Drugs & Cosmetics Act
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? An Act to regulate the import, manufacture, distribution and sale of drugs and
cosmetics.
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? Human blood is covered under the Definitions of `Drug' under Sec. 3(b) ofDrugs & Cosmetics Act.
? Imperative that Blood Banks need to be regulated under the Drugs &
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Cosmetics Act and rules there under.
? License is required to Manufacture/Collect/ Sale/Distribution.
Drugs & Cosmetics Act
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? The Drugs & Cosmetics Act ,1940 is a substantial part, where we find
the definitions, prohibitions & punishments and are divided into
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various Chapters and Sections.? The Drugs & Cosmetics Rules, 1945 is a procedural part, where the
processes are defined to implement the relevant Sections of the Act
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and are divided into various Parts, Rules and Schedules.
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Drugs & Cosmetics Rules, 1945? In the year 1967, Central Govt. (Ministry of Health) enacted a separate
provision in Schedule F Part XI B of Drugs & Cosmetics Rules.
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? State Drugs Controllers were authorized to issue the licenses for blood
banks.
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? The standards for `Whole Human Blood' are prescribed in IndianPharmacopoeia.
? Various requirements such as Accommodation, Technical staff,
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equipments etc. for operation of blood bank were included in this Part.
Drugs & Cosmetics Rules, 1945
The Ministry of Health & Family Welfare (Govt. of India) issued a
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notification in the year 1989 under the Drugs and Cosmetics Rules and
made the test HIV 1&2 antibodies of Whole Human Blood as mandatory
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requirement before transfusion.Drugs & Cosmetics Rules, 1945
? D&C Rules were amended (Rules 68A, Part XB and Part XI B of Schedule F)
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in the year 1992-93 and Drugs Controller General (India) was vested with
the power of Central License Approving Authority.
? Central License Approving Authority
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? Central Drugs Standard Control Organization
? www.cdsco.nic.in
Definitions................
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? `Blood' means and includes whole human blood, drawn from a donor
and mixed with an anti-coagulant
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? `Blood Component' means a drug prepared, obtained, derived orseparated from a unit of blood drawn from a donor.
? `Blood Product' means a drug manufactured or obtained from pooled
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plasma or blood by fractionation, drawn from donors.
Part X B : Conditions For License
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( Rule 122EA to Rule 122P)Drugs and Cosmetics Rules, Part X-B
? Rule - 122 EA ? Definitions
? Rule ? 122F to 122N - License Application Procedure / Inspection /
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Reporting by Inspection Team / Grant or Rejection of License /
Duration of license /Appeal provision
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? License granted by Licensing Authority? Approval by Central License Approving Authority
? License is granted & delivered to Applicant.
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Part X B : Procedure and Conditions For License(Rule 122EA to Rule 122P)
Rule - 122O ? Procedure of Cancellation and Suspension of Licenses.
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Rule ? 122P ? Conditions of licenses:
Maintenance of Staff / Plant / Premises / Equipment
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? Testing of whole blood / Component / Product? Inspections
? Reporting to SLA / CLAA about changes in staff / premise
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Directions issued by SLA / CLAA / Recall Directions:
? Conditions for distribution of whole blood / component / products.
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? To comply provisions of the Act and Rules? Destruction of infected blood and implementation of Bio-Medical
Wastes (Management and Handling) Rules, 1996
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Schedule F Part XI B ? Subpart IRequirements for Blood Bank / Blood Components
A. General
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I. List of Equipments
B. Accommodation
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J. Special ReagentsC. Personnel
K. Testing of whole blood
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D. Maintenance
L. Records
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E. Equipments and CalibrationM. Labels
F. Supplies & Reagents
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G. Good Manufacturing PracticesH. Criteria for Blood Donation
Schedule F Part XI B ? Subpart I Blood Donation Camps
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? Permission for camps to:? Licensed designated Regional Blood Transfusion Centre
? Licensed Govt. Blood Bank
? Indian Red Cross Society
? Licensed blood bank run by registered voluntary or charitable
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organizations recognised by SBTC
A. Premises
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B. Personnel for out-door campsC. Equipment
Schedule F Part XI B ? Subpart I I Processing of Blood
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ComponentsA. Accommodation
B. Equipment
C. Personnel
D. Testing facility
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E. Categories of Blood ComponentsF. Apheresis
? Donor Criteria
? Monitoring
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Schedule F Part XI C Manufacturing of Blood Products
A. General Requirements
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B. Collection and Storage of Plasma for FractionationC. Personnel
D. Production Control
E. Viral Inactivation Process
F. Quality Control
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G. TestingH. Storage of Finished products
I. Labeling
J. Records
K. Master Formula Record
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Compliance must be specifical y observed in the fol owingaspects
Staff
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? Change of staff must be informed to the DCA.? All staff members must be vaccinated and the records be available.
