Presentation on blood and blood product regulation in India.

1. BLOOD AND BLOOD
PRODUCTS REGULATION
IN INDIA
PREPARED BY : DIMPLE .D.
MARATHE
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2. 2.CONTENT
1. Introduction
2. National blood policy
3. Regulations
4. General requirements
5. GMPS/SOPS
6. Conclusion
7. Refrence
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3. 3. INTRODUCTION
•Requirements of blood and/or its components including
blood products regulated by the Drugs and Cosmetics
Act, 1940 and its subsequent amendments.
•The Drugs and Cosmetics Act, 1940 specifies about
accommodation, manpower, equipment, supplies and
reagents, good manufacturing practices, and process
control to be followed in Indian.
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4. 4 NATIONAL BLOOD
POLICY
•Government of India published in the year 2002 the National
Blood Policy.
•The objective of the policy is to provide safe, adequate quantity
of blood, blood components and products.
•The main aim of the policy is to procure non remunerated
regular blood donors by the blood banks
•The policy also addresses various issues with regard to
technical
personnel, research , development and to eliminate profiteering
by 4

5. 5.
‘blood component’
means a drug prepared, obtained, derived or separated
from a unit
of blood drawn from a donor.
‘blood product’
means a drug manufactured or obtained from pooled
plasma or
blood by fractionation, drawn from donors.
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6. 6 REGULATIONS
•Human blood is covered under the definition of ‘Drug’
under Sec. 3(b) of Drugs & Cosmetics Act. Therefore,
blood banks and blood transfusion service are regulated
under the Drugs & Cosmetics Act and rules thereunder.
• In order to improve the standards of Blood and its
components, the Government of India has formulated a
comprehensive legislation to ensure better quality
control system on collection, storage, testing and
distribution of blood and its components.
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7. 7
•Part X B of Drugs & Cosmetics Rules prescribes the
requirements for the collection, storage, processing and
distribution of whole human blood, human blood
components by blood banks and manufacture of blood
products. PART XII B to the Schedule F of Drugs &
Cosmetics Rules defines the requirements for the
functioning and operation of a blood bank and/or for
preparation of blood components, whereas PART XII C
prescribes the requirements for manufacture of blood
products.
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8. 8
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9. 9 GENERAL
REQUIREMENTS
ACCORDING TO SCHEDULE F: PART XII
Location: an area of 100 square meter for its operations and an
additional area of 50 square meter for preparation of blood
components.
Surrounding: It shall be maintained in a clean and orderly
manner
Building: it should have adequate space for the orderly
placement of equipment and materials
Requirements for processing: blood establishment must have
separate component labs for processing of blood into
components and area shall not be access to other people. 9

10. 10
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Storage and quarantine areas : proper racks, bins and platforms
have been provided for the storage and
adequate areas have been allocated for products in quarantine
area.
Health: Personnel must have practice good sanitation and health
habit.
Premises: the premises has been designed constructed and
maintained to suit the manufacturing operations
Cleaning and sanitation: Specify the cleaning procedure of the
operation areas. Whether cleaning procedure is validated
Waste disposal: Specify the system of disposal of biomedical
waste, and effluents (solid, liquid, and gas)
from the manufacturing site

11. 11
122-F.
• application for license for operation of Blood
Bank/processing of whole human blood for
components/manufacture or Blood Products for sale or
distribution.
• Application for the grant and/or renewal of license for the
operation of Blood Bank/processing of Human Blood for
components/manufacture of Blood Products shall be made in Form
27-C or Form 27-E.
• license fees of rupees six thousand & an inspection fees of
rupees one thousand &five hundred for every inspection thereof or
for the purpose of renewal of license
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12. 12
• If the applicant applies for renewal of license after the expiry
but within six months of such expiry fee payable for such
renewal of the license shall be rupees six thousand and
inspection fees of rupees one thousand.
• Applicant holding a license in Form 28-C or Form 28-E.
• A fee of rupees one thousand shall be paid for a duplicate
copy of license issued under this rule, if the original is
defaced, damaged or lost.
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13. 13
122-G :
• 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.
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14. 14
122-H
• Duration of License - An original license in Form 28-C
or Form 28 –E or a renewed license in Form 26-G or
Form 26-I unless sooner suspended or cancelled shall
valid for a period of five years and from the date on
which the year in which it is granted or renewed.
122-I
• Inspection before grant or renewal of license by one or
more inspectors, appointed under the Act and / or
along with the Expert in the field concerned.
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15. 15
• The Inspector or Inspectors shall examine all portions of the
premises and appliances/ equipment's and inspect the process
of
Manufacture for operation
of blood bank/processing of whole human blood
122-J
Report by Inspector - The Inspector or Inspectors shall forward a
detailed descriptive report giving his finding on each aspect of
inspection along with his recommendation in accordance with the
provisions of Rule 122-I to the Licensing Authority or to the
Central License Approving Authority.
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16. 16
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17. 17 GOOD MANUFACTURING PRACTICES (GMPS)
/STANDARD OPERATING PROCEDURES (SOPS)
• Written Standard Operating Procedures should be maintained
and should include all steps to be followed 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 made available to the personnel for
use in the concerned areas
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18. 18 CONCLUSION
Indian blood transfusion industry is considered an area
which requires legal regulations as industry not only
fragmented or decentralized, but equally diversified in
ownership pattern. Our analysis suggested that several
areas are needs to be addressed for example donor
management, improvement in quality standard of testing,
regular checking and maintenance of temperatures, storage
and re-evaluation of GMP for blood establishment etc.
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19. 19 REFERENCE:
1.https://www.researchgate.net
2.http://www.cfdamp.nic.in
3.http://ijdra.com
4.https://www.slideshare.net
5. https://cdsco.gov.in
6. http://www.naco.gov.in
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20. THANK
YOU
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