Pharmacovigilance in Nepal

Pharmacovigilance plays a vital role in ensuring the safe and effective use of medicines in any country. In Nepal, efforts to strengthen the pharmacovigilance system have significantly advanced in recent years. With the rise of new drugs, complex therapies, and increasing patient awareness, monitoring adverse drug reactions (ADRs) has become more important than ever.

What is Pharmacovigilance?

Pharmacovigilance, as defined by the World Health Organization (WHO, 2002), is:

“The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.”

The primary aim of pharmacovigilance is to reduce the risk of drug-related harm and ensure rational and safe use of medicines. It also supports health professionals in identifying, reporting, and managing ADRs, contributing to improved patient care.

Pharmacovigilance System in Nepal

Recognizing the global importance of drug safety, the Government of Nepal took a major step by nominating the Department of Drug Administration (DDA) as the National Pharmacovigilance Centre in October 2004.

Nepal officially became a member of the WHO Programme for International Drug Monitoring (PIDM) in July 2006, enabling the country to report ADRs to the global database managed by the Uppsala Monitoring Centre (UMC), Sweden.

Regional Pharmacovigilance Centers in Nepal

Currently, there are 20 Regional Pharmacovigilance Centers (RPCs) across Nepal. These centers are responsible for collecting ADR reports from healthcare professionals, analyzing the data, and submitting it to the national center (DDA).

Here is the list of RPCs:

1. Tribhuvan University Teaching Hospital, Maharajgunj
2. Civil Service Hospital, Minbhawan
3. Manipal Teaching Hospital, Pokhara
4. KIST Medical College, Imadol
5. Nepal Medical College Teaching Hospital, Jorpati
6. Patan Hospital, Lalitpur
7. B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan
8. Dhulikhel Hospital, Banepa
9. Shree Birendra Hospital, Chhauni
10. Norvic International Hospital, Thapathali
11. Nepal Cancer Hospital and Research Center, Harisiddhi
12. College of Medical Sciences – Teaching Hospital
13. Nepal Mediciti Hospital, Kathmandu
14. Chitwan Medical College, Chitwan
15. National Tuberculosis Control Center, Bhaktapur
16. Hetauda Hospital, Makwanpur
17. Bharatpur Hospital, Chitwan
18. Kanti Children’s Hospital, Kathmandu
19. Bhaktapur Cancer Hospital
20. NAMS – Bir Hospital, Kathmandu

How ADR Reporting Works in Nepal

Nepal uses Vigiflow, an online data entry tool for ADR reporting and communication with the UMC.

ADR reporting flow:

1. Healthcare professionals (doctors, pharmacists, nurses) report suspected ADRs to the Regional Centers.
2. RPCs evaluate and enter the reports into Vigiflow.
3. The National Pharmacovigilance Center (DDA) reviews, validates, and forwards the data to the Uppsala Monitoring Centre (UMC).

Why Pharmacovigilance Matters in Nepal

• Ensures patient safety by identifying harmful or ineffective medications.
• Encourages rational drug use.
• Assists in updating clinical guidelines and regulatory decisions.
• Strengthens trust in healthcare systems and pharmaceuticals.
• Prevents widespread harm from adverse drug events (ADEs).

Conclusion

Pharmacovigilance in Nepal has made substantial progress, especially with the establishment of multiple regional centers and integration into the global ADR monitoring system. Continued collaboration among healthcare professionals, institutions, and regulatory bodies is essential for building a robust and responsive pharmacovigilance system.

Pharma Info Nepal encourages all pharmacy professionals and students to understand and participate in pharmacovigilance activities. Reporting even a single ADR can save lives and improve drug safety across the country.

ADR Reporting Form