Maharashtra FDA issues blood bank compliance order

On August 7, 2026, the India — Maharashtra Food and Drug Administration (FDA) issued a comprehensive compliance order for all licensed blood centres and blood storage facilities across the state, the first such statewide order. The order prescribes uniform procedures for donor selection, blood collection, mandatory testing for HIV, Hepatitis B, Hepatitis C, Syphilis, and Malaria, storage, labelling, record management, quality control, biomedical waste management, and daily updates on the e-RaktKosh portal. It follows inspections that revealed non-compliance with the Drugs and Cosmetics Rules, 1945, and the suspension of operations at Sir J.J. Metropolitan Blood Centre and Maya Blood Centre in late June 2026. FDA Commissioner Tukaram Mundhe stated the order aims to ensure uniform standards, transparency, and regulatory compliance across all blood centres, protecting donors and patients. The order requires centres to appoint qualified staff, implement 2020 donor selection criteria, maintain cold chains, quarantine suspected units, and conduct self-audits. Non-compliance will invite legal action under the Drugs and Cosmetics Act, 1940.