S. Gupta et al. International Journal of Drug Regulatory Affairs.

2018; 6(2):72-84

Available online on 15 June 2018 at [Link]

International Journal of Drug Regulatory Affairs

Open Access to Pharmaceutical and Medical Research
© 2013-18, Publisher and Licensee IJDRA.

Review Article Open Access

Regulation of Blood and Blood products in India, USA and EU
Swati Gupta* and Harvinder Popli
Delhi Pharmaceutical Sciences & Research University (DPSRU), Mehrauli-Badarpur Road, Puspvihar Sector 3 New Delhi 110017,
India.

ABSTRACT
Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and
invention in science and technology, yet we cannot make blood hence, human blood has no substitute. The availability of safe blood and
blood products is essential for diverse modern healthcare services including some surgeries, treatments for cancer, chronic medical
conditions, trauma care, organ transplantation, and childbirths that ultimately improve life for millions of patients who are need of
transfusion annually. We do not have yet well-defined and stringent regulatory framework for blood products regulation. Frailty may
arise from the inability of governments to enforce laws, regulations, and policies and personnel who may not aware or cannot follow
quality assurance and/ or good manufacturing practices. While the health sector in developed nation has made outstanding
accomplishments in the past few decades. The study sheds on the overview of blood transfusion system in India and other developed
nations. There were a mix of methodologies, including literature review (government documents), interviews with key officials in Indian
Red Cross Society and analysis of data was used. Results of analysis showed that there are several areas that need to be addressed as it
potentially affect the timely availability of safe blood products, which calls for strengthening the planning and monitoring of blood
transfusion services.
Keywords: Transfusion medicine, blood transfusion, Transfusion transmitted infection (TTI).

Article Info: Received 19 May, 2018; Review Completed 28 May 2018; Accepted 30 May 2018
Cite this article as:
Gupta S, Popli H. Regulation of Blood and Blood products in India, USA and EU. International Journal of Drug
Regulatory Affairs [Internet]. 15 Jun.2018 [cited 15 Jun. 2018]; 6(2):72-84. Available from:
[Link]
DOI: 10.22270/ijdra.v6i2.246
*Corresponding author. Tel.: +91-8285274412;
E-mail address: [Link]@[Link] ([Link]).

1. Introduction Blood transfusion is a medical process in which blood is

With more than 1200 road accidents occurring every day drawn from the healthy person transfer into patient’s
in India, 60 million surgeries are performed in the country, bloodstream (1). In India, more than 40 Lakh units of red
240 million major operations, 331 million cancers related blood cells, platelets, and plasma are transfused to treat
procedures like chemotherapy and 10 million pregnancy clinical conditions and patient’s serious illness (2). It is
complications all require a serious call for blood evident that Blood transfusion has been recognized as one
transfusion. Therefore, well-organized, well-structured of the eight key life-saving interventions by WHO (3).
and effective blood transfusion service is vital for the However blood transfusions have been associated with
some risk to recipient even when they have given a right
health-care delivery system. Unfortunately millions of
blood type (4). In 1980s an incident of HIV epidemic was
people are exposed to unsafe blood due to poor storage, a great cause of fear. Nevertheless the risk has been
inappropriate checking and they might not get a blood largely eliminated by strict donor selection and
because of the shortage, Due to scarcity of blood during improvements in testing standard of donated blood for the
an emergency, the onus is on the patient's relatives or presence of contaminants including bacteria, viruses, and
friends to arrange for replacement of blood and here the parasites (4).
healthcare provider fails to ensure public health.

