FDA Cracks Down on Blood Banks in Maharashtra; Action Taken Against 38 Centres, Four Licences Permanently Cancelled

Food and Drug Administration suspends 34 licences and permanently revokes four after inspections reveal serious violations of safety and quality standards.

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Mumbai: The Maharashtra Food and Drug Administration (FDA) has launched a major enforcement drive against blood banks and blood storage centres across the state, taking action against 38 institutions during the three-month period from April to June 2026.

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According to the FDA, 34 licences have been suspended while four licences have been permanently cancelled after inspections uncovered serious violations of regulatory norms governing blood collection, storage, testing, and quality management.

The crackdown is aimed at ensuring that patients receive safe, high-quality blood and blood components in accordance with the provisions of the Drugs and Cosmetics Act, 1940, and the rules framed under it.

Maharashtra currently has 413 licensed blood banks and 468 licensed blood storage centres. The FDA conducts both routine and surprise inspections to verify compliance with standards relating to blood collection, component separation, temperature control, quality assurance, trained personnel, record maintenance, and biomedical waste management.

During the inspection drive, authorities suspended the licences of 21 blood banks and 13 blood storage centres, while two blood banks and two blood storage centres had their licences permanently cancelled due to serious non-compliance.

Officials cited multiple violations, including breaches of licence conditions, deficiencies in quality management systems, discrepancies in records, failure to maintain prescribed standards, and violations of the Drugs and Cosmetics Act.

Among the affected institutions were blood banks in Amravati, Washim, Kalyan, Pune, Sangli, Satara, and Shirur. Several blood storage centres in Pune, Thane, Amravati, and Badlapur also faced regulatory action.

The licences of Patil Hospital Blood Storage Centre in Pune and Aadhar Blood Storage Centre in Bhiwandi were permanently cancelled. In Mumbai, the FDA also revoked the licences of Maya Blood Centre and Sir J.J. Metropolitan Blood Centre after inspections reportedly found serious irregularities and violations that could compromise blood safety.

FDA Commissioner Tukaram Mundhe said that blood is a life-saving resource that cannot be manufactured artificially, making strict compliance with safety standards essential. He warned that institutions compromising patient safety for commercial interests would face stringent legal action.

The commissioner further stated that regular and surprise inspections of blood banks and blood storage centres across Maharashtra will continue with greater intensity to safeguard public health and ensure the availability of safe blood for patients suffering from conditions such as thalassemia, haemophilia, cancer, and those requiring emergency surgeries or trauma care.

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