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OPERATIONAL FRAMWORK

Operational Framework for implementation of Pharmacovigilance Program

In order to implement the Pharmacovigilance scheme in systematic order and to develop a proper Adverse Drug Reactions (ADR) reporting system and monitoring of the progress, constitution of the following committees Pharmacovigilance Programme has been recommended by the PAC –

Steering & Monitoring Committee :

  • Head, DCC, Ministry of AYUSH
  • Director/Co-ordinator from NPvCC, AIIA
  • Coordinator from IPvCC
  • Representative from CDSCO
  • Representative from IPC
  • Representative from PCIM&H

Technical Advisory Committee :

  • Chairman of Scientific Body of PCIM&H
  • Chairmen of APC, UPC, SPC and HPC
  • Head, DCC, Ministry of AYUSH
  • Director/Co-ordinator from NPvCC, AIIA
  • Representative from IPC
  • Representative from CDSCO
  • Pharmacology expert from AIIMS/ ICMR
  • WHO representative of Pharmacovigilance programme (Technical Officer dealing with medicines and pharmacovigilance in WHO country office)

Central Signal Detection & Causality Assessment Committee:

  • Coordinator of NPvCC
  • AYUSH clinical expert
  • Pharmacy expert of AYUSH system
  • Pharmacology / Toxicology expert

Last update on: 21st Feb 2019