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Historical background of transfusion medicine introduced into that person’s body, it won’t recognized the
new cells as foreign and won’t attack them, but if type B
Long before scientist really understood that blood was a
blood is injected into a type A blood person, the anti-B
magic elixir flowing inside our body. Someone who was
antibodies on the donated blood will be seen as foreign.
sick or dying they would usually drink the blood which
The host’s body will reject the transfusion. A patient of a
had no effect. The idea of blood transfusion didn’t
given blood group type can only be transfused with blood
actually occur until William Harvey’s 1628 discovery that
of the same type. Another factor for rejection comes down
blood circulates through the body in one direction (5).
to protein on the surface of red blood cells called Rhesus
It was then, that scholars and doctors realized that or Rh factor. Blood cells are either possesses the protein
transfusion were a possible method of rejuvenating the or not. These factors combine to make eight blood types
sick. By the end of 17th century, physicians were using (1, 7).
quills as needles and silver pipes to transfer blood from a Blood usage pattern
donor to a patient but donor was usually an animal. But no According to WHO blood transfusion safety report, there
one knew at the time was animal’s blood cells are is a great inconsistency in the access to safe blood. (3)
incompatible with human blood. It wasn’t until Many patients do not get blood when they need. It is
obstetrician James Blundell started using human blood to estimated 80 million units of blood donated annually
replace blood lost in childbirth. In the early 1800, that worldwide, only 38% are collected in the developing
transfusion had started working, atleast some of the time. world which is home to 80% of the world’s population.
The shortage of blood has a significant impact on women
Physician Karl Landsteiner set out to figure out why some
with complications of pregnancy, children with serious
blood transfusion patient lived and others died a line of life-threatening anaemia (8). Hence there is a need to have
inquiry that led him to discover the ABO blood type group the blood donation culture to meet the annual
in 1901. It was Landsteiner’s groundbreaking work that requirements of blood to patient in developing countries.
helped classify blood into one of four categories: A, B, Access to a quality blood can help to prevent deaths of
AB and O. These are defined by the antigens and patients who are need of blood transfusion (9).
antibodies on the red cells (5, 6). The requirements of blood are differs markedly across the
People with type A blood for example, have A antigen on globe. It is given in [figure 1]. These data show the
the surface of their red cells and their bodies cannot importance of blood donation and usage in countries (8).
produce the anti- A antibodies so, if any type A blood is

Estimated use of red cell

transfusion in developing
countries

Surgery
7% 11%
Medical
17% 18% Pregnancy-related
13%
34% Children
Trauma

Estimated use of red cell

transfusion in developed
countries Surgery

Medical
15%
7% 34% Pregnancy-
3% related
6% Children
35% Trauma

Figure 1. Blood Usage Pattern (8)

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Regulation in US and EU The regulation of blood and blood products is crucial and
followed continuously in every step and process that the
The Food and Drug Administration (FDA or USFDA) is blood passes through. These steps include: blood bank
an agency of United States department of health and establishment, donor recruitment, donor selection, donor
human services. It is responsible for protecting and records maintenance, light and temperature control,
promoting public health through the regulations and storage, SOPs for performance, refrigerator usage, legal
supervision of drugs, food safety, tobacco products, documents and records, inventory, all of which are
medical devices, biologics, and cosmetics (10). necessary for proper blood bank maintenance and for the
USFDA control and regulates biologics as per the safety and health of the patient.
following: The key areas are:
 Cellular & Gene Therapy Products.  Establishment of blood bank
 Tissue & Tissue Products.  Selection of donor
 Vaccines.  Blood Donor Education
 Blood & Blood Products.  Assessment of Fitness for Donation
 Allergens  Premises for Blood Donation
 Xeno transplantation.  Testing quality
Blood products regulation is regulated by office of blood  Quality assurance of blood product
research and review in the centre for biologics evaluation  Blood storage and inventory management
and research. Currently it has more than 150 staff that 2. Establishment of Blood Bank Requirement in India
works into three divisions: the division of transfusion
The regulatory body of India is Central Drugs Standard
transmitted disease, the division of hematology, and the
Control Organization (CDSCO) which is headed by the
division of blood application (10). Drugs Controller General (India). The drugs controller has
While legislation/regulations in EU for blood is regulated many more areas such as drugs, devices, biologics and
by European Commission collaborates with Council of clinical trial etc to look after and one of them is blood
Europe. It is responsible for license of blood bank banks. The Drugs and Cosmetics Act, 1940 identify
establishment. Legislation on blood bank is based on the clearly about accommodation, manpower, equipment,
good practised guideline which is described in blood supplies and reagents and good manufacturing practices.
Licensing and monitoring of the blood bank is
directive 2005/62/EC (11).
responsibility of Drug Controller General of India (12).

