Maharashtra Orders Statewide Blood Bank Inspection Drive After FDA Crackdown On Safety Violations

Mumbai, June 29: Days after the Maharashtra Food and Drug Administration (FDA), under Commissioner Tukaram Munde, suspended the licences of JJ Mahanagar Blood Bank, Mumbai, and Maya Blood Centre, Badlapur (Thane), and initiated action against another blood centre over serious violations of blood safety norms, the State Blood Transfusion Council (SBTC) has ordered an immediate statewide inspection of all government and private blood centres.

The FDA's action exposed major deficiencies in blood banking practices and appears to have prompted the SBTC to initiate a comprehensive compliance drive across Maharashtra.

Significantly, the action against the JJ Mahanagar Blood Bank, which functions under the administrative oversight of the SBTC, has raised questions over regulatory monitoring, forcing the Council to tighten surveillance of blood centres across the state.

Statewide Inspection Ordered

In a circular issued by Assistant Director Dr Suhas Mohanalkar, with the approval of the Director of Health Services and Director of the SBTC, all Deputy Directors of Health Services, Deans of Government Medical Colleges, Civil Surgeons and the Director of Public Health, BMC, have been directed to immediately inspect every blood centre under their jurisdiction.

The circular mandates Blood Transfusion Officers to verify compliance with the Drugs and Cosmetics Act, 1940, and Schedule F, Part XII-B of the Drugs and Cosmetics Rules. Inspections will focus on whether blood collection is based on actual requirements, bulk transfer of blood to other states, rates charged for plasma supplied to fractionators, updating of blood stocks on the e-RaktKosh portal, display of approved processing charges, availability of qualified technical staff, blood stock audits, reconciliation of blood bags and review of complaints received by blood centres.

Reports To Be Submitted Quarterly

The SBTC has also instructed that quarterly inspection reports be submitted to both the Council and the FDA. Where violations are detected, proposals for regulatory action against the concerned blood centres must be forwarded to the SBTC and the Food and Drug Administration.

The circular further states that the listed inspection points are only indicative, and Blood Transfusion Officers are expected to use their professional expertise to identify any additional deficiencies affecting the quality, safety and transparency of blood services.

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The statewide inspection order signals a significant regulatory tightening following the FDA's enforcement action, with authorities now seeking to identify systemic lapses, strengthen oversight and ensure strict compliance with blood banking standards across Maharashtra.

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