STRATEGY TO IMPROVE VACCINE PRODUCTION IN PAKISTAN

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STRATEGY TO IMPROVE VACCINE PRODUCTION IN
PAKISTAN
Dr. K. Naeem Khawaja CSO, Program Leader
(Animal Health), NARC (naeem22_at_comsats.net.pk)
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• KEY ISSUES
• Epidemiological information about infectious
  diseases
• Identification of Microbes reference labs and
  biologics regulatory authorities
• Categorization of institutions based on
  capacity for vaccine production/ QC/ R D
• Harmonization of vaccine manufacturing and QC
  protocols
• Monitoring the above affairs

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• Epidemiological Information about Infectious
  Diseases
• Establish Disease Monitoring, Reporting and
  Confirmation system
• Select major diseases of interest and confirm
  type/subtype of pathogen
• Identify type of vaccine and develop vaccine
  production vaccination programs
• Set up post-vaccination monitoring system
  through epidemiological centres
• Set up national priorities for R D on vaccine
  development

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• Identification of Microbes reference labs and
  biologics regulatory authorities
• Based on available capacity of each institute
  ONE reference lab for diagnosis and culture
  collection for livestock and ONE for poultry
  disease should be set up.
• NRLPD, NARC for Poultry Diseases and NVL
  for Livestock diseases
• Identify NVL as Biologics Regulatory Authority
  both for public and private sector
• Identify R D monitoring cell
• Set up post-vaccination monitoring system
  through epidemiological centres

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• Categorization of institutions based on capacity
  for vaccine production/ QC/ R D
• Outline vaccine production standards and
  examine each vaccine unit accordingly
• All vaccine units to be licenced and follow MOH
  standards
• Identify capacity of institutes for R D work
  and award specific task. Out put to be PATENTED
• Based on the demand of products, more than one
  unit can produce one product
• Special products (AI vaccine, Anthrax) be
  permitted at one place fulfilling biosafety
  requirements
• Train staff, improve facilities accordingly
• Both internal and national QC approval required
  before batch release

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• Harmonization of Vaccine Manufacturing
  QC Protocols
• All the present protocols for production and QC
  need harmonization
• This should include source of culture, raw
  material and testing kits/reagents.
• Future protocols will be developed by R D and
  patented for dissemination to the interested
  institutions.
• Any procedure/protocol developed by private
  sector can also be patented and shared with
  Biologics Regulatory Authorities.

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• Monitoring Biologics Issues
• Based on available capacity of each institute
  ONE reference lab for diagnosis and culture
  collection for livestock and ONE for poultry
  disease should be set up.
• NRLPD, NARC for Poultry Diseases and NVL
  for Livestock diseases
• Vet Biologics Monitoring Committee, comprising
  of provincial/federal vaccinologists should
  monitor the proposed suggestions

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• Future Scenario
• Once the R D, QC and regulatory institutions
  are in place, the similar policy can be applied
  on imported vaccines
• The above described approach can be adopted
  for Biotechnology based vaccines
• We may require technical support from
  international organizations (USDA/DEFRA/FAO/WHO)
  to undertake the proposed steps for improving
  and enhancing vaccine production in Pakistan