REGULATORY REQUIREMENTS OF BLOOD AND/OR ITS COMPONENTS

INCLUDING BLOOD PRODUCTS

INTRODUCTION

Blood Transfusion Service is a vital part of the National Health Service and
there is no substitute for Human Blood and its components. Increasing advancement
in the field of Transfusion Technology has necessitated to enforce 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 ovt. has the full responsibility for the blood programme even
though, in some countries, the management of blood transfusion services are
delegated fully or partly to an appropriate non!governmental organi"ation #N$s%
&orking on a non!profit basis, e.g. 'ed (ross Society. )hen a N$ is assigned this
responsibility, the ovt. should formally recogni"e 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.

In order to improve the standards of Blood and its components, the (entral
ovt. through *rugs (ontroller eneral of India, has formulated a comprehensive
legislation to ensure better quality control system on collection, storage, testing and
distribution of blood and its components. (entral ovt. amended from time to time
the e+isting requirements of Blood Banks in the *rugs , (osmetics -ct, ./01 and
'ules thereunder to meet the latest standards. (onsequent to a public litigation case
recently, Supreme (ourt of India directed (entral ovt. to enact a comprehensive
legislation on Blood Banks in collection, storage, testing and distribution of blood and
its components. In this conte+t, the office of *rugs (ontroller eneral of India
made draft rules to further amend the e+isting la& in the *rugs , (osmetics -ct,
./01 and 'ules thereunder to meet the direction of Hon2ble Supreme (ourt in order to
improve the blood banking system in the country.

NATIONAL BLOOD POLICY

overnment of India published in the year 3113 the National Blood
4olicy. The ob5ective 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 &ith regard to technical personnel, research , development and to
eliminate profiteering by the blood banks by selling blood. The policy also envisages
that fresh licences to stand alone blood banks in private sector shall not be granted and
rene&al of such blood banks shall be sub5ected to thorough scrutiny.

SCENARIO OF LEGAL FRAMEWORK

Human blood is covered under the definition of 6*rug2 under Sec. 7#b% of *rugs ,
(osmetics -ct. Hence, it is imperative that Blood Banks need to be regulated under
the *rugs , (osmetics -ct and rules thereunder.

In the year ./89, (entral ovt. #:inistry of Health% enacted a separate
provision in Schedule ; 4art <II B of *rugs , (osmetics 'ules. =arious
requirements such as -ccommodation, Technical staff, equipments etc. for operation
of blood bank &ere included in this 4art. State *rugs (ontrollers &ere authori"ed to
issue the licences for blood banks. The standards for 6)hole Human Blood2 &as
prescribed in Indian 4harmacopoeia.

*ue to prevalence of -I*S virus, the :inistry of Health , ;amily )elfare
#ovt. of India% issued a notification in the year ./>/ under the *rugs and (osmetics
'ules and made the test HI= .,3 antibodies of )hole Human Blood as mandatory
requirement before transfusion. It is imperative that each unit of blood and blood
products &ere regulated in the year .//1 and 7 laboratories vi". NI(* *elhi, NI=
4une and (:(, =ellore &ere notified to function as laboratory under 7- of *rugs and
(osmetics 'ules to test HI= antibodies in respect of human blood and human blood
products.

-s trained technicians &ere not available in the Blood Banks to carry out the
test for HI= .,3 antibodies, the :inistry of Health , ;amily )elfare notified ..3
Surveillance (entres to act as a testing lab for the blood banks for carrying out the
above test #?BT(%. The list of ..3 Surveillance (entres is anne+ed.

;ollo&ing :@s. ;erguson2s 'eport #&hich brought out various deficiencies
&ith regard to quality control of blood and blood products etc. in the year .//1 and
based on concern e+pressed in different fora and in 4arliament, the *,( 'ules &ere
again amended #'ules 8>-, 4art <B and 4art <IIB of Schedule ;% in the year .//3!/7
and *rugs (ontroller eneral #India% &as vested &ith the po&er of (entral Aicence
-pproving -uthority #(A--% to approve the licence of notified drugs vi". Blood and
Blood 4roducts, I.=. ;luids and =accines and Sera.

The requirement of a blood bank is inserted in 4art <!B of the *rugs and
(osmetics 'ules, ./0B. The 'ules from .33; to .334 e+plain the various procedure
of making applications by a blood bank, fees to be paid for grant@rene&al of licence
by the applicant and conditions of licence to be follo&ed by the applicant after
grant@rene&al and conditions of licence to be follo&ed by the applicant after
grant@rene&al of licnece.

In accordance &ith the Supreme (ourt order, blood bank legislation has been
e+tensively revised on B.0../// to include ood :anufacturing 4ractices, Standard
$perating 4rocedure and validation of equipments etc. The brief requirements for
grant@rene&al of blood bank licences are as follo&sC

PART X-B

REQUIREMENTS FOR THE COLLECTION, STORAGE, PROCESSING AND
DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY
BLOOD BANKS AND MANUFACTURE OF BLOOD PRODUCTS

122-EA. De!"!#!$"%.! #.% In this 4art and in the ;orms contained in Schedule - and
in 4art <II B and 4art <II( of schedule ;, unless there is anything repugnant in the
sub5ect or conte+t,!

#a% 6apheresis2 means for the process by &hich blood dra&n from a donor, after
separating plasma or platelets or leucocytes, is retransfused D simultaneously
into the said donorE
#b% 6autologous blood2 means the blood dra&n from the patient for re!transfusion
unto himself later onE
#c% 6blood2 means and includes &hole human blood, dra&n from a donor and
mi+ed &ith an anti!coagulantE
#d% 6blood bank2 means a place or organi"ation or unit or institution or other
arrangements made by such organi"ation, unit or institution for carrying out all
or any of the operations for collection, apheresis, storage, processing and
distribution of blood dra&n from donors and@or for preparation, storage and
distribution of blood componentsE
#e% 6blood component2 means a drug prepared, obtained, derived or separated from
a unit of blood dra&n from a donorE
#f% 6blood product2 means a drug manufactured or obtained from pooled plasma or
blood by fractionation, dra&n from donorsE
#g% 6donor2 means a person &ho voluntarily donates blood after he has been
declared fit after a medical e+amination, for donating blood, on fulfilling the
criteria given hereinafter, &ithout accepting in return any consideration in cash
or kind from any source, but does not include a professional or a paid donor.

EXPLANATION.! ;or the purposes of this clause, benefits or incentives like pins,
plaques, badges, medals, commendation certificates, time!off from &ork, membership
of blood assurance programme, gifts or little or intrinsic monetary value shall not be
construed as considerationE

#h% 6leucapheresis2 means the process by &hich the blood dra&n from a donor,
after leucocyte concentrates have been separated, is re!transfused
simultaneously into the said donorE
#i% 6plasmapheresis2 means the process by &hich the blood dra&n from a donor,
after plasma has been separated, is re!transfused during the same sitting into the
said donorE
#5% 6plateletpheresis2 means the process by &hich the blood dra&n from a donor,
after platelet concentrates have been separated, is re!transfused simultaneously
into the said donor.
#k% 6professional donor2 means a person &ho donates blood for a
valuable consideration, in cash or kind, from any source, on behalf of the
recipient D patient and includes a paid donor or a commercial donorE
(l) 6replacement donor2 means a donor &ho is a family friend or a relative of the
patient Drecipient.


122-F. F$&' $ ())*!+(#!$" $& *!+e"+e $& $)e&(#!$" $ B*$$, B("-/)&$+e%%!". $
/0$*e 01'(" 2*$$, $& +$')$"e"#%/'("1(+#1&e $& B*$$, P&$,1+#% $& %(*e $&
,!%#&!21#!$" #.% -pplication for the grant and@or rene&al of licence for the
operation of Blood Bank@processing of Human Blood for components@manufacture of
Blood 4roducts shall be made to the Aicensing -uthority appointed under 4art =II in
;orm 39!( or ;orm 39!F as the case may be and shall be accompanied by licence fees
of rupees si+ thousand and an inspection fees of rupees one thousand and five hundred
for every inspection thereof or for the purpose of rene&al of licence.

4rovided that if the applicant applies for rene&al of licence after the e+piry but
&ithin si+ months of such e+piry the fee payable for the rene&al of the licnece shall
be rupees si+ 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.

4rovided further that a licensee holding a licence in ;orm 3>!( or ;orm 3>!F as
the case may be for operation of blood bank@processing of &hole human blood for
components@manufacture of blood products shall apply for grant of licence under sub!
rule #.% before the e+piry of the said licnece on ;orm 39!( or ;orm 39!F as the case
may be and he shall continue to operate the same till the orders on his application are
communicated to him.

.. GF<4A-N-TI$N.! ;or the purpose of this rule, 6Blood Bank2 means a
place or organi"ational unit or an institution, or other arrangement made
by such organi"ational unit or institution for carrying out all or any of the
operations of manufacture of human blood components or blood products
or &hole human blood for its collection, storage, processing, distribution
from selected human donors.H
3. - fee of rupees one thousand shall be paid for a duplicate copy of licence
issued under this rule, if the original is defaced, damaged or lost.
7. -pplication 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.
0. $n receipt of the application for the grant or rene&al of such licence, the
Aicensing -uthority shall, !

#i% verify the statements made in the application form.
#ii% (ause the manufacturing and testing establishment to be
inspected in accordance &ith the provisions of rules .33!IE and
#iii% In case the application is for rene&al of licence, call for
information of past performance of the licensee.

B. If the Aicensing -uthority is satisfied that the applicant is in position to
fulfill the requirements laid do&n in the rules, he shall prepare a report to
that effect and for&ard it along &ith the application and the licence #in
triplicate% to be granted or rene&ed, duly completed to the (entral
Aicence -pproving -uthorityC

4rovided that if the Aicensing -uthority is of the opinion that the
applicant is not in a position to fulfill the requirements laid do&n in these
rules, he may, by order, for reason to be recorded in &riting, refuse to
grant or rene& the licence, as the case may be.

8. If, on receipt of application and the report of the Aicensing -uthority
referred to in Sub!rule B and after taking such measures including
inspection of the premises, by the inspector, appointed by the (entral
ovt. under Section 3. of the -ct, and@or along &ith e+pert in the field
concerned if deemed necessary, the (entral Aicence -pproving
-uthority, is satisfied that the applicant is in a position to fulfill the
requirement laid do&n in this rule. He may grant or rene& the licnece, as
the case may beC

4rovided that if the (entral Aicence -pproving -uthority is of the
opinion that the applicant is not in a position to fulfill the requirements
laid do&n in these rules he may, not&ithstanding the report of the
Aicensing -uthority, by order, for reason to be recorded in the &riting,
re5ect the application for grant or rene&al of licence as the case may be
and shall supply the applicant &ith a copy of the inspection report.

.33!. ;orm of licence for the operation of a Blood Bank@4rocessing of )hole
Human Blood for components and manufacture of Blood products and the conditions
for the grant or rene&al of such licence.! - licence for the operation of a Blood Bank
or for processing &hole Human Blood for components and manufacture of blood
products shall be issued in ;orm 3>!( or ;orm!3>!F or ;orm 38! or ;orm 38!I as
the case may be. Before a licence in ;orm 3>!( or ;orm!3>!F or ;orm 38! or ;orm
38!I, as the case may be, is granted or rene&ed the follo&ing conditions shall be
complied &ith by the applicant.!

#i% The operation of the Blood Bank and@or processing of &hole 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 &ho is &hole time
employee and &ho is a :edical $fficer, and possessing!
a% 4ost raduate degree in :edicine!:.*.
#4athology@Transfusion :edicines%E or
b% *egree in :edicine #:.B.B.S.% &ith *iploma in 4athology
or Transfusion :edicines having adequate kno&ledge in
blood group serology, blood group methodology and
medical principles involved in the procurement of blood
and@or preparation of its componentsE or
c% *egree in :edicine #:.B.B.S.% having e+perience in Blood
Bank for one year during regular service and also has
adequate kno&ledge and e+perience 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 recogni"ed by the
(entral overnment.

F<4A-N-TI$N! ;or the purposes of this condition, the
e+perience in Blood Bank for one year shall not apply in the case
of persons &ho are approved by the Aicensing -uthority and@or
(entral Aicence -pproving -uthority prior to the commencement
of the *rugs , (osmetics #Second -mendment% 'ules,.///.

