Drug Management Department Fails to Inspect Foreign Medicine Industries for Three Years
Summary
The Department of Drug Management has not carried out on-site inspections of foreign medicine industries for three years, despite a yearly WHO GMP audit provision. Stakeholders warn the lapse could increase the risk of substandard medicines and trigger shortages of essential drugs in Nepal.
Key Points
- The Department of Drug Management has failed to inspect foreign medicine industries on-site for the past three years, even though annual WHO GMP audits are required.
- Importers and stakeholders warn that relying only on documents could allow substandard, expired, or counterfeit medicines into Nepal and disrupt supply.
- The department says it will prioritize uninspected foreign industries by risk assessment and register new medicines only after GMP compliance is confirmed.
- A new risk-based registration system has been introduced to improve continuity of medicine supply and reduce importer monopoly and delays.
