Maharashtra FDA Issues First Statewide Compliance Order For Blood Centres, Warns Of Strict Action
· Free Press Journal
Mumbai: In a first-of-its-kind move, the Maharashtra Food and Drug Administration (FDA) has issued a comprehensive compliance order for all licensed blood centres and blood storage centres across the state, prescribing uniform standards for blood collection, testing, storage and distribution while warning of strict legal action against facilities violating statutory norms.
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Order Follows Inspections Revealing Regulatory Violations
The order follows inspections of several blood centres that revealed non-compliance with provisions under the Drugs and Cosmetics Rules, 1945, prompting the regulator to standardise implementation across Maharashtra. Human blood and its components are classified as a "drug" under the Drugs and Cosmetics Act, 1940, making compliance with licensing and operational norms mandatory.
In the last week of June 2026, FDA had suspended all operations at Sir J.J. Metropolitan Blood Centre, Mumbai, and Maya Blood Centre, Badlapur (Thane) after an inspection uncovered serious violations of blood banking regulations.
Guidelines Cover Collection, Testing, Storage And Distribution
The compliance order lays down detailed guidelines covering infrastructure, appointment of qualified medical and technical staff, donor selection, mandatory screening of every blood unit for HIV, Hepatitis B, Hepatitis C, Syphilis and Malaria, blood component preparation, storage, labelling, quality control, biomedical waste management, transportation and maintenance of the cold chain. Blood centres have also been directed to conduct regular self-audits and update blood stock details daily on the e-RaktKosh portal. There are 410 blood banks including private ones in the state.
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The FDA has instructed all licensed blood centres to immediately review their existing systems and implement necessary corrective measures. Non-compliance with the order will invite strict action under the Drugs and Cosmetics Act and Rules.
FDA Commissioner Tukaram Mundhe said the objective of the order is to ensure uniform standards, transparency and regulatory compliance across all blood centres in the state. "Every blood donor and every patient has the right to receive safe, quality-assured and reliable blood and blood components. Through this comprehensive order, we aim to strengthen blood safety and ensure consistent compliance across Maharashtra," he said.
Officials said the order is the first statewide compliance framework issued specifically for blood centres and blood storage centres, with the aim of improving patient safety and strengthening oversight of blood banking services.
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