Blood bank compliance in India
Caresoft BBMS keeps the records Indian blood banks are inspected on: Drugs and Cosmetics Rules Schedule F Part XII-B registers, NBTC and NACO monthly figures, NABH quality indicators, haemovigilance forms and eRaktKosh exports, with consent records for the DPDP Act. Software supports compliance; the licence holder remains responsible.
Which requirements does BBMS support, and how?
| Requirement | How BBMS supports it |
|---|---|
| Drugs and Cosmetics Rules, Schedule F Part XII-B | Registers for donors, collection, testing, components, issue and discard; licence details on labels and slips |
| NBTC and NACO guidelines | Donor eligibility thresholds, TTI testing, component QC parameters, monthly summary report |
| NABH blood bank standards | Quality indicators, transfusion reaction records, audit trail, SOP control and CAPA (Enterprise) |
| Haemovigilance Programme of India | Transfusion reaction and donor reaction forms with medical officer review |
| eRaktKosh | Stock and donation export in the required format; direct sync planned once access is issued |
| ABDM | ABHA number captured for donors and patients |
| DPDP Act 2023 | Recorded consent for contact, opt-out from every message, confidential deferral reasons |
| ISBT 128 | Donation numbers, product codes and labels in the Enterprise edition |
Questions people ask
Is Caresoft BBMS certified by a regulator?
Blood bank software is not licensed separately in India; the blood bank holds the licence. BBMS is built to support the records and checks inspectors ask for. The company, Caresoft Systems, is CMMI Level 5 and ISO 27001 certified.
See it with your own stock and workflow
A 30-minute demo walks through donor to bedside, the safety stops, and how BBMS connects to your HIS.