Botswana’s leading pharmaceutical firms warn that government misinterpretations of local manufacturing could endanger the country’s medical supply chain, amid claims by the health ministry that they are merely middlemen
GAZETTE REPORTER
Top pharmaceutical firms have expressed concern over ‘misunderstandings and mischaracterizations’ of local pharmaceutical manufacturing by the government, warning that such misconceptions could be detrimental to national medical supply chain.
The concerns follow repeated remarks by the new administration characterising local firms as mere middlemen who simply package medicines and sell them to government at inflated prices. Speaking at Parliament yesterday, the Minister of Health, Dr Stephen Modise indicated a preference to procure medicines “directly from manufacturers,” in Abu Dhabi, a position the companies worry overlooks the scope of local pharmaceutical operations.
The companies say they have been licensed by Botswana Medicines Regulatory Authority, Trade Ministry and are recognised by the World Health Organization has manufacturers.
WHO Standards Compliant
In a detailed letter, leaked by the Ministry of Health sources, addressed to the health Ministry, the Botswana Medicines Regulatory Authority, and the trade and Industry Ministry, the companies stressed that recent claims suggesting Botswana’s pharmaceutical operations are limited to “packaging-only” activities are incorrect and not aligned with international standards.
The companies highlighted that under the World Health Organization (WHO) definition, pharmaceutical manufacturing encompasses a broad range of activities beyond just active pharmaceutical ingredient (API) production. These include quality control (QC) testing, batch certification and release, primary and secondary packaging, stability testing, and adherence to Good Manufacturing Practices (GMP).
Local Operations Meet Manufacturing Criteria
“Facilities conducting QC testing and packaging are legitimate manufacturing entities, not simple packaging operations,” the letter reads, noting that these activities require licensed premises, qualified personnel, and regulatory oversight.
International Comparisons
The letter also referenced international examples, pointing out that countries such as South Africa, Kenya, Ethiopia, and EU nations recognize facilities that perform QC testing and packaging of imported bulk products as manufacturers eligible for public procurement. In Botswana, the companies argue, excluding such operations from procurement decisions could contradict national industrial policy and Vision 2036 goals.
Risks to Medicine Supply and Industrialization
Beyond the legal and regulatory arguments, the pharmaceutical sector warned that ignoring these definitions could jeopardize medicine supply security, regulatory control, industrialization, skills development, and crisis preparedness. They urged the government to align procurement policies with technical compliance, regulatory approvals, and international best practices rather than narrow interpretations of manufacturing.
Call for Technical Engagement
To foster clarity, the companies proposed technical briefings by Ministry pharmaceutical experts, independent GMP verification, and a review of local QC testing and batch release systems. They emphasized that their submission is intended to refine public statements and policy decisions without undermining confidence in Botswana’s healthcare system.
Awaiting Government Response
The government is yet to respond to the letter, but stakeholders in the health and industrial sectors are watching closely, as the outcome could in the nearby future affect the country’s ARV supply chain and local pharmaceutical industrialization ambitions. Sources at the Ministry of Health say that industry representatives were recently turned away in their attempt to secure a meeting with the Ministry’s top officials for a meaningful engagement on the way forward.