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. Definitions.- (1) In this Part and
in the Forms contained in Schedule A and in Part XII B and Part XIIC of
schedule F, unless there is anything repugnant in the subject or context,-
(a) ‘apheresis’ means for the process by which blood drawn from
a donor, after separating plasma or platelets or leucocytes, is retransfused
– simultaneously into the said donor;
(b) ‘autologous blood’ means the blood
drawn from the patient for re-transfusion unto himself later on;
(c) ‘blood’ means and includes whole human blood, drawn from a
donor and mixed with an anti-coagulant;
(d) ‘blood bank’ means a place or organization or unit or
institution or other arrangements made by such organization, unit or
institution for carrying out all or any of the operations for collection,
apheresis, storage, processing and distribution of blood drawn from donors
and/or for preparation, storage and distribution of blood components;
(e) ‘blood component’ means a drug prepared, obtained, derived
or separated from a unit of blood drawn from a donor;
(f) ‘blood product’ means a drug manufactured or obtained from
pooled plasma or blood by fractionation, drawn from donors;
(g) ‘donor’ means a person who voluntarily donates blood after
he has been declared fit after a medical examination, for donating blood, on
fulfilling the criteria given hereinafter, without accepting in return any
consideration in cash or kind from any source, but does not include a
professional or a paid donor.
EXPLANATION.- For the purposes of this clause,
benefits or incentives like pins, plaques, badges, medals, commendation
certificates, time-off from work, membership of blood assurance programme,
gifts or little or intrinsic monetary value shall not be construed as
consideration;
(h) ‘leucapheresis’ means the process by which the blood drawn
from a donor, after leucocyte concentrates have been separated, is
re-transfused simultaneously into the said donor;
(i) ‘plasmapheresis’ means the process by which the blood drawn
from a donor, after plasma has been separated, is re-transfused during the
same sitting into the said donor;
(j) ‘plateletpheresis’ means the process by which the blood
drawn from a donor, after platelet concentrates have been separated, is
re-transfused simultaneously into the said donor.
(k) ‘professional donor’ means a person who donates blood for a
valuable consideration, in cash
or kind, from any source, on behalf of the recipient – patient and includes a
paid donor or a commercial donor;
(l) ‘replacement donor’ means a donor who is a family friend or
a relative of the patient –recipient.
122-F. Form of application for licence for operation
of Blood Bank/processing of whole human blood for components/manufacture or
Blood Products for sale or distribution – (1) Application for the
grant and/or renewal of licence for the operation of Blood Bank/processing of
Human Blood for components/manufacture of Blood Products shall be made to the
Licensing Authority appointed under Part VII in Form 27-C or Form 27-E as the
case may be and shall be accompanied by licence fees of rupees six thousand
and an inspection fees of rupees one thousand and five hundred for every
inspection thereof or for the purpose of renewal of licence.
Provided that if the
applicant applies for renewal of licence after the expiry but within six
months of such expiry the fee payable for the renewal of the licnece shall be
rupees six thousand and inspection fees of rupees one thousand and five
hundred plus an additional fees at the rate of rupees one thousand per month
or a part thereof in additional to the inspection fee.
Provided further that a
licensee holding a licence in Form 28-C or Form 28-E as the case may be for
operation of blood bank/processing of whole human blood for
components/manufacture of blood products shall apply for grant of licence
under sub-rule (1) before the expiry of the said licnece on Form 27-C or Form
27-E as the case may be and he shall continue to operate the same till the
orders on his application are communicated to him.
1. {EXPLANATION.- For the purpose of
this rule, ‘Blood Bank’ means a place or organizational unit or an
institution, or other arrangement made by such organizational unit or
institution for carrying out all or any of the operations of manufacture of
human blood components or blood products or whole human blood for its
collection, storage, processing, distribution from selected human donors.}
2. A fee of rupees one thousand shall be paid for a duplicate
copy of licence issued under this rule, if the original is defaced, damaged
or lost.
3. Application by licensee to
manufacture additional drugs listed in the application shall be accompanied
by a fee of rupees three hundred for each drug listed in the application.
