State launches surprise inspections at blood banks after FDA crackdown

The State Blood Transfusion Council (SBTC) carried out surprise inspections between July 17 and 19 in Pune, Solapur, Nashik, Mumbai city and the Mumbai suburbs

A week after the Food and Drug Administration (FDA) suspended the licence of Pune’s Metro Blood Bank and initiated action against nine other blood centres in the district over serious violations, the Maharashtra public health department has launched a statewide surprise inspection drive to tighten oversight of blood banks.

The drive follows its June 27 directive after FDA inspections exposed serious lapses at several government and blood centres. (REPRESENTATIVE PIC)

The State Blood Transfusion Council (SBTC) carried out surprise inspections between July 17 and 19 in Pune, Solapur, Nashik, Mumbai city and the Mumbai suburbs. The drive follows its June 27 directive after FDA inspections exposed serious lapses at several government and private blood centres.

Since blood is classified as a drug under the Drugs and Cosmetics Act, 1940, authorities said strict compliance with norms governing its collection, processing, storage and distribution is mandatory to ensure patient safety.

Three-member teams comprising two medical officers and a finance department official are auditing blood centres. In some districts, National Health Mission officials have replaced finance officers.

The audits cover blood collection and utilisation, transfer of blood components to other states, plasma supplied to fractionation units, compliance with National Blood Transfusion Council guidelines, real-time updates on the e-RaktKosh portal, display of processing charges, availability of qualified technical staff, stock audits, blood bag records and grievance handling.

“The inspections are aimed at strengthening the safety, transparency and quality of blood banking services across the state. Any blood centre found violating prescribed norms or showing serious deficiencies will face strict administrative action as per the rules,” the public health department said in a statement.

Officials said reports will be submitted to the SBTC and the FDA for action. Surprise inspections will continue to ensure blood banks maintain prescribed standards and regulatory compliance.

The drive comes days after the FDA suspended Metro Blood Bank’s licence and initiated action against nine other blood centres in Pune district after inspections uncovered serious irregularities, raising concerns over quality control and patient safety, officials said.