A research report on the establishment of private independent blood banks in india for civilian use

A Research Report on the Establishment
of Private Independent Blood Banks in
India for Civilian Use

Presented By: Rijo Stephen Cletus B.E

A Research Report on the Establishment of Private
Independent Blood Banks in India for Civilian Use

Presented By
Rijo Stephen Cletus

2

Abstract
Blood Transfusion Service Network is an important factor of any health care delivery
scheme of any country. There is no substitute for Human Blood and its components, and
hence an integrated strategy for provision of safe and adequate blood transfusion
services to the people and provisions for Blood Safety is required for elimination of
transfusion transmitted infections. The continuous advancement in the field of
Transfusion Technology has necessitated in enforcing stricter control over the quality of
Blood and its products.

In India the Blood Transfusion Service is highly decentralised and lacks many crucial
resources like manpower, infrastructure and financials. One of the major issues which
plagues blood banking system in the country, is fragmented management. The standards
differ from State to State, cities to cities and centre to centre in the same city. In spite of
hospital based system, many large hospitals and nursing homes do not have their own
blood banks (we can see the proof of this as we look into the primary research component
later in this report) and this need has led to increased number of stand-alone private
blood banks.

The blood component production/availability and utilisation is very inadequate. There is
scarcity of qualified health-care professionals in the field of transfusion medicine. For
quality, safety and efficiency of blood and blood products, well-equipped blood centres
with sufficient satisfactory infrastructure and qualified manpower is an important
prerequisite. For effective clinical use of blood, it is essential to have trained clinical
staff. The requirements of good manufacturing practices and implementation of quality
system moving towards total quality management, have posed a challenge to the
organisation and management of blood transfusion services to attain highest safety.

In this report we try to understand what is the legal guideline for establishment of a
Blood Bank, to manufacture components and for administration of Blood also who can
donate blood. It also looks briefly into what is the demand for Blood Components (on a
rough estimate, it availability, the infrastructure available to prepare components etc.,

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Dedication

I would like to dedicate this study to My Parents and my Late

Grandmother for their cooperation in me joining this Post Graduate

Diploma Program and sacrifice throughout the program to help me

manage my timings for this program, by altering their routines.

They also stood as a strong pillar behind me in every step and

motivating me to effectively complete this program.

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Acknowledgement
I wish to express my sincere gratitude to Dr Nagalingappa Dean of PESIT for his support
and Guidance, Mrs. Jagruthi Bhatia, COO, HOSMAC Foundation, Mumbai, for being my
guide in this research.

I am thankful to Dr. Prashanth Pandey, Head of Department of Transfusion Medicine,
BGS Global Hospital, Kengeri, Bangalore, for giving his valuable time, guidance,
support and also for his readily helping hand towards anything sought in completing this
Research, without his encouragement and guidance this project would not have
materialized. I also thank him for inviting me to attend the CME on ―Rational Use and
Recent Trends in Blood Component Therapy in Modern Clinical Practice‖

I am utmost grateful to Mr. Dattatreya Kotagal Sathyanarayana Rao, VP Marketing,
BGS Global Hospitals, Kengeri, Bangalore, for his immensely valuable guidance, advice,
suggestion and constant encouragement rendered to me at every stage. He has been a
strong pillar for me at Global Hospital and his valuable guidance regarding the study and
also in putting me across to the right people in various hospitals/institutions, for doing my
research.

I thank, Dr. Major Madhu and Dr. Jithendra Kumar for their valuable support extended at
all times during the course of study. They were the internal guides who have been
guiding me in the very structuring of the research and also at every stage they were very
accessible in clarifying any doubts.

The guidance and support received from my classmates, colleagues who contributed to
this study was vital for the completion of this study. I am also grateful to Mr.Rajesh, the
course coordinator from HOSMAC for his role in supporting this activity. I thank all
others for who have contributed either directly or indirectly towards completion of my
study for their support and guidance.

Rijo Stephen Cletus

5

CERTIFICATE

A Report on “The Establishment of Private Independent Blood Banks in India for
Civilian Use” Submitted in partial fulfillment of the requirement for the award of the
POST GRADUATE DIPLOMA IN HOSPITAL AND HEALTHCARE
MANAGEMENT To Visvesvaraya Technological University, Belgaum, Karnataka.

Submitted by : Rijo Stephen Cletus
USN. : 08PD1HHM05

Under the Guidance of:

External Guide. ……………………….. Internal Guide……………………………

HOSMAC Foundation PES Institute of Technology
95, 4th Main, HAL 2nd Stage, Department Of PGDHHM,
Behind Leela Palace, 100 Ft. Ring Road, BSK 3rd Stage
Bangalore 560085 Bangalore - 560008

October 2009
Bangalore

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Table of Contents
Introduction ....................................................................................................................... 19
History of Blood Transfusion ........................................................................................... 21
General Statistical Information about Blood .................................................................... 28
National Blood Policy ....................................................................................................... 29
LEGAL FRAMEWORK .................................................................................................. 31
Requirements for the Collection, Storage, Processing and Distribution of Whole Human
Blood, Human Blood Components by Blood Banks and Manufacture of Blood Products
........................................................................................................................................... 32
Rule 122-EA. Definitions.............................................................................................. 32
Rule 122-F. Form of application for license for operation of Blood Bank .................. 34
Rule 122-G. Form for renewal of license for the operation of a Blood Bank .............. 36
Rule 122-H. Duration of License .................................................................................. 37
Rule 122-I. Inspection before grant or renewal of license ............................................ 37
Rule 122-J. Report by Inspector. ................................................................................... 38
Rule 122-K. Further application after rejection. ........................................................... 38
Rule 122-L. Delegation of powers by the Central Licensing Approving Authority. .... 38
Rule 122-M. Provision for appeal to the State Government by a Party whose license
has not been granted or renewed. .................................................................................. 39
Rule 122-N. Additional information to be furnished by an [applicant] for license or by
a licensee to the Licensing Authority. ........................................................................... 39
Rule 122-O.Cancellation and suspension of licenses.................................................... 39
Rule 122-P. Conditions of license ................................................................................. 40
Form 26-G ......................................................................................................................... 44
Certificate Of Renewal Of License To Operate A Blood Bank For Processing Of
Whole Human Blood And/Or For Preparation For Sale Or Distribution Of Its
Components................................................................................................................... 44
Form 26-I .......................................................................................................................... 45
Certificate of Renewal of License for Manufacture of Blood Products ........................ 45
Form 27-C ......................................................................................................................... 46

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Application for Grant / Renewal of License for the Operation of a Blood Bank for
Processing Of Whole Blood and/or Preparation of Blood Components ....................... 46
Form 27-E ......................................................................................................................... 48
Application for Grant/Renewal of License to Manufacture Blood Products for Sale or
Distribution.................................................................................................................... 48
Form 28-C ......................................................................................................................... 50
License to Operate a Blood Bank for Collection, Storage and Processing Of Whole
Human Blood and/or Its Components for Sale or Distribution ..................................... 50
Conditions of License ................................................................................................ 51
Form 28-E ......................................................................................................................... 52
License to Manufacture and Store Blood Products for Sale or Distribution ................. 52
Conditions of License ................................................................................................ 53
Requirements for the functioning and operation of a Blood Bank and/or for preparation of
Blood Components............................................................................................................ 54
I. Blood Banks / Blood Components ................................................................................ 54
A. General ..................................................................................................................... 54
1. Location and Surroundings: ............................................................................... 54
2. Building: ............................................................................................................. 54
3. Health, clothing and sanitation of staff: ............................................................. 54
B. Accommodation for a blood bank ........................................................................... 54
C. Personnel .................................................................................................................. 55
D. Maintenance ............................................................................................................. 56
E. Equipment ................................................................................................................ 57
F. Supplies and Reagents ............................................................................................. 59
G. Good Manufacturing pracTices (gmps)/Standard Operating Procedures (SOPS) ... 60
H. Criteria for Blood Donation .................................................................................... 62
1) General ................................................................................................................. 62
2) Additional qualifications of a donor..................................................................... 63
Table: Deferment of Blood Donation ........................................................................ 63
3) List of Diseases for persons from whom blood shouldn‘t be taken. .................... 64
I. General Equipments and Instruments ....................................................................... 65
1. For blood collection room .................................................................................. 65

