Traditionally, African countries have imported drugs from countries where the prices are cheaper, such as India and China. However, the tightening of regulatory and patent laws in these countries means this source will no longer be an option. Coupled with the escalation in the number of people suffering from tuberculosis, malaria and HIV, the local manufacture of cheap, essential medicines that are independent of supplies from overseas pharmaceutical companies is imperative.

Pharmaceutical companies operating in countries such as South Africa, Uganda, Tanzania, the Democratic Republic of Congo and Ethiopia are investing in new or upgraded facilities that can manufacture these drugs. Some African companies have been granted licences from large multinationals to manufacture specific drugs, but these local companies have to ensure their facilities comply with both local and international standards. This has led to a dramatic advance in regulatory requirements for African pharmaceutical manufacturing facilities. Previously, there was neither official nor locally developed standards, but now the general trend is to adopt international principles, such as those of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S), World Health Organization (WHO) or the EU.

During 2007, the African Union drafted thePharmaceutical Manufacturing Plan for Africa, but to implement this, several obstacles must be overcome:

• Technical expertise is a critical prerequisite, but to produce adequate numbers of graduates in biology, chemistry, biochemistry, and process and pharmaceutical engineering, a substantial investment in education is required.
• The legislative framework needs to be conducive to local drug production, which extends beyond legislation, ensuring good manufacturing practice (GMP), good clinical practice, good distribution practice and good laboratory practice. Legislation regarding the regulation of related duties and taxes on imported raw materials and intermediates, as well as internal procurement legislation and pricing policies, is likely to require amendment.
• Reliable, sustainable and reasonably priced electricity and water supplies, as well as other essential infrastructure, must be ensured. For example, a fully compliant facility in Zimbabwe, which was recently completed using donor funding, struggles to operate because of the inability of the government to supply sufficient electricity, diesel fuel and other essential supplies.
• Adequate funding must be located. While some companies manufacturing essential medicines such as antiretrovirals (ARVs) have been well-supported by donor funds, others that manufacture a variety of basic medicines struggle to raise the funding necessary to comply with required standards.