Brief description about cdsco, pharmacovigilance programme of India (PvPI) and the process of reporting an ADR in India.

1. Central Drugs Standard Control
Organisation
(CDSCO)
P.OMKARA SAI KIRAN
PHARM D

2. CES College of
Pharmacy
Department of
Pharmacy Practice
Introduction
THE CENTRAL DRUGS STANDARD CONTROL ORGANIZATION
(CDSCO) is the Central Drug Authority for discharging functions assigned to
the Central Government under the Drugs and Cosmetics Act.
CDSCO has
 6 - zonal offices,
 4 - sub-zonal offices,
 13 - port offices and
 7 - laboratories under its control.

3. CES College of
Pharmacy
Department of
Pharmacy Practice
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4. CES College of
Pharmacy
Department of
Pharmacy Practice

5. CES College of
Pharmacy
Department of
Pharmacy Practice
How to get an CDSCO ADR
reporting form?

6. CES College of
Pharmacy
Department of
Pharmacy Practice
Where to submit CDSCO reporting
form?
After completing, return this form to the nearest
Pharmacovigilance centre/ADR monitoring
centre.

7. CES College of
Pharmacy
Department of
Pharmacy Practice
List of ADR monitoring centres (AMC) under
Pharmacovigilance Programme of India (PvPI)

8. CES College of
Pharmacy
Department of
Pharmacy Practice
List of new ADR monitoring centres (AMC) under
PvPI

9. CES College of
Pharmacy
Department of
Pharmacy Practice
Causality assessment
CDSCO recommends the use of WHO causality
assessment scale for assessing an ADR.
Causality assessment of and ADR is done by
regional centres/ zonal centres.

10. CES College of
Pharmacy
Department of
Pharmacy Practice
WHO causality assessment scale

11. CES College of
Pharmacy
Department of
Pharmacy Practice

12. CES College of
Pharmacy
Department of
Pharmacy Practice

13. CES College of
Pharmacy
Department of
Pharmacy Practice
WHO-UMC
NPC/CDSCO
Zonal centre
Regional centre
Peripheral centre
Healthcare professionals
FlowofADRreportin
India

14. CES College of
Pharmacy
Department of
Pharmacy Practice
Peripheral centres:
 collect and record the adverse event.
Regional centres:
 to collect & scrutinize the data, causality analysis is performed.
Zonal centres:
 to verify/validate causality analysis.
 statistical analysis is done & consolidated report submited to NPC.
 provide training & support to regional centre.

15. CES College of
Pharmacy
Department of
Pharmacy Practice
NPC/CDSCO:
 monitor ADRs sends recommendations pertaining to regulatory issues to
CDSCO.
 maintain liaison with international Pharmacovigilance regulatory authority.
 review PSUR of pharmaceutical analysis.
WHO-UMC:
 provide information on drug safety to regulatory bodies, researchers and
pharmacists

16. CES College of
Pharmacy
Department of
Pharmacy Practice