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2. For haemoglobin determination ......................................................................... 65
3. For temperature and pulse determination ........................................................... 65
4. For blood containers ........................................................................................... 65
5. Emergency equipments/items ............................................................................ 66
6. Accessories ..........................................................Error! Bookmark not defined.
7. Laboratory equipment ........................................................................................ 67
J. Special Reagents ....................................................................................................... 68
K. Testing of Whole Blood ........................................................................................... 68
L. Records .................................................................................................................... 69
M. Labels:..................................................................................................................... 70
II. Blood Donation Camps. ............................................................................................... 71
A) Premises, Personnel etc. .......................................................................................... 72
B) Personnel For Out-Door Blood Donation Camp ..................................................... 73
C) Equipments .............................................................................................................. 73
III. Processing of Blood Components from Whole Blood by a Blood Bank .................... 74
A. Accommodation ..................................................................................................... 74
B. Equipment .............................................................................................................. 74
C. Personnel ................................................................................................................ 75
D. Testing Facilities .................................................................................................... 75
E. Categories of Blood Components .......................................................................... 75
(1) Concentrated Human Red Blood Corpuscles ..................................................... 75
F. Processing .............................................................................................................. 77
(2) Platelets Concentrates: ........................................................................................ 77
(3) Granulocyte Concentrates ................................................................................... 79
(4) Fresh Frozen Plasma ........................................................................................... 80
(5) Cryoprecipitate .................................................................................................... 80
I. Requirements for Manufacture of Blood Products ........................................................ 82
A. General Requirements ............................................................................................. 82
B. Collection and Storage of Plasma for Fractionation .............................................. 85
a) Collection ........................................................................................................... 85
b) Storage Area ....................................................................................................... 85

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C. Personnel ................................................................................................................. 86
D. Production Control .................................................................................................. 87
E. Viral Inactivation Process ....................................................................................... 88
F. Quality Control ....................................................................................................... 88
G. Testing Of Blood Products .................................................................................... 89
H. Storage of Finished Product .................................................................................. 90
I. Labelling ................................................................................................................. 90
J. Records ................................................................................................................... 90
K. Master Formula Records ....................................................................................... 90
II. Requirements for Manufacture of Blood Products from Bulk Finished Products 91
Guidelines for Approval of Blood and/or Its Components to Storage Centres and First
Referral Unit, Community Health Centre, Primary Health Centre or Any Hospital ........ 91
Guidelines before grant of approval for operation of whole human blood and/or its
components storage centers run by first referral unit, community health centre, primary
health centre or any hospital. ............................................................................................ 93
Certificate of Approval to Blood Storage Centre for Storage of Whole Human Blood
and/or Its Components ...................................................................................................... 96
Conditions ..................................................................................................................... 97
List of Equipment required for the Blood Banks ............................................................ 100
CLINICAL INFORMATION TRANSFUSION MEDICINE ........................................ 102
Blood Grouping and Cross Matching ............................................................................. 102
1. ABO System:........................................................................................................... 103
2. Rh System: .............................................................................................................. 103
3. Kell System: ............................................................................................................ 104
4. Lewis System: ......................................................................................................... 104
5. P System: ................................................................................................................. 104
6. I and I ...................................................................................................................... 105
7. MNSSU ................................................................................................................... 105
8. Kidd ......................................................................................................................... 105
9. Duff ......................................................................................................................... 105
Cross Matching ............................................................................................................... 105
Paradigm Shift in Safe Blood Transfusion ..................................................................... 106

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How can the concepts of Medicine change? ................................................................... 107
1. Autologus Blood Transfusion: ................................................................................ 109
2. Adverse Effects Of Blood Transfusion ................................................................... 111
A. GvHD (Graft Versus Host Disease) ................................................................... 111
B. TRALI (Transfusion Related Acute Lung Injury) .............................................. 111
C. Immune suppression ........................................................................................... 112
D. Fever ................................................................................................................... 112
3. Blood Components .................................................................................................. 114
Life span of: ............................................................................................................. 114
Platelet transfusion ...................................................................................................... 115
A. Platelet Rich Plasma (PRP): ............................................................................... 115
B. Platelet Concentrates:.......................................................................................... 115
C. Plateletpheresis: .................................................................................................. 116
4. Massive Blood Transfusion..................................................................................... 116
Transfusion Transmissible Agents .................................................................................. 118
Table-1: Transfusion Transmitted Agents ...................................................................... 119
Viruses contamination of Blood .................................................................................. 120
Hepatitis B Virus (HBV): ........................................................................................ 120
Hepatitis C Virus (HCV): ........................................................................................ 121
Hepatitis Delta Virus (HDV) ................................................................................... 122
Hepatitis A Virus (HAV):........................................................................................ 122
Hepatitis G Virus (HGV):........................................................................................ 122
Human Immunodeficiency Virus (HIV).................................................................. 123
HTLV, (Type I and II) ............................................................................................. 123
CMV ........................................................................................................................ 123
Parvovirus B 19 ....................................................................................................... 124
EBV ......................................................................................................................... 124
HHV-8 or Kaposi‘s sarcoma ................................................................................... 124
Creutzfeld - Jacob Disease (C JD) ........................................................................... 124
Bacterial contamination of Blood ............................................................................... 124
Protozoa (Parasitic contamination of Blood) .............................................................. 125

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Parasitic diseases may also be transmitted by labile cellular blood products. Of great
concern are post-transfusion .................................................................................... 125
Malaria ..................................................................................................................... 125
Chagas' disease: ..................................................................................................... 126
Toxoplasma Gondii: ............................................................................................... 126
Leishmaniasis: ......................................................................................................... 126
ADMINISTRATION OF BLOOD ................................................................................. 128
Introduction ..................................................................................................................... 128
Clinicians must be aware of ............................................................................................ 128
Transfusion process ........................................................................................................ 128
Blood Transfusion ........................................................................................................... 129
Ordering Blood:........................................................................................................... 129
Steps to be taken in the blood bank at the time of the issue of blood: ........................ 130
Administration of the blood ........................................................................................ 130
A. Receiving the blood from the bank. .................................................................... 130
B. Steps to be taken by the transfusionist at the time of transfusion: ...................... 131
C. Starting the transfusion ....................................................................................... 131
D. Care during transfusion....................................................................................... 132
E. Rate of Transfusion ............................................................................................. 132
F. Discontinuing transfusion.................................................................................... 133
G. Blood transfusion filters ............................................................................................. 133
H. If the flow rate is slow................................................................................................ 134
I. Blood warming ............................................................................................................ 134
i. Indications for Blood warming are .......................................................................... 134
ii. Blood warming ........................................................................................................ 134
iii. Undue blood warming occurs in clinical practice because of.............................. 134
J. Addition of drugs & medications to the blood bag is prohibited ................................ 135
K. Few undesirable practices .......................................................................................... 135
L. Don‘ts For Blood Transfusion .................................................................................... 135
M. Clinicians have a dual responsibility ......................................................................... 136
1. Adverse Reactions to Blood Transfusion .................................................................. 136

