Functions of Central Drugs Laboratory

  • Quality Control of Immunobiologicals (Vaccines and Sera) imported, produced indigenously for domestic use or for exports.
  • Advice to NRA on technical matters and interaction with manufacturers for improvement in the quality of Immunobiologicals including Post Approval Changes.
  • Scrutiny of manufacturer's Summary Lot Protocols and evaluation of CMC Module-III of manufacturing and quality control of Immunobiologicals.
  • Pre-licensing and Post-Licensing testing for assuring consistency of production
  • Development, evaluation, establishment and implementation of testing procedures
  • Review of reports on quality defects & provision of advice on withdrawals of vaccines & sera.
  • Research and development in the field of quality control of Immunobiologicals.
  • Participation in WHO Collaborative Studies.