ACCORDING TO SCHEDULE F: PART XII-B

GENERAL REQUIRMENTS:
 Location: an area of 100 square metre for its operations and an additional area of 50 square metres for
preparation of blood components.
 Surrounding: It shall be maintained in a clean and orderly manner
 Building: it should have adequate space for the orderly placement of equipment and materials
 Requirements for processing: blood establishment must have separate component labs for processing of
blood into components and area shall not be access to other people.
 Storage and quarantine areas:proper racks, bins and platforms have been provided for the storage and
adequate areas have been allocated for products in quarantine area.
 Health:Personnel must have practice good sanitation and health habit.
 Premises:the premises has been designed constructed and maintained to suit the manufacturing operations
 Cleaning and sanitation: Specify the cleaning procedure of the operation areas.
Whether cleaning procedure is validated
 Waste disposal: Specify the system of disposal of biomedical waste, and effluents (solid, liquid, and gas)
from the manufacturing site.
KEY REQUIREMENTS:
 Collection, transportation and storage of blood products in brief.
 Qualifications of medical officers, technicians and technical supervisor engaged in the work.
 Quality control for testing.
 Mandatory blood testing: Human Immunodeficiency Virus , Syphilis, Hepatitis B, Hepatitis C &Malaria
 List of equipments provided.
 List of blood products required.
 Details of labels.
 Standard operating procedures

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LEGAL DOCUMENTS: Covering letter with court fee stamp with 5 rupees affixed, Form 27.C (Refer Statutory
forms), Chalan for Rs. 7500 and Plan of the building.
“The licence for operating a blood bank grants in form 28 C”

Processing and Approval examine all the section of premises, equipment, testing
facilities and other things related to operation of blood
For grant and renewal of licence for operation of blood bank and processing of whole blood into components (13).
bank shall be granted in Form 28-F The inspectors shall

SUBMIT ONLINE/OFFLINE
APPLICATION 1. Examine the application and verifies the information given
in the form.
2. Reviews all the necessary supporting documents.
3. Verifies the payment modes (if specified)
RECEIVED BY 4. If satisfied , forwards to LEVEL II for further processing
FACILITATOR LEVEL I

1. Schedule inspection ( inspection of the manufacturing

PROCESSING BY SENIOR unit or blood bank or distribution unit)
INSPECTOR/INSPECTOR 2. Upload inspection report (senior inspector /inspector will
OF DRUGS LEVEL II compile and upload the inspection report in portal
within 48 hours of inspection)
3. Forward application to LEVEL III

1. Raise query (if inspection report is unsatisfactory ,

PROCESSING AND clarification from inspecting authority might be
sought)
APPROVAL BY
2. APPROVE APPLICATION (based upon compliance
LICENSING
found in the inspection report)
AUTHORITIES LEVEL III 3. REJECT APPLICATION (with valid reason given to
the applicant)

TIMELINE FOR APPROVAL

120 days from the date of submission of application form, provided that documents are valid and complete as per
the checklist

Figure 2. Approval process of blood bank establishment (14)

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3. Donor selection regulation National AIDS Control Organization (India), American

society of Anaesthesiologists, American Association of
Donor selection is the process which determines the Blood Banks and British Committee for Standards in
eligibility of donor to donate blood on any given day. Haematology.
Guidelines for the selection of donors have been published The step for safety of blood products with references to
by regulatory authority or many scientific organizations managing risk the focus area must be on donor selection
towards safe blood transfusions. Some of them are (15-17).