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Introduction ................................................................................................................. 136
Acute Adverse Reactions (<24 HRS ): ....................................................................... 137
Delayed Adverse Reaction to Transfusion (>24 HRS): .............................................. 138
Recognition of Acute Transfusion Reaction ............................................................... 139
The Role of Transfusionist In Case Of an Acute Transfusion Reaction ..................... 139
The Role of Blood Bank Laboratory ........................................................................... 140
2. Febrile Non Hemolytic Transfusion Reaction (FNHTR) ........................................... 140
Aetiology: .................................................................................................................... 140
Clinical picture: ........................................................................................................... 140
Warning sign: .............................................................................................................. 140
Recurrence:.................................................................................................................. 140
Management: ............................................................................................................... 140
Prevention: .................................................................................................................. 141
3. Allergic Urticarial Reaction ........................................................................................ 141
Incidence: .................................................................................................................... 141
Aetiology: .................................................................................................................... 141
Clinical picture: ........................................................................................................... 141
Management: ............................................................................................................... 141
Prevention: .................................................................................................................. 141
Acute Immune Hemolytic Transfusion Reaction (AIHTR): .......................................... 141
Incidence; .................................................................................................................... 141
Fatality rate:................................................................................................................. 141
Aetiology: .................................................................................................................... 141
Pathophysiology: ......................................................................................................... 142
Clinical features: ......................................................................................................... 142
1) Symptoms: ........................................................................................................ 142
2) Signs: ................................................................................................................ 142
3) In an Unconscious patient: ............................................................................... 142
Treatment and Work Up Of AIHTR: .......................................................................... 143
Prevention.................................................................................................................... 143
Non Immune Hemolysis - Bacterial Contamination:...................................................... 143

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Aetiology ..................................................................................................................... 143
Organisms.................................................................................................................... 144
Risk of bacterial contamination................................................................................... 144
Fatality rate .................................................................................................................. 144
Clinical features: ......................................................................................................... 144
Treatment and workup ................................................................................................ 144
Prevention.................................................................................................................... 145
Anaphylactic Reaction .................................................................................................... 145
Incidence ..................................................................................................................... 145
Aetiology ..................................................................................................................... 145
Clinical features........................................................................................................... 145
Treatment .................................................................................................................... 145
Prevention: .................................................................................................................. 145
TRALI (Transfusion Related Acute Lung Injury): ......................................................... 146
Incidence ..................................................................................................................... 146
Aetiology ..................................................................................................................... 146
Pathophysiology .......................................................................................................... 146
Clinical presentation is characterized by..................................................................... 146
Treatment .................................................................................................................... 146
Prevention.................................................................................................................... 146
Transfusion Associated Graft Versus Host Disease - Ta GvHD .................................... 146
Incidence ..................................................................................................................... 146
Aetiology ..................................................................................................................... 146
Patient at risk ............................................................................................................... 147
Components implicated in TaGvHD ........................................................................... 148
Components not implicated in TaGvHD:.................................................................... 148
Comparison of TaGvHD and GvHD in BMT: ............................................................ 148
Prevention.................................................................................................................... 148
Mortality ...................................................................................................................... 149
Anaphylactoid reaction to ACE inhibition. .................................................................... 149
Reaction ....................................................................................................................... 149

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Mechanism .................................................................................................................. 149
Procedures associated. ................................................................................................. 149
Delayed Hemolytic Transfusion Reaction ...................................................................... 149
Two types .................................................................................................................... 149
Incidence ..................................................................................................................... 149
Clinical presentation .................................................................................................... 149
Mortality ...................................................................................................................... 150
Anaphylactoid reaction to ACE inhibition. ................................................................. 150
Reaction ................................................................................................................... 150
Mechanism............................................................................................................... 150
Procedures associated .............................................................................................. 150
Delayed Hemolytic Transfusion Reaction ...................................................................... 150
Incidence ..................................................................................................................... 150
Clinical presentation .................................................................................................... 150
Antibodies implicated ................................................................................................. 150
Investigations .............................................................................................................. 151
Treatment .................................................................................................................... 151
Prevention.................................................................................................................... 151
Post Transfusion Purpura ................................................................................................ 151
Incidence ..................................................................................................................... 151
Presentation ................................................................................................................. 151
Pathophysiology .......................................................................................................... 151
Course.......................................................................................................................... 152
Treatment .................................................................................................................... 152
Prognosis ..................................................................................................................... 152
Prevention.................................................................................................................... 152
Platelet Refractoriness .................................................................................................... 152
Incidence ..................................................................................................................... 152
Criteria......................................................................................................................... 152
Causes.......................................................................................................................... 152
Immune causes ............................................................................................................ 152

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Strategies for prevention ............................................................................................. 153
ARTIFICIAL BLOOD.................................................................................................... 153
Introduction ................................................................................................................. 153
History ......................................................................................................................... 153
Need ............................................................................................................................ 154
Types & Composition ................................................................................................. 154
1. Plasma Expanders ................................................................................................ 155
2. RBC Substitutes................................................................................................... 155
Plasma Expanders .................................................................................................... 155
Colloid expanders can be of several types............................................................... 155
RBC Substitutes....................................................................................................... 157
Future Directions: .................................................................................................... 159
Current scenario of blood substitutes: ..................................................................... 159
APPENDIX I .................................................................................................................. 161
Objectives of the National Blood Policy: .................................................................... 161
1 - To reiterate firmly the Govt. commitment to provide safe and adequate quantity of
blood, blood components and blood products. ............................................................ 161
2 - To make available adequate resources to develop and re-organise the blood
transfusion service in the entire country. .................................................................... 163
3 - To make latest technology available for operating the blood transfusion services and
ensure its functioning in an updated manner. .............................................................. 164
4 - To launch extensive awareness programs for blood banking services including
donor motivation, so as to ensure adequate availability of safe blood. ....................... 166
5 - To encourage appropriate clinical use of blood and blood products. .................... 167
6 - To strengthen the manpower through Human Resource Development. ................ 169
7 - To encourage Research & Development in the field of Transfusion Medicine and
related technology. ...................................................................................................... 170
8 - To take adequate legislative and educational steps to eliminate profiteering in blood
banks............................................................................................................................ 171
Appendix II - News and Press Releases ......................................................................... 173
1. High demand for blood platelets ................................................................................. 173
2. Medical hub Delhi low on blood ............................................................................. 174

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3. Metro blood bank project hits roadblock ................................................................. 176
4. New blood bank has plugged city demand-supply gap, says state .......................... 178
5. Setting up of four Metro Blood Banks as Centres of Excellence in Transfusion
Medicine ......................................................................................................................... 179
6. Maharashtra to start blood bank training ................................................................. 180
7. Donate blood, save lives .......................................................................................... 182
8. Ban on payment to donors causes blood shortage in India...................................... 183
INDEX…………….……………………………………………………………………184

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Introduction

A well organized Blood Transfusion Service (BTS) is a important factor of any health
care delivery scheme. Blood Transfusion Service is therefore a vital part of the National
Health Service and there is no substitute for Human Blood and its components. An
integrated strategy for Blood Safety is required for elimination of transfusion transmitted
infections and for provision of safe and adequate blood transfusion services to the people.
To achieve this and also the continuous advancement in the field of Transfusion
Technology has necessitated in enforcing stricter control over the quality of Blood and its
products. In most of the developed countries, the blood banking system has advanced in
all facets of donor management, storage of blood, grouping and cross matching, testing
of transmissible diseases, rationale use of blood and distribution. The Govt. has the full
responsibility for the blood program even though, in some countries, the management of
blood transfusion services are delegated fully or partly to an appropriate non-
governmental organization (NGOs) working on a non-profit basis, e.g. Red Cross
Society. When a NGO is assigned this responsibility, the Govt. should formally
recognize it and give a clear mandate formulating the national blood policy, it is
important to consider policy decisions enforcing appropriate regulations or necessary
functions of health service to ensure high quality service and safe blood.

The Blood Transfusion Service in India is highly decentralised and lacks many crucial
resources like manpower, infrastructure and financials. The main issue, which plagues
blood banking system in the country, is fragmented management. The standards differ
from State to State, cities to cities and centre to centre in the same city. In spite of
hospital based system, many large hospitals and nursing homes do not have their own
blood banks (we can see the proof of this as we look into the primary research component
later in this report) and this need has led to increased number of stand-alone private blood
banks.

The blood component production/availability and utilisation is very inadequate. There is
scarcity of qualified health-care professionals in the field of transfusion medicine. For

19

quality, safety and efficiency of blood and blood products, well-equipped blood centres
with sufficient satisfactory infrastructure and qualified manpower is an important
prerequisite. For effective clinical use of blood, it is essential to train clinical staff. The
requirements of good manufacturing practices and implementation of quality system
moving towards total quality management, have posed a challenge to the organisation
and management of blood transfusion services to attain highest safety.

