ADR Reporting in India: How the PvPI System Actually Works
A plain-language guide to ADR reporting under the Pharmacovigilance Programme of India — reporters, causality scales, and VigiBase.
Adverse drug reaction (ADR) reporting is the backbone of drug safety, and in India it runs through the Pharmacovigilance Programme of India (PvPI). This explainer walks through who reports, what happens to a report, and why every pharmacist should treat reporting as part of routine practice.
What counts as an adverse drug reaction
An ADR is any noxious and unintended response to a medicine that occurs at doses normally used in humans. The definition deliberately excludes overdose and medication error as separate categories, though those are also captured by the wider pharmacovigilance system. Understanding the boundary matters because it decides how a case is classified.
Reactions are graded by seriousness and by causality. A serious reaction is one that is fatal, life-threatening, or leads to hospitalisation or disability — and these carry expedited reporting timelines.
Who can report
PvPI accepts reports from doctors, pharmacists, nurses and, increasingly, from patients directly. The reporter does not need to prove causality; a reasonable suspicion is enough. Lowering that bar is intentional — under-reporting, not over-reporting, is the real threat to a safety database.
The journey of an ADR report
A report begins at an ADR Monitoring Centre (AMC), typically located in a teaching hospital. From there it flows to the National Coordination Centre, is entered into the WHO global database (VigiBase) via the Uppsala Monitoring Centre, and contributes to worldwide signal detection.
- Reporter completes the suspected ADR reporting form
- AMC reviews and assesses causality
- Data uploaded to VigiBase for global pooling
- Signals reviewed by expert committees
Causality assessment
Causality is judged with structured tools such as the WHO-UMC scale and the Naranjo algorithm. These convert clinical judgement into a reproducible category — certain, probable, possible or unlikely — so that reports from different centres can be compared fairly.
Why pharmacists are central
Pharmacists sit at the interface between prescription and patient, which makes them ideally placed to spot and document reactions. Building ADR reporting into dispensing routines — a quick question, a completed form — measurably improves the quality of the national safety picture. It is one of the highest-leverage habits a practising pharmacist can adopt.
