blood centres to immediately suspend all activities, including blood collection, preparation of blood components, testing, storage, distribution, sale of blood, organisation of blood donation camps, and all other operations related to the functioning of the blood banks. The FDA has also issued show-cause notices to both institutions and initiated further regulatory proceedings under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.
Major tertiary hospitals less likely to be hit
However, the suspension of services of the blood banks is less likely to affect major tertiary hospitals, as most of them have their own licensed blood banks.
Dr Tushar Palve, Medical Superintendent, Cama and Albless Hospital, said, “However, it could impact patients in Mumbai and its suburbs who rely on blood supplied by external blood centres, particularly those requiring regular transfusions such as thalassaemia and sickle cell patients. The timing is also a concern because the monsoon season typically brings an increase in dengue and malaria cases, leading to a higher demand for platelets.”
Dr Ajay Suman Haribhau Bhandarwar, Dean, Grant Government Medical College and Sir J J Group of Hospitals, said, “Although the Sir J J Metropolitan Blood Centre is located on the J J Hospital campus, its suspension will not affect patient care at the Sir J J Group of Hospitals because we have our own blood bank. The impact will primarily be felt by smaller hospitals and nursing homes that depend on the Sir J J Metropolitan Blood Centre for blood and blood components.”
Maharashtra Food and Drug Administration received information about alleged violations in blood collection, processing and distribution at the two blood bank facilities in Mumbai and Than. (Photo credit: AI-Generated) 
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