#ii% 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 is given in
Schedule 6;2, 4art <II!B and @ or <II!(.
#iii% The applicant shall provide and maintain adequate technical staff as
specified in Schedule 6;2, 4art <II!B and@or <II!(.
#iv% The applicant shall provide adequate arrangements for storage of
)hole Human Blood, Human Blood (omponents and blood
products.
#v% The applicant shall furnish to the Aicensing -uthority, if required to
do so, data on the stability of )hole Human Blood, its components
or blood products &hich are likely to deteriorate, for fi+ing the date
of e+piry &hich shall be printed on the labels of such products on the
basis of the data so furnished.

.33!H. *uration of Aicence.! -n original licence in ;orm 3>!( or ;orm 3> DF or a
rene&ed licence in ;orm 38! or ;orm 38!I unless sooner suspended or cancelled
shall valid for a period of five years and from the date on &hich the year in &hich it is
granted or rene&ed.

.33!I. Inspection before grant or rene&al of licence for operation of Blood Bank,
processing of )hole Human Blood for (omponents and :anufacture of Blood
4roducts.! Before a licence in ;orm 3>!( or ;orm 3> DF is granted or a rene&al of
licence in ;orm 38! or ;orm 38!I is made ,as the case may be, the Aicensing
-uthority or (entral Aicence -pproving -uthority, as the case may be , shall cause
the establishment in &hich Blood Bank is proposed to be operated@ &hole human
blood for component is processedI@J blood products are manufactured to be inspected
by one or more inspectors, appointed under the -ct and @ or along &ith the F+pert in
the field concerned. The Inspector or Inspectors shall e+amine all portions of the
premises and appliances@ equipments and inspect the process of manufacture intended
to be employed or being employed along &ith the means to be employed or being
employed for operation of blood bank@processing of &hole human blood
for components@ manufacture of blood products together &ith their ItestingJ facilities
and also enquire into the professional qualification of the e+pert staff and other
technical staff to be employed.
.33!K. 'eport by Inspector.! The Inspector or Inspectors shall for&ard a detailed
descriptive report giving his finding on each aspect of inspection along &ith his
recommendation in accordance &ith the provisions of 'ule .33!I to the Aicensing
-uthority or to the (entral Aicence -pproving -uthority.

.33!L. ;urther application after re5ection.! If &ithin a period of si+ months from the
re5ection of application for a licence the applicant informs the licensing -uthority that
the conditions laid do&n have been satisfied and deposits an inspection fee of rupees
t&o hundred and fifty the Aicensing -uthority, if after causing further inspection to be
made is satisfied that the conditions for the grant of a licence have been complied
&ith, shall grant or rene& a licence in ;orm 3>!( or ;orm 3> DFE

4rovided that in case of drug notified by the (entral overnment under
rule 8>!-, the application , together &ith the inspection report and the ;orm of licence
#in triplicate to be granted or rene&ed%, duly completed shall be sent, to the (entral
Aicence -pproving -uthority, &ho may approve the same and return it to the licensing
-uthority for issue of the licence.

.33!A. *elegation of po&ers by the (entral Aicensing -pproving -uthority.! The
(entral Aicensing -pproving -uthority may, &ith the approval of the (entral
overnment, by notification delegate his po&er of signing licences and any other
po&er under rules to persons under his control having same qualifications as
prescribed for (ontrolling -uthority under 'ule B1!-, for such areas and for such
periods as may be specified.

.33!:. 4rovision for appeal to the State overnment by a 4arty &hose licence has
not been granted or rene&ed.! -ny person &ho is aggrieved by the order passed by the
Aicensing -uthority or (entral Aicence -pproving -uthority, as the case may be, may
&ithin thirty days from the date of receipt of such order, appeal to the State
overnment or (entral overnment, 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 vie& in the matter may pass such order in relation thereto as it thinks
fit.

.33!N. additional information to be furnished by an IapplicantJ for licence or by a
licensee to the Aicensing -uthority.! The applicant for the grant of licence or any
person granted a licence under the part shall, on demand furnish to the Aicensing
-uthority, before the grant of the licence or during the period the licence is in force as,
as the case may be, documentary evidence in respect of the o&nership or occupation,
rental or other basis of the premises, specified in the application for licence or in the
licence granted, constitution of the firm or any other relevant matter, &hich may be
required for the purpose of verifying the correctness of the statement made by the
applicant or the licensee, &hile applying for or after obtaining the licence, as the case
may be.

.33!$.(ancellation and suspension of licences.! #.% The Aicensing -uthority or
(entral Aicence -pproving -uthority may for such licences granted or rene&ed by
him after giving the licensee an opportunity to sho& cause by such an order should
not be passed by an order in &riting stating the reason thereof, cancel a licence issued
under this part or suspend it for such period as he thinks fit, either &holly or in respect
of some of the substances to &hich it relates, Ior direct the licensee to stop collection,
storage, processing, manufacture and distribution of the said substances and
Ithereupon order the destruction of substances andJ stocks thereof in the presence of
an InspectorJ if in his opinion, the licensee has failed to comply &ith any of the
conditions of the licence or &ith any provision of the -ct or 'ules thereunder.

#3% - licensee &hose licence has been suspended or cancelled, &ithin
three months of the date of the order under sub!rule #.% prefer an appeal against that
order to the State overnment or (entral overnment, &hich shall decide the same.

.33!4. (onditions of licence! - licence in ;orm 3>!(, ;orm 3>!F, ;orm 38! or ;orm
38!I shall be sub5ect to the special conditions set out in Schedule ;, 4art <II!B and
4art <II!(, as the case may be, &hich relate to the substance in respect of &hich the
licence is granted or rene&ed and to the follo&ing general conditions, namelyC!
#i% #a% The licensee shall provide and maintain adequate staff,
plant and premises for the proper operation of a Blood
Bank for processing &hole human blood, its components
and@or manufacture of blood products.

#b% The licensee shall maintain staff, premises and equipments
as specified in 'ule .33!. The licensee shall maintain
necessary records and registers as specified in Schedule ;,
4arts <II!B and <II!(.

#c% The licensee shall test in his o&n laboratory &hole human
blood, its components and blood products and Imaintain
records andJ registers in respect of such tests as specified in
Schedule ;, 4art <II!B and 4art <II!(. 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 Isample
andJ supply to the Inspector the reference sample of the
&hole 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.

#ii% The licensee shall allo& an inspector appointed under the
-ct to enter, &ith or I&ithoutJ prior notice, any premises
&here the activities of the Blood Bank are being carried
out, for the processing of )hole Human Blood and@or
Blood 4roducts, to inspect the premises and plant and the
process of manufacture and the means employed for
standardi"ing and testing the substance.

#iii% The licensee shall allo& an Inspector appointed under the
-ct 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 &hether the
provisions of the -ct and 'ules thereunder have been
observed.

#iv% The licensee shall from time to time report to the
Aicensing -uthority any changes in the e+pert staff
responsible for the operation of a Blood Bank@processing of
&hole human blood for components and@or manufacture of
blood products and any material alterations in the premises
or plant used for that purpose &hich have been made since
the date of last inspection made on behalf of the Aicensing
-uthority before the grant of the licence.

#v% The licensee shall on request furnish to the Aicensing
-uthority, or (entral Aicence -pproving -uthority or to
such -uthority as the Aicensing -uthority, or the (entral
Aicence -pproving -uthority may direct, from any batch
unit of drugs as the Aicensing -uthority or the (entral
Aicence -pproving may from time to time specify, sample
of such quantity as may be considered adequate by such
-uthority for any e+amination and, if so required, also
furnish full protocols of the test &hich have been applied.

#vi% If the Aicensing -uthority or the (entral Aicence
-pproving -uthority so directs, the licensee shall not sell
or offer for sale any batch@unit in respect of &hich a sample
is, or protocols are furnished under the last preceding sub!
paragraph until a certificate authori"ing the sales of
batch@unit has been issued to him by or on behalf of the
Aicensing -uthority or the (entral Aicence -pproving
-uthority.

#vii% The licensee shall on being informed by the Aicensing
-uthority or the (ontrolling -uthority that any part of any
batch@unit of the substance has been found by the Aicensing
-uthority or the (entral Aicence -pproving -uthority not
to conform &ith the standards of strength, quality or purity
specified in these 'ules and on being directed so to do so,
&ithdra&, 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.

#viii% No drug manufactured under the licence shall be sold
unless the precautions necessary for preserving its
properties have been observed throughout the period after
manufacture. ;urther no batch@unit manufactured under this
licence shall be supplied@distributed to any person &ithout
prescription of 'egistered :edical 4ractitioner.

#i+% The licensee shall comply &ith the provisions of the -ct
and of these 'ules and &ith such further requirements, if
any, as may be specified in any 'ules subsequently made
under (hapter I= of the -ct, provided that &here such
further requirements are specified in the 'ules, these &ould
come in force four months after publication in the $fficial
a"ette.

#+% The licensee shall maintain an Inspection Book in ;orm
7B to enable an Inspector to record his impressions and
defects noticed.

#+i% The licensee shall destroy the stocks of batch@unit &hich
does not comply &ith standard tests in such a &ay that it
&ould not spread any disease@infection by &ay of proper
disinfection method.

#+ii% -ll bio!medical &aste shall be treated, disposed off or
destroyed as per the provisions of The Bio!:edical )astes
#:anagement and Handling% 'ules .//8.

#+iii% 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 dra&n from such a donor.

F$&' 23-G
#See 'ule .33!;%

CERTIFICATE OF RENEWAL OF LICENCE TO OPERATE A BLOOD BANK FOR
PROCESSING OF WHOLE HUMAN BLOOD AND/OR4 FOR PREPARATION
FOR SALE OR DISTRIBUTION OF ITS COMPONENTS

. (ertified that licence number MMMMMMMMMMMMMMMMMMMMMMMMgranted on
MMMMMMMM to :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM for the operation
of a Blood Bank for processing of &hole blood and @ or for preparation of its
components at the premises situated at MMMMMMMMMMMMMMMMMMMMMMM is hereby
rene&ed &ith effect from MMMMMMMMMMMMMMMM to MMMMMMMMMMMMMMMMMMM.

3 Name #s% of Items C
..
3.
7.

7. Name#s% of competent Technical Staff C
..
3.
7.
0.
B.
8.

*ated MMMMMMMMMMMMMMMMM Signature MMMMMMMMMMMMMMMMMMMMMMMM

Name and *esignation MMMMMMMMMMMMMMMMMMMM
Aicensing -uthority
MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM
MMMMMM
(entral Aicence -pproving -uthority

N delete, &hichever is not applicable.OE

#b% after ;orm 38!H, the follo&ing ;orm shall be inserted, namely C!

5F$&' 23-I
#See rule .33!I%

CERTIFICATE OF RENEWAL OF LICENCE FOR
MANUFACTURE OF BLOOD PRODUCTS

(ertified that licence number MMMMMMMMMMMMMMMMMMMMMMMMgranted on
MMMMMMMMMMM to :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMM for manufacture of
blood products at the premises situated at MMMMMMMMMMMMMMMMMM is hereby
rene&ed &ith effect from MMMMMMMMMMMMM to MMMMMMMMMMMMMMMMMMM.

3. Name#s% of item#s% C
..
3.
7.

7. Names of competent Technical Staff C
#a% responsible for manufacturing #b% responsible for
testing

.. ..
3. 3.
7. 7.
0. 0.

Signature MMMMMMMMMMMMMMMMMM

Name and *esignation MMMMMMMMMMMMMM
Aicensing -uthority
MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM
(entral Aicence -pproving -uthorityO.E


#c% for ;orm 39!(, the follo&ing form shall be substituted, namelyC!


5F$&' 26-C
#See rule .33!;%

APPLICATION FOR GRANT / RENEWAL 4 OF LICENCE FOR THE
OPERATION OF A BLOOD BANK FOR PROCESSING OF WHOLE BLOOD
AND/OR4 PREPARATION OF BLOOD COMPONENTS

.. I@)e MMMMMMMMMMMMMMMMMMMof
:@sMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMhereby apply for the grant of licence @
rene&al of licence number MMMMMMMMMMMMMMdated MMMMMMMMMMMMMMMMMMMMMMM
to operate a Blood Bank, for processing of &hole blood and@orN for preparation
of its components on the premises situated at
MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM.