Donation Technical Blood Bank

 Focus on recruiting
(100% voluntary  Quality  Hierarchy - for release &
donors).  State of art manufacture of
 Focus on education components
testing
 Storage of blood
 Stringent donor •Serology products
selection criteria •NAT  Transportation of blood
 Focus on clinical risk  Processing – products
closed systems  Inventory Management
 Measure, improve,  Appropriate clinical
investigate best  Maintaining the usage
methods cold chain  Issue of blood products
 Haemovigilance
programme

Figure 3. Regulation matrix for safe blood products (18)

Regulation: safe donor selection 

The process of selection must include evaluation of
each donor carried out by licensed physician who has
 Recruit only voluntary non-remunerated regular been trained accepted guidelines. The evaluation tool
blood donors (VNRBD) as they have the lowest involves a series of questionnaire about past health
frequency of transfusion transmissible infections history, an interview and further direct questions.
(TTIs). Hence considered to be safest  The questionnaire must be clear and information
 Procedure for safe selection of donor, appropriate should be relevant to health condition and lifestyle of
interview and eligibility evaluation must be the donor. On completion of paperwork, the donor
implemented as well as maintained. They must occur will move on to confidential interview with trained
before each donation and must be comply with the staff member in which the answer on the form will be
requirements sets by each country checked. The donor is then required sign a informed
 There must be specific and secure identification code consent.
as well as registering of the contact details of donors.  Perform safe blood collection techniques
 Upon arrival at blood bank, potential donors must  Donors must be instructed to inform blood bank if
provide authentication of their identity. All donors sign and symptoms take place after a donation
must undergo stringent screening process to assess  Suitability record and final evaluation of donors must
their suitability. be signed by healthcare professionals of the blood
 Only healthy person with good medical condition can bank (19).
considered as donor. Rigorous donor selection & screening protocols criteria of
India, US and EU is compiled in table 1.
Table 1. Donor inclusion and exclusion criteria reference (16, 20-22)
India outlined by CDSCO, accrediting organizations such as NABH & nodal agency NACO
and individual donation centres
United states American red cross society (ARCS)/AABB

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European union Blood directive: 2004/33/EC “Eligibility of donors .....quality and safety requirements of
blood

Donor deferral guidelines –Local culture

–Available resources
In the medical history interview, some conditions come up
Premises requirement for Blood Donation
that will prevent people from being able to donate a blood,
we call it “deferral”. The blood centres has criteria for Blood donation camp shall have sufficient area and
acceptance or deferral of blood donors. These criteria are the location shall be hygienic so as to allow proper
based on international/WHO guidelines (15, 19,). operation, maintenance and cleaning.
WHO Blood Donor Selection Guidelines- purpose All information about personnel working, equipment
used and facilities available at such a Camp shall be
Protection of donor’s health and safety
Ensure recipient’s safety well documented and made available for inspection, if
Ensure the highest quality of blood and blood required (15).
products 4. Requirements in relation to Immunodiagnostic test
Minimise wastage of resources by collection of kits and test reagents
unsuitable donations
National deferral guideline In US, IVDs that involve blood testing kits for screening
of life threatening infections is usually performed within
WHO give guidance every country must have their own
blood policy. India blood collection system uses principles the centre for biologics evaluation and research.
outlined in the Standards of Practice for Blood Regulation of laboratories performing diagnostic kits is
Transfusion (23). performed by Centre for Medicare and Medicaid services
Deferral criteria should consider through authority Clinical Laboratory Improvement
–donor population’s profile Amendment (CLIM) of 1988 (24).
–Epidemiology of life threatening infections and
disease
How the FDA regulates blood products

