Regulatory requirements for blood banks in India

1. REGULATORY REQUIREMENTS
FOR BLOOD BANKS IN INDIA
Dr. Md.Mustafeed Uddin,
JR, Dept of Hosp. Admin.,
NIMS

2. 1940
 Human Blood covered under the
definition of “Drug”.
 BloodBanks therefore regulated underDrugs
CosmeticsAct,1940 and rulesthere under

3.  The Drugs & Cosmetics Act 1940 is a Substantial
part, where we could find the definitions,
prohibitions & punishments and are divided into
various Chapters and Sections
&
 The Drugs & Cosmetics Rules, 1945 is
Procedural part, where the processes are defined
to implement the relevant Sections of theAct and
are divided into various Parts, Rules and Schedules

4. Drugs & Cosmetics Rules, 1945
 In the year 1967, Central Govt. (Ministry of
Health) enacted a separate provision in Schedule F
Part XII B of Drugs & Cosmetics Rules.
 State Drugs Controllers were authorized to issue
the licenses for blood banks.
 The standards for ‘Whole Human Blood’ are
prescribed in Indian Pharmacopoeia.

5. Drugs & Cosmetics Rules, 1945
 Human blood is covered under the definition of ‘Drug’
under Sec. 3(b)(i) of Drugs & Cosmetics Act; which
reads as follows:
 All medicines for internal or external use of human
beings or animals and all substances intended to be
used for or in the diagnosis, treatment, mitigation or
prevention of any disease or disorder in human beings
or animals, including preparations applied on human
body for the purpose of repelling insects like
mosquitoes.
 Hence, it is imperative that Blood Banks need to be
regulated under the Drugs & Cosmetics Act and rules
there under.
 License is required to Manufacture/Collect,
Sale/Distribution of ‘Whole Human Blood’ and other
blood products.

6.  ‘Blood’ means and includes whole human
blood, drawn from a donor and mixed with an
anti-coagulant
 ‘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.
Few Definitions

7. 1989: Following Reports of AIDS
Notification by Central Govt. under DrugsCosmetics
Rules for mandatorytestingforHIV
1990 :Following Fergusson Report
Drugs rules amended, and Drugs Controller General
of India vested with the power of Central Licence
ApprovingAuthority

8.  1992 : PublicInterest Litigation filed byMr.
H.D.Shourie
 1996 : Consequentto P.I.L.,SupremeCourt of
Indiagivesdirectiveto the Govt. of Indiato:
• bancommercial/paid donors
• formulate comprehensivelegislationon blood
transfusionservices.
• form National andStateBloodTransfusion Councils

9. 1996 : In line with SupremeCourt directives
 Govt.of IndiadirectsDrugs Controller
Generalof India to formulate comprehensive
legislation
 Establishmentof Committeeto formulate
National BloodPolicy
 Formationof National Blood Transfusion
Council
RegisteredasaSociety

10. Structureof TransfusionService
N.B.T.C
.
S.B.T.C./U.T.B.T.C
.
RedCross
BloodCentre
NGO
BloodCentre
Govt.
BloodCentre
Satellite
BloodCentre
R.B.T
.C.
: National BloodTransfusion Council
: State BloodTransfusion Council
: UnionTerritory BloodTransfusion
N.B.T.C.
S.B.T
.C.
U.T.B.T.C.
Council
R.B.T.C. : RegionalBloodTransfusion Centre
2002:Asper National Blood
Policy

11. Organizationssupporting
TransfusionService
NACO– NationalAidsControlOrganization
to allocatingbudgetto NBTC
DCGI- DrugsControllerGeneralofIndia
Toestablishandenforcestandardsfor bloodandblood products
Ministry of Health & FamilyWelfare
Tolay guidelines onbio-safetyfor all Blood Centres
2002:Asper National BloodPolicy

13. Key areas in Regulation of Blood
banks
The regulation of blood and blood products is crucial
and followed continuously in every step and process
that the blood passes through.
The key areas are:
1. Establishment of blood bank
2. Selection of donor
3. Blood Donor Education
4. Assessment of Fitness for Donation
5. Premises for Blood Donation
6. Testing quality
7. Quality assurance of blood product
8. Blood storage and inventory management

14. KEY REQUIREMENTS:
Collection, transportation and storage of blood products in
brief.
Qualifications of medical officers, technicians and technical
supervisor engaged in the work.
Quality control for testing.
Mandatory blood testing: Human Immunodeficiency Virus ,
Syphilis, Hepatitis B, Hepatitis C &Malaria
List of equipments provided.
List of blood products required.
Details of labels.
Standard operating procedures
 LEGAL DOCUMENTS: Covering letter with court fee
stamp with 5 rupees affixed, Form 27.C (Refer Statutory
forms), Challan for Rs. 7500 and Plan of the building.
 “The licence for operating a blood bank grants in form 28

15. Part X B : Procedure and Conditions For License
( Rule 122EA to Rule 122P)
Drugs and Cosmetics Rules, Part X-B
Rule -122 EA –Definitions
Rule–122Fto122N-LicenseApplication
Procedure/Inspection/Reporting by Inspection
Team/ Grant or Rejection of Licence/Duration
of licence /Appeal provision
License granted by Licensing Authority
Approval by Central License Approving Authority
License is granted & delivered to Applicant.