3. Name#s% of the item#s%C
..
3.
7.

7. The name#s%, qualification and e+perience of competent Technical Staff
are as
under C

#a% Name#s% of :edical $fficer.

#b% Name#s% of Technical Supervisor.

#c% Name#s% of 'egistered Nurse.

#d% Name#s% of Blood Bank Technician.

0. The premises and plant are ready for inspection@ &ill be ready for inspection
on
MMMMMMMMMMMMMMMMMMMMMMM.


B. - licence fee of rupees MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM and an
inspection fee of rupees MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM has been
credited to the overnment under the Head of -ccount
MMMMMMMMMMMMMMMMMMMMMMM #receipt enclosed%.


Signature
MMMMMMMMMMMMMMMMMMMMMMMMMMMM

*ated MMMMMMMMMMMMMMM Name and *esignation
MMMMMMMMMMMMMMMMMMM

N delete, &hichever is not applicable.

Note .. The application shall be accompanied by a plan of the premises,
list of machinery and equipment for collection, processing,
storage and testing of &hole blood and its components,
memorandum of association@ constitution of the firm, copies of
certificate relating to educational qualifications and e+perience of
the competent technical staff and documents relating to o&nership
or tenancy of the premises.

3. - copy of the application together &ith the relevant enclosures
shall also be sent to the (entral Aicence -pproving -uthority and
to the concerned ?onal@Sub! ?onal $fficers of the (entral *rugs
Standard (ontrol $rgani"ation.OE

#d% after ;orm 39!*, the follo&ing ;orm shall be inserted, namely C!

5F$&' 26-E
#See rule .33!;%

APPLICATION FOR GRANT/RENEWAL4OF LICENCE TO MANUFACTURE
BLOOD PRODUCTS FOR SALE OR DISTRIBUTION

.. I@)e MMMMMMMMMMMMMMMMMMMMof :@sMMMMMMMMMMMMMMMMMMMMMMMMMMMhereby
apply for the grant of licence@rene&al of licence number MMMMMMMMMMMMMMMMMMMMM
dated MMMMMMMMMMMMMMMMMMMMM to manufacture blood products on the premises
situated at MMMMMMMMMMMMMMMMMMMMMM

3. Name#s% of item#s% C
..
3.
7.
0.

7. The name#s%, qualification and e+perience of competent Technical Staff
as under C
#a% responsible for manufacturing #b% responsible for
testing

.. ..
3. 3.
7. 7.

0. The premises and plant are ready for inspection @ &ill be ready for inspection
onMMMMMMMMMMMMMMMMMMMMMMMMMMMM

B. - licence fee of rupees MMMMMMMMMMMMMMand an inspection fee of rupees
MMMMMMMMMMMMMMMMMMMMMMMMMMM has been credited to the overnment under the
Head of -ccount MMMMMMMMMMMMMMMMM #receipt enclosed%,

*ated MMMMMMMMMMMM signature MMMMMMMMMMMMMMMMMMMMMMMM

Name , *esignation
MMMMMMMMMMMMMMM

N delete, &hichever is not applicable.

N$TF .. 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 e+perience of the competent
technical staff and documents relating to o&nership or tenancy of the
said premises.
3. - copy of the application together &ith the relevant enclosures shall
also be sent to the (entral Aicence -pproving -uthority and to the
concerned ?onal @ Sub ?onal $fficers of the (entral *rugs Standard
(ontrol $rganisation.OE

#e% for ;orm 3>!(, the follo&ing ;orm shall be substituted, namely C!

5F$&' 27-C
#See rule .33!%

LICENCE TO OPERATE A BLOOD BANK FOR COLLECTION, STORAGE
AND
PROCESSING OF WHOLE HUMAN BLOOD AND/OR4 ITS COMPONENTS
FOR
SALE OR DISTRIBUTION

.. Number of licence MMMMMMMMMMMMMMMMMMMMM date of issue
MMMMMMMMMMMMMMMMat
the premises situated at MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM

3. :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM is hereby licensed to
collect, store, process and distribute &hole blood and @ or its components.

7. Name#s% of the item#s% C
..
3.
7.

0. Name#s% of competent Technical Staff C
..
3.
7.
0.
B.
8.

B. The licence authori"es licensee to manufacture, store, sell or distribute the
blood products, sub5ect to the conditions applicable to this licence.
8. The licence shall be in force from MMMMMMMMMMMM to MMMMMMMMMMMMM
9. The licence shall be sub5ect to the conditions stated belo& and to such other
conditions as may be specified from time to time in the 'ules made under the
*rugs and (osmetics -ct, ./01.

*ated MMMMMMMMMMMMM Signature
MMMMMMMMMMMMMMMMMMMMMMMM

Name and *esignation
MMMMMMMMMMMMM
Aicensing -uthority
MMMMMMMMMMMMMMMMMMMMMMMMMMM
MMMMM
(entral Aicence -pproving
-uthority
Ndelete, &hichever is not applicable

CONDITIONS OF LICENCE

.. The licensee shall neither collect blood from any professional donor nor
paid donor nor shall he prepare blood components from the blood collected
from such a donor.
3. The licence and any certificate of rene&al in force shall be displayed on the
approved premises and the original shall be produced at the request of an
Inspector appointed under the *rugs and (osmetics -ct, ./01.
7. -ny change in the technical staff shall be forth&ith reported to the Aicensing
-uthority and @ or (entral Aicence -pproving -uthority.
0. The licensee shall inform the Aicensing -uthority and@or (entral Aicence
-pproving -uthority in &riting in the event of any change in the constitution of
the firm operating under the licence. )here any change in the constitution of
the firm takes place, the current licence shall be deemed to be valid for
ma+imum period of three months from the date on &hich the change has taken
place unless, in the meantime, a fresh licence has been taken from the
Aicensing -uthority and@or (entral Aicence -pproving -uthority in the name
of the firm &ith the changed constitution.OE

#f% after ;orm 3>!*, the follo&ing ;orm shall be inserted, namely C!

5F$&' 27-E
#See rule .33!%

LICENCE TO MANUFACTURE AND STORE BLOOD PRODUCTS FOR
SALE OR DISTRIBUTION

.. Number of licence MMMMMMMMMMMMMMMMMMMMM date of issue
MMMMMMMMMMMMMMMMat
the premises situated at MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM
3. :@s MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMis hereby licensed to
manufacture, store, sell or distribute the follo&ing blood products C!
7. Name#s% of the item#s% C
..
3.
7.
0.
B.
0. Name#s% of competent Technical Staff C
#a%responsible for manufacturing #b% responsible for testing
.. ..
3. 3.
7 7.
B. The licence authori"es licensee to manufacture, store, sell or distribute the
blood products, sub5ect to the conditions applicable to this licence.
8. The licence shall be in force from MMMMMMMMMMMMMMMMMMMMM to
MMMMMMMMMMMMM
9. The licence shall be sub5ect to the conditions stated belo& and to such other
conditions as may be specified from time to time in the 'ules made under the
*rugs and (osmetics -ct, ./01.

*ated MMMMMMMMMMMMM Signature
MMMMMMMMMMMMMMMMMMMMMMMM

Name and *esignation
MMMMMMMMMMMMM
Aicensing -uthority
MMMMMMMMMMMMMMMMMMMMMMMMMMM
MM
(entral Aicence -pproving
-uthority
Ndelete, &hichever is not applicable

CONDITIONS OF LICENCE
.. The licensee shall not manufacture blood products from any professional
donor or paid donor.
3. This licence and any certificate of rene&al in force shall be displayed on the
approved premises and the original shall be produced at the request of an
Inspector appointed under the *rugs and (osmetics -ct, ./01.
7. -ny change in the technical staff shall be forth&ith reported to the Aicensing
-uthority and @ or (entral Aicence -pproving -uthority.
0. The licensee shall inform the Aicensing -uthority and@ or (entral Aicence
-pproving -uthority in &riting in the event of any change in the constitution of
the firm, operating under the licence. )here any change in the constitution of
the firm takes place, the current licence shall be deemed to be valid for
ma+imum period of three months from the date on &hich the change has taken
place unless, in the meantime, a fresh licence has been taken from the
Aicensing -uthority and@or (entral Aicence -pproving -uthority in the name
of the firm &ith the changed constitution.E


5PART XII B
REQUIREMENTS FOR THE FUNCTIONING AND OPERATION OF A BLOOD
BANK AND / OR FOR PREPARATION OF BLOOD COMPONENTS.

I. BLOOD BANKS / BLOOD COMPONENTS
A. GENERAL

.. Aocation and Surroundings C The blood bank shall be located at a place &hich
shall be a&ay from open se&age, drain, public lavatory or similar unhygienic
surroundings.

3 Building C The building #s%, used for operation of a blood bank and@or
preparation of blood components shall be constructed in such a manner so as to
permit the operation of the blood bank and preparation of blood components
under hygienic
conditions and shall avoid the entry of insects, rodents and flies. It shall be
&ell lighted, ventilated and screened #mesh%, &herever necessary. The &alls
and floors of the rooms, &here collection of blood or preparation of blood
components or blood products is carried out shall be smooth, &ashable and
capable of being kept clean. *rains shall be of adequate si"e and &here
connected directly to a se&er, shall be equipped &ith traps to prevent back
siphonage.

7. Health, clothing and sanitation of staff C The employees shall be free
from contagious or infectious diseases. They shall be provided &ith clean
overalls, head!gears, foot!&ears and gloves, &herever required. There shall be
adequate, clean and convenient hand &ashing and toilet facilities.

B. ACCOMODATION FOR A BLOOD BANK 8

- blood bank shall have an area of .11 square meters for its operations and
an additional area of B1 square meters for preparation of blood components. It
shall be consisting of a room each for D

#.% 'egistration and medical e+amination &ith adequate furniture and facilities
for registration and selection of donorsE

#3% blood collection #air!conditioned%E

#7% blood component preparation. #This shall be air!conditioned to maintain
temperature bet&een 31 degree centigrade to 3B degree centigrade%E

#0% laboratory for blood group serology. #air!conditioned%

#B% laboratory for blood transmissible diseases like Hepatitis, Syphilis, :alaria,
HI=!antibodies #air!conditioned%E

#8% sterili"ation!cum!&ashingE

#9% refreshment!cum!rest room #air!conditioned%E

#>% store!cum!records.

NOTES 8
#.% The above requirements as to accommodation and area may be
rela+ed, In respect of testing laboratories and sterili"ation!cum!
&ashing room, for reasons to be recorded in &riting by the Aicensing
-uthority and @ or the (entral Aicence -pproving -uthority, in
respect of blood banks operating in Hospitals, provided the hospital
concerned has a pathological laboratory and a sterili"ation!cum!
&ashing room common &ith other departments in the said hospital.

#3% 'efreshments to the donor after phlebotomy shall be served so that
he
is kept under observation in the Blood Bank.

C. PERSONNEL

Fvery blood bank shall have follo&ing categories of &hole time competent
technical staff C!
#a% :edical $fficer, possessing the qualifications specified in condition
of rule .33!.

#b% Blood Bank Technician#s% ,possessing !
#i% *egree in :edical Aaboratory Technology #:.A.T.% &ith si+
monthsP e+perience in the testing of blood and@or its
componentsE or
#ii% *iploma in :edical Aaboratory Technology #:AT% &ith
one yearPs e+perience in the testing of blood and@or its
components, the degree or diploma being from a
Qniversity@Institution recognised by the (entral overnment
or State overnment.

#c% 'egistered Nurse#s%.

#d% Technical Supervisor#&here blood components are manufactured%,
possessing !

#i% *egree in :edical Aaboratory Technology #:.A.T.% &ith si+
monthsP e+perience in the preparation of blood componentsE
or
#ii% *iploma in :edical Aaboratory Technology #:.A.T% &ith
one yearPs e+perience in the preparation of blood
components, the degree or diploma being from a
Qniversity@Institution recognised by the (entral overnment
or State overnment.

