The Maharashtra Food and Drug Administration (FDA) has stepped up its scrutiny of blood and blood storage centres, issuing a state-wide compliance order aimed at strengthening patient safety and ensuring uniform adherence to regulatory requirements.
Under the directive, every blood bag must undergo mandatory testing for HIV, Hepatitis B, Hepatitis C, syphilis and malaria before it is cleared for use.
The move follows recent inspections that uncovered serious regulatory violations at blood centres, prompting the FDA to tighten compliance requirements across the state.
ALSO READ: Licence Cancelled: Tukaram Mundhe-Led FDA Cracks Down on Pune's Inducare Pharma
As part of the new measures, blood centres have also been directed to conduct regular self-audits and ensure that their records on the e-RaktKosh portal are updated daily. The FDA has warned that facilities failing to comply with the directives could face strict legal action.
FDA Commissioner Tukaram Mundhe has cautioned blood centres against lapses in following the prescribed safety and testing protocols, underscoring the need for strict compliance to protect patients receiving transfusions.
The order marks the Maharashtra FDA's first such state-wide, stringent compliance directive covering blood and blood storage centres, according to the department.
The testing requirements are intended to ensure that blood units are screened for major transfusion-transmissible infections before they reach patients, while regular audits and daily digital reporting are expected to improve monitoring and accountability across blood centres.
ALSO READ: Tukaram Mundhe's Big Warning To Pharmacists Amid Rising Antimicrobial Resistance
On Thursday, August 6, 2026 Tukaram Mundhe-led Maharashtra's Food and Drug Administration (FDA) permanently cancelled Ayurvedic drug manufacturing licence of Pune-based Inducare Pharma Pvt. Ltd.
The action was taken for violations of Good Manufacturing Practices (GMP) and the provisions of the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.
Earlier, the FDA in a statememt said that the regulator has already begun suspending licences of errant pharmacies, warning that the regulator would "come after you heavily if we see something wrong."
According to media reports, Tukuaram said that antibiotics being given out without prescriptions was a huge concern, and that pharmacists found selling such drugs without valid prescriptions would not be spared.
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