Thus, a need for amendment and modification in the blood transfusion service has
necessitated formulation of a new National Blood Policy and development of a National
Blood Programme which will also make sure implementation of the directives of
Supreme Court of India - 1996.

In order to improve the standards of Blood and its components, the Central Govt. through
Drugs Controller General of India, has formulated a comprehensive legislation to ensure
better quality control system on collection, storage, testing and distribution of blood and
its components. Central Govt. amended from time to time the existing requirements of
Blood Banks in the Drugs & Cosmetics Act, 1940 and Rules there under to meet the
latest standards. Consequent to a public litigation case recently, Supreme Court of India
directed Central Govt. to enact a comprehensive legislation on Blood Banks in collection,
storage, testing and distribution of blood and its components. In this context, the office
of Drugs Controller General of India made draft rules to further amend the existing law in
the Drugs & Cosmetics Act, 1940 and Rules there under to meet the direction of
Honorable Supreme Court in order to improve the blood banking system in the country.

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History of Blood Transfusion

1492 - Pope Innocent VIII, in Rome, had an apoplectic stroke; became weak and went
into a coma. His physician advised a Blood transfusion as a therapeutic measure for the
Pope's illness. Employing crude methods, the Pope did not benefit and died by the end of
that year.
1615 - Andreas Libavius described his technique of Blood transfusion. It was
unfortunately not adequately publicized.
1616- William Harvey discovered that blood has a flow inside the animal body.
1628 - English physician William Harvey (1578-1657) described the functions of the
heart and the circulation of Blood. He showed that the heart was a pump and that the
pulse wave was caused by the contraction of the heart which expelled Blood into the
arteries. The same Blood then returned to the heart by travelling through the veins.
Hence, Blood moved in a circle in the body. Harvey was also able to deduce that the
function of the valves was to prevent backflow of the Blood in the veins.
1665 - The first Blood transfusions of record take place. Animal experiments conducted
by Richard Lower, an Oxford physician started as dog-to-dog experiments and proceeded
to animal-to-human over the next two years. Dogs were kept alive by the transfusion of
Blood from other dogs.
1667- The first recorded blood transfusion into vein or artery took place in France in
1667 and was unsuccessful. A cupful of lamb‘s blood was transfused into a man via a
silver tube. The man survived two transfusions and then died.
1668- The Pope banned any kind of experiment on blood,
1678 - Transfusion from animals to humans, having been tried in many different ways,
was deemed to be unsuccessful, and was subsequently outlawed by the Paris Society of
Physicians because of reactions, many resulting in death.
1795 - In Philadelphia an American physician, Philip Syng Physick, performed the first
known human Blood transfusion, although he did not publish the particulars.
1818 - James Blundell, a British obstetrician, performed the first successful transfusion of
human Blood to a patient for the treatment of postpartum hemorrhage. Using the patient's
husband as a donor, he extracted a small amount of Blood from the husband's arm and,

21

using a syringe, he successfully transfused the wife. Between 1825 and 1830, he
performed ten documented transfusions, five of which proved beneficial to his patients,
and published these results. He also devised various instruments for performing Blood
transfusions.
1840 - In London England, Samuel Armstrong Lane, aided by consultant Dr. Blundell,
performed the first successful whole Blood transfusion to treat hemophilia.
1867 - English surgeon Joseph Lister utilized antiseptics to control infection during
Blood transfusions.
1873 to 1880 - Physicians in the United States are documented, during these years, to
have transfused milk (from cows and goats) to humans.
1874- William Highmore first suggested autologous transfusion.
1875- Karl Landsteiner was first to notice that just any man‘s blood cannot be transfused
to another.
1884 - Saline infusion replaced milk as a 'Blood substitute' due to increased frequency of
adverse reaction to milk.
1901 - Karl Landsteiner, an Austrian physician, and the most important individual in the
field of Blood transfusion, documented the first three human Blood groups (based on
substances present on the red Blood cells), A, B and O.
1902 - A fourth main Blood type, AB was found by A. Decastrello and A. Sturli.
1907 - Hektoen suggested that the safety of transfusion might be improved by cross-
matching Blood between donors and patients to exclude incompatible mixtures. Reuben
Ottenberg performed the first Blood transfusion using Blood typing and cross-matching.
Ottenberg also observed the 'Mendelian inheritance' of Blood groups and recognized the
―universal‖ utility of group O donors. Please read Mayo Clinic note on 'universal'
donors HERE.
1908 - French surgeon Alexis Carrel devised a way to prevent Blood clotting. His method
involved joining an artery in the donor, directly to a vein in the recipient with surgical
sutures. He first used this technique to save the life of the son of a friend, using the father
as donor. This procedure, not feasible for Blood transfusion, paved the way for successful
organ transplantation, for which Carrel received the Nobel Prize in 1912.
1908 - Carlo Moreschi documented the antiglobulin reaction.

22

1912 - Roger Lee, a Massachusetts General Hospital visiting physician, along with P. D.
White, formulated and developed the 'Lee-White' clotting time. Lee further demonstrated
that Blood from all groups can be given to group AB patients.
1914 - Dr. Hustin‘s use. of sodium citrate removed the problems in coagulation of blood.
Long-term anticoagulants, among them sodium citrate, were developed, allowing longer
preservation of Blood.
1915 - At Mt. Sinai Hospital in New York City, Richard Lewisohn was documented to
have used sodium citrate as an anticoagulant which was to, in the future, transform
transfusion procedure from one that had to be performed with both the donor and the
receiver of the transfusion in the same place at the same time, to basically the Blood
banking system in use today. Further, in the same time period, R. Weil demonstrated the
feasibility of refrigerated storage of such anticoagulated Blood.
1916 - Francis Rous and J. R. Turner introduced a citrate-glucose solution that permitted
storage of Blood for several days after collection. Also, as in the 1915 Lewisohn
discoveries, this allowed for Blood to be stored in containers for later transfusion, and
aided in the transition from the vein-to-vein method to direct transfusion. This discovery
also directly led to the establishment of the first Blood 'depot' by the British during World
War I. Oswald Robertson was credited as the creator of the Blood depots.
1925 - Karl Landsteiner, then working in New York City, in collaboration with Phillip
Levine, discovered three more Blood groups: M, N and P. View Nobel Biography.
1926 - The British Red Cross instituted the first human Blood transfusion service in the
world.
1930 - Karl Landsteiner, the most important figure in transfusion medicine, who
discovered the first three human Blood groups, received the Nobel Prize for Medicine.
1930- The first mobile blood bank was set up in the 1930s during the Spanish civil war.
1932 - The first facility functioning as a Blood bank was established in a Leningrad
Russia hospital.
1937 - Bernard Fantus, director of therapeutics at the Cook County Hospital in Chicago,
Illinois (U. S.), established the first hospital Blood bank in the United States. In creating a
hospital laboratory that could preserve and store donor Blood, Fantus originated the term
'Blood bank.' Within a few years, hospital and community Blood banks began to be

23

established across the United States. In the U. S., some of the earliest documented were
in Cincinnati, Miami, New York and San Francisco.
1939- India‘s first blood bank was set up in the School of Tropical Medicine, Kolkata
(Calcutta) by Sir Upendranath Brahmachari, the then Chairman of Bengal Red Cross
Society.
1939 and 1940 - The Rh Blood group system was discovered by Karl Landsteiner, Alex
Wiener, Philip Levine and R. E. Stetson and was soon recognized as the cause of the then
majority of transfusion reactions. Known as the Rhesus (Rh) system, once this reliable
test for this grouping had been established, transfusion reactions became rare.
Identification of the Rh factor has stood next to ABO as another important breakthrough
in Blood banking.
1940 - Edwin Cohn, a professor of biological chemistry at Harvard Medical School,
developed a cold ethanol fractionation; the process of breaking down plasma into
components and products. Albumin, a protein with powerful osmotic properties, plus
gamma globulin and fibrinogen were isolated and became available for clinical use. The
efficacy of the use of albumin in transfusion was then first demonstrated by John Elliott.
1941- Blood collecting bottles and also the collection quantity per unit was specified.
1941 - Isodor Ravdin, a prominent surgeon from Philadelphia, effectively treated victims
of the Pearl Harbor attack with Cohn's albumin for shock. Injected into the Blood stream,
albumin absorbs liquid from surrounding tissues, preventing Blood vessels from
collapsing; the finding associated with shock.
1943 - The introduction by J.F. Loutit and P. L. Mollison of acid citrate dextrose (ACD)
solution, which reduces the volume of anticoagulant, permitted transfusions of greater
volumes of Blood and longer term Blood storage.
1943 - P. Beeson published the classic description of transfusion-transmitted hepatitis.
1945 - Coombs, Mourant and Race described the use of antihuman globulin (the
―Coombs Test‖) to identify ―incomplete‖ antibodies.
1947 - The American Association of Blood Banks (AABB) was formed to "promote
common goals among Blood banking facilities and the American Blood donating public."