NOTES8
#.% The requirements of qualification and e+perience in respect of Technical
Supervisor and Blood Bank Technician shall apply in the cases of persons
&ho are approved by the Aicensing -uthority and@or (entral Aicence
-pproving -uthority after the commencement of the *rugs and
(osmetics# -mendment% 'ules, .///.
#3% -s regards, the number of &hole time competent technical personnel, the
blood bank shall comply &ith the requirements laid do&n in the *irectorate
eneral of Health Services :anual.
#7% It shall be the responsibility of the licensee to ensure through maintenance
of records and other latest techniques used in blood banking system that the
personnel involved in blood banking activities for collection, storage,
testing and distribution are adequately trained in the current ood
:anufacturing 4ractices@Standard $perating 4rocedures for the tasks
undertaken by each personnel. The personnel shall be made a&are of the
principles of ood :anufacturing 4ractices@Standard operating 4rocedures
that affect them and receive initial and continuing training relevant to their
needs.

D. MAINTENANCE 9

The premises shall be maintained in a clean and proper manner to ensure
adequate cleaning and maintenance of proper operations. The facilities shall
include D

# .% 4rivacy and thorough e+amination of individuals to determine their suitability
as donors.

#3% (ollection of blood from donors &ith minimal risk of contamination or
e+posure to
activities and equipment unrelated to blood collection.

#7% Storage of blood or blood components pending completion of tests.
#0% 4rovision for quarantine, storage of blood and blood components in a
designated location, pending repetition of those tests that initially give
questionable serological results.

#B% 4rovision for quarantine, storage, handling and disposal of products and
reagents not suitable for use.

#8% Storage of finished products prior to distribution or issue.

#9% 4roper collection, processing, compatibility testing, storage and distribution of
blood and blood components to prevent contamination.

#>% -dequate and proper performance of all procedures relating to
plasmapheresis, plateletpheresis and leucapheresis.

#/% 4roper conduct of all packaging, labeling and other finishing operations.

#.1% 4rovision for safe and sanitary disposal of D

#i% Blood and@or blood components not suitable for use, distribution or
sale.

#ii% Trash and items used during the collection, processing and
compatibility
testing of blood and@or blood components.

E. EQUIPMENT 8

Fquipment used in the collection, processing, testing, storage and sale@distribution of
blood and its components shall be maintained in a clean and proper manner and so
placed as to facilitate cleaning and maintenance. The equipment shall be observed,
standardised and calibrated on a regularly scheduled basis as described in the Standard
$perating 4rocedures :anual and shell operate in the manner for &hich it &as
designed so as to ensure compliance &ith the official requirements #the equipments%
as stated belo& for blood and its components.

Fquipment that shall be observed, standardised and calibrated &ith at least the
follo&ing frequencies C!

FRQI4:FNT 4F';$':-N(F ;'FRQFN(S ;'FRQFN(S $;
(-AIB'-TI$N
.. Temperature recorder (ompare against
thermometer
*aily -s often as necessary
3. 'efrigerated
centrifuge
$bserve speed and
temperature
Fach day of use -s often as necessary
7. Hematocrit
centrifuge
!! !! Standardise before
initial use, after repair or
ad5ustments, and
annually.

0. eneral
lab. centrifuge
!! !! Tachometer. every 8
months,
B. -utomated Blood
typing
$bserve controls for
correct results
Fach day of use !!!
8. Haemoglo! bihometer Standardi"e
against cyanamethemo!
globulin standard
Fach day of use !!!
9. 'efractiometer or
Qrinometer
Standardi"e against
distilled &ater .
!!!ditto
!!!
!!!
>. Blood
container &eighing
device
standardi"e against
container of kno&n
&eight
!!!ditto !! -s often as necessary,
/. )ater Bath $bserve Temperature !!!ditto
!!
!!!!ditto!!!!
.1. 'h vie& bo+#&herever
necessary%
!!ditto !! !!ditto!! !!!!ditto!!!!
... -utoclave !!ditto !! Fach time
of use
!! ditto !!
.3. serologic rotators $bserve controls for
correct results
Fach day of use speed as often as
necessary
.7. Aaboratory
thermometers
!! !! Before initial use
.0. Flectronic
thermometers
!! :onthly !!
.B. Blood agitator $bserve &eight of the
first container of blood
filled for correct results
Fach day of use standardi"e &ith
container of kno&n mass
or volume before initial
use, and after repairs or
ad5ustments.

F. SUPPLIES AND REAGENTS8

-ll supplies and reagents used in the collection, processing, compatibility,
testing, storage and distribution of blood and blood components shall be stored at
proper temperature in a safe and hygienic place, in a proper manner and in particular D

#a% all supplies coming and contact &ith blood and blood components intended
for
transfusion shall be sterile, pyrogen!free, and shall not interact &ith the product
in such a manner as to have an adverse effect upon the safety, purity, potency or
effectiveness of the product.

#b% supplies and reagents that do not bear an e+piry date shall be stored in a
manner
that the oldest is used first.

#c% supplies and reagents shall be used in a manner consistent &ith instructions
provided by the manufacturer .

#d% all final containers and closures for blood and blood components not intended
for
transfusion shall be clean and free of surface solids and other contaminants.

#e% each blood collecting container and its satellite container#s%, if any, shall be
e+amined visually for damage or evidence of contamination prior to its use and
immediately after filling. Such e+amination shall include inspection for
breakage of seals, &hen indicated, and abnormal discoloration. )here any
defect is observed, the container shall not be used or, if detected after filling,
shall be properly discarded.

#f% representative samples of each lot of the follo&ing reagents and@or solution
shall
be tested regularly on a scheduled basis by methods described in the Standard
$perating 4rocedures :anual to determine their capacity to perform as
required C

'eagents and solutions ;requency of testing
along&ith controls

-nti!human serum Fach day of use
Blood grouping serums Fach day of use
Aectin Fach day of use
-ntibody screening and reverse Fach day of use
grouping cells
Hepatitis test reagents Fach run
Syphilis serology reagents Fach run
Fn"ymes Fach day of use
HI= I and II reagents Fach run
Normal saline #AISS and 4BS% Fach day of use
Bovine -lbumin Fach day of use

G. GOOD MANUFACTURING PRACTICES :GMP%;/STANDARD
OPERATING
PROCEDURES :SOP%;8

)ritten Standard $perating 4rocedures shall be maintained and shall include
all
steps to be follo&ed in the collection, processing, compatibility testing, storage and
sale or distribution of blood and@or preparation of blood components for homologous
transfusion, autologous transfusion and further manufacturing purposes. Such
procedures shall be available to the personnel for use in the concerned areas. The
Standard $perating 4rocedures shall inter alia include C

.. #a% criteria used to determine donor suitability.

#b% methods of performing donor qualifying tests and measurements
Including minimum and ma+imum values for a test or procedure,
&hen a factor in determining acceptabilityE

#c% solutions and methods used to prepare the site of phlebotomy so
as to give ma+imum assurance of a sterile container of bloodE

#d% method of accurately relating the product#s% to the donorE

#e% blood collection procedure, including in!process precautions
taken to measure accurately the quantity of blood dra&n from the
donorE

#f% methods of component preparation including, any time
restrictions for specific steps in processingE

#g% all tests and repeat tests performed on blood and blood
components during processingE

#h% pre!transfusion testing, &herever applicable,
including precautions to be taken to identify accurately the
recipient blood components during processingE

#i% procedures of managing adverse reactions in donor and recipient
reactions

#5% storage temperatures and methods of controlling storage
temperatures for blood and its components and reagentsE

#i% length of e+piry dates, if any, assigned for all final productsE

#I% criteria for determining &hether returned blood is suitable for re!
issueE

#m% procedures used for relating a unit of blood or blood component
from the donor to its final disposalE

#n% quality control procedures for supplies and reagents employed in
blood collection, processing and re!transfusion testingE

#o% schedules and procedures for equipment maintenance and
calibrationE

#p% labelling procedures to safe guard its mi+!ups, receipt, issue,
re5ected and in!handE

#q% procedures of plasmapheresis, plateletphersis and leucapheresis
if performed, including precautions to be taken to ensure re!
infusion of donorPs o&n cells.

#r% procedures for preparing recovered #salvaged% plasma if
performed, including details of separation, pooling, labeling,
storage
and distribution.

#s% all records pertinent to the lot or unit maintained pursuant to
these regulations shall be revie&ed before the release or
distribution of a lot or unit of final product. The revie& or
portions of the revie& may be performed at appropriate periods
during or after blood collection, processing, testing and storage -
thorough investigation, including the conclusions and follo&!up,
of any une+plained discrepancy or the failure of a lot or unit to
meet any of its specification shall be made and recordedE

3. - licensee may utilise current Standard $perating 4rocedures, such as
the :anuals of the follo&ing organisations, so long as such specific
procedures are consistent &ith, and at least as stringent as, the
requirements contained in this 4art, namely C!

#i% *irectorate eneral of Health Services :anual.
#ii% $ther $rganisations or individual blood bankPs manuals, sub5ect
to the approval of State Aicensing -uthority and (entral Aicence
-pproving -uthority.

H. CRITERIA FOR BLOOD DONATION C

(onditions for donation of blood C

# .% eneral !No person shall donate blood and no blood bank shall dra& blood from a
person, more than once in three months. The donor shall be in good health, mentally
alert and physically fit and shall not be inmates of 5ail, persons having multiple se+
partners and drug!addicts. The donors shall fulfill the follo&ing requirements,
namely C!

#a% the donor shall be in the age group of .> to 81 years.
#b% the donor shall not be less than 0B kilogramsE
#c% temperature and 4ulse of the donor shall be normalE
#d% the systolic and diastolic blood pressures are &ithin normal limits
&ithout medicationE
#e% haemoglobin &hich shall not be less than .3.B gramsE
#f% the donor shall be free from acute respiratory diseasesE
#g% the donor shall be free from any skin diseases at the site of phlebotomy E
#h% the donor shall be free from any disease transmissible by blood transfusion,
insofar as can be determined by history and e+amination indicated aboveE
#i% the arms and forearms of the donor shall be free from skin punctures or
scars indicative of professional blood donors or addiction of self in5ected
narcotics

#3% -dditional qualifications of a donor. !No person shall donate blood, and no blood
bank shall dra& blood from a donor, in the conditions mentioned in column #.%
of the Table given belo& before the e+piry of the period of deferment
mentioned in the column #3% of the said Table.

TableC *eferment of blood donation

CONDITIONS PERIOD OF DEFERMENT
#.% #3%

#a% -bortions 8 months
#b% History of Blood transfusion 8 months
#c% Surgery .3 months
#d% Typhoid .3 months after recovery
#e% History of :alaria and 7 months #endemic%
duly treated 7 years #non endemic area%
#f% Tattoo 8 months
#h% Breast feeding .3 months after delivery
#i% Immuni"ation #(holera, .B days
Typhoid, *iphtheria,
Tetanus, 4lague,
ammaglobulin%
#5% 'abies vaccination . year after vaccination
#k% History of Hepatitis in .3 months
family or close contact
#l% Immunoglobulin .3 months.

#7% No person shall donate blood and no brood bank shall dra& blood from a person,
suffering from any of the diseases mentioned belo&, namely .!

a. (ancer
b. Heart disease
c. -bnormal bleeding tendencies
d. Qne+plained &eight loss
e. *iabetes!controlled on Insulin
f. Hepatitis infection
g. (hronic nephritis
h. Signs and symptoms, suggestive of -I*S
i. Aiver disease
5. Tuberculosis
k. 4olycythemia =era
l. -sthma
m. Fpilepsy
n. Aeprosy
o. Schi"ophrenia
p. Fndocrine disorders

I. GENERAL EQUIPMENTS AND INSTRUMENTS C

.. ;or blood collection room C
#i% *onor beds, chairs and tablesC These shall be suitably and comfortably
cushioned and shall be of appropriate si"e.
#ii% Bedside table.
#iii% Sphygmomanometer and Stethoscope.
#iv% 'ecovery beds for donors.
#v% 'efrigerators, for storing separately tested and untested blood, maintaining
temperature bet&een 3 to 8 degree centigrade &ith digital dial thermometer,
recording thermograph and alarm device, &ith provision for continuous
po&er
supply.
#vi% )eighing devices for donor and blood containers.

3. ;or haemoglobin determination C

#i% (opper sulphate solution #specific gravity ..1B7%
#ii% Sterile lancet and impregnated alcohol s&abs.
#ii% (apillary tube #..7+..0+/8 mm or pasteur pipettes%
#iv% 'ubber bulbs for capillary tubings.
#v% SahliPs haemoglobinometer@(olorimeteric method.

