Bridging the gap? Local production of medicines on the national essential medicine lists of Kenya, Tanzania and Uganda.

BACKGROUND: Essential medicines (EMs) are those that satisfy the basic healthcare needs of the population. However, access to EMs remains a global health challenge. The World Health Organization (WHO) and the East African Community (EAC) manufacturing plan 2017-2027 support local production of EMs as a strategy to improve access to medicines. The aim of this study was to determine for each therapeutic class on the national essential medicine lists (NEMLs) of Kenya, Tanzania and Uganda, the number of EMs produced in each country. METHODS: In 2018, we analysed NEMLs and national drug registers (NDRs) in each country to identify local manufacturers and local products by EM status. For each local manufacturer we determined the number of EM products and individual EMs, and analysed EMs in each therapeutic class by registration status and whether produced locally. RESULTS: There were nine companies manufacturing locally in Kenya, four in Tanzania and six in Uganda. Most local medicine products were non-EM products. Of the 946 locally produced products in Kenya, 310 were EM products; of the 97 locally produced products in Tanzania, 39 were EM products; and of the 181 locally produced products in Uganda, 100 were EM products. Many local EM products were duplicate. Only a small proportion of EMs on each NEML were produced locally: 21% (92/430) in Kenya, 5% (24/510) in Tanzania, and 10% (55/526) in Uganda. Kenya, Tanzania and Uganda had no local EM products in 13/32, 17/28 and 15/32 therapeutic classes, respectively. The proportion of EMs that were registered varied across the countries from 327 (76%) in Kenya, 269 (53%) in Tanzania, and 319 (60%) in Uganda. CONCLUSIONS: This study highlights the importance of auditing NDRs and NEMLs for local production to inform regional and national local manufacturing strategies. EMs should be prioritized for local production and drug registration to ensure that production is aligned with local health needs.

Availability of brands of six essential medicines in 124 pharmacies in Maharashtra.

BACKGROUND: The aim of this study is to assess the availability and rational use of six essential medicines in private retail outlets in Maharashtra state. The study focuses on the range of brands for each medicine, and the availability of these brands in the pharmacies. The medicines were chosen because they are included in the World Health Organization's (WHO) essential medicines list (EML), the Indian national and Maharashtra state medicines list, and are all included in existing Indian public health initiatives and national disease control programmes. METHODS: Data was gathered on the availability of the medicines and the range and frequency of brands in 124 private retail pharmacies between January and May 2012. As there is currently no centralised database in India of available pharmaceutical brands, we collected data on the range of products of the 6 essential medicines available in the Indian market by consulting three open access Indian pharmaceutical databases, CIMS India, Medindia, and Medguide, and the commercial database, Pharmatrac; we compared this data with the results of the survey. The six essential medicines used in this study are: artemisinin (malaria), lamivudine (HIV/AIDS), rifampicin (tuberculosis control), oxytocin (reproductive health), fluoxetine (mental health) and metformin (diabetes). RESULTS: The study found that for each of the selected medicines there were multiple approved products listed in Indian databases, 2186 in total. The Pharmatrac database lists only 1359 brands of the selected medicines; 978 (72%) of these had zero sales in 2011-2012. Our survey found very low availability of the brands: 17% Pharmatrac marketed brands (163/978) and 12% of all Pharmatrac brands (163/1359) were available. Metformin was the only medicine with high availability in the study pharmacies at 91%, Rifampacin was the second highest at 64.5%; the other four medicines were available in less than half the pharmacies. A small number of brands were dominating the market. CONCLUSION: the survey shows that market competition has generated a large number of brands of the six study medicines but this has not translated into sufficient availability of these medicines in the study pharmacies. The data calls for a review of available brands, taking into consideration levels of sale and grounds for approval, and the setting up of a centralised database of registered pharmaceutical products.

Social networks and health policy: the case of misoprostol and the WHO model essential medicine list.

The WHO Essential Medicines List (EML) was established to help countries prioritise medicines according to their health care needs. Selection for the List is based on rigorous scrutiny of public health relevance, evidence on efficacy and safety, and comparative cost effectiveness. The WHO ideal is that a medicine and its efficacy are based on science, but in reality a medicine has a social life and the acceptance of a pharmaceutical intervention involves the interaction of a wide array of governmental and civil society organisations, and industry. Misoprostol is a medicine widely used for both abortion and prevention of postpartum haemorrhage in low income countries. Although the evidence for the latter is highly contested it was nevertheless added to the WHO EML in 2011. We use social network analysis to examine the social, political and economic field surrounding the WHO EML applications and health policy. We describe a chronology of the drug's use and of the applications to the WHO EML and carry out a social network analysis of the organisations and individuals involved in the applications, research and dissemination. The research identified a network of 238 organisations and individuals involved in the promotion of misoprostol for postpartum haemorrhage and present at the time of the WHO EML applications. There is a strong interdependency between the funding bodies, civil society organisations, researchers and clinician organisations. The research was part of an EU FP7 funded project on Accessing Medicines in Africa and South Asia (2010-2013).