Maharashtra Seeks Status Of All Blood Storage Units After FDA Crackdown On Regulatory Violations

Mumbai, October 6, 2026: In the wake of regulatory violations detected at blood centres across Maharashtra, the State Blood Transfusion Council (SBTC) has now sought details of all functional and non-functional Blood Storage Units (BSUs) attached to blood centres in the state.

In a letter dated September 30, the SBTC directed all blood centre heads and district blood transfusion officers to submit details of operational and non-operational blood storage units within three days. Officials have also been asked to provide copies of the licences of the respective storage units.

FDA Enforcement Actions

The directive assumes significance following a series of enforcement actions by the Maharashtra Food and Drug Administration (FDA) against blood centres for violations of statutory norms.

As reported by The Free Press Journal in July, the FDA had suspended the licences of 34 blood centres and blood storage facilities and permanently cancelled four licences between April and June 2026. The action followed inspections that found violations relating to quality, records and licensing requirements.

In June, the FDA had also suspended operations at Sir J.J. Metropolitan Blood Centre in Mumbai and Maya Blood Centre in Badlapur after inspections uncovered serious regulatory lapses.

The violations included deficiencies in blood and component storage and control, handling of reactive and expired blood bags, biomedical waste disposal and equipment-related shortcomings.

Statewide Compliance Order

The FDA subsequently issued a statewide compliance order covering blood collection, testing, storage, labelling, quality control, biomedical waste management, transportation and cold-chain maintenance. The SBTC had also ordered inspections of government and private blood centres following the FDA action.

The latest exercise specifically seeks to establish how many blood storage units are actually functional. Centres without any attached storage unit have been asked to submit a Nil report.

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Updated Database Of Storage Units

The move could provide the state with an updated database of licensed storage facilities and help identify units that remain licensed but are non-operational, particularly amid concerns over blood availability and regulatory compliance.

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