3 weeks ago
Maharashtra FDA Issues First Statewide Compliance Order For Blood Centres
The food and drug safety group in Maharashtra, India, has made new rules for blood banks.
Blood banks are special places that collect and store blood to help sick or injured people.
The new rules tell blood banks how to collect, test, keep, and share blood safely.
Every bag of donated blood must be checked for HIV, Hepatitis B, Hepatitis C, Syphilis, and Malaria.
The rules were made because some blood banks were not following the old rules.
Two blood banks were even shut down for a while in late June because they broke the rules.
Now every blood bank must check its own work and fix any problems right away.
Blood banks also have to update their blood supply information every day on a computer system called e-RaktKosh.
The leader of the safety group said patients and donors deserve safe, good-quality blood.
Blood banks that do not follow the rules could get in serious trouble.
Maharashtra's FDA issued its first statewide compliance order for all licensed blood centres and blood storage centres.
The order prescribes uniform standards for blood collection, testing, storage and distribution and warns of strict legal action for violations.
It follows inspections that revealed non-compliance with the Drugs and Cosmetics Rules, 1945.
Every blood unit must be screened for HIV, Hepatitis B, Hepatitis C, Syphilis and Malaria, with stock updated daily on the e-RaktKosh portal.
In the last week of June 2026, the FDA suspended Sir J.J. Metropolitan Blood Centre in Mumbai and Maya Blood Centre in Badlapur (Thane) for serious violations.
- Who
- Maharashtra Food and Drug Administration (FDA), led by FDA Commissioner Tukaram Mundhe
- What
- Issued the first statewide compliance order setting uniform standards for blood collection, testing, storage and distribution at all licensed blood centres
- Where
- Maharashtra, India, including suspended centres in Mumbai and Badlapur (Thane)
- When
- Announced on Friday, August 7, 2026, after inspections in the last week of June 2026 revealed serious violations at two centres
- Why
- To strengthen blood safety, ensure uniform standards, transparency and regulatory compliance, and protect patients and donors
Key facts
- Regulator
- Maharashtra Food and Drug Administration (FDA)
- Order scope
- First statewide compliance order for all licensed blood centres and blood storage centres
- Blood banks in state
- 410 including private ones
- Legal framework
- Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945
- Mandatory screening
- HIV, Hepatitis B, Hepatitis C, Syphilis and Malaria for every blood unit
- Suspended centres (June 2026)
- Sir J.J. Metropolitan Blood Centre, Mumbai; Maya Blood Centre, Badlapur (Thane)
- Stock reporting
- Daily updates on the e-RaktKosh portal
- FDA Commissioner
- Tukaram Mundhe
Quotes
Tukaram Mundhe
Commissioner, Maharashtra Food and Drug Administration
“"Every blood donor and every patient has the right to receive safe, quality‑assured and reliable blood and blood components. Through this comprehensive order, we aim to strengthen blood safety and ensure consistent compliance across Maharashtra."”
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