21CFR606 FDA/CBER/CDRH ACCREDIATION

Regulates the
cGMP for blood and American Association of
collection of blood &
blood components Blood Banks (AABB)
blood components
Subpart A-General Provisions
*Cell separation devices Accreditation US Blood Bank and
Subpart B-Organization and
*Blood collection educational programs
Personnel
containers
Subpart C-Plant and Facilities Develops and enforces quality
*HIV screening tests
Subpart D-Equipment standards
*Inspects blood
Subpart E-Labeling Standards for
Blood and Blood Components establishments
*Monitors adverse DONOR INCLUSION and
Subpart F-Records and Reports
clinical events EXCLUSION CRITERIA

Figure 4. FDA regulation of blood products (25)

An overview of FDA approval and regulation of HIV Blood donors screening IVDs devices
screening tests
Devices used for blood donor screening are regulated by
HIV screening is the first step in ensuring patient for
the Office of Blood Research and Review (OBRR) in the
seeking immediate treatment. Blood test kits or reagents
Centre for Biologics Evaluation and Research (CBER).
are belongs to category of In-vitro diagnostic devices are
FDA regulations require that blood donor screening
the products that are used to collect and examine of
testing be performed and the donor screening devices used
human samples, such as blood or components or tissues,
be “approved for such use” and performed “in accordance
to deliver information for making health care decision.

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with the manufacturer’s instructions” (21 CFR 610.40(a), donors of human cells, tissues, and cellular and tissue-
(b)). FDA has enforced these regulatory requirements of based products (HCT/Ps) be screened for evidence of
IVDs that are donor screening devices including HLA relevant communicable diseases using licensed, approved,
testing for blood compatibility and confirmatory testing or cleared donor screening devices (21 CFR 1271.80)
are subjected to similar regulation as that of In-vitro (24).
diagnostic devices. The regulations also require that

Medical devices
In-vitro diagnostic
devices

 Required to meet notification

 Adverse event reporting requirements
 Applicable premarket review

Figure 5. Share of IVDs regulation in FDA

Reporting on adverse events related to their IVDs must complete the MedWatch 3500A form available at

[Link]
MedWatch 3500A form must contain all the information described in 21 CFR Part 803.52 (26)

What needs to be followed?

For screening devices requires a most stringent regulation to ensure the safety and efficacy of blood products. Device must
show “scientific evidence” that it is safe and effective in its intended use (27).

Analytical validity clinical validity clinical utility

Accuracy and reliability of test to measure accuracy of how well a test detects or likelihood test used to inform clinical
a specific biomaker Predicates clinical diagnoses or outcome decisions and improve outcomes.

 Analytical sensitivity 
Clinical sensitivity  Appropriate intervention
 Analytical specificity 
Clinical specificity  Quality assurance
 Limits of detection 
Prevalence  Monitoring
 stability +ve or –ve predictive
  Economic benefits
value
Figure 6. Specific requirements to devices which is submitted for its intended use

