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Application for Renewal of licence for the operation of a Blood Bank for processing of whole blood and / or preparation of blood components. Form 27 C

License Fees of Rs. 6000 plus inspection fees of Rs. 1500 (Rs 7500)

DepartmentState Drugs Control Administration
TypeNew
StagePre-Operation
Fee₹7,500
AppliedApply on NSWS
Apply on National Single Window System

Documents to submit

#DocumentConditionRequired
1 A declaration/undertaking be obtained from the HOD — Required
2 A copy of Key-Plan of the building with relation to the nearby/adjoining roads,building,plots, etc — Required
3 A copy of layout plan (at least 100 square metre) of the blood bank premises depicting the dimensions & position of various sections,doors, windows etc — Required
4 Attested photocopies of certificates of qualification,experience,Bio-data,appointment letter,letter of approval and joining report of competant technical staff,viz Medical Officer,Regd Nurse and Technicians employed by the blood bank on regular basis — Required
5 List of Machinery and equipment installed for blood collection/processing giving full details viz Make capacity,material of which it is made and whether it is automatic or manual etc — Required
6 List of laboratory equipments/apparatus,reagents and reference book etc. duly signed by an authorised person/medical officer — Required
7 List of Human Blood components intended to be processed and the method for their preparation,duly signed by an authorised person/medical officer — Required
8 Draft specimen labels of whole human blood/blood components intended to be collected/processed — Required
9 SOP's for various procedures in blood banking duly signed by an authorised person/medical officer — Required
10 An undertaking from the blood bank that it will not draw blood from paid/professional donors — Required
11 NOC from State Blood Tranfusion Council,Assam — Required
12 Memorandum of Association/ constitution of the firm — Required
13 Documents relating to ownership or tenancy of the premises — Required

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