4. On receipt of the
application for the grant or renewal of such licence, the Licensing Authority
shall, -
(i)
verify the statements made in the application
form.
(ii) Cause the
manufacturing and testing establishment to be inspected in accordance with
the provisions of rules 122-I; and
(iii) In case the application is for renewal of licence, call for
information of past performance of the licensee.
5. If the Licensing Authority is
satisfied that the applicant is in position to fulfill the requirements laid
down in the rules, he shall prepare a report to that effect and forward it
along with the application and the licence (in triplicate) to be granted or
renewed, duly completed to the Central Licence Approving Authority:
Provided that if the Licensing Authority
is of the opinion that the applicant is not in a position to fulfill the
requirements laid down in these rules, he may, by order, for reason to be
recorded in writing, refuse to grant or renew the licence, as the case may
be.
6. If, on receipt of
application and the report of the Licensing Authority referred to in Sub-rule
5 and after taking such measures including inspection of the premises, by the
inspector, appointed by the Central Govt. under Section 21 of the Act, and/or
along with expert in the field concerned if deemed necessary, the Central
Licence Approving Authority, is
satisfied that the applicant is in a position to fulfill the requirement laid
down in this rule. He may grant or renew
the licnece, as the case may be:
Provided that if the Central Licence
Approving Authority is of the opinion that the applicant is not in a position
to fulfill the requirements laid down in these rules he may, notwithstanding the report of the Licensing Authority, by
order, for reason to be recorded in the writing, reject the application for
grant or renewal of licence as the case may be and shall supply the applicant
with a copy of the inspection report.
122-G. Form of licence for the operation of a Blood
Bank/Processing of Whole Human Blood for components and manufacture of Blood
products and the conditions for the grant or renewal of such licence.- A licence for the
operation of a Blood Bank or for processing whole Human Blood for components
and manufacture of blood products shall be issued in Form 28-C or Form-28-E
or Form 26-G or Form 26-I as the case may be. Before a licence in Form 28-C
or Form-28-E or Form 26-G or Form 26-I, as the case may be, is granted or
renewed the following conditions shall be complied with by the applicant.-
(i) The operation of the Blood Bank and/or processing of whole
human blood for components/manufacture of blood product shall be carried out
under the active direction and personal supervision of component technical
staff consisting of at least one person who is whole time employee and who is
a Medical Officer, and possessing-
a) Post Graduate
degree in Medicine-M.D. (Pathology/Transfusion Medicines); or
b) Degree in
Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having
adequate knowledge in blood group serology, blood group methodology and
medical principles involved in the procurement of blood and/or preparation of
its components; or
c) Degree
in Medicine (M.B.B.S.) having experience in Blood Bank for one year during
regular service and also has adequate knowledge and experience in blood group
serology, blood group methodology and medical principles involved in the
procurement of blood and/or preparation of its components,
The degree or diploma being from a university
recognized by the Central Government.
EXPLANATION- For the purposes of this
condition, the experience in Blood Bank for one year shall not apply in the
case of persons who are approved by the Licensing Authority and/or Central
Licence Approving Authority prior to the commencement of the Drugs &
Cosmetics (Second Amendment) Rules,1999.
(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 ‘F’, Part XII-B and / or XII-C.
(iii) The applicant shall provide and maintain adequate technical
staff as specified in Schedule ‘F’, Part XII-B and/or XII-C.
(iv) The applicant shall provide adequate arrangements for
storage of Whole Human Blood, Human Blood Components and blood products.
(v) The applicant shall furnish to the Licensing Authority, if
required to do so, data on the stability of Whole Human Blood, its components
or blood products which are likely to deteriorate, for fixing the date of
expiry which shall be printed on the labels of such products on the basis of
the data so furnished.
122-H.
Duration of Licence.- An original licence in Form 28-C or Form 28 –E or a renewed
licence in Form 26-G or Form 26-I unless sooner suspended or cancelled shall valid for a period of five years and from
the date on which the year in which it is granted or renewed.
122-I.
