Maharashtra FDA Suspends Metro Blood Bank Licence Over Multiple Regulatory Violations

According to a recent media report in The Hindustan Times, the action forms part of a broader enforcement drive undertaken by the Maharashtra FDA, during which 10 blood centres in Pune district had their licences suspended between April and June 2026—the highest number recorded in the state during the period.

Metro Blood Bank, which obtained licences from the Central Drugs Standard Control Organisation (CDSCO) and the Maharashtra FDA in September 2023 after a prolonged approval process, serves as one of the major blood component separation centres catering to healthcare institutions across Pune district.

During the inspection, FDA officials observed that the approved technical supervisor had resigned in March 2025, yet blood component separation activities allegedly continued without the appointment of an approved replacement. The inspection further revealed deficiencies including incomplete blood component documentation, non-performance of mandatory sterility testing on 1% of platelet apheresis units processed in 2025, use of uncoded blood bags, and autoclaving procedures carried out without temperature-recording facilities.

The regulatory action extended beyond Metro Blood Bank. Across Maharashtra, the FDA initiated enforcement measures against 23 blood centres and 15 blood storage centres between April and June 2026. During this period, licences of 21 blood centres were suspended and two were cancelled, while 13 blood storage centres faced suspension and two storage centre licences were cancelled.

Among the suspended blood centres, 10 were located in Pune district, including facilities at Dehu Road, Mangalwar Peth, Shirur, Rasta Peth, and Metro Blood Bank at Aundh District Hospital. Blood storage centres situated at Vishrantwadi, Lohegaon, Uruli Kanchan, Daund, Junnar, and Shivajinagar were also subjected to regulatory suspension.

Established under the State Blood Transfusion Council, Metro Blood Bank was conceptualised in 2012 as Pune's central "mother blood bank" and commenced operations after receiving regulatory approvals in September 2023. The facility supplies a range of blood components, including packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate, to hospitals throughout Pune district.

FDA Commissioner Tukaram Mundhe reaffirmed the department's commitment to strengthening regulatory oversight of blood centres and blood storage facilities across the state.

While reiterating the importance of maintaining high standards in blood banking services, FDA Commissioner Tukaram Mundhe told HT, “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.”