FDA Keeps Strict Vigil on Blood Centers: Comprehensive ‘Compliance Order’ Issued in Maharashtra for the First Time

Strict Legal Action Warned for Violations

Mumbai, August 7: In a major initiative to ensure blood safety, maintain blood quality, and protect patient interests across the state, the Food and Drug Administration (FDA) has taken a significant step. For the first time, a comprehensive ‘Compliance Order’ has been issued for all licensed blood centers and blood storage units in Maharashtra. Under these new directives, a strict standard operating procedure has been established for every stage, right from blood collection to its distribution, along with a firm warning of stringent legal action against centers that violate the rules.

The Food and Drug Administration clarified that human blood and blood components are classified as ‘drugs’ under the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Consequently, collecting, storing, or distributing blood without a valid license will be treated as a serious offense.

The decision was prompted by inspections of several blood centers across the state, during which the FDA observed that conditions specified under Schedule ‘F’ (Part 12-B) of the Drugs and Cosmetics Rules were not being fully complied with. To ensure uniform standards and transparency across the state, this new regulatory framework has been enforced. Moving forward, every blood center must mandatorily possess adequate infrastructure, a counseling room, a quality control department, and qualified medical officers, technicians, and nurses.

Under the strict criteria set for blood testing and storage, every collected blood bag must undergo mandatory testing for infectious diseases such as HIV, Hepatitis B and C, Syphilis, and Malaria. Blood and its components must be stored at prescribed temperatures to preserve the cold chain, and a dedicated ‘quarantine’ area must be maintained for suspected blood bags. Furthermore, blood centers are required to regularly update real-time information regarding blood stock, blood donation drives, and safe transportation on the e-RaktKosh portal.

“Access to safe, quality, and reliable healthcare is a fundamental right of every citizen. It is the administration’s responsibility to ensure that everyone, from blood donors to patients in need, receives superior service. This order will establish uniform quality, transparency, and legal discipline across the state,” said Tukaram Mundhe, Commissioner, Food and Drug Administration.