7. ;or temperature and pulse determinationC
#i% (linical thermometers.
#ii% )atch #fitted &ith a seconds!hand% and a stop!&atch.

0. ;or blood containers C

#a% $nly disposable 4=( blood bags shall be used #closed system% as per the
specifications of I4@QS4@B4.
#b% -nti!coagulantsC The anti!coagulant solution shall be sterile, pyrogen!free
and of the follo&ing composition that &ill ensure satisfactory safety and
efficacy of the &hole blood and@or for all the separated blood components.
#i% (itrate 4hosphate *e+trose -denine solution #(4*-% or (itrate
4hosphate
*e+trose -denine! . #(4*-!.% !!!!.0 ml. Solution shall be required for .11
ml of blood.

N$TF .. #i% In case of single@double@triple@quadruple blood
collection bags used for blood component preparations,
(4*- blood collection bags may be used.
#ii% -cid (itrate *e+trose solution #-.(.* &ith ;ormula!
-%. I.4. !! .Bml. Solution shall be required for .11ml of
blood.
#iii% -dditive solutions such as S-:, -*S$A,
NQT'I(FA may be used for storing, and retaining 'ed
Blood (orpuscles upto 03 days.

N$TF3. The licensee shall ensure that the anti!coagulant solutions
are of a licensed manufacturer and the blood bags in &hich
the said solutions are contained have a certificate of
analysis of the said manufacturer.

B. Fmergency equipments@items .

#i% $+ygen cylinder &ith mask, gauge and pressure regulator.
#ii% B percent lucose or Normal Saline.
#iii% *isposable sterile syringes and needles of various si"es.
#iv% *isposable sterile I.=. infusion sets.
#v% -mpoules of -drenaline, Noradrenaline, :ephentin, Betamethasone
or *e+amethasone, :etoclorpropamide in5ections
#vi% -spirin.

8. -ccessories C

#i% Such as blankets, emesis basins, haemostats, set clamps, sponge
forceps, gau"e, dressing 5ars, solution 5ars, &aste cans.
#ii% :edium cotton balls, ..3B cm. adhesive tapes.
#iii% *enatured spirit, Tincture Iodine, green soap or liquid soap.
#iv% 4aper napkins or to&els.
#v% -utoclave &ith temperature and pressure indicator.
#vi% Incinerator
#vii% Stand!by generator.

9. Aaboratory equipmentC

#i% 'efrigerators, for storing diagnostic kits and reagents, maintaining a
temperature bet&een 0 to 8 degree ceritigrade #plus@minus 3 degree
centigrade% &ith digital dial thermometer having provision for
continuous po&er supply.
#ii% (ompound :icroscope &ith lo& and high po&er ob5ectives.
#iii% (entrifuge Table :odel
#iv% )ater bathC having range bet&een 79 degree centigrade to B8 degree
centigrade
#v% 'h vie&ing bo+ in case of slide technique.
#vi% Incubator &ith thermostatic control.
#vii% :echanical shakers for serological tests for Syphilis.
#viii% Hand!lens for observing tests conducted in tubes.
#i+% Serological graduated pipettes of various si"es
#+% 4ipettes #4asteur%
#+i% lass slides
#+ii% Test tubes of various si"es@micrometer plates #Q or = type%
#+iii% 4recipitating tubes 8mm+B1mm of different si"es and glass
beakers of different si"es
#+iv% Test tube racks of different specifications.
#+v% Interval timer electric or spring &ound. .
#+vi% Fquipment and materials for cleaning glass &ares adequately.
#+vii% Insulated containers for transporting blood, bet&een 3 degree
centigrade to .1 degree centigrade temperatures, to &ards and
hospitals.
#+viii% )ash bottles
#+i+% ;ilter papers
#++% *ielectric tube sealer.
#++i% 4lain and F*T - vials
#++ii% (hemical balance #&herever necessary%
#++iii% FAIS- reader &ith printer, &asher and micropipettes.

<. SPECIAL REAGENTS8

#.% Standard blood grouping sera -nti -, -nti B and -nti * &ith kno&n controls.
'h typing sera shall be in double quantity and each of different brand or if from
the same, supplier each supply shall be of different lot numbers.
#3% 'eagents for serological tests for syphilis and positive sera for controls.
#7% -nti Human lobulin Serum #(oombPs serum%
#0% Bovine -lbumin 33 percent Fn"yme reagents for incomplete antibodies.
#B% FAIS- or '4H- test kits for Hepatitis and HI= I , II.
#8% *etergent and other agents for cleaning laboratory glass&ares.

K. TESTING OF WHOLE BLOOD 8

# .% It shall be responsibility of the licensee to ensure that the &hole blood
collected, processed and supplied conforms to the standards laid do&n in the
Indian 4harmacopoeia and other tests published, if any, by the overnment.

#3% ;reedom from HI= antibodies #-I*S% Tests !Fvery licensee shall get samples
of every blood unit tested, before use, for freedom from HI= I and HI= II
antibodies either from laboratories specified for the purpose by the (entral
overnment or in his o&n laboratory. The results of such testing shall be
recorded on the label of the container.

#7% Fach blood unit shall also be tested for freedom from Hepatitis B surface
antigen, and Hepatitis ( =irus antibody =*'A and malarial parasite and results
of such testing shall be recorded on the label of the container.
N$TFC
#a% Blood samples of donors in pilot tube and the blood samples of the
recipient shall be preserved for 9 days after issue.
#b% The blood intended for transfusion shall not be fro"en at any stage.
#c% Blood containers shall not come directly in contact &ith ice at any
stage.

L. RECORDS 8

The records &hich the licensee is required to maintain shall include inter alia
the follo&ing particulars, namelyC!

#.% Blood donor recordC It shall indicate serial number, date of bleeding, name,
address and signature of donor &ith other particulars of age, &eight,
hemoglobin, blood grouping, blood pressure, medical e+amination, bag number
and patientPs detail for &hom donated in case of replacement donation,
category of donation #voluntary@replacement% and deferral records and
signature of :edical $fficer In!charge.

#3% :aster records for blood and its componentsC It shall indicate bag serial
number, date of collection, date of e+piry, quantity in ml. -B$@'h roup,
results for testing of HI= I and HI= II antibodies, :alaria, =.*.'.A., Hepatitis
B surface antigen and Hepatitis ( virus antibody and irregular antibodies #if
any%, name and address of the donor &ith particulars, utilisation issue number,
components prepared or discarded and signature of the :edical $fficer
Incharge.

#7% Issue register C It shall indicate serial number, date and time of issue, bag
serial number, -B$@'h roup, total quantity in ml, name and address of the
recipient, group of recipient, unit@institution, details of cross!matching report,
indication for transfusion.

#0% 'ecords of components suppliedC quantity suppliedE compatibility report,
details of recipient and signature of issuing person.

#B% 'ecords of -.(.*.@(.4.*@(4*!-@S-: bags giving details of manufacturer,
batch number, date of supply, and results of testing.

#8% 'egister for diagnostic kits and reagents usedC name of the kits@reagents,
details of batch number, date of e+piry and date of use.

#9% Blood bank must issue the cross matching report of the blood to the patient
together &ith the blood unit.

#>% Transfusion adverse reaction records.

#/% 'ecords of purchase, use and stock in hand of disposable needles, syringes,
blood bags, shall be maintained.

N$TFC The above said records shall be kept by the licensee for a period of five years.

:. LABELS8

The labels on every bag containing blood and@or component shall contain the
follo&ing particulars, namelyC

#.% The proper name of the product in a prominent place and in bold letters
on the bag.
#3% Name and address of the blood bank
#7% Aicence number
#0% Serial number
#B% The date on &hich the blood is dra&n and the date of e+piry as
prescribed under Schedule 4 to these rules.
#8% - colored label shall be put on every bag containing blood. The
follo&ing color scheme for the said labels shall be used for different
groups of bloodC

Blood roup (olor of the label
$ Blue
- Sello&
B 4ink
-B )hite

#9% The results of the tests for Hepatitis B surface antigen, and Hepatitis (
virus antibody, syphilis, freedom from HI= I and HI= II antibodies and
malarial parasite.
#>% The 'h group.
#/% Total volume of blood, the preparation of blood, nature and percentage
of anti!coagulant.
#.1% Leep continuously temperature at 3 degree centigrade to 8 degree
centigrade for &hole human blood and@or components as contained
under III of 4art <II B.
#..% *isposable transfusion sets &ith filter shall be used in administration
equipment.
#.3% -ppropriate compatible cross matched blood &ithout a typical antibody
in recipient shall be used.
G.7% The contents of the bag shall not be used if there is any visible evidence
of deterioration .ike haemolysis, clotting or discoloration.
#.0% The label shall indicate the appropriate donor classification like
T=oluntary *onorT or T'eplacement *onorT in no less prominence than
the proper name.

N$TFSC
..ln the case of blood components, particulars of the blood from &hich such
components have been prepared shall be given against item numbers #B%, #9%,
#>%, #/% and #.0%.
3. The blood and@or its components shall be distributed on the prescription of a
'egistered :edical 4ractitioner .

II. BLOOD DONATION CAMPS.

- blood donation camp may be organi"ed by !

#a% a licensed designated 'egional Blood Transfusion (entreE or
#b% a licensed overnment blood bankE or
#c% the Indian 'ed (ross Society E or
#d% a licenced blood bank run by registered voluntary or charitable
organi"ations recogni"ed by State or Qnion Territory Blood
Transfusion (ouncil.

N$TFC
#i% T*esignated 'egional Blood Transfusion (entreT shall be a centre
approved and designated by a Blood Transfusion (ouncil constituted
by a State overnment to collect, process and distribute blood and
its components to cater to the needs of the region and that centre has
also been licensed and approved by the Aicensing -uthority and
(entral Aicence -pproving -uthority for the purpose.
#ii% The designated 'egional Blood Transfusion (entre. overnment
blood bank and Indian 'ed (ross Society shall intimate &ithin a
period of seven days, the venue &here blood camp &as held and
details of group &ise blood units collected in the said camp to the
licensing -uthority and (entral Aicence -pproving -uthority.

;or holding a blood donation camp, the follo&ing requirements shall be
fulfilled@complied &ith, namelyC!

:A; PREMISES, PERSONNEL ETC.

#a% 4remises under the blood donation camp shall have sufficient area and
the location shall be hygienic so as to allo& proper operation,
maintenance and cleaning.
#b% -ll information regarding the personnel &orking, equipment used and
facilities available at such a (amp shall be &ell documented and made
available for inspection, if required, and ensuringU
#i% continuous and uninterrupted electrical supply for equipment
used in the (ampE
#ii% adequate lighting for all the required activitiesE
#iii% hand!&ashing facilities for staffE
#iv% reliable communication system to the central office of the
(ontroller@$rganiser of the (ampE
#v% furniture and equipment arranged &ithin the available placeE
#v5% refreshment facilities for donors and staffE
#vii% facilities for medical e+amination of the donorsE
#viii% proper disposal of &aste.

#B% PERSONNEL FOR OUT-DOOR BLOOD DONATION CAMPC

To collect blood from B1 to 91 donors in about 7 hours or from .11 to .31
donors in B hours, the follo&ing requirements shall be fulfilled@complied
&ith C!

#i% $ne :edical $fficer and t&o nurses or phlebotomists for managing 8!>
donor tablesE
#ii% t&o medico social &orkersE
#iii% three blood bank techniciansE
#iv% t&o attendantsE
#v% vehicle having a capacity to seat >!.1 persons, &ith provision for
carriage of donation goods including facilities to conduct a blood
donation camp.

