A drug’s safety story doesn’t end at approval — it begins there. Pharmacovigilance is the system that watches marketed drugs for harm, and in India that system is the PvPI. The reporting chain below is how a single suspected reaction reaches the global database.
Definition & aims
Pharmacovigilance (WHO): the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
- Aims: patient safety, safe & rational drug use, early signal detection, risk–benefit assessment, regulatory action and risk communication.
- Scope (now broader than ADRs): medication errors, lack of efficacy, drug interactions, misuse/abuse, and substandard/counterfeit drugs.
- Origin: the Thalidomide disaster (1961, phocomelia) led to the WHO Programme for International Drug Monitoring (1968). A signal = reported information on a possible causal relationship between an event and a drug, previously unknown or incompletely documented.
Methods of pharmacovigilance
| Method | What it is |
|---|---|
| Passive (spontaneous) | Voluntary ADR reporting (Yellow Card / PvPI form) — the cornerstone, but limited by under-reporting. |
| Active surveillance | Sentinel sites, cohort event monitoring, registries, prescription event monitoring (PEM). |
| Comparative observational | Cohort, case-control and cross-sectional studies (pharmacoepidemiology). |
| Data mining | Disproportionality analysis (PRR, ROR) on safety databases and health records. |
ADR reporting
- Who: healthcare professionals and, increasingly, patients (consumer reporting).
- What: all suspected ADRs — especially serious, unexpected, and those involving new drugs.
- Form: the CDSCO/PvPI Suspected ADR Reporting Form (or CIOMS form); causality assessed by WHO-UMC and Naranjo scales.
Pharmacovigilance Programme of India (PvPI)
| Launched | July 2010, by CDSCO (Ministry of Health & Family Welfare). |
| National Coordinating Centre | Indian Pharmacopoeia Commission (IPC), Ghaziabad. |
| Field network | ADR Monitoring Centres (AMCs) — medical colleges & hospitals. |
| Database | VigiFlow → WHO VigiBase (Uppsala Monitoring Centre, Sweden). |
| Tools | Suspected ADR form, toll-free PvPI helpline, and the ADR mobile app. |
Related vigilance programmes
- Materiovigilance (MvPI) — medical devices; launched 2015; NCC also at IPC Ghaziabad.
- Haemovigilance (HvPI) — blood and blood products.
- AEFI surveillance — vaccines; cosmetovigilance — cosmetics.
Periodic safety reporting
PSUR (Periodic Safety Update Report) for marketed drugs — under NDCT 2019, every 6 months for the first 2 years, then annually for the next 2. DSUR (Development Safety Update Report) is used during clinical development, alongside Risk Management Plans (RMP) and signal management.
Exam tip: pin the PvPI facts — launched 2010, NCC = IPC Ghaziabad, AMCs, VigiFlow → VigiBase (WHO-UMC, Uppsala). Pharmacovigilance was born from Thalidomide (1961), and spontaneous reporting is the cornerstone. Remember PSUR (marketed) vs DSUR (trials).
Pharmacovigilance is how medicine keeps learning about its drugs after launch. Know the definition, the methods, and the Indian machinery (PvPI), and you can answer any safety-surveillance question with authority.
Test yourself
0 / 2A quick check on this topic — tap an answer for instant feedback.
Q1. The National Coordinating Centre for the PvPI is located at:
The Indian Pharmacopoeia Commission (IPC), Ghaziabad, is the NCC for the PvPI.Q2. The cornerstone method of pharmacovigilance is:
Spontaneous ADR reporting (Yellow Card / PvPI form) is the cornerstone, despite under-reporting.