Variations in regulatory requirements governing labels on herbal medicines; An observational study of selected herbal medicines sourced from Ghana, India, China, and Australia.

OBJECTIVE

Labelling on herbal medicines (HM) is critical for ensuring safe and effective use. However, regulatory requirements and enforcement vary substantially across countries. This research focused on assessing compliance of selected HM labels with a checklist on manufacturer information based on WHO-recommended labelling requirements.

METHOD: A total of 322 selected HM products were purchased between 2019 and 2024 from Ghana (n=131), India (n=62), China (n=127), and Australia (n=2). Labels were examined for the presence of manfacturer information including: licensing information, manufacturer details, source of raw materials, expiry date, batch number and one quality control indicator namely metal testing indication. Two independent reviewers assessed each label (Cohen's κ=0.92). Statistical comparisons used chi-square tests.

RESULTS

HM labelling compliance is significantly poorer in Ghana compared to India, China, and Australia, particularly for licensing, expiry dates, and batch numbers. Critically, disclosure of raw material sourcing and metal testing is inadequate across all four countries, representing a global safety concern.

CONCLUSION

We recommend harmonised enforcement of raw material traceability and mandatory metal testing for all HM products, with technical assistance from WHO to low-resource regulatory agencies such as Ghana's Food and Drugs Authority.