:C; EQUIPMENTS 8

.. B4 apparatus.
3. Stethoscope.
7. Blood bags #single, double, triple, quadruple%
0. *onor questionnaire.
B. )eighing device for donors.
8. )eighing device for blood bags,
9. -rtery forceps, scissors.
>. Stripper for blood tubing.
/. Bed sheets, blankets@matress.
.1. Aancets, s&ab stick@tooth picks.
... lass slides.
.3. 4ortable Hb meter@copper sulphate.
.7. Test tube #big% and .3+.11 mm #small%
.0. Test tube stand.
.B. -nti!-, -nti!B and -nti.-B, -ntisera and -nti!*
.8. Test tube sealer film.
.9. :edicated adhesive tape.
.>. 4lastic &aste basket
./. *onor cards and refreshment for donors.
31. Fmergency medical kit
3.. Insulated blood bag containers &ith provisions for storing bet&een 3
degree centigrade to .1 degree centigrade.
33. *ielectric sealer or portable sealer
37. Needle destroyer #&herever necessary%

I**. PROCESSING OF BLOOD COMPONENTS FROM WHOLE BLOOD
BY A BLOOD BANK

The Blood components shall be prepared by blood banks as a part of the Blood
Bank services. The conditions for grant or rene&al of licence to prepare blood
components shall be as follo&sC !
:A; ACCOMMODATION 8
#.% 'ooms &ith adequate area and other specifications, for preparing blood
components depending on quantum of &ork load shall be as specified in
item B under the heading TI. BA$$* B-NLS@BA$$*
($:4$NFNTST of this 4art.
#3% 4reparation of Blood components shall be carried out only under closed
system using single, double, triple or quadruple plastic bags e+cept for
preparation of 'ed Blood (ells (oncentrates, &here single bags may be
used &ith transfer bags.

:B; EQUIPMENT 8
#i% -ir conditionerE
#ii% Aaminar air flo& benchE
#iii% Suitable refrigerated centrifugeE
#iv% 4lasma e+presserE
#v% (lipper and clips and or dielectric sealerE
#vi% )eighing deviceE
#vii% *ry rubber balancing materialE
#viii% -rtery forceps, scissorsE
#i+% 'efrigerator maintaining a temperature bet&een 3 degree centigrade to
8 degree centigrade, a digital dial thermometer &ith recording
thermograph and alarm device, &ith provision for continuous po&er
supplyE
#+% 4latelet agitator &ith incubator #&herever necessary%
#+i% *eep free"ers maintaining a temperature bet&een minus 71 degree
centigrade to minus 01 degree centigrade and minus 9B degree
centigrade to minus >1 degree centigradeE
#+ii% 'efrigerated )ater bath for 4lasma Tha&ingE
#+iii% Insulated blood bag containers &ith provisions for storing at
appropriate temperature for transport purposesC

:C; PERSONNEL8
The &hole time competent technical staff meant for processing of Blood
(omponents #that is :edical $fficer, Technical Supervisor, Blood
Bank Technician and 'egistered Nurse% shall be as specified in item (, under
the heading TI. BA$$* B-NLS@BA$$* ($:4$NFNTST of this 4art.

:D; TFSTIN ;-(IAITIFSC
eneralC ;acilities for -,B, -B and $ groups and 'h#*% grouping.
HepatitisC B Surface antigen and Hepatitis ( virus antibody, =*'A, HI= I and
HI= II antibodies and malarial parasites shall be mandatory for every blood
unit before it is used for the preparation of blood components. The results of
such testing shall be indicated on the label.

:E; CATEGORIES OF BLOOD COMPONENTS8
#.% CONCENTRATED HUMAN RED BLOOD CORPUSCLES8 The product
shall be kno&n as T4acked 'ed Blood (ellsT that is 4acked 'ed Blood (ells
remaining after separating plasma from human blood.

eneral 'equirements C
#a% StorageC Immediately after processing, the 4acked 'ed Blood (ells
shall be kept at a temperature maintained bet&een 3 degree centigrade to
8 degree centigrade.
#b% InspectionC The component shall be inspected immediately after
separation of the plasma, during storage and again at the time of issue.
The product shall not be issued if there is any abnormality in color or
physical appearance or any indication of microbial contamination.
#c% Suitability of *onorC The source blood for 4acked 'ed Blood (ells
shall be obtained from a donor &ho meets the criteria for Blood
*onation as specified in item H under the heading TI. BA$$*
B-NLS@BA$$* ($:4$NFNTST of this 4art.
#d% Testing of )hole BloodC Blood from &hich 4acked 'ed Blood (ells
are prepared shall be tested as specified in item L relating to Testing of
)hole Blood under the heading TI.BA$$* B-NLS@BA$$*
($:4$NFNTST of this 4art.
#e% 4ilot samplesC 4ilot samples collected in integral tubing or in separate
pilot tubes shall meet the follo&ing specificationsC
#i% $ne or more pilot samples of either the original blood or of the
4acked 'ed Blood (ells being processed shall be preserved &ith
each unit of 4acked 'ed Blood (ells &hich is issued.
#ii% Before they are filled, all pilot sample tubes shall be marked or
identified so as to relate them to the donor of that unit or 4acked 'ed
Blood (ells.
#iii% Before the final container is filled or at the time the final product is
prepared, the pilot sample tubes accompanying a unit of 4acked 'ed
Blood (ells, shall be attached in a tamper!proof manner that shall
conspicuously identify removal and re!attachment.
#iv% -ll pilot sample tubes, accompanying a unit of packed red blood
cells, shall be filled immediately after the blood is collected or at the
time the final product is prepared, in each case, by the person &ho
performs the collection of preparation.

:F; PROCESSING 8
#i% SeparationC 4acked 'ed Blood (ells shall be separated from the &hole blood,!
#a% if the &hole blood is stored in -(* solution &ithin 3.days, and
#b% if the &hole blood is stored in (4*-!. solution, &ithin 7B days, from
the date of collection. 4acked 'ed Blood (ells may be prepared either by
centrifugation done in a manner that shall not tend to increase the
temperature of the blood or by normal undisturbed sedimentation
method. - portion of the plasma, sufficient to ensure optimal cell
preservation, shall be left &ith the 4acked 'ed Blood (ells.

#ii% 4acked 'ed Blood (ells ;ro"enC (ryophylactic substance may be added to the
4acked 'ed Blood (ells for e+tended manufacturerPs storage not &armer than
minus 8B degree centigrade provided the manufacturer submits data to the
satisfaction of the Aicensing -uthority and (entral Aicence -pproving
-uthority, as adequately demonstrating through in!vivo cells survival and other
appropriate tests that the addition of the substance, the material used and the
processing methods results in a final product meets the required standards of
safety, purity and potency for 4acked 'ed Blood (ells, and that the fro"en
product shall maintain those properties for the specified e+piry period.

#iii% TestingC 4acked 'ed Blood (ells shall conform to the standards as laid do&n
in the Indian 4harmacopoeia.

:2; PLATELETS CONCENTRATES8
The product shall be kno&n as T4latelets (oncentratesT that is platelets
collected from one unit of blood and re!suspended in an appropriate volume of
original plasma.
eneral 'equirements C
#i% SourceC
The source material for platelets shall be platelet!rich plasma or buffy
coat &hich may be obtained from the &hole blood or by plateletpheresis.
#ii% 4rocessingC
#a% Separation of buffy!coat or platelet!rich plasma and platelets and re!
suspension of the platelets shall be in a closed system by!centrifugal
method &ith appropriate speed, force and time.
#b% Immediately after collection, the &hole blood or plasma shall be held
in storage bet&een 31 degree centigrade to 30 degree centigrade. )hen
it is to be transported from the venue of blood collection to the
processing laboratory, during such transport action, the temperature as
close as possible to a range bet&een 31 degree centigrade to 30 degree
centigrade shall be ensured. The platelet concentrates shall be separated
&ithin 8 hours after the time of collection of the unit of &hole blood or
plasma.
#c% The time and speed of centrifugation shall be demonstrated to produce
an unclamped product, &ithout visible haemolysis, that yields a count
of not less than 7.B+.1.1 #7.B+.1 raised to the po&er of .1% and
0.B+.1.1#0.B+.1 raised to the po&er ten% i.e. platelets per unit from a
unit of 7B1 ml and 0B1 ml blood respectively. $ne percent of total
platelets prepared shall be tested of &hich 9B percent of the units shall
conform to the above said platelet count.
#d% The volume of original plasma used for re!suspension of the platelets
shall be determined by the maintenance of the pH of not less than 8
during the storage period. The pH shall be measured on a sample of
platelets &hich has been stored for the permissible ma+imum e+piry
period at 31 degree centigrade to 30 degree centigrade.
#d% ;inal containers used for platelets shall be colorless and transparent to
permit visual inspection of the contents. The caps selected shall
maintain a hermetic seal to prevent contamination of the contents. The
container material shall not interact &ith the contents, under the normal
conditions of the storage and use, in such a manner as to have an
adverse effect upon the safety, purity, potency, or efficacy of the
product. -t the time of filling, the final container shall be marked or
identified by number so as to relate it to the donor.
#iii% StorageC
Immediately after re!suspension, platelets shall be placed in storage not
e+ceeding for a period B days, bet&een 31 degree centigrade to 30
degree centigrade, &ith continuous gentleagitation of the platelet
concentrates maintained throughout such storage.
#iv% TestingC
The units prepared from different donors shall be tested at the end of the
storage period for !
#a% 4latelet countE
#b% pH of not less than 8 measured at the storage temperature of the
unitE
#c% measurement of actual plasma volumeE
#d% one percent of the total platelets prepared shall be tested for sterilityE
#e% the tests for functional viability of the platelets shall be done by
s&irling movement before issueE
#f% if the results of the testing indicate that the product does not meet
the specified requirements, immediate corrective action shall be
taken and records maintained.
#iv% (ompatibility TestC
(ompatible transfusion for the purpose of variable number of 'ed
Blood (ells, -, B, -B and $ grouping shall be done if the platelets
concentrate is contaminated &ith red blood cells.

:=; GRANULOCYTE CONCERNTRATES8
#i% StorageC It shall be kept bet&een 31 degree centigrade to 30 degree
centigrade for a ma+imum period of 30 hours.
#ii% Qnit of granulocytes shall not be less than . +.1.1 #i.e. .+.1 raised
to the po&er of .1% &hen prepared on cell separator.
#iii% roup specific tests@HA- test &herever required shall be carried out.

:>; FRESH FRO?EN PLASMA8
4lasma fro"en &ithin 8 hours after blood collection and stored at a temperature
not &armer than minus 71 degree centigrade, shall be preserved for a period of
not more than one year.

:@; CRYOPRECIPITATE8
(oncentrate of anti!hemophiliac factor shall be prepared by tha&ing of the
fresh plasma fro"en stored at minus 71 degree centigrade.

#a% StorageC
(ryoprecipitate shall be preserved at a temperature not higher than minus 71
degree centigrade and may be preserved for a period of not more than one
year from the date of collection.

#b% -ctivityC
-nti!hemophiliac factor activity in the final product shall be not less than >1
units per bag. $ne percent of the total cryoprecipitate prepared shall be
tested of &hich seventy five percent of the unit shall conform to the said
specification.

:3; PLASMAPHERESIS, PLATELETPHERESIS, LEUCAPHERESIS
USING A CELL SEPARATOR.
-n area of .1 square meters shall be provided for apheresis in the blood Bank.
The blood banks specifically permitted to undertake the said apheresis on the
donor shall observe the criteria as specified in item H relating to (riteria for
blood donation under the heading TI. Blood Banks@Blood (omponentsT of this
4art. The &ritten consent of the donor shall be taken and the donor must be
e+plained, the ha"ards of apheresis. The :edical $fficer shall certify that donor
is fit for apheresis and it shall be carried out by a trained person under
supervision of the :edical $fficer.

:A; PLASMAPHERESIS, PLATELET PHERESIS AND
LEUCAPHERESIS8
The donors sub5ected to plasmapheresis, plateletpheresis and leucopheresis
shall, 5n addition to the criteria specified in item H relating to the ('ITF'I-
;$' BA$$* *$N-TI$N, under the heading TI. BA$$* B-NLS@ BA$$*
($:4$NFNTST of this 4art being observed, be also sub5ected to protein
estimation on post!pheresis@ first sitting &hose results shall be taken as a
reference for subsequent 4heresis@Sitting. It shall also be necessary that the
total plasma obtained from such donor and periodicity of 4lasmapheresis shall
be according to the standards described under validated Standard $perating
4rocedures.
N$TFC
#i% -t least 0> hours must elapse bet&een successive apheresis and not
more than t&ice in a &eek.
#ii% F+tracoporeal blood volume shall not e+ceed .BV of donorPs
estimated blood =olume.
#iii% 4latelet pheresis shall not be carried out on donors &ho have taken
medication containing -sprin &ithin 7 days prior to donation.
#iv% If during plateletpheresis or leucapheresis, 'B(s cannot be re!
transfused then at least .3 &eeks shall elapse before a second
cytapheresis procedure is conducted.

