FDA officials said the approved technical supervisor at the bank had resigned in March 2025, but blood component separation allegedly continued without an approved replacement.
Pune: The Maharashtra Food and Drug Administration (FDA) has suspended the licence of the Metro Blood Bank at Aundh District Hospital (ADH) after inspections found serious violations in technical supervision, blood component processing, sterility testing and record maintenance, officials said.
The action is part of a wider crackdown in which 10 blood centres in Pune district had their licences suspended between April and June 2026, the highest in Maharashtra, according to the FDA.
The Metro Blood Bank, which received licences from the Central Drugs Standard Control Organisation (CDSCO) and the FDA in September 2023 after a decade-long wait, is a major blood component separation centre serving Pune district.
FDA officials said the approved technical supervisor had resigned in March 2025, but blood component separation allegedly continued without an approved replacement. Inspectors also found missing blood component records, failure to conduct mandatory sterility tests on 1% of platelet apheresis units prepared in 2025, uncoded blood bags and autoclaving without temperature-recording facilities.
Statewide, the FDA took action against 23 blood centres and 15 blood storage centres between April and June. It suspended the licences of 21 blood centres and cancelled two, while 13 blood storage centres were suspended and two licences were cancelled.
Of the 21 blood centres suspended, 10 are in Pune district, including the Metro Blood Bank and centres at Dehu Road, Mangalwar Peth, Shirur and Rasta Peth. Blood storage centres at Vishrantwadi, Lohegaon, Uruli Kanchan, Daund, Junnar and Shivajinagar also faced suspension.
The Metro Blood Bank, conceived in 2012 under the State Blood Transfusion Council as Pune’s “mother blood bank”, began operations after receiving regulatory approval in September 2023. It supplies blood components, including packed red blood cells, platelets, fresh frozen plasma and cryoprecipitate, to hospitals across the district.
FDA commissioner Tukaram Mundhe said the department would continue strict surveillance of blood centres and storage facilities.
“Blood is not an ordinary drug but a life-saving necessity. Providing citizens with safe and quality blood and blood components that meet prescribed standards is the highest responsibility of the FDA. Blood centres and blood storage centres must strictly comply with the Drugs and Cosmetics Act, 1940, and the rules framed under it. The FDA is committed to protecting public health through continuous surveillance and action against centres violating the rules,” Mundhe said.
