Central Drugs Laboratory, Kasauli

Central Drugs Standard Control Organisation
Ministry of Health & Family Welfare
Government of India

Viral Vaccine

Function and Responsibilities of viral vaccine unit

  • Lot Release of viral Immunobiologicals, Imported and indigenously produced.
  • Lab Access
  • IP Monographs on Viral Vaccines.
  • National Repository of Biological Reference Standards.
  • Evaluation of Technical Dossiers of manufacturing and Quality Control of viral vaccines.
  • Review of reports of Quality defects and provision of advice on withdrawals.
  • Participation in WHO proficiency testing of vaccines.
  • Participation in Joint inspection like GMP, routine inspection.
  • Annually Viral vaccine Unit received approximately 1700 batches of the various viral vaccines for testing or pre release certification.
  • The batches received from manufacturer, importer and from inspecting authorities for EPI supply are subjected to lot release.
  • The sample received from Drug Inspector or field samples are tested as per their request, AEFI samples are tested as per the safety parameter.
  • The unit has qualified and experienced staff to review the summary lot protocol, review of dossiers, post approval change and perform the quality control analysis of vaccine samples.

Type of samples received in viral vaccine unit

Vaccine Units
Bacterial
Antisera
Viral
Manufacturer List for Units
Bacterial
Antisera
Viral