Pharmacovigilance Centre

Pharmacovigilance, as defined by the World Health Organization, is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and complementary medicines, blood products, biological, medical devices and vaccines. For further details please visit http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ Working of Pharmacovigilance

If there is any suspicion that an adverse event or adverse reaction has occurred, the healthcare professional attending to the patient, can fill up the suspected ADR former patient suspects that he has experienced an ADR can report to the nearest ADR Monitoring Centers (AMCs) under Pharmacovigilance Programme of India (PvPI). There is a prescribed form that can be used in making reports to AMCs which can be downloaded from the website of IPC http://www.ipc.gov.in/PvPI/ADRReportingForm.pdf. The details of IPC are given in the website of IPC i.e. http://www.ipc.gov.in/PvPI/pv_home.html. The ADRs will be sent to WHO-Uppsala Monitoring Center (UMC) for analysis and signal detection. http://www.who-umc.org/DynPage.aspx?id=105196&mn1=7347&mn2=7489. Simultaneously ADRs are evaluated at NCC and the inferences are used to recommend regulatory body i.e. CDSCO to take necessary regulatory interventions, besides communicating risks to healthcare professionals and the public.

Regional Resource and Training& Technical Support Center for North India. (AMC-PGIMER)

PGIMER Chandigarh was identified as ADR Monitoring Centre (AMC) in July 2010. Dr. Bikash Medhi was appointed as Coordinator right from the first phase of Pharmacovigilance Program of India. PGIMER Chandigarh was later identified by National Coordinating Center as Regional Resource and Training& Technical Support Center for North India. Apart from the collection of ICSR’s; AMC has been actively involved in creating awareness amongst the health care professionals by means of organizing different CME’s throughout the Northern India.


Working of AMC-PGIMER

  • Collection of ADR reports from hospital of PGIMER, Chandigarh.
  • Reviewing the ICSRs for seriousness and expectedness.
  • Checking the completeness of reports for quality followed by causality assessment of ADR/AE cases, Follow up with the reporter for any incomplete information.
  • Entry of ADR reports into Vigiflow (WHOs database) by using inbuilt WHO-ART, ICD10, WHO drug dictionary.
  • Delivering lecture on trending news and issues on drug safety, importance of reporting the ADR’s; for sensitization of healthcare professionals (Doctors, Nurses, Pharmacists).
  • Preparing the monthly report of the ADR monitoring center.
  • Documentation and archival of the ADR reports in both soft and hard copies.
  • Providing training to the personnel under pharmacovigilance program of India in north India on Vigiflow, reporting form, SOPs