24

1949 and 1950 - The U. S. Blood collection system had now grown to approximately
1,500 hospital Blood banks, 46 community Blood centers and 31 American Red Cross
regional Blood centers.
1950 - The use of glycerol cryoprotectant for freezing red Blood cells became
widespread.
1950 - Carl Walter and W. P. Murphy, Jr., introduced the plastic bag for Blood
collection. This replaced breakable glass bottles with rugged plastic bags. This technical
development enabled the evolution of a collection system capable of safer and easier
preparation of multiple Blood components from a single unit of whole Blood.
1951 - The AABB (American Association of Blood Banks) was established as a
clearinghouse providing a centralized system in the United States for exchanging Blood
among Blood banks.
1953 - Development of the refrigerated centrifuge began to further expedite Blood
component therapy.
1954 - The Blood product Cryoprecipitate (now AHF) was developed for people
suffering from hemophilia.
1954 to 1958 - Products made from Blood plasma were developed to treat diseases such
as chicken pox.
1957- Dr. Gibson found out the process of storing blood upto 28 days in a temperature of
4 - 6°C by mixing it up with a solution of ACD and sodium dihydrogen phosphate.
1959 - Max Perutz of Cambridge University deciphered the molecular structure of
hemoglobin, the molecule that transports oxygen and gives red Blood cells their color.
1960 - A. Solomon and J. L. Fahey reported the first therapeutic plasmapheresis
procedure.
1961 - The role of platelet concentrates in reducing mortality from hemorrhage in cancer
patients was recognized.
1962 - The first antihemophilic factor (AHF) concentrate to treat coagulation disorders in
hemophilia patients was developed through the process of fractionation.
1962 - The United States reported approximately 4,400 hospital Blood banks, 123
community Blood centers and 55 American Red Cross Blood centers, collecting, in
aggregate total, as many as six million units of Blood per year.

25

1964 - Plasmapheresis was introduced as a means of collecting Plasma for fractionation.
1964-- Infection of jaundice through blood transfusion was confirmed.
1967 - Rh immune globulin was commercially introduced to prevent Rh disease in the
newborns of Rh-negative women.
1967 - National Blood Resources Program at National Heart and Lung Institute is
established.
1969 - S. Murphy and F. Gardner demonstrated the feasibility of storing Platelets at room
temperature, which revolutionized platelet transfusion therapy.
1971 - Hepatitis B surface antigen (HBsAg) testing of donated Blood began in the United
States.
1972 - Apheresis was used to extract one cellular component, returning the rest of the
Blood to the donor.
1979 - A new anticoagulant preservative, CPDA-1, which extends the shelf life of whole
Blood and red Blood cells to 35 days, increasing the Blood supply and facilitating
resource sharing among Blood banks is introduced.
Early 1980s - Doctors began training in the specialties of Blood transfusion and actively
participated in patient care.
1981- Use of polythene bags for collection, storage and transfusion of blood was
legalised.
1983 - Newly introduced Blood additive solutions resulted in extend shelf life of treated
red Blood cells to 42 days.
1985 - The first Blood screening test to detect the probable presence of HIV was licensed
and implemented by Blood banks in the United States.
1986- First AIDS patient due to blood transfusion in Mumbai was reported.
1987 - Two tests for screening for indirect evidence of hepatitis C were developed and
implemented: hepatitis B core antibody (anti-HBc) and the alanine aminotransferase test
(ALT).
1989 - In the United States, human T lymphotropic virus I antibody (anti-HTLV-I)
testing of donated Blood began.

26

1990 - The first specific test for hepatitis C was introduced. This major cause of ―non-A,
non-B‖ hepatitis. (the hepatitis C virus, HCV, has, as of the date of this writing, not been
isolated)
1992 - Testing of donor Blood for HIV-1 and HIV-2 antibodies (anti-HIV-1 and anti-
HIV-2) was implemented.
1996 - Testing of donated Blood for the HIV p24 antigen began. The test did not do a
complete job, but improved on the previous tests, in that, the time taken to clear donated
Blood for use was shortened substantially.
1996- Supreme Court‘s judgment on blood transfusion and blood banking in India; as a
result of which National Blood Transfusion Council and State Blood Transfusion
Councils are established for improvement of Blood Banking services in the country.
1996 and 1997 - The United States Government issued reports suggesting problems with
the Blood supply in the United States, and suggested methods and procedures to improve
Blood safety, including regulatory reform.
1999 - The Blood manufacturing community began implementation of Nucleic Acid
Amplification Testing (NAT) under the FDA‘s Investigational New Drug (IND)
application process. NAT employs a testing technology that directly detects the genetic
materials of viruses like HCV and HIV.
2000- World Health Day on 7th April 2000 was celebrated with, ―Safe blood starts with
me‖ as the slogan of the year.
2001- Every year, over 100 million blood units are collected from blood donors
throughout the world. 6. 5 million blood units are collected, every year, in India.

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General Statistical Information about Blood

1. Human body contains 4-5 liters of Blood, or about 8% of Body Weight.
2. 40-45% of Blood is made up of red blood cells which carry oxygen.
3. The remaining 55-60% is plasma with a small proportion of white blood cells
for defending the body, clotting factors and platelets preventing the blood leak.
4. The average person has 25 billion red blood cells.
5. If every capillary, vein and artery in person‘s body were lined up end to end,
they would cover a distance of 150, 000 kilometers. Heart, by its powerful
pumping action circulates blood throughout the body through this closed channel.
6. All the iron in an average person‘s blood could make a 2‖ nail (gross), still iron
deficiency anemia is rampant in India.
7. Lifespan of red blood cells is about 120 days and white blood cells normally
last 3-9 days. New blood cells are constantly generated in the body.
8. After each donation of blood it takes 36 hours for the body to reconstitute the
blood volume and 21 days for the blood count to return to a normal level.
9. Every year, over 100 million blood units are collected from blood donors
throughout the world.
10. Upto 7% HIV Infection in India is due to transfusion of blood and blood
products. Transmission of HIV infection by infected blood transfusion is almost
100% effective in each case.
11. One can donate blood 168 times in his lifetime, which measures to whopping 58
liters of blood ie. 12 times the total blood volume of the body. This is the amazing
potential of blood donor.

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National Blood Policy

Government of India published in the year 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 procure non remunerated regular blood
donors by the blood banks. The policy also addresses various issues with regard to
technical personnel, research, and development and to eliminate profiteering by the blood
banks by selling blood. The policy also envisages that fresh licenses to stand alone blood
banks in private sector shall not be granted and renewal of such blood banks shall be
subjected to thorough scrutiny.

The objectives of the new National Blood Policy are as follows:
1. To reiterate firmly the Govt. commitment to provide safe and adequate quantity of
blood, blood components and blood products.
2. To make available adequate resources to develop and re-organise the blood
transfusion services in the entire country.
3. To make latest technology available for operating the blood transfusion services
and ensure its functioning in an updated manner.
4. To launch extensive awareness programmes for donor information, education,
motivation, recruitment and retention in order to ensure adequate availability of
safe blood.
5. To encourage appropriate clinical use of blood and blood products.
6. To strengthen the manpower through human resource development.
7. To encourage Research & Development in the field of Transfusion Medicine and
related technology.
8. To take adequate regulatory and legislative steps for monitoring and evaluation of
blood transfusion services and to take steps to eliminate profiteering in blood
banks.