:B; MONITORING FOR APHERESIS8
Before starting apheresis procedure. hemoglobin or haematocrit shall be done.
4latelet count, )B( counts, differential count may be carried out. In repeated
plasmapheresis, the serum protein shall be 8 gm @.11 ml.

:C; COLLECTION OF PLASMA8
The quantity of plasma separated from the blood of a donor shall not e+ceed
B11 ml per sitting and once in a fortnight or shall not e+ceed .111 ml per
month.

PART XII C

I. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS

The blood products shall be manufactured in a separate premises other than that
meant for blood bank. The requirements that are essential for grant or rene&al of
licence to manufacture blood products such as -lbumin, 4lasma 4rotein ;raction,
Immunoglobins and (oagulation ;actor (oncentrates, shall be as follo&s,
namelyC!

A. GENERAL REQUIREMENTS
.. Aocation and surroundings, buildings and &ater supplyC
The requirements as regards location and surrounding, buildings and &ater
supply as contained in paragraphs ....., ....3, ....7 of 4art I of Schedule :
shall apply mutatis mutandis to the manufacture of blood products.
3. *isposal of &aste and infectious materialsC
#i% The requirement as regards disposal of &aste and infectious materials
as contained in paragraph ....0 of 4art I of Schedule : shall apply
mutatis mutandis to the manufacture of blood products.
#ii% 4roper facility shall also be provided for potentially infectious
materials, particularly HI= I , HI= II, Hepatitis B #surface antigen and
Hepatitis ( virus antibody% through autoclaving, incineration or any
other suitable validated methods.
7. Health, clothing and sanitation of personnelC
#i% The requirement as contained in paragraph 7 of 4art I of Schedule :
shall be complied &ith.
#ii% The personnel &orking in the manufacturing areas shall be vaccinated
against Hepatitis B virus and other infectious transmitting diseases.
0. 'equirements for manufacturing area for Blood 4roductsC
#i% ;or the manufacture of blood products, separate enclosed areas
specifically designed for the purpose shall be provided. These areas be
provided &ith air locks for entry and shall be essentially dust free and
ventilated &ith an air supply. -ir supply for manufacturing area shall be
filtered through bacteria retaining filters #HF4- ;ilters% and shall be at a
pressure higher than in the ad5acent areas.
The filters shall be checked for performance on installation and
periodically thereafter, and records thereof shall be maintained.
#ii% Interior surfaces #&alls, floors and ceilings% shall be smooth and free
from cracks, they shall not shed matter and shall permit easy cleaning
and disinfection. *rains shall be e+cluded from aseptic areas.
'outine microbial counts of the manufacturing area shall be carried out
during manufacturing operations. The results of such counts shall be
checked against &ell documented in!house standards and records
maintained.
-ccess to the manufacturing areas shall be restricted to a minimum
number of authorised personnel. Special procedures for entering and
leaving of the manufacturing areas shall be prominently displayed.
#iii% Sinks shall be e+cluded from aseptic areas. -ny sink installed in other
clean areas shall be of suitable material such as stainless steel, &ithout
an overflo&, and be supplied &ith &ater of potable quality. -dequate
precautions shall be taken to avoid contamination of the drainage system
&ith dangerous effluents and airborne dissemination of pathogenic
micro!organisms.
#iv% Aighting, air!conditioning, ventilation shall be designed to maintain a
satisfactory temperature and relative humidity to minimise
contamination and to take account of the comfort of personnels &orking
&ith protective clothing.
#v% 4remises used for the manufacture of blood products shall be suitably
designed and constructed to facilitate good sanitation.
#vi 4remises shall be carefully maintained and it shall be ensured that
repair and maintenance operations do not present any ha"ard to the
quality of products. 4remises shall be cleaned and, &hereapplicable,
disinfected according to detailed &ritten validated procedures.
#vii% -dequate facilities and equipments shall be used for the manufacture
of blood products derived from blood plasma.
#viii% -ll containers of blood products, regardless of the stage of
manufacture, shall be identified by securely attached labels. (ross
contamination shall be prevented by adoption of the follo&ing measures,
namely C!
#a% processing and filling shall be in segregated A areas E
#b% manufacture of different products at the same time shall be
avoidedE
#c% simultaneous filling of the different products shall be avoidedE
#d% ensure transfer, containers@materials by means of airlocks, air
e+traction, clothing change and careful &ashing and
decontamination of equipmentE
#e% protecting containers@materials against the risk of contamination
caused by re!circulation of untreated air or by accidental re!entry
of e+tracted airE
#f% using containers that are sterilised or are of documented lo&
TbioburdenT.
#i+% 4ositive pressure area shall be dedicated to the processing area
concernedE

#+% -ir!handling units shall be dedicated to the processing area concernedE
#+i% 4ipe &ork, valves and vent filters shall be properly designed to
facilitate cleaning and sterlisation. =alves on fractionation @ reacting
vessels shall be completely steam!sterlisable. -ir vent filters shall be
hydrophobic and shall be validated for their designated useE
B. -ncillary -reasC
#i% 'est and refreshment rooms shall be separated from other areas.
#ii% ;acilities for changing and storing clothes and for &ashing and toilet
purposes shall be easily accessible and appropriate for the number of
users. Toilets shall not be connected directly &ith production or storage
areas.
#iii% :aintenance &orkshops shall be separated from production areas.
)herever parts and tools are stored in the production area, they shall be
kept in rooms or lockers reserved for that use.
#iv% -nimal houses shall be &ell isolated from other areas, &ith separate
entrance.

B. COLLECTION AND STORAGE OF PLASMA FOR FRACTIONATION8
#a% (ollection C
#.% 4lasma shall be collected from the licensed Blood Banks through
a cold chain process and stored in fro"en condition not &armer
than minus t&enty degree centigradeE
#3% Individual plasma shall remain in quarantine till it is tested for
Hepatitis B surface antigen and Hepatitis ( virus antibody HI= I
and HI= II.
#7% - sample from pooled !lot plasma of about .1!.3 units of
different donors shall be tested for Hepatitis B surface antigen and
Hepatitis ( virus antibody, HI= I and HI= II and if the sample
found negative, only then it shall be taken up for fractionation.
#b% Storage -rea C
#.% Storage areas shall be of sufficient space and capacity to allo&
orderly storage of the various categories of materials,
intermediates, bulk and finished products, products in quarantine,
released, re5ected, returned, or recalled products.
#3% Storage areas shall be designed or adopted to ensure good
storage conditions. In particular, they shall be clean, dry and
maintained &ithin temperature required for such storage and
&here special storage conditions are required #e.g. temperature,
humidity%, these shall be provided, checked and monitored.
#7% 'eceiving and dispatch bays shall protect materials and products
from the &eather and shall be designed and equipped to allo&
containers of incoming materials to be cleaned, if necessary,
before storage.
#0% )here quarantine status is ensured by storage in separate areas,
these areas shall be clearly marked and their access restricted only
to authorised personnel.

#B% There shall be separate sampling area for ra& materials. If
sampling is performed in the storage area, it shall be conducted in
such a &ay so as to prevent contamination or cross!contamination.
#8% Segregation shall be provided for the storage of re5ected,
recalled, or returned materials or products.
#9% -dequate facility shall be provided for supply of ancillary
material, such as ethanol, &ater, salts and polyethylene glycol.
Separate facilities shall be provided for the recovery of organic
solvents used in fractionation.

C. PERSONNEL 8
# .% :anufactureC
The manufacture of blood products shall be conducted under the
active direction and personal supervision of competent technical
staff, consisting of at least one person &ho shall be a &hole time
employee, &ith one year practical e+perience in the manufacture
of blood products @ plasma fractionation and possesses D
#a% 4ost!graduate degree in :edicine !:.*. #:icrobiology@
4athology@ Bacteriology @ Immunology @ Biochemistry%E or
#b% 4ost!graduate degree in Science #:icrobiology%E or
#c% 4ost!graduate degree in 4harmacy #:icrobiology%, from a
recognised Qniversity or Institution.
#3% Testing C
The head of the testing unit shall be independent of
the manufacturing unit and testing shall be conducted under the
active direction and personal supervision of competent technical
staff consisting at least one person &ho shall be a &hole time
employee. The Head of the, testing unit shall have eighteen
months practical e+perience in the testing of drugs, especially the
blood
products and possesses D
#a% 4ost!graduate degree in 4harmacy or Science !
#(hemistry@:icrobiology@Bio!chemistry%E or
#b% 4ost!graduate degree in :edicine!:.*. #:icrobiology
@4athology @ Biochemistry%,from a recognised Qniversity or
Institution.

D PRODUCTION CONTROL 8
#.% The production area and the viral inactivation room shall be
centrally air!conditioned and fitted &ith HF4- ;ilters having
rade ( #(lass .1,111% environment as given in the Table belo&.
#3% The filling and sealing shall be carried out under aseptic
conditions in centrally air!conditioned areas fitted &ith HF4-
;ilters having rade - or, as the case may be, grade B #(lass .11%
environment given in the said Table

TABLE
AIR CLASSIFICATION SYSTEM FOR MANUFACTURE
OF STERILE PRODUCTS.

:a+imum number of particles permitted per m7


:-<I:Q: NQ:BF' $;
4-'TI(AFS 4F':ITTF*
4F' m7
:-<I:Q: NQ:BF' $;
=I-BAF :I('$$'-NIS:
4F':ITTF* 4F' m7
'-*F 1.B !B
micron
Aess than B
micron
- #(lass .11%
#Aaminar! -irflo&
&orkstation%
7B11 None Aess than .
B #(lass .11% 7B11 None Aess than B
( #(lass .1111% 7B1111 3111 Aess Than .11

#7% The physical and chemical operations used for the manufacture
of plasma fractionation shall maintain high yield of safe and
effective protein.
#0% The fractionation procedure used shall give a good yield of
products meeting the in!house quality requirements as approved
by the Aicensing -uthority and (entral Aicence -pproving
-uthority reducing the risk of microbiological contamination and
protein denaturation to the minimum.
#B% The procedure adopted shall not affect the antibody activity and
biological half!life or biological characteristics of the products.

E. AIRAL INACTIAATION PROCESS 8
The procedure used by the licensee to inactivate the pathogenic organisms such
as enveloped and non!enveloped virus, especially infectivity from HI= I
, HI= II, Hepatitis B surface antigens and Hepatitis ( virus antibody the viral
inactivation and validation methods adopted by the licensee, shall be submitted
for approval to the Aicensing -uthority and (entral Aicence -pproving
-uthority
NOTESC
#.% No preservative # e+cept stabiliser to prevent Dprotein denaturation
such as glycine, sodium chloride or sodium caprylate% shall be
added to -lbumin, 4lasma 4rotein ;raction, Intravenous
Immunoglobulins or (oagulation ;actor (oncentrates &ithout the
prior approval of Aicensing -uthority and (entral Aicence
-pproving -uthority.
#3% The licensee shall ensure that the said stabilisers do not have
deleterial effect on the final product in the quantity present so as not
to cause any unto&ard or adverse reaction in human beings.

F. QUALITY CONTROL C
Separate facilities shall be provided for Ruality (ontrol such as Hematological,
Bio!chemical, 4hysico!chemical, :icrobiological, 4yrogens, Instrumental and
Safety testing. The Ruality (ontrol *epartment shall have inter alia the
follo&ing principal duties, namely.!
# .% To prepare detailed instructions, in &riting for carrying out test and
analysis.
#3% To approve or re5ect ra& material, components.containers, closures, in!
process materials, packaging material, labeling and finished products.
#7% To release or re5ect batch of finished products &hich are ready for
distribution.
#0% To evaluate the adequacy of the conditions under &hich ra& materials,
semi!finished products and finished products are stored.
#B% To evaluate the quality and stability of finished products and &hen
necessary of ra& materials and semi!finished products.
#8% To revie& production records to ensure that no errors have occurred or
if errors have occurred that they have been fully investigated.
#9% To approve or re5ect all procedures or specifications impacting on the
identity, strength, quality and purity of the product.
#>% To establish shelf!life and storage requirements on the basis of stability
tests related to storage conditions.
#/% To establish and &hen necessary revise, control procedures and
specifications.
#.1%To revie& complaints, recalls, returned or salvaged products and
investigations conducted thereunder for each product.
#..% To revie& :aster ;ormula 'ecords@(ards periodically.