5. Regulation of blood screening devices in India Syphilis Specific treponemal antibody

Hepatitis B Hepatitis B surface antigen
The two main types of test are necessary before blood is (HBsAg)
suitable for human use, first is testing for Transfusion Hepatitis C Anti-HCV antibody
Transmissible Infections (TTIs) diseases and other is Malaria Malaria antigen to all four
species plasmodium vivax,
testing to match the blood type of the donor to the
falciparum, malariae and ovale
recipient. As per the drug and cosmetic act of India
mandatory screening for blood donation is given in table Screening for Infections
2.  All blood donations to be tested mandatory for five
infections before it is transfused into a patient
Table 2 Mandatory screening tests/markers requiring blood
Mandatory TTI s Serological Markers  For HIV Screening, it includes anti-HIV-1/2
Human Antibodies to HIV-1 and 2 antibodies as the minimum required screening target.
Immunodeficiency
Virus
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 For viral hepatitis Screening shall contain Hepatitis B 4. After applying of specimen or reagent, the test kits
surface antigen (HBsAg) for Hepatitis B and anti- should require minimal operator involvement or less
HCV anti-body for Hepatitis C as the minimum procedural steps during the results
required screening targets. 5. The test kit must be in the form that does not require
 Test for Syphilis shall contain specific treponemal any special storage conditions (e.g. refrigeration or
antibodies as the minimum required screening target freezers).
(28).
6. All test kit must not requires any specialized equipment
Selection of assay/kits/reagents
such as centrifuge, washers, spectrophotometers, etc or
All the test kits/test regents must be licensed / CDSCO technique to conduct or perform a test (28).
approved and mandatory to use kits before expiry date.
All testing activities, handling of blood samples, 6. Regulation in Europe
sampling, analysis and data processing should be taken
unconventionally diagnostic testing of patients (28, 29). Blood and blood products regulation is described in blood
directive 2002/98/EC of European Parliament and council
General principles are:
on setting “standards of safety and quality for the
 Suitable tests are performed on the correct samples. collection, processing, testing, storage and distribution of
 Authentic assays are used. human blood and blood components “and directive
 Accurate and reliable results are obtained 2005/62/EC which specified “community standard and
consistently. specification relating to a quality system for blood
 Screened blood and blood components are available establishment”. Each transfusion centre must develop as
in the blood issues inventory. well as maintain quality standard based on directive
 Only screen non-reactive blood and blood 2002/98/EC and must compliance with requirements
components are released for transfusion. specified in directive 2005/62/EC (31).
 Health of blood donors, recipients and staff is
protected Quality in blood establishment
Quality system defines organizational structure,
Table 3 Classification as per Indian regulation (30) personnel’s responsibilities, process controls, procedures,
Device name Risk Intended use human resources necessary to maintain high quality
class services/products. In blood transfusion services quality
Blood Class B It is used to system provide a regulatory framework for safe and
Administration kits administer blood effective blood transfusion to patients in needs (31, 32).
from a container to a The components of quality system are:
patient's vascular
system through a  Quality management
needle or catheter  Blood component recall
inserted into a vein  Quality assurance
In vitro Diagnostic Class D Intended for blood  external and internal auditing and issuance of
Medical Devices for grouping or tissue blood components
Blood Grouping or typing  Continues quality improvement, premises and
Tissue Typing personnel
Reagents/ Kits for Class D test reagents/kits is a  Non conformities and corrective and preventive
the detection of medical device measures are included
transmissible agents intended for the  Control of equipment, electronic data records
- screening & screening of life and documentation
confirmatory threatening  Quality control testing of components are done
infections following the recommended percent of all
produced components
Specific Consideration  Collection, processing and testing
 Release/issue, storage and distribution
1. The test kits for diagnosing HIV1 and HIV 2 must be
able to show the result within 30 minute after Test kits/immunodiagnostic reagents
specimen/sample is applied without any calibration and Screening devices use for screening of severe life
calculation. threatening infection are belongs to the class D of IVDs
and therefore subjected to similar regulatory requirements
2. The test kit must be able to use directly with
unprocessed specimens and unprocessed whole blood. represented in IVD devices directive 98/79/EC which
described essential requirements for products/kits and
3. All the test kits must be presented with reagent or requires a manufacture to perform conformity assessment
diluents to conduct a test without any additional and demonstrates compliance with those of key
manipulation. requirements.
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Section of blood screening devices in IVD’s classification

Class D Class C Class B Class A

High risk to public Moderate to high Low to moderate Low risks

public risk public health risk
Examples: Examples:
 HIV ½ Examples: Examples:  Blood containers
 Hepatitis C & B  Companion  Self test devices  Wash buffers
viruses diagnostic including  Instruments
 Blood grooping  Blood glucose pregnancy test
ABO meters/ strips kits
 Chagas  Blood gas
 syphilis analysers

Figure 7. Classes of IVD devices (33)

