Source: NDTV
Subject: International Organisation
Context: Union Health Minister announced that India has risen to 8th position globally in contributions to the WHO pharmacovigilance database, from 123rd a decade ago.
About WHO Pharmacovigilance:
What it is?
- WHO pharmacovigilance refers to the global system for monitoring, detecting, assessing, and preventing adverse effects of medicines and vaccines, coordinated through international data-sharing mechanisms.
Organisation involved: World Health Organization (WHO)
Aim:
- Ensure patient safety by early identification of medicine- and vaccine-related risks.
- Strengthen regulatory decision-making through real-world safety data.
- Promote safe, rational, and effective use of medicines worldwide.
Key functions:
- ADR collection and analysis: Systematically gathers reports of adverse drug and vaccine reactions from hospitals, manufacturers, and regulators, and analyses them to identify safety patterns across diverse populations.
- Signal detection: Identifies new, rare, or unexpected side effects by detecting statistical signals in large datasets that may not appear during pre-marketing clinical trials.
- Risk–benefit assessment: Continuously evaluates whether the therapeutic benefits of a medicine or vaccine outweigh its risks, especially when used long-term or in vulnerable groups.
- Regulatory support: Provides evidence-based inputs for regulatory actions such as safety warnings, label modifications, usage restrictions, or market withdrawal of unsafe products.
- Capacity-building and data sharing: Strengthens national pharmacovigilance systems through training and technical support, while enabling global exchange of safety data among WHO member countries.
Significance:
- Protects public health beyond clinical trials by capturing long-term and population-wide effects
- Strengthens trust in immunisation and drug programmes
- Supports national initiatives like Universal Immunisation Programme, National TB Elimination Programme, and Anaemia Mukt Bharat
India’s rank:
- 2009–2014: 123rd globally.
- 2025: 8th globally in WHO pharmacovigilance contributions.
- Recognition of Indian Pharmacopoeia standards in 19 Global South countries.