G. TESTING OF BLOOD PRODUCTS8
The products manufactured shall conform to the standards specified in the
Indian 4harmacopoeia and &here standard of any product is not specified in the
4harmacopoeia, the standard for such product shall conform to the standard
specified in the Qnited States 4harmacopoeia or the British 4harmacopoeia.
The final products shall be tested for freedom from HI= I and HI= II
antibodies, Hepatitis B surface antigen and Hepatitis ( virus antibody.WW

H. STORAGE OF FINISHED PRODUCT8
#i% The final products shall be stored bet&een t&o degree centigrade to
eight degree centigrade, unless other&ise specified by the (entral
Aicence -pproving -uthority.
#iii% The shelf!life assigned to the products by the licensee shall be
submitted for approval to the Aicensing -uthority and (entral Aicence
-pproving -uthority.

I. LABELLING8
The products manufactured shall be labeled as specified in the Indian
4harmacopoeia, the British 4harmacopoeia or the Qnited States 4harmacopoeia
&hich shall be in addition to any other requirement stated under 4art I< or 4art
< of these rules. The labels shall indicate the results of tests for Hepatitis B
surface antigen and Hepatitis ( =irus antibody, freedom from HI= I and HI=
II antibodies.

<. RECORDS8
The licensee shall maintain records as per Schedule Q and also comply &ith
Batch manufacturing records as specified in 4aragraph / of 4art I of Schedule
: and any other requirement as may be directed by Aicensing -uthority and
(entral Aicence -pproving -uthority.

K. MASTER FORMULA RECORDS8
The licensee shall maintain :aster ;ormula 'ecords relating to all
manufacturing and quality control procedures for each product, &hich shall be
prepared and endorsed by the competent Technical Staff, i.e., Head of the
manufacturing unit. The :aster ;ormula 'ecords shall contain !!
#i% the patent or proprietary name of the product along&ith the generic
name, if any, strength and the dosage formE
#ii% a description or identification of the final containers, packaging
materials, labels and closures to be usedE
#iii% the identity, quantity and quality of each ra& material to be used
irrespective of &hether or not it appears in the finished product. The
permissible overage that may be included in a formulated batch shall be
indicatedE
#iv% a description of all vessels and equipments and the si"es used in the
processE
#v% manufacturing and control instructions along &ith parameters for
critical steps such as mi+ing, drying, blending, sieving and sterilising the
productE
#vi% the theoretical yield to be e+pected from the formulation at different
stages of manufacture and permissible yield limitsE
#vii% detailed instructions on precautions to be taken in the manufacture and
storage of drugs and of semi!finished productsE and
#viii% the requirements in!process quality control tests and analysis to be
carried out during each stage of manufacture including the designation of
persons or departments responsible for the e+ecution of such tests and
analysis.

II. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS
FROM BULK FINISHED PRODUCTS

)here the blood products, such as -lbumin, 4lasma 4rotein ;raction,
Immunoglobulins and (oagulation ;actor (oncentrates are manufactured through the
manufacturing activities of filling and sealing the blood products from bulk po&der
or solution or both, the requirements as they apply to the manufacture of blood
products from &hole blood shall apply mutatis mutandis to such manufacture of
blood products, unless other requirements have been approved by the (entral
Aicence -pproving -uthority.
GUIDELINES FOR APPROAAL OF BLOOD AND/OR ITS COMPONENTS
TO STORAGE CENTRES AND FIRST REFERRAL UNIT, COMMUNITY
HEALTH CENTRE, PRIMARY HEALTH CENTRE OR ANY HOSPITAL

:inistry of Health , ;amily )elfare #*eptt. of Health% vide Notification No.
S' /1/#F% dated 31th *ecember, 311. e+empted blood storage centers run by ;'Q,
(ommunity Health (entre, 4H( or any hospital from the purvie& of obtaining licence
for operation. This notification has been inserted under Schedule L of *rugs ,
(osmetics rules, ./0B under serial no. BB. The main aim of this notification is to
make abundant availability of &hole human blood or its components to the said
hospitals &ithout taking licence. Ho&ever, this e+emption is applicable to those
centers &hich are transfusing blood and@or its components less than 3111 units per
annum.

In order to ensure the safety and quality of blood and@or its components to be
stored in such blood storage centres, the follo&ing conditions are applicable before
getting e+emption from the purvie& of taking of a licence from the respective State
*rugs (ontrollersC!

XBB. )hole Human
Blood I.4. and @ or its
components stored for
transfusion by a ;irst 'eferral
Qnit, (ommunity Health
(entre, 4rimary Health (entre
and a Hospital
The provisions of (hapter I= of the -ct and the rules made
thereunder &hich require obtaining of a licence for operation of a
blood bank or processing )hole Human Blood and @ or its
components, sub5ect to the follo&ing conditions, namelyC!

#.% The ;irst 'eferral Qnit, (ommunity Health (entre, 4rimary
Health (entre and @ or any Hospital shall be approved by the
State @ Qnion Territory Aicensing -uthority after satisfying
the conditions and facilities through inspection.

#3% The captive consumption or )hole Human Blood I.4. or its
components in the ;irst 'eferral Qnit, (ommunity Health
(entre, 4rimary Health (entre and@or any Hospital shall not
be more than 3111 units annually.

#7% The )hole Human Blood and@or its components shall
be procured only from overnment Blood Bank and@or
Indian 'ed (ross Society Blood Bank and@or 'egional Blood
Transfusion (entre duly licensed.

#0% The approval shall be valid for a period of t&o years
from the date of issue unless sooner suspended or cancelled
and ;irst 'eferral Qnit, (ommunity Health (entre, 4rimary
Health (entre or the Hospital shall apply for rene&al to the
State Aicensing -uthority three months prior to the date of
e+piry of the approval.

#B% The ;irst 'eferral Qnit, (ommunity Health
(entre, 4rimary Health (entre and@or any Hospital shall
have the follo&ing technical staff for storage of blood or its
componentsC!
#a% - trained :edical $fficer for proper procurement,
storage and cross matching of blood and@or its
components. He@she shall also be responsible for
identifying haemolysed blood and ensure non!supply
of date e+pired blood or its components.
#b% - blood bank Technician &ith the qualification and
e+perience as specified in 4art <II B of Schedule ; or
an e+perienced laboratory technician trained in blood
grouping and cross matching.

#B% The ;irst 'eferral Qnit, (ommunity Health (entre,
4rimary Health (entre and Hospital shall have an area of
.1 sq. metres. It shall be &ell lighted, clean and preferably
air!conditioned. Blood bank refrigerator of appropriate
capacity fitted &ith alarm device and temperature indicator
&ith regular temperature monitoring shall be provided to
store blood units bet&een 3Y( to >Y( and if the
components are proposed to be stored, specified
equipments as specified in 4art <II B of Schedule ; shall
also be provided.

#8% The ;irst 'eferral Qnit, (ommunity Health (entre,
4rimary Health (entre and Hospital shall maintain records
and registers including details of procurements of )hole
Human Blood I.4. and@or blood components, as required
under 4art <II B of Schedule ;.

#9% The ;irst 'eferral Qnit, (ommunity Health (entre,
4rimary Health (entre and Hospital shall store samples of
donors blood as &ell as patients sera for a period of seven
days after transfusion.O


INo. < D ..1.0@7@311.!*:S , 4;-J



#*FF4-L Q4T-%
K$INT SF('FT-'S $; SF('FT-'S $; IN*I-



GUIDELINES BEFORE GRANT OF APPROAAL FOR OPERATION OF WHOLE
HUMAN BLOOD AND/OR ITS COMPONENTS STORAGE CENTRES RUN BY
FIRST REFERRAL UNIT, COMMUNITY HEALTH CENTRE, PRIMARY
HEALTH CENTRE OR ANY HOSPITAL.
NNNNN

The follo&ing guidelines may be follo&ed before e+empting the said institutions
for obtaining of a licence for operation of a Blood Bank or processing )hole
Human Blood @ or its components C

.. The applicant shall be ;irst 'eferral Qnit, (ommunity Health (entre, 4rimary
Health (entre or any Hospital.

3. The applicant shall furnish an undertaking to the licensing authority that the
captive consumption of )hole Human Blood or (omponents shall not be more
than 3111 units annually.

7. The applicant shall enclose list of equipment needed for storage vi" blood bank
refrigerator &ith alarm system , temperature indicator. - separate list of
equipments for blood components &ould be enclosed if proposed to be stored.

0. The applicant shall furnish the follo&ing C
a Name of the medical officer responsible for conducting operation of
blood storage center.
b -ttested certified copies of :BBS or :* qualification
c Name, certified copies of qualification and e+perience of the blood bank
technician.
d Name, attested certified copies of qualification and e+perience of the
blood bank technician having non!*:AT qualification

B. The applicant shall furnish the source of procurement of )hole Human Blood @
Blood (omponents namely the name and address of the Blood Banks.
a. The source of procurement of blood @ components shall be from
licensed Blood Banks run by ovt. Hospitals @ Indian 'ed (ross
Society @ 'egional Blood Transfusion (entres only.
b. - letter of consent from the above Blood Banks &ho intend to supply
)hole Human Blood @ Blood (omponents to the Blood Storage (entres
shall be furnished along &ith the application.

8. The applicant shall submit the plan of the premises. - minimum area of .1 sq.
meter is essential for the Blood Storage (entre.

9. In order to satisfy the conditions and facilities, an inspection of the proposed
Blood Storage (entre may be carried out by the respective State *rug (ontrol
*epartment.



>. The Inspection team shall also inspect the Blood Banks &ho have given
consent letters for supply of )hole Human Blood @ (omponents. The
inspection team may verify &hether the Blood Banks have sufficient quantity
of blood units to be supplied to the Blood Storage (entres and also verify the
mode of shipper or containers used for supply of blood units @ components to
ensure that the proper storage condition is maintained as per the
pharmacopeia. The Blood Bank shall label the blood units @ components as per
the *rugs , (osmetics 'ules, ./0B.

/. The Blood Banks &ho intend to supply the blood units @ components shall test
the follo&ing mandatory tests before supplying to Blood Storage (entres.
a. Blood rouping
b. -nti Body Testing
c. Haemoglobin (ontent
d. HI= I , II -nti Bodies
e. Hepatitis B Surface antigen
f. Hepatitis ( -nti Body
g. :alarial 4arasite
h. Syphillis or =*'A

The label of the tested blood unit shall contain the above particulars &ith date
of testing before supplying to Blood Storage (entres.
The Blood Bank shall maintain a separate register for supply of blood units @
components to Blood Storage (entres &ith all necessary details.

.1. The validity of approval shall be for a period of 3 years from the date of issue
of the approval.

... The State Aicensing -uthority shall for&ard the approved Blood Storage
(entres to the concerned ?onal $fficer immediately.

.3. - format of the approval proforma is enclosed.



CERTIFICATE OF APPROAAL TO BLOOD STORAGE CENTRE FOR
STORAGE OF WHOLE HUMAN BLOOD AND4 / OR ITS COMPONENTS


No. MMMMMMMMMM *ate of Issue
MMMMMMMMMMMMMMM

:@s MMMMMMMMMMMMMMMMMMMMMM is hereby approved to store the follo&ing items on
the premises situated at MMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMMM under the
supervision of the follo&ing technical staff C
.. Names of the approved medical officer C
.. Names of the items C
3. Name of the qualified Blood Bank Technician C
7. Name , address of the licensed Blood C
Bank from &hom the blood units &ould be procured.
B. The approval shall be inforce from to
Signature
*esignation
Aicensing -uthority
*ated
N *elete &hichever is not applicable.
CONDITIONS

The Blood storage center shall comply &ith the conditions as stipulated under item BB
of Schedule L of the *rugs and (osmetics 'ules &hich also includes as under C!

.. The captive conception of )hole Human Blood or its components in the above said
center shall not be more than 3111 units annually.

3. In the event of any change in the technical staff shall be forth&ith reported to the
licensing authority.

7. In the event of any change in the name of the licensed blood bank from &hom the
blood units are procured, the same shall be intimated to the licensing authority for
approval.

0. The center shall apply for rene&al of the approval to the licensing authority three
months prior to the date of e+piry of the approval.

B. The center shall maintain records and registers including the details of procurement
of bloodN @ its components.

8. The center shall store samples of donors2 blood as &ell as patients2 sera for a period
of 9 days after transfusion.