- Law
- Drugs and Cosmetics Act, 1940 and Rules, 1945 — Part X-B and Schedule F Part XII-B
- 2020 change
- G.S.R. 166(E), 11 March 2020: 'Blood Bank' renamed 'Blood Centre'; staffing, equipment and donor criteria revised
- Authorities
- State Licensing Authority and Central Licence Approving Authority (CDSCO)
- Medical officer
- At least one whole-time MBBS medical officer with blood transfusion or pathology qualification or experience
Blood centre or blood storage centre?
A blood centre collects, tests, processes, stores and distributes blood and components. A blood storage centre, usually inside a hospital, stores and issues blood received from a licensed blood centre. Requirements, staffing and approvals differ — the choice depends on your bed strength, surgical volume and whether a licensed blood centre is close enough to supply you reliably.
What licensing involves
Blood centres are licensed under Part X-B of the Drugs and Cosmetics Rules and Schedule F, Part XII-B, by the State Licensing Authority together with the Central Licence Approving Authority (CDSCO). The application and licence forms (Forms 27C and 28C) were updated by the 2020 amendment to refer to blood centres.
Key requirements include:
- Staff — at least one whole-time MBBS medical officer with qualifications or experience in blood transfusion or pathology, plus technical supervisors, technicians and counselling staff as specified
- Accommodation — donor area, laboratories, component room, storage, store-cum-records and a counselling area
- Equipment — cold-chain equipment with calibrated monitoring, testing for transfusion-transmitted infections, calibrated weights and pipettes
- Donor selection — age 18–65 (first-time donors not over 60), intervals of 90 days for men and 120 days for women, haemoglobin at least 12.5 g/dL
- Quality control for every component — packed red cells, platelets, fresh frozen plasma, cryoprecipitate
NABH accreditation for blood centres
NABH runs a dedicated Blood Banks / Blood Centres Accreditation Programme. For hospitals, transfusion safety is also assessed within the hospital standard's care-of-patients chapter. We help with both the licence and the quality system.
Frequently asked questions
Who can apply for a blood centre licence?
Under the 2020 amendment, applications for a blood centre licence may come from government bodies, the Indian Red Cross Society, hospitals, charitable trusts or voluntary organisations. Charitable and voluntary blood centres need approval from the State or UT Blood Transfusion Council.
What changed in the blood bank rules in 2020?
The Drugs and Cosmetics (Second Amendment) Rules, 2020 (G.S.R. 166(E), 11 March 2020) replaced the term 'blood bank' with 'blood centre', redefined it to include collection, apheresis, processing, storage and distribution, and revised staffing, accommodation, equipment, donor criteria and blood component standards.
What are the blood donor criteria under the 2020 rules?
The revised Schedule F sets a donor age of 18 to 65 years, with first-time donors not over 60, donation intervals of 90 days for men and 120 days for women for whole blood, and a minimum haemoglobin of 12.5 g/dL.
Official sources
Fees and rules change. Always confirm on the official page before you apply.
Get a free gap assessment for your facility
Tell us your facility type, bed or chair count and city. Dr. Ashutosh Sharma will tell you which NABH programme fits, what it will cost and how long it will realistically take — before you commit to anything.
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