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Maharashtra FDA issues strict new rules for blood centres across the state

hellohimachalse@gmail.com 07 Aug 2026 50 min ago

New Delhi: The Maharashtra Food and Drug Administration has issued a fresh compliance order for blood centres and blood storage centres across the state. The directive focuses on blood collection, testing, storage and distribution, with licensed centres asked to follow existing legal and safety requirements more strictly.

The order has been issued under FDA Commissioner Tukaram Mundhe. It applies to licensed blood centres across Maharashtra and refers to provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945.

What changes for blood centres in Maharashtra?

The FDA has said blood cannot be collected, tested, stored or distributed without a valid licence.

Every blood centre must have the required infrastructure and trained staff. This includes doctors, technical supervisors, laboratory technicians, nursing staff and counsellors.

Donor selection rules and deferral guidelines revised in 2020 will have to be followed.

The order has also made testing compulsory for major infections before donated blood can be used.

Blood from every donor must be tested for:

  • HIV
  • Hepatitis B
  • Hepatitis C
  • Syphilis
  • Malaria

Blood storage and cold chain rules get fresh focus

The FDA has asked centres to follow scientific storage standards for blood and blood components.

Cold chain requirements must be maintained, and quarantine arrangements should be available where required.

Blood centres will need to carry out regular self-audits and maintain records in the prescribed format.

These checks matter because blood and its components can be sensitive to storage conditions. Any failure in temperature control or testing can create a direct risk for patients receiving transfusions.

Blood donation camps will face tighter checks

Blood donation camps will also have to meet minimum requirements for equipment, staff and emergency care.

The FDA order says centres organising camps should have trained personnel and proper facilities in place before collecting blood.

Another key requirement concerns e-RaktKosh, the government’s online blood stock platform.

All blood centres have been directed to update their blood stock and related information on the portal every day.

This could help hospitals and patients get a clearer picture of blood availability in different centres.

FDA warns of action for violations

The FDA has warned that blood centres that fail to follow the rules could face legal and administrative action.

Commissioner Tukaram Mundhe said, “Access to safe and quality blood is a fundamental right of every citizen. This order will ensure uniform standards, transparency, quality control, and regulatory compliance across all blood centers in the state, thereby making safe and reliable blood available to every patient.”

The directive puts greater responsibility on blood centres to maintain licences, staff, testing standards, stock records and storage systems.

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