- Hospitalization (initial or prolonged)
- Disability (significant, persistent or permanent)
- Congenital anomaly
- Report intervention to prevent permanent impairment or damage
A duly filled in Suspected Adverse Drug Reaction Reporting Form can be sent to the nearest Adverse Drug Reaction Monitoring Centre (AMC) or directly to the National Coordination Centre (NCC) for PvPI. Call on Helpline (Toll Free) 1800 180 3024 to report ADRs, or directly mail this filled form to [email protected]. A list of nationwide AMCs is available at : http://www.ipc.gov.in
ADR Forms- HCP Version 1.4, AEFI, COVID-19 and Kala Azar
Download - Version-1.4 - ADR Form for Healthcare Professionals
Download- Serious AEFI Case Notification Form
Download - ADR Reporting Form for Drugs used in Covid-19
Download - ADR reporting form for Kala Azar (Black fever)
What happens to the submitted information?
- Information provided in this form is handled in strict confidence. The causality assessment is carried out at AMCs by using WHO-UMC scale. The analyzed forms are forwarded to the NCC -PvPI through ADR database. Finally, the data is analyzed and forwarded to the Global Pharmacovigilance Database managed by WHO Uppsala Monitoring Centre in Sweden.
- The reports are periodically reviewed by the NCC -PvPI. The information generated on the basis of these reports helps in continuous assessment of the benefit-risk ratio of medicines.
- The Signal Review Panel of PvPI reviews the data and suggests any interventions that may be required.