Inspection before grant or renewal of licence for operation of Blood Bank,
processing of Whole Human Blood for Components and Manufacture of Blood
Products.-
Before a licence in Form 28-C or Form 28 –E is granted or a renewal of
licence in Form 26-G or Form 26-I is made ,as the case may be, the Licensing
Authority or Central Licence Approving Authority, as
the case may be , shall cause the establishment in which Blood Bank is proposed to be operated/ whole human blood for component
is processed[/] blood products are manufactured to be inspected by one or
more inspectors, appointed under the Act and / or along with the Expert in
the field concerned. The Inspector or Inspectors shall examine all portions
of the premises and appliances/ equipments and inspect the process of
manufacture intended to be employed or being employed along with the means to
be employed or being employed for operation of blood bank/processing of whole
human blood for components/ manufacture
of blood products together with their [testing] facilities and also enquire
into the professional qualification of the expert staff and other technical
staff to be employed.
122-J.
Report by Inspector.- The Inspector or Inspectors shall forward a detailed
descriptive report giving his finding on each aspect of inspection along with
his recommendation in accordance with the provisions of Rule 122-I to the
Licensing Authority or to the Central Licence Approving Authority.
122-K. Further
application after rejection.- If within a period of six months from the
rejection of application for a licence the applicant informs the licensing
Authority that the conditions laid down have been satisfied and deposits an
inspection fee of rupees two hundred and fifty the Licensing Authority, if
after causing further inspection to be made is satisfied that the conditions
for the grant of a licence have been complied with, shall grant or renew a
licence in Form 28-C or Form 28 –E;
Provided
that in case of drug notified by the Central Government under rule 68-A, the
application , together with the inspection report and the Form of licence (in
triplicate to be granted or renewed), duly completed shall be sent, to the
Central Licence Approving Authority, who may approve the same and return it
to the licensing Authority for issue of the licence.
122-L.
Delegation of powers by the Central Licensing Approving Authority.- The Central
Licensing Approving Authority may, with the approval of the Central
Government, by notification delegate his power of signing licences and any
other power under rules to persons under his control having same
qualifications as prescribed for Controlling Authority under Rule 50-A, for
such areas and for such periods as may be specified.
122-M.
Provision for appeal to the State
Government by a Party whose
licence has not been granted or renewed.- Any person who is aggrieved by the
order passed by the Licensing Authority or Central Licence Approving
Authority, as the case may be, may within thirty days from the date of receipt of such order, appeal
to the State Government or Central Government, as the case may be,
after such enquiry, into the matter as it considers necessary and after giving the said person an opportunity for
representing his view in the matter may pass such order in relation thereto
as it thinks fit.
122-N.
additional information to be furnished by an [applicant] for licence or by a
licensee to the Licensing Authority.- The applicant for the grant of licence or
any person granted a licence under the part shall, on demand furnish to the
Licensing Authority, 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 ownership 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, which may be required
for the purpose of verifying the correctness of the statement made by the
applicant or the licensee, while applying for or after obtaining the licence,
as the case may be.
122-O.Cancellation
and suspension of licences.- (1) The Licensing Authority or Central
Licence Approving Authority may for such licences granted or renewed by him
after giving the licensee an opportunity to show cause by such an order should not be passed by an order in
writing stating the reason thereof, cancel a licence issued under this part
or suspend it for such period as he thinks fit, either wholly or in respect
of some of the substances to which it relates,
[or direct the licensee to stop collection, storage, processing, manufacture
and distribution of the said substances and [thereupon order the destruction
of substances and] stocks thereof in
the presence of an Inspector] if in his opinion, the licensee has failed to
comply with any of the conditions of the licence or with any provision of the Act or Rules thereunder.
(2) A licensee whose licence has been suspended or cancelled,
within three months of the date of the order under sub-rule (1) prefer an
appeal against that order to the State Government or Central Government,
which shall decide the same.
122-P.
Conditions of licence- A licence in Form 28-C, Form 28-E, Form 26-G or Form 26-I
shall be subject to the special conditions set out in Schedule F, Part XII-B
and Part XII-C, as the case may be, which relate to the substance in respect
of which the licence is granted or renewed and to the following general
conditions, namely:-
(i) (a) The
licensee shall provide and maintain adequate
staff, plant and premises for
the proper operation of a Blood Bank for processing whole human blood, its
components and/or manufacture of blood products.