Appendix 1 gives us an in-depth view of the Objectives of National Blood Policy and
also the strategy

29

This new National Blood Policy aims to make sure easily available and sufficient supply
of safe and quality blood and blood components collected / procured from a voluntary
and unpaid blood donor in well equipped premises, which is free from transfusion
transmitted infections, and is stored and transported under optimum environment.
Transfusion, under supervision of trained personnel for all who need it irrespective of
their financial or societal status through widespread, efficient and a total quality
management approach, will be ensured under the policy.

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LEGAL FRAMEWORK

Human Blood is covered under the definition of ‗Drug‘ under Sec. 3(b) of Drugs &
Cosmetics Act. Hence, it is imperative that Blood Banks need to be regulated under the
Drugs & Cosmetics Act and rules there under.

In the year 1967, Central Govt. (Ministry of Health) enacted a separate provision in
Schedule F Part XII B of Drugs & Cosmetics Rules. Various requirements such as
Accommodation, Technical staff, equipments etc. for operation of blood bank were
included in this Part. State Drugs Controllers were authorized to issue the licenses for
blood banks. The standards for ‗Whole Human Blood‘ were prescribed in Indian
Pharmacopoeia.

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. It is imperative that each unit of blood and blood products were
regulated in the year 1990 and 3 laboratories viz. NICD Delhi, NIV Pune and CMC,
Vellore were notified to function as laboratory under 3A of Drugs and Cosmetics Rules
to test HIV antibodies in respect of human blood and human blood products.

As trained technicians were not available in the Blood Banks to carry out the test for HIV
1&2 antibodies, the Ministry of Health & Family Welfare notified 112 Surveillance
Centers to act as a testing lab for the blood banks for carrying out the above test
(ZBTC). The list of 112 Surveillance Centers is annexed.

Following M/s. Ferguson‘s Report (which brought out various deficiencies with regard to
quality control of blood and blood products etc. in the year 1990 and based on concern
expressed in different fora and in Parliament, the D&C Rules were again amended (Rules
68A, Part XB and Part XIIB of Schedule F) in the year 1992-93 and Drugs
Controller General (India) was vested with the power of Central License Approving

31

Authority (CLAA) to approve the license of notified drugs viz. Blood and Blood
Products, I.V. Fluids and Vaccines and Sera.

The requirement of a blood bank is inserted in Part X-B of the Drugs and Cosmetics
Rules, 1945. The Rules from 122F to 122P explain the various procedure of making
applications by a blood bank, fees to be paid for grant/renewal of license by the applicant
and conditions of license to be followed by the applicant after grant/renewal and
conditions of license to be followed by the applicant after grant/renewal of license.

In accordance with the Supreme Court order, blood bank legislation has been extensively
revised on 5.4.1999 to include Good Manufacturing Practices, Standard Operating
Procedure and validation of equipments etc. The brief requirements for grant/renewal of
blood bank licenses are as follows:

Requirements for the Collection, Storage, Processing and Distribution of Whole
Human Blood, Human Blood Components by Blood Banks and Manufacture of
Blood Products

Rule 122-EA. Definitions
(1) In this Part and in the Forms contained in Schedule A and in Part XII B and Part XIIC
of schedule F, unless there is anything repugnant in the subject or context,
a) ‗Apheresis‘ means for the process by which blood drawn from a donor, after
separating plasma or platelets or leucocytes, is retransfused – simultaneously into
the said donor;
b) ‗Autologous Blood‘ means the blood drawn from the patient for re-transfusion
unto himself later on;
c) ‗Blood‘ means and includes whole human blood, drawn from a donor and mixed
with an anti-coagulant;
d) ‗blood bank‘ means a place or organization or unit or institution or other
arrangements made by such organization, unit or institution for carrying out all or
any of the operations for collection, apheresis, storage, processing and distribution

32

of blood drawn from donors and/or for preparation, storage and distribution of
blood components;
e) ‗Blood Component‘ means a drug prepared, obtained, derived or separated from a
unit of blood drawn from a donor;
f) ‗Blood Product‘ means a drug manufactured or obtained from pooled plasma or
blood by fractionation, drawn from donors;
g) ‗Donor‘ means a person who voluntarily donates blood after he has been declared
fit after a medical examination, for donating blood, on fulfilling the criteria given
hereinafter, without accepting in return any consideration in cash or kind from
any source, but does not include a professional or a paid donor.ExplanationFor
the purposes of this clause, benefits or incentives like pins, plaques, badges,
medals, commendation certificates, time-off from work, membership of blood
assurance program, gifts or little or intrinsic monetary value shall not be
construed as consideration
h) ‗Leucapheresis‘ means the process by which the blood drawn from a donor, after
leucocyte concentrates have been separated, is re-transfused simultaneously into
the said donor;
i) ‗Plasmapheresis‘ means the process by which the blood drawn from a donor, after
plasma has been separated, is re-transfused during the same sitting into the said
donor;
j) ‗Plateletpheresis‘ means the process by which the blood drawn from a donor, after
platelet concentrates have been separated, is re-transfused simultaneously into the
said donor.
k) ‗Professional Donor‘ means a person who donates blood for a
valuable consideration, in cash or kind, from any source, on behalf of the
recipient – patient and includes a paid donor or a commercial donor;
l) ‗Replacement Donor‘ means a donor who is a family friend or a relative of the
patient –recipient.

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Rule 122-F. Form of application for license for operation of Blood Bank
Form of application for license for operation of Blood Bank/processing of Whole Human
Blood for Components/manufacture or Blood Products for sale or distribution.

(1) Application for the grant and/or renewal of license for the operation of Blood
Bank/processing of Human Blood for components/manufacture of Blood Products shall
be made to the Licensing Authority appointed under Part VII in Form 27-C or Form 27-E
as the case may be and shall be accompanied by license fees of rupees six thousand and
an inspection fees of rupees one thousand and five hundred for every inspection thereof
or for the purpose of renewal of license.

Provided that if the applicant applies for renewal of license after the expiry but within six
months of such expiry the fee payable for the renewal of the license shall be rupees six
thousand and inspection fees of rupees one thousand and five hundred plus an additional
fees at the rate of rupees one thousand per month or a part thereof in additional to the
inspection fee.

Provided further that a licensee holding a license in Form 28-C or Form 28-E as the case
may be for operation of blood bank/processing of whole human blood for
components/manufacture of blood products shall apply for grant of license under sub-rule
(1) before the expiry of the said license on Form 27-C or Form 27-E as the case may be
and he shall continue to operate the same till the orders on his application are
communicated to him.

1. EXPLANATION: For the purpose of this rule, ‗Blood Bank‘ means a place or
organizational unit or an institution, or other arrangement made by such
organizational unit or institution for carrying out all or any of the operations of
manufacture of human blood components or blood products or whole human blood
for its collection, storage, processing, distribution from selected human donors.}
2. A fee of rupees one thousand shall be paid for a duplicate copy of license issued
under this rule, if the original is defaced, damaged or lost.

