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S.P. SHANI TECHNICAL OFFICER  (Drugs) CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (DIRECTORATE GENERAL OF HEALTH SERVICES) MINISTRY OF HEALTH & FAMILY WELFARE, NEW DELHI
Structure of CDSCO ,[object Object],[object Object],[object Object],[object Object]
Surveillance of  adverse event following immunization  ( Regulatory Issues)
Definition of Drugs ,[object Object],[object Object]
Definition of Adverse Drug Reaction ,[object Object]
Types of Adverse Drug Reaction ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
REGULATORY ISSUES ,[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],DRUGS & COSMETICS ACT &  RULES THEREUNDER
DRUGS & COSMETICS ACT &  RULES THEREUNDER ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
STANDARDS ,[object Object],[object Object]
Approval of new vaccines ,[object Object],[object Object],[object Object],[object Object],[object Object]
CDL is responsible for  Pre-release Certification of Vaccine  in the Country
MAJOR PLAYER IN REPORTING ADVERSE EVENTS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
COORDINATION  ACTIVITIEWS AT  THE LEVEL OF DCGI  DURING REPORTING OF ADVERSE EVENTS DCGI Reporting of  Adverse Events State Licensing Authority Zonal Office  of CDSCO STATE  EPI  CDL Statutory  Action  Manufacturer
CASES REPORTED AT DCGI ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
MODUS OPERANDI ADOPTED AT THE  TIME OF ADVERSE EVENTS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
LIMITATIONS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
SUGGESTIONS ,[object Object],[object Object],[object Object],[object Object]
Suggestions ,[object Object],[object Object],[object Object],[object Object]
THANK  YOU

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09 aefi shani

  • 1. S.P. SHANI TECHNICAL OFFICER (Drugs) CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (DIRECTORATE GENERAL OF HEALTH SERVICES) MINISTRY OF HEALTH & FAMILY WELFARE, NEW DELHI
  • 2.
  • 3. Surveillance of adverse event following immunization ( Regulatory Issues)
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  • 12. CDL is responsible for Pre-release Certification of Vaccine in the Country
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  • 14. COORDINATION ACTIVITIEWS AT THE LEVEL OF DCGI DURING REPORTING OF ADVERSE EVENTS DCGI Reporting of Adverse Events State Licensing Authority Zonal Office of CDSCO STATE EPI CDL Statutory Action Manufacturer
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