Maharashtra Orders Blood Centre Inspections After Two Facilities Closed
The Maharashtra State Blood Transfusion Council (SBTC) has ordered comprehensive inspections of all government and private blood centres across the state. This directive comes days after the Food and Drug Administration (FDA) ordered the closure of the Sir J J Metropolitan Blood Centre in Mumbai and the Maya Blood Centre in Badlapur due to serious regulatory violations.
SBTC Director Dr. Suhas Mohanalkar issued a circular instructing blood transfusion officers to inspect every blood centre under their jurisdiction. The officers must submit quarterly inspection reports to both the SBTC and concerned FDA officials, recommending action against any facilities found violating safety and operational standards.
According to the circular, blood is classified as a "drug" under the Drugs and Cosmetics Act, 1940. This classification makes compliance with standards governing its collection, processing, storage, and distribution mandatory.
During the upcoming quarterly inspections, officers are tasked with verifying technical standards, ensuring blood collection matches actual demand, and inspecting the transportation of blood supplied to other states. All such interstate transfers must be reported to the SBTC. The directive also states that blood collection should not exceed the average requirement of the previous three years.
Additionally, the inspections will cover agreements for plasma supplied to fractionators, the updating of daily blood stock on the government's e-Blood Bank portal, and the display of processing charges. Staffing levels, audit records, reconciliation of blood bags, and the disposal of unused or damaged blood bags will also be reviewed alongside customer complaints and actions taken.
Dr. Mohanalkar described the circular as a reiteration of existing norms, emphasizing that regular audits are essential to detect deficiencies before they compromise public safety. He warned that facilities failing to meet the standards set by the National Blood Transfusion Council, the National AIDS Control Organisation, and the FDA could face closure similar to the recent cases.
The inspections were triggered by recent FDA actions against two specific facilities. At Mumbai's Sir J J Metropolitan Blood Centre, inspectors discovered deficiencies in the storage and control of blood components, improper handling of reactive and expired blood bags, malfunctioning equipment, and shortcomings in biomedical waste disposal. At the Maya Blood Centre in Badlapur, inspectors found expired equipment calibration, lack of quality control testing, biomedical waste management irregularities, and missing mandatory approvals for blood donation camps.
