cdsco and adr reporting in india

Central Drugs Standard Control Organisation

(CDSCO)

P.OMKARA SAI KIRANPHARM D

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.



ORGANISATION



How to get an CDSCO ADR reporting form?

ADR reporting form.mp4



Where to submit CDSCO reporting form?

After completing, return this form to the nearest Pharmacovigilance centre/ADR monitoring centre.



List of ADR monitoring centres (AMC) under Pharmacovigilance Programme of India (PvPI)



List of new ADR monitoring centres (AMC) under PvPI



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.



WHO causality assessment scale



WHO-UMC

NPC/CDSCO

Zonal centre

Regional centre

Peripheral centre

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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.



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

cdsco and adr reporting in india

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