? Record of the staff training, training manual and training calendar
must be available.
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? Medical examination of the donors must be carried out by the
Medical Officer.
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Facility Layout? Any modifications must be notified to the Licensing Authority.
? Rest and Refreshment room must be available for the donors.
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? Reception area must not be used as refreshment room for donors.
? Privacy must be available for the medical examination of the donors.
Equipments
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? Alarm systems of the blood storage refrigerators must be functional.
? Recording thermograph must be available and functional for the
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blood storage areas.? Instruments must be periodically calibrated.
? Emergency medicines must be checked for expiry dates.
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Testing
? Sterility test of CPDA solution must be performed at the time of
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receipt.? Manufacturer's report must be available.
? Sterility test of the blood bags after the blood collection must be
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performed.
Grouping & Cross-matching
? Grouping and cross matching must be carried out by tube technique
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and not by slide technique.
? Tests for atypical antibodies must be carried out.
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ELISA TESTTest method including the Positive and Negative control must be as per
the literature.
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Documentation
? Laboratory manual must be prepared and available.
? Standard Operating Procedures must be prepared, reviewed and available.
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? Donor's records, including the address, must be complete.
? Batch number of the blood bag must be recorded in the Donor Blood
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Collection Record.? Calibration records must be available.
? Records of disposal of Sero-reactive blood and its components must be
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maintained appropriately.
? Records of sterilization must be maintained.
Processes
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? Labels must be affixed only after complete testing.
? Two separate storages must be available for under testing and tested
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blood and components.? Hospital Transfusion Committee must be formed and should be
functional.
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National Blood Policy
National Blood Policy & National Blood Program have been developed
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by the Govt of India, for the provision of Safe and Adequate bloodtransfusion services to the people.
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National Blood Policy-Mission Statement? Easily accessible and adequate supply of safe and quality blood collected
from voluntary non-remunerated regular blood donor in well equipped
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premises, and is stored and transported under optimum conditions.
? Transfusion under supervision of trained personnel for all who need it
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irrespective of their economic or social status through Total QualityManagement Approach.
OBJECTIVES OF NBP
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1. To reiterate firmly the Govt. commitment to provide safe and adequate
quantity of blood, blood components and blood products.
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2. To make available adequate resources to develop and reorganise theblood transfusion services in the entire country.
3. To make latest technology available for operating the blood transfusion
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services and ensure its functioning in an updated manner.
4. To launch extensive awareness programmes for donor information,
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education, motivation, recruitment and retention in order to ensureadequate availability of safe blood.
OBJECTIVES OF NBP.......
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5. To encourage appropriate clinical use of blood and blood products.6. To strengthen the manpower through Human Resource Development.
7. To encourage Research & Development in the field of Transfusion Medicine
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and related technology.
8. To take adequate regulatory and legislative steps for monitoring and
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evaluation of blood transfusion services and to take steps to eliminateprofiteering in blood banks.
Haemovigilance Program of India
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? Collection of data related to the blood transfusion safety chain (vein
to vein).
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? A system for monitoring , reporting and investigation of adverseevents/near misses related to blood transfusion
Hemovigilance Program of India
? Haemovigilance is a continuous process of data collection and analysis of
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Transfusion-related Adverse Reactions in order to investigate their causes
and outcomes and prevent their occurrence or recurrence.
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? All serious incidents following transfusion of blood / components /products are reported to a central point for collation , coordination of
investigation & action taken in response to the incidents.
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? National Institute of Biologicals, India.
Hemovigilance Program of India
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Objectives:1. To track Adverse Reactions/ Events and incidence associated with Blood
Transfusion and Blood Product Administration (Hemovigilance).
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2. To help identify trends, recommend best practices and interventions
required to improve patient care and safety, while reducing overall cost of the
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healthcare system.
Hemovigilance Program of India......
? Haemovigilance is an essential part of the quality circle
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? Information is fed back into the transfusion system to improve overall
safety and quality of transfusion
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? Both BTS and hospital transfusion activities are included? Open, honest reporting and investigation are essential
THANK YOU
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