34

3. Application by licensee to manufacture additional drugs listed in the application shall
be accompanied by a fee of rupees three hundred for each drug listed in the
application.
4. On receipt of the application for the grant or renewal of such license, the Licensing
Authority shall,
4.1. Verify the statements made in the application form.
4.2. Cause the manufacturing and testing establishment to be inspected in accordance
with the provisions of rules 122-I; and
4.3. In case the application is for renewal of license, call for information of past
performance of the licensee.
5. If the Licensing Authority is satisfied that the applicant is in position to fulfill the
requirements laid down in the rules, he shall prepare a report to that effect and
forward it along with the application and the license (in triplicate) to be granted or
renewed, duly completed to the Central License Approving Authority:
Provided that if the Licensing Authority is of the opinion that the applicant is not
in a position to fulfill the requirements laid down in these rules, he may, by order, for
reason to be recorded in writing, refuse to grant or renew the license, as the case may
be.
6. If, on receipt of application and the report of the Licensing Authority referred to in
Sub-rule 5 and after taking such measures including inspection of the premises, by the
inspector, appointed by the Central Govt. under Section 21 of the Act, and/or along
with expert in the field concerned if deemed necessary, the Central
License Approving Authority, is satisfied that the applicant is in a position to fulfill
the requirement laid down in this rule. He may grant or renew the license, as the case
may be:
Provided that if the Central License Approving Authority is of the opinion that the
applicant is not in a position to fulfill the requirements laid down in these rules he
may, notwithstanding the report of the Licensing Authority, by order, for reason to be
recorded in the writing, reject the application for grant or renewal of license as the
case may be and shall supply the applicant with a copy of the inspection report.

35

Rule 122-G. Form for renewal of license for the operation of a Blood Bank
Form of license for the operation of a Blood Bank/Processing of Whole Human Blood for
components and manufacture of Blood products and the conditions for the grant or
renewal of such license.

A license for the operation of a Blood Bank or for processing whole Human Blood for
components and manufacture of blood products shall be issued in Form 28-C or Form-
28-E or Form 26-G or Form 26-I as the case may be. Before a license in Form 28-C or
Form-28-E or Form 26-G or Form 26-I, as the case may be, is granted or renewed the
following conditions shall be complied with by the applicant.

1) The operation of the Blood Bank and/or processing of whole human blood for
components/manufacture of blood product shall be carried out under the active
direction and personal supervision of component technical staff consisting of at least
one person who is whole time employee and who is a Medical Officer, and
possessing

a) Post Graduate degree in Medicine-M.D. (Pathology/Transfusion Medicines); or
b) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion
Medicines having adequate knowledge in blood group serology, blood group
methodology and medical principles involved in the procurement of blood and/or
preparation of its components; or
c) Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year
during regular service and also has adequate knowledge and experience in blood
group serology, blood group methodology and medical principles involved in the
procurement of blood and/or preparation of its components, the degree or diploma
being from a university recognized by the Central Government.

EXPLANATION: For the purposes of this condition, the experience in Blood Bank
for one year shall not apply in the case of persons who are approved by the Licensing

36

Authority and/or Central License Approving Authority prior to the commencement of
the Drugs & Cosmetics (Second Amendment) Rules,1999.

2) The applicant shall provide adequate space, plant and equipment for any or all the
operations of blood collection or blood processing. The space, plant and equipment
required for various operations are given in Schedule ‗F‘, Part XII-B and / or XII-C.

3) The applicant shall provide and maintain adequate technical staff as specified in
Schedule ‗F‘, Part XII-B and/or XII-C.

4) The applicant shall provide adequate arrangements for storage of Whole Human
Blood, Human Blood Components and blood products.

5) The applicant shall furnish to the Licensing Authority, if required to do so, data on
the stability of Whole Human Blood, its components or blood products which are
likely to deteriorate, for fixing the date of expiry which shall be printed on the labels
of such products on the basis of the data so furnished.

Rule 122-H. Duration of License
An original license in Form 28-C or Form 28 –E or a renewed license in Form 26-G or
Form 26-I unless sooner suspended or cancelled shall valid for a period of five years and
from the date on which the year in which it is granted or renewed.

Rule 122-I. Inspection before grant or renewal of license
Inspection before grant or renewal of license for operation of Blood Bank, processing of
Whole Human Blood for Components and Manufacture of Blood Products. Before a
license in Form 28-C or Form 28 –E is granted or a renewal of license in Form 26-G or
Form 26-I is made ,as the case may be, the Licensing Authority or Central
License Approving Authority, as the case may be , shall cause the establishment in
which Blood Bank is proposed to be operated/ whole human blood for component is
processed[/] blood products are manufactured to be inspected by one or more inspectors,

37

appointed under the Act and / or along with the Expert in the field concerned. The
Inspector or Inspectors shall examine all portions of the premises and appliances/
equipments and inspect the process of manufacture intended to be employed or being
employed along with the means to be employed or being employed for operation of blood
bank/processing of whole human blood for components/ manufacture of blood products
together with their [testing] facilities and also enquire into the professional qualification
of the expert staff and other technical staff to be employed.

Rule 122-J. Report by Inspector.
The Inspector or Inspectors shall forward a detailed descriptive report giving his finding
on each aspect of inspection along with his recommendation in accordance with the
provisions of Rule 122-I to the Licensing Authority or to the Central License Approving
Authority.

Rule 122-K. Further application after rejection.
If within a period of six months from the rejection of application for a license the
applicant informs the licensing Authority that the conditions laid down have been
satisfied and deposits an inspection fee of rupees two hundred and fifty the Licensing
Authority, if after causing further inspection to be made is satisfied that the conditions for
the grant of a license have been complied with, shall grant or renew a license in Form 28-
C or Form 28 –E;
Provided that in case of drug notified by the Central Government under rule 68-A, the
application , together with the inspection report and the Form of license (in triplicate to
be granted or renewed), duly completed shall be sent, to the Central License Approving
Authority, who may approve the same and return it to the licensing Authority for issue of
the license.

Rule 122-L. Delegation of powers by the Central Licensing Approving Authority.
The Central Licensing Approving Authority may, with the approval of the Central
Government, by notification delegate his power of signing licenses and any other power
under rules to persons under his control having same qualifications as prescribed for

38

Controlling Authority under Rule 50-A, for such areas and for such periods as may be
specified.

Rule 122-M. Provision for appeal to the State Government by a Party whose license
has not been granted or renewed.
Any person who is aggrieved by the order passed by the Licensing Authority or Central
License Approving Authority, as the case may be, may within thirty days from the date
of receipt of such order, appeal to the State Government or Central Government, as the
case may be, after such enquiry, into the matter as it considers necessary and after
giving the said person an opportunity for representing his view in the matter may pass
such order in relation thereto as it thinks fit.

Rule 122-N. Additional information to be furnished by an [applicant] for license or
by a licensee to the Licensing Authority.
The applicant for the grant of license or any person granted a license under the part shall,
on demand furnish to the Licensing Authority, before the grant of the license or during
the period the license is in force as, as the case may be, documentary evidence in respect
of the ownership or occupation, rental or other basis of the premises, specified in the
application for license or in the license granted, constitution of the firm or any other
relevant matter, which may be required for the purpose of verifying the correctness of the
statement made by the applicant or the licensee, while applying for or after obtaining the
license, as the case may be.

Rule 122-O.Cancellation and suspension of licenses
1) The Licensing Authority or Central License Approving Authority may for such
licenses granted or renewed by him after giving the licensee an opportunity to
show cause by such an order should not be passed by an order in writing stating the
reason thereof, cancel a license issued under this part or suspend it for such period as
he thinks fit, either wholly or in respect of some of the substances to which it relates,
[or direct the licensee to stop collection, storage, processing, manufacture and
distribution of the said substances and [thereupon order the destruction of

39

substances and] stocks thereof in the presence of an Inspector] if in his opinion, the
licensee has failed to comply with any of the conditions of the license or with
any provision of the Act or Rules there under
2) A licensee whose license has been suspended or cancelled, within three months of the
date of the order under sub-rule (1) prefer an appeal against that order to the State
Government or Central Government, which shall decide the same.

