State Drugs Controller,
Food and Drugs Administration (FDA) Haryana.
Email ID: tanejamanmohan19@gmail.com
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Last Updated on May 27, 2023 by The Health Master
Operation of Blood Storage Centres
Operation of Whole Human Blood and / or its Components for Blood Storage Centres
Guidelines & Approval Pathway for Operation of Whole Human Blood and/or its Components for Blood Storage Centres
Introduction:
G.S.R. 909(E) dated 20.12.2001 exempted Blood Storage Centres run by FRU, CHCs, PHCs or a hospital etc. from the purview of obtaining license for operation.
Schedule-K:
Above notification has been inserted in Schedule-K of Drugs & Cosmetics Rules, 1945 under serial no. 5B.
Objective:
To make abundant availability of Whole Human Blood and its components
Scope:
This exemption is applicable to those centres which are transfusing blood and/or its components less than 2000 units per year.
Who Can Sponsor:
Duly licensed Blood Banks run by:
- Govt. Blood Bank
- Indian Red Cross Society Blood Bank
- Regional Blood Transfusion Centre (RBTC)
Suggested Quantities of Blood Units at Storage Centres:
A, B, O (+ve) – 5 units each
AB (+ve) – 2 units
A, B, O (-ve) – 1 unit each
Requirements as per NACO Guidelines & Schedule-K:
As per Schedule-K of Drugs & Cosmetics Rules following are the requirements for Blood Storage Centres:-
- Space – 10 sq. mtrs
- Technical Staff – 01 Medical Officer, 01 Lab Technician
(both should be trained) - Electricity – 24 hours regular supply with generator backup
- Equipments – Refrigerator with capacity of 50 units, Insulated
- Carriers with ice-packs, Deep Freezer,
- Microscope, Centrifuge Reagents
- Disinfectants
- Approval Pathway
Procedure
Application with sponsorship letter from licensed Blood Bank alongwith relevant documents as per NACO guidelines to State Licensing Authority (SLA)
Inspection of Blood Storage Centre by officers under control of SLA to verify facilities as per Schedule-K
Inspection of Blood Bank who has sponsored
Verify spare quantity of blood units and
Mode of shippers
Submission of report by concerned officers
Certificate of approval by SLA on NACO’s prescribed format
Validity:
Two years from the date of issue.
Renewal must be applied before 3 months of expiry
List of SOPs used in Blood Centres
List of SOPs used in Blood Centres, click the link below to download:
List of SOPs used in Blood Centres
NACO Guidelines
NACO – Guidelines for Setting up Blood Storage Centres 2007
NACO – Guidelines for Setting up Blood Storage Centres 2007
Notifications
G.S.R. 909E dt 20-12-2001 Blood Storage Centre
G.S.R.-909E-dt-20-12-2001-Blood-Storage-Centre
For notifications of Blood Bank / Centre, click below link:
Notifications – Blood Bank / Centre
Latest Notifications: Blood Centre / Bank
Blood Centre (Bank) – requirements at a glance
FAQs – on Blood Bank / Centre (Part-1)
FAQs – on Blood Bank / Centre (Part-2)
FAQs – on Blood Bank / Centre (Part-3)
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