CERTIFICATE OF APPROVAL TO BLOOD STORAGE CENTRE FOR STORAGE OF WHOLE HUMAN BLOOD AND* / OR ITS COMPONENTS No._________________________________ Date of Issue _________________________________ M/s ______________________ is hereby approved to store the following items on the premises situated at __________________________________ under the supervision of the following technical staff : 1. Names of the approved medical officer : 2. Names of the items : 3. Name of the qualified Blood Bank Technician : 4. Name & address of the licensed Blood : 5. Bank from whom the blood units would be procured : 6. The approval shall be inforce from to : Dated Signature Designation Licensing Authority CONDITIONS The Blood Storage Centre shall comply with the conditions as stipulated under item 5B of Schedule K of the Drugs and Cosmetics Rules which also includes as under : 1. The captive conception of Whole Human Blood or its components in the above said centre shall not be more than 2000 units annually. 2. In the event of any change in the technical staff shall be forthwith reported to the licensing authority. 3. In the event of any change in the name of the licensed blood bank from whom the blood units are procured, the same shall be intimated to the licensing authority for approval. 4. The centre shall apply for renewal of the approval to the licensing authority three months prior to the date of expiry of the approval. 5. The centre shall maintain records and registers including the details of procurement of blood* / its components. 6. The centre shall store samples of donors' blood as well as patients' sera for a period of 7 days after transfusion. * NA whichever is not applicable.