Rule 122-P. Conditions of license
A license in Form 28-C, Form 28-E, Form 26-G or Form 26-I shall be subject to the
special conditions set out in Schedule F, Part XII-B and Part XII-C, as the case may be,
which relate to the substance in respect of which the license is granted or renewed and to
the following general conditions, namely:-
1)
a) The licensee shall provide and maintain adequate staff, plant and premises for the
proper operation of a Blood Bank for processing whole human blood, its
components and/or manufacture of blood products.
b) The licensee shall maintain staff, premises and equipments as specified in Rule
122-G. The licensee shall maintain necessary records and registers as specified in
Schedule F, Parts XII-B and XII-C.

c) The licensee shall test in his own laboratory whole human blood, its components
and blood products and [maintain records and] registers in respect of such tests as
specified in Schedule F, Part XII-B and Part XII-C. The records and registers
shall be maintained for a period of five years from the date of manufacture.

d) The licensee shall maintain/preserve reference [sample and] supply to the
Inspector the reference sample of the whole human blood collected by him in
adequate quantity to conduct all the prescribed tests. The licensee shall supply to
the Inspector the reference sample for the purpose of testing.

40

2) The licensee shall allow an inspector appointed under the Act to enter, with or
[without] prior notice, any premises where the activities of the Blood Bank are being
carried out, for the processing of Whole Human Blood and/or Blood Products, to
inspect the premises and plant and the process of manufacture and the means
employed for standardizing and testing the substance.

3) The licensee shall allow an Inspector appointed under the Act to inspect all registers
and records maintained under these rules and to take samples of the manufactured
product and shall supply to Inspector such information as he may require for the
purpose of ascertaining whether the provisions of the Act and Rules thereunder have
been observed.

4) The licensee shall from time to time report to the Licensing Authority any changes in
the expert staff responsible for the operation of a Blood Bank/processing of whole
human blood for components and/or manufacture of blood products and any material
alterations in the premises or plant used for that purpose which have been made since
the date of last inspection made on behalf of the Licensing Authority before the grant
of the license.

5) The licensee shall on request furnish to the Licensing Authority, or Central License
Approving Authority or to such Authority as the Licensing Authority, or the Central
License Approving Authority may direct, from any batch unit of drugs as the
Licensing Authority or the Central License Approving may from time to time specify,
sample of such quantity as may be considered adequate by such Authority for any
examination and, if so required, also furnish full protocols of the test which have been
applied.

6) If the Licensing Authority or the Central License Approving Authority so directs, the
licensee shall not sell or offer for sale any batch/unit in respect of which a sample is,
or protocols are furnished under the last preceding sub-paragraph until a certificate

41

authorizing the sales of batch/unit has been issued to him by or on behalf of the
Licensing Authority or the Central License Approving Authority.

7) The licensee shall on being informed by the Licensing Authority or the Controlling
Authority that any part of any batch/unit of the substance has been found by the
Licensing Authority or the Central License Approving Authority not to conform with
the standards of strength, quality or purity specified in these Rules and on being
directed so to do so, withdraw, from sales and so far as may in the particular
circumstances of the case be practicable recall all issues already made from that
batch/unit.

8) No drug manufactured under the license shall be sold unless the precautions
necessary for preserving its properties have been observed throughout the period after
manufacture. Further no batch/unit manufactured under this license shall be
supplied/distributed to any person without prescription of Registered Medical
Practitioner.

9) The licensee shall comply with the provisions of the Act and of these Rules and with
such further requirements, if any, as may be specified in any Rules subsequently
made under Chapter IV of the Act, provided that where such further requirements are
specified in the Rules, these would come in force four months after publication in the
Official Gazette.

10) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to
record his impressions and defects noticed.

11) The licensee shall destroy the stocks of batch/unit which does not comply with
standard tests in such a way that it would not spread any disease/infection by way of
proper disinfection method.

42

12) All bio-medical waste shall be treated, disposed off or destroyed as per the provisions
of The Bio-Medical Wastes (Management and Handling) Rules 1996.

13) The licensee shall neither collect blood from any professional donor or paid donor nor
shall he prepare blood components and/or manufacture blood products from the blood
drawn from such a donor.

43

Form 26-G
(See Rule 122-F)

Certificate Of Renewal Of License To Operate A Blood Bank For Processing Of
Whole Human Blood And/Or For Preparation For Sale Or Distribution Of Its
Components

1) Certified that license number ________________________granted on ________ to
M/s ___________________________________ for the operation of a Blood Bank for
processing of whole blood and / or for preparation of its components at the premises
situated at _______________________ is hereby renewed with effect
from ________________ to ___________________.

2) Name(s) of Items:
1.
2.
3.

3) Name(s) of competent Technical Staff:
1.
2.
3.
4.
5.
6.

Dated _________________________________

Signature _______________________________

Name and Designation ____________________

Licensing Authority_______________________________________

Central License Approving Authority

44

(b) After Form 26-H, the following Form shall be inserted, namely:

Form 26-I
(See rule 122-I)

Certificate of Renewal of License for Manufacture of Blood Products

1. Certified that license number ___________________________granted on
___________ to M/s _____________________________ for manufacture of blood
products at the premises situated at __________________ is hereby renewed with
effect from _______________ to ___________________.

2. Name(s) of item(s) :
1.
2.
3.

3. Names of competent Technical Staff :

(A) Responsible for manufacturing (B) Responsible for testing
1. 1.
2. 2.
3. 3.
4. 4.

Dated _________________________________

Signature _______________________________

Name and Designation ____________________

Licensing Authority_______________________________________

Central License Approving Authority

45

(c) For Form 27-C, the following form shall be substituted, namely:-

Form 27-C
(See rule 122-F)

Application for Grant / Renewal of License for the Operation of a Blood Bank for
Processing Of Whole Blood and/or Preparation of Blood Components

1. I/We ___________________of M/s_______________________________ hereby
apply for the grant of license / renewal of license number ______________dated
_______________________ to operate a Blood Bank, for processing of whole
blood and/or* for preparation of its components on the premises situated at
______________________________________________________.

2. Name(s) of the item(s):
1.
2.
3.

3. The name(s), qualification and experience of competent Technical Staff are as
under :

(a) Name(s) of Medical Officer.

(b) Name(s) of Technical Supervisor.

(c) Name(s) of Registered Nurse.

(d) Name(s) of Blood Bank Technician.

4. The premises and plant are ready for inspection/ will be ready for inspection on
_______________________.

5. A license fee of rupees ___________________________________ and an
inspection fee of rupees ________________________________ has been credited
to the Government under the Head of Account _______________________
(receipt enclosed).

Signature ____________________________

Dated _______________

Name and Designation ___________________

46

Note:
1. The application shall be accompanied by a plan of the premises, list of machinery and
equipment for collection, processing, storage and testing of whole blood and its
components, memorandum of association/ constitution of the firm, copies of certificate
relating to educational qualifications and experience of the competent technical staff and
documents relating to ownership or tenancy of the premises.

2. A copy of the application together with the relevant enclosures shall also be sent to the
Central License Approving Authority and to the concerned Zonal/Sub- Zonal Officers of
the Central Drugs Standard Control Organization.‖;

47

(d) After Form 27-D, the following Form shall be inserted, namely:

Form 27-E
(See rule 122-F)

Application for Grant/Renewal of License to Manufacture Blood Products for Sale
or Distribution

1) I/We ____________________of M/s___________________________ hereby apply
for the grant of license/renewal of license number _____________________ dated
_____________________ to manufacture blood products on the premises situated
at ______________________

2) Name(s) of item(s) :
1.
2.
3.
4.

3) The name(s), qualification and experience of competent Technical Staff as under :

(A) Responsible for manufacturing (B) Responsible for testing
1. 1.
2. 2.
3. 3.

4) The premises and plant are ready for inspection / will be ready for inspection
on____________________________

5) A license fee of rupees ______________and an inspection fee of rupees
___________________________ has been credited to the Government under the
Head of Account _________________ (receipt enclosed),

Signature ____________________________

Dated _______________

Name and Designation ___________________

48

Note:
1) The application shall be accompanied by a plan of the premises, list of machinery and
equipment for manufacture of blood products, memorandum of
association/constitution of the firm, copies of certificate relating to educational
qualifications and experience of the competent technical staff and documents relating
to ownership or tenancy of the said premises.
2) A copy of the application together with the relevant enclosures shall also be sent to
the Central License Approving Authority and to the concerned Zonal / Sub Zonal
Officers of the Central Drugs Standard Control Organization.

49

A research report on the establishment of private independent blood banks in india for civilian use

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