National Pharmacovigilance Centre

A National Pharmacovigilance Centre (NPC) is a designated organization within a country that oversees activities related to pharmacovigilance, the science and activities concerned with the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The NPC typically operates under the authority of the national regulatory body for medicines and works in collaboration with healthcare professionals, pharmaceutical companies, and other stakeholders.

Key Functions of an NPC:

Adverse Drug Reaction (ADR) Monitoring:

• Collecting reports of suspected ADRs from healthcare professionals, patients, and pharmaceutical companies.
• Maintaining a national database of ADR reports.

Signal Detection and Risk Assessment:

• Analyzing collected data to identify new safety signals.
• Assessing risks associated with medicines and recommending regulatory actions if necessary.

Regulatory Decision-Making Support:

• Providing safety information to the national regulatory authority for decision-making.

• Recommending label updates, usage restrictions, or withdrawal of unsafe medicines.

Collaboration with Global Organizations:

• Collaborating with the World Health Organization (WHO) and participating in the WHO Programme for International Drug Monitoring (PIDM).

• Sharing safety data with international pharmacovigilance systems like the VigiBase database managed by the WHO.

Public and Professional Awareness:

• Promoting awareness about drug safety among healthcare providers and the general public.

• Providing guidance and training to healthcare professionals on reporting ADRs.

Pharmacovigilance in Clinical Trials:

• Monitoring the safety of medicines during clinical trials within the country.

Importance of an NPC:

• Enhances patient safety by reducing harm from ADRs.

• Improves public confidence in the healthcare system.
• Facilitates informed regulatory decisions based on local and global safety data.
• Supports rational use of medicines through evidence-based findings.

Examples:

• In India, the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI) operates under the Indian Pharmacopoeia Commission.
• In the United Kingdom, pharmacovigilance is managed by the Medicines and Healthcare products Regulatory Agency (MHRA).
• In the United States, the FDA Adverse Event Reporting System (FAERS) collects and analyzes safety reports.