Pune, April 14, 2025: The Food and Drug Administration (FDA) has intensified its oversight of blood banks and blood storage centers across Pune division, cancelling licenses of 3 units and suspending 48 others over serious safety and legal violations. The enforcement action was part of a comprehensive inspection drive conducted between April 2024 and March 2025.

The Pune division — comprising Pune, Solapur, Satara, Kolhapur, and Sangli districts — witnessed a high concentration of infractions, with Pune district alone accounting for more than 70% of the cases, officials said.

Out of the 205 blood centers and storage units inspected during the year, multiple were found breaching crucial provisions under the Drugs and Cosmetics Act, 1940. According to FDA officials, violations included improper storage of blood products, non-compliance with hygiene standards, unavailability of qualified medical personnel, and failure to maintain required documentation.

Girish Hukare, Joint Commissioner (Drugs), FDA Pune Division, stated, “Ensuring the safety of blood and its components is paramount. These inspections are not just regulatory formalities—they are essential to protect patients who rely on transfusions during emergencies and treatments.”

The FDA emphasized that action was taken only after due process, giving the operators multiple opportunities to present their case. 

This crackdown is part of the FDA’s broader campaign to ensure safe, ethical, and compliant practices in the medical and pharmaceutical sectors. The department reiterated its commitment to upholding public health standards and warned of continued action against defaulters in the coming months.

Action Taken By FDA 

Enforcement Actions