Inspection of blood establishment blood establishment inspection. Available at

Inspection is important for all blood establishment, it help [Link]
to identify incident and records through critical Two manuals
examination of the place. Regulatory inspection is
 EUBIS develops “criteria for inspection of blood
performed by competent authorities, accreditation body and
establishments” based on directive 2002/23/EC
EU Blood Inspection System (EUBIS) (34).
 EUBIS audit/inspection training guidelines.
EUBIS brought by the European Commission governed by
public health program to develop a standard and criteria for  Current practices and projects by various stakeholders
to improve the performance of blood transfusion

Current practices and projects by various stakeholders to improve the performance of blood transfusion

 EU-Optimal Use of Blood Project- cofounded by the European Commission

main aimed is promoting improvement in the quality of transfusion practices.

 The EU-Q-Blood –SOP Project – directed by the European Commission.

 The European Commission, Public Health Program.

 Donor management in Europe(DOMAINE)

 Engage with regulators and manufactures to promote

best practices

 EUBIS

7. Storage, transport and distribution conditions the blood collected after donation cannot last for
for blood and blood components more than eight hours in room conditions since it
is highly prone to bacterial contamination. Due to
 The storage conditions play an important role in this technological constraint, the process of
determining the effective duration for which component separation has to be completed within
blood and its components can be used. Typically, a few hours after collection. Once the components

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have been separated they have to be stored in Some section must be focuses specifically on freezers
different conditions as shown in Table 4 or refrigerators since domestic refrigerators do not
Table 4 Blood components stored in different required same level of attention
conditions (35, 36)
1. Action on reception of refrigerators or freezers
Product Storage Max. Duration 2. Location
Condition of Storage 3. Door seals
° °
4. Cleaning
Red Blood 2 C-6 C 35-49 days 5. Energy supply
Cells depending on 6. Starting the equipment
storage Temperature Monitoring
conditions 
Standard for blood bank and transfusion services
Platelets °
20 C -24 C °
5 days necessitate that refrigerators, freezers and platelet
incubators must have a system to monitor
(in a constantly temperature continuously and must record the
stirred condition) temperature at least every four hours.
 Temperature shall be displayed digitally and
Fresh Frozen -18 °C to -25 °C 1 Year previous recording should be readily available to
Plasma (FFP) easily see trends.
White Blood No storage --  On power failure, the system shall ensure no
compromise of monitoring for a period of time to
Cells possible
be specified by the manufacturer
 Data backup must ensure that in the event of
The useful life of whole blood (WB) and RBC is hardware failure that the system integrity and
considered to be 30 days which means that whole temperature data integrity is not compromised.
blood (WB) and RBC units which have not been Alarms
transfused within one month have to be discarded.  In the standard for blood bank and transfusion
Similarly, platelets need to be discarded after five days
services require that the alarms must be presented
if they have not been transfused. Since the life of
platelets is very small compared to other components, on refrigerators, freezers, and platelets incubators
blood banks typically end up discarding a lot of and must activate at temperature that will allow
platelets. Plasma can survive up to almost one year in you to take proper action before stored blood or
frozen state. White blood cells (WBCs) are usually not components reach out exceed temperature.
transfused. But in those cases where such transfusion  An audible alarm equipped on refrigerators or
is required, WBCs have to be prepared immediately freezers must be activated within seconds of
since they cannot be stored (35).
temperature shifts or critical power failures, which
Refrigerator Requirements allows you to take appropriate action before the
Refrigerators are very important in order to maintain stored units reached undesirable temperature.
the integrity of blood or blood components.  An alarm should be audible and covers maximum
personnel coverage area so that immediate proper
The blood refrigerators and plasma freezers shall be action can be taken.
installed with the help of refrigeration expert/  Alarm systems are mandatory to monitor a
maintenance technician from govt/ manufacturer’s temperature as well as critical power failures and
representative. to inform unsafe temperature in order to rectify
situation and move a units in timely manner.
Therefore, it must be checked regularly and all
checks must be recorded (35).
Table 5 Comparionsof blood products regulations and laws of India, EU and US
Parameter India EU US
Competent authority CDSCO headed by Drug European Commission FDA (food and drug
and related organisation Controller General Of collaborates with Council administration).
India: license and regulation of Europe (CoE) for
of blood bank license blood bank Centre for biologics
establishment. evaluation and research
National AIDS Control (CBER) responsible for
Organization (NACO) acts Joint Accreditation ICT devices related to blood and
as a supporter of the Europe and EBMT cellular products.

