Evaluating National Essential Medicine Lists, Drug Registration, and Local Production of Anti-Cancer Medicines in South Asia: A Data-Driven Assessment

OBJECTIVES: Cancer poses a significant health burden in South Asia, which has the lowest health and education expenditure, lowest Universal health Coverage index, and highest out-of-pocket expenditure among developing countries. Access to anti-cancer medicines is crucial for effective treatment, and is influenced by National Essential Medicines Lists (NEMLs), drug registration, and local production capabilities. This study evaluates the alignment of anti-neoplastic section of NEMLs with the World Health Organization's Essential Medicines List (WHO EML), registration status, extent of local production and importation in South Asia.

METHODS: The anti-neoplastic section of WHO EML 2023 with 67 anti-cancer medicines was used as a standard as WHO stated this list for universal health coverage and local production. Data on NEMLs, registered medicines, local production and import was extracted from each country's regulatory authorities. Descriptive analysis and Pearson correlation were conducted in Microsoft Excel.

RESULTS: There is significant variability in the alignment of NEMLs with the WHO EML, with some countries maintaining updated lists (e.g., Pakistan, India) and others lagging behind (e.g., Bangladesh, Afghanistan). Drug registration practices also vary. Local production capabilities are unevenly distributed; India and Bangladesh have robust pharmaceutical industries, while Bhutan and the Maldives rely entirely on imports. Six countries have pharmaceutical industries with 5 producing anti-cancer medicines and India was main producer and exporter. A positive correlation between NEMLs' medicines and registered medicines (r=0.55), and strong associations between number of NEMLs' medicines with both locally produced (r=0.68) and imported anti-cancer medicines (r=0.67) was found.

CONCLUSIONS: Updating NEMLs and registering essential anti-cancer medicines are crucial for improving access in South Asia. Local production of these medicines may assist in lowering out-of-pock cost, hence towards Universal Health Coverage. Regional collaborative local production should be explored as it may enhance supply resilience, reduce costs, and improve affordability and accessibility of anti-cancer medicines.