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

Mumbai, October 6, 2026 - The State Blood Transfusion Council (SBTC) in Maharashtra has requested comprehensive information on all Blood Storage Units (BSUs) associated with blood centres across the state following regulatory breaches identified by the Maharashtra Food and Drug Administration (FDA). A directive issued on September 30 granted blood centre heads and district blood transfusion officers three days to provide details of both operational and non-operational BSUs, along with copies of the associated licenses.

The FDA's recent enforcement actions, which included suspending 34 blood centres and permanently canceling four licenses between April and June 2026, prompted the SBTC's move. Inspections conducted by the FDA in June revealed serious violations concerning blood and component storage, handling of reactive and expired blood bags, biomedical waste disposal, and equipment shortcomings.

Following these findings, the FDA imposed a statewide compliance order covering blood collection, testing, storage, labeling, quality control, biomedical waste management, transportation, and cold-chain maintenance. The SBTC's latest exercise aims to determine the number of functional BSUs, with non-functional centres required to submit a Nil report.

This initiative could lead to an updated database of licensed storage facilities, particularly addressing concerns over blood availability and regulatory adherence.