Operation of Blood Storage Centres

Operation of Whole Human Blood and / or its Components for Blood Storage Centres

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Blood Blood Bank Blood donation
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Manmohan Taneja
2 min. read

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

Also read:
1. Bombay Blood Group
2. Why India needs more blood donors: Article

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