August 11, 2026
Blood Centre Licensing Inspection Checklist
Keep the licence, staff, testing, traceability and Schedule F records ready for a drug inspector, with NABH assessment evidence indexed separately.
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Compliance & Accreditation
NABH, NBTC and Drugs & Cosmetics Act requirements for Indian blood centres, and how to be ready when an inspector arrives.
About Compliance & Accreditation
A blood centre in India answers to more than one authority at once. The licence itself sits under the Drugs and Cosmetics Act rules, renewed on Form 27-C against Rule 122G; the technical standards come from the National Blood Transfusion Council; the state council wants its own periodic return; eRaktKosh wants collection and stock data at the national level; and NABH, if you are accredited or working towards it, wants performance indicators that have to be calculated from the same records.
Almost none of that is difficult in principle. It becomes difficult because the same facts are wanted in several different shapes, on several different schedules, and a centre keeping registers by hand ends up compiling each one separately from the others. That is where the discrepancies come from that an assessor finds — not from anyone being careless, but from the same event being written down four times.
The articles here go through the records themselves: what a deferral record has to preserve so it still works when the donor comes back, what a cold-chain excursion record needs for someone to reconstruct it afterwards, how long each register has to be retained, and what licence renewal actually involves.