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S. Gupta et al. International Journal of Drug Regulatory Affairs. 2018; 6(2):72-84

Ministry of Health and (JACIE).

Family Welfare to Indian Accreditation board:
blood transfusion services EBA European blood American Association of
Alliance. Blood Banks (AABB)
Blood products safety is develops and enforces a
ensured through the, DAC The European quality standard.
(Department of AIDS commission, public
Control) by providing all health program
test kits

Accreditation board:
NABH
Laws and regulation The Drugs and Cosmetics 2002/98/EC “Standards Food drug and cosmetic
Act, 1940 identify clearly of quality and safety for act of 1938
about accommodation, the collection, testing,
manpower, equipment, processing, storage, Centre for Medicare and
supplies and reagents, good &distribution of human Medicaid Services (CMS)
manufacturing practices blood and blood
Schedule F Part XII-B components. The Clinical Laboratory
“requirements for Improvement Amendments
functioning and operation of 2004/33/EC “Eligibility (CLIA) of 1988
blood bank “ of donors .....quality and 21 CFR Code of Federal
safety requirements of Regulations
blood  606: cGMP for blood and
blood components
EDQM guide to the  610: regulatory
preparation use and requirement for donor
quality assurance of screening devices.
blood components  803: MDR requirements
 814: premarket approval
European pharmacopeia requirements
8th edition  820: quality system
regulation requirements.
Donor selection Specified by CDSCO/ Annex III of Directive Sets by American red cross
and interview NACO/red cross 2004/33/EC society/AABB& FDA
society/individual hospital travel history.  Previous residents of
Eligibility criteria doesn’t Zika virus other countries.
account for any travel Mad cow disease  Zika virus infection
history, Men who have sex West nile viruses  Mad cow disease
with other men and Chagas disease  West nile viruses
exchange sex for drug and Recently introduced
money  Men who have sex with
No up gradation from past other men.
12 years  Exchange sex for drug
and money
 Medical procedure that
involve receipt of dura
mater graft
Serological testing Mandatory TTI s HIV1 &HIV 2 Blood donor screening and
of donation  Human Hepatitis testing
Immunodeficiency Ebola virus  Chagas disease
Virus (HIV) Chickungunya virus  Haemoglobin screening/
 Syphilis Dengue virus iron management
 Hepatitis B Cytomegalovirus  Hepatitis
 Hepatitis C West nile virus  HIV
 Malaria Herpes simplex virus  Malaria
Malaria  West nile virus
Babesiosis  Zika virus
Syphilis
Neisseria gonorrhoea

NAT testing Not yet mandatory Mandatory Mandatory

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S. Gupta et al. International Journal of Drug Regulatory Affairs. 2018; 6(2):72-84

Post-donation  Indian Pharmacopoeia European haemovigilance U.S. Biovigilance Network

follow up and Commission (IPC), in network (EHN) collect and analyse the data
hemovigilance collaboration with Legal framework: and recommend best policy
National Institute of Article 9 of to ensure blood safety.
Biologicals (NIB) Directive2005/61/EC
 National blood donor Viligance pyramids
vigilance programme  Rapid alerts
under the haemovigilance  Notification of
programme of India adverse occurrences
 Surveillance of
emerging risks

8. Conclusion Study [Internet]. Pubmed; 2001 Jul [cited 2018 Feb

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