Blood Bank Regulation

• The Government of India has formulated

comprehensive legislation to ensure better
quality control system on collection, storage,
testing and distribution of blood and its
components.
• The standards for ‘Whole Human Blood’ are
prescribed in Indian Pharmacopoeia.
• The government published in 2002 the
National Blood Policy.
• The objective of the policy is to provide safe,
adequate quantity of blood , blood
components and products.
• The main aim of the policy is to also procure
blood donors by the blood bank.
• Human blood is covered under the definition
of drug under section 3B of Drugs and
Cosmetics Act.
• The Drugs and Cosmetics Act was amended in
1992 and 1993.
• The drug controller of India was rested with
the power of central licensing authority for
blood banks.
 Drugs & Cosmetics Rules, 1945
• Due to prevalence of AIDS virus, the Ministry
of Health & Family Welfare (Govt. of India)
issued a notification in the year 1989 under
the Drugs and Cosmetics Rules and made the
test HIV 1&2 antibodies of Whole Human
Blood as mandatory requirement before
transfusion
• Hence, it is imperative that Blood Banks need
to be regulated under the Drugs & Cosmetics
Act and rules there under.
• License is required to Manufacture/Collect,
Sale/Distribution of ‘Whole Human Blood’ and
other blood products
 Drugs & Cosmetics Rules, 1945
(contd…)
• ‘Blood’ means and includes whole human
blood, drawn from a donor and mixed with an
anti-coagulant
• ‘Blood Component’ means a substance or a
drug prepared, obtained, derived or separated
from a unit of blood drawn from a donor.
• ‘Blood Product’ means a drug manufactured
or obtained from plasma or blood drawn from
donors.
Procedure and Conditions For License
• License Application Procedure / Inspection /
Reporting by Inspection Team / Grant or
Rejection of Licence / Duration of licence /
Appeal provision
• License granted by Licensing Authority
• Approval by Central License Approving
Authority
• License is granted & delivered to Applicant.
Procedure and Conditions For License
• Maintenance of Staff / Plant / Premises /
Equipment.
• Testing of whole blood / Component /
Product. Inspections.
• Reporting about changes in staff / premise.
•
• Directions for/ Recall Directions.
• Conditions for distribution of whole blood /
component / products.
• To comply provisions of the Act and Rules
• Destruction of infected blood and
implementation of Bio-Medical Wastes
(Management and Handling) Rules
 Forms for License
• Blood and Components Application: 27-C
License:28-C,Renewal: 26-G

• Blood Products Application:27-E, License: 28-E

Renewal:26 – I
 Compliance must be specifically
observed in the following aspects.
• Change of staff must be informed to the
authority. All staff members must be
vaccinated and the records be available.
• Record of the staff training, training manual
and training calendar must be available.
• Medical examination of the donors must be
carried out by the Medical Officer.
• Any modifications must be notified to the
Licensing Authority.
• Rest and Refreshment room must be available
for the donors.
• Reception area must not be used as
refreshment room for donors.
• Privacy must be available for the medical
examination of the donors
• Alarm systems of the blood storage
refrigerators must be functional.
• Recording thermograph must be available and
functional for the blood storage areas.
• Instruments must be periodically calibrated.
• Emergency medicines must be checked for
expiry dates
• Sterility test of the blood bags after the blood
collection must be performed.
• Test method including the Positive and Negative
control must be as per the literature.
• Laboratory manual must be prepared and
available.
• Standard Operating Procedures must be
prepared, reviewed and available.
• Donor’s records, including the address, must be
complete. Batch number of the blood bag must
be recorded in the Donor Blood Collection
Record.
• Labels must be affixed only after complete
testing.
• Two separate storages must be available for
under testing and tested blood and
components.
• Hospital Transfusion Committee must be
formed and should be functional
Requirement regarding collection, storage , processing
and distribution of whole human blood components by
blood banks and manufacture of blood products
• Periodic inspection of the blood bank
• Licensee is required to inform the authority if
there is any change in the expert staff
responsible for operations or any material
changes in the premises
• No batch unit supplied distributed to any
person without prescription of a registered
Medical Practitioner.
• Maintain an inspection book for the licensee
for inspector to record his impression.
• The licensee is supposed to destroy the stocks
of batch not complying with standard tests in
such a way that it would not spread any
disease.
• Biomedical Waste Management Act to be
followed thoroughly when it comes to
disposing and destroying of the substances.
• The licensee shall neither collect blood from
any professional donor or paid donor.
• Location and surroundings
• Hygiene and Sanitation
• Health/ Sanitation of staff
 Accommodation for blood bank
• Minimum 100 Sq m.
• Separate room for registration and medical
examination and blood collection
• Lab for testing of hepatitis, syphilis , malaria
and HIV
• Sterilisation and washing room
• Store room and record room
 Staff
• Medical Officer
• Blood Bank Technicians
• Registered supervisor and Technical supervisor
where components are manufactured.
 Facilities and maintenance
• Thorough examinations of individuals in
privacy to determine their suitability as
donors
• Collection of blood from donors with minimal
risk of contamination
• Provision of quarantine for blood/
components with questionable serological
results
• Storage space for finished products prior to
usage
• Proper packaging, labelling and other finishing
operations
• Provision for safe and sanitary disposal
 The equipment
• Cleaning
• Calibration
 Supplies and Reagents
• Assured quality
• Proper storage
• Safe and hygienic place
 Good Manufacturing Practices
• SOPs governing the major aspects
• Compatibility test
• Leukopheresis
• Plateletpheresis
• Preparation of blood components for
homologous or autologous transfusion
 Criteria for blood donation/ donor
selection
• Good health, mental alertness, physical fitness
• Donation not more than 3 months
• Age group 18-60 years and weight not less
than 45 Kg
• Temperature, pulse and BP within normal limit
• Haemoglobin not below 12.5
• Free of diseases transmissible by blood
• No INDICATION OF SKIN DISEASE AT THE SITE
OF PHLEBOTOMY OR SKIN PUNCTURE
INDICATIVE OF PROFESSIONAL DONORS
 Emergency Equipments
• Oxygen cylinder with mask and pressure
regulator
• Glucose and normal saline
• Disposable sterile syringes and needles of
various sizes
• Disposable sterile IV infusion sets
• Ampoules of adrenaline, noradrenaline
• Aspirin
 Testing of blood
• The blood shall be tested and shall conform to
the standards laid down in Indian
Pharmacopia
• Free from HIV antibodies, hepatitis B surface
antigen, hepatitis C virus antibody, VDRL and
malarial parasite and the results of such tests
shall be recorded on the label of the container
 Maintenance of records
• Blood donor record
• Master record of blood and the components
• Issue register
• Register of diagnostics kits and reagents used
• Records of adverse transfusion reactions and
investigations
• Record of issue of cross matching report along
with blood unit to the patient
 Labels
• Name of the Product
• Name and address of the blood bank
• License no
• Serial number
• Date on which the blood drawn and the date
of expiry
• Colour code as prescribed
• The results of tests for Hepatitis B, surface
antigen, Hepatitis C virus antibody, Syphilis,
HIV IHIVII antibodies and Malarial parasite
• The RH group
• Total volume of blood and nature and
percentage of anticoagulant
• Donor classification- Voluntary donor or
replacement donor