(b) The licensee shall maintain staff, premises and equipments
as specified in Rule 122-G. The licensee shall maintain necessary records and
registers as specified in Schedule F, Parts XII-B and XII-C.
(c) The licensee
shall test in his own laboratory whole human blood, its components and blood
products and [maintain records and] registers in respect of such tests as
specified in Schedule F, Part XII-B and Part XII-C. The records and registers
shall be maintained for a period of five years from the date of manufacture.
(d) The
licensee shall maintain/preserve reference [sample and] supply to the
Inspector the reference sample of the whole human blood collected by him in
adequate quantity to conduct all the prescribed tests. The licensee shall
supply to the Inspector the reference sample for the purpose of testing.
(ii)
The licensee shall allow an inspector appointed under the
Act to enter, with or [without] prior notice, any premises where the
activities of the Blood Bank are being carried out, for the processing of
Whole Human Blood and/or Blood Products, to inspect the premises and plant
and the process of manufacture and the means employed for standardizing and
testing the substance.
(iii) The
licensee shall allow an Inspector appointed under the Act to inspect all
registers and records maintained under these rules and to take samples of the
manufactured product and shall supply to Inspector such information as he may
require for the purpose of ascertaining whether the provisions of the Act and
Rules thereunder have been observed.
(iv) The
licensee shall from time to time report to the Licensing Authority any
changes in the expert staff responsible for the operation of a Blood
Bank/processing of whole human blood for components and/or manufacture of
blood products and any material alterations in the premises or plant used for
that purpose which have been made since the date of last inspection made on
behalf of the Licensing Authority before the grant of the licence.
(v) The
licensee shall on request furnish to the Licensing Authority, or Central
Licence Approving Authority or to such Authority as the Licensing Authority,
or the Central Licence Approving Authority may direct, from any batch unit of
drugs as the Licensing Authority or the Central Licence Approving may from
time to time specify, sample of such quantity as may be considered adequate
by such Authority for any examination and, if so required, also furnish full
protocols of the test which have been applied.
(vi) If
the Licensing Authority or the Central Licence Approving Authority so
directs, the licensee shall not sell or offer for sale any batch/unit in
respect of which a sample is, or protocols are furnished under the last
preceding sub-paragraph until a certificate authorizing the sales of batch/unit
has been issued to him by or on behalf of the Licensing Authority or the
Central Licence Approving Authority.
(vii) The
licensee shall on being informed by the Licensing Authority or the
Controlling Authority that any part of any
batch/unit of the substance has been found by the Licensing Authority or the
Central Licence Approving Authority not to conform with the standards of
strength, quality or purity specified in these Rules and on being directed so
to do so, withdraw, from sales and so far as may in the particular
circumstances of the case be practicable recall all issues already made from
that batch/unit.
(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. Further no batch/unit manufactured under this
licence shall be supplied/distributed to any person without prescription of
Registered Medical Practitioner.
(ix) The
licensee shall comply with the provisions of the Act and of these Rules and
with such further requirements, if any, as may be specified in any Rules
subsequently made under Chapter IV of the Act, provided that where such
further requirements are specified in the Rules, these would come in force
four months after publication in the Official Gazette.
(x) The
licensee shall maintain an Inspection Book in Form 35 to enable an Inspector
to record his impressions and defects noticed.
(xi) The
licensee shall destroy the stocks of batch/unit which does not comply with
standard tests in such a way that it would not spread any disease/infection
by way of proper disinfection method.
(xii) All bio-medical waste shall be treated, disposed off or
destroyed as per the provisions of The Bio-Medical Wastes (Management and
Handling) Rules 1996.
(xiii) The
licensee shall neither collect blood from any professional donor or paid
donor nor shall he prepare blood components and/or manufacture blood products
from the blood drawn from such a donor.
FORM 26-G
CERTIFICATE OF
RENEWAL OF LICENCE TO OPERATE A BLOOD BANK FOR PROCESSING OF WHOLE HUMAN
BLOOD AND/OR FOR PREPARATION FOR
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Sunday, 6 July 2014
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