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