FIGURE 4-4 Number of sub-Saharan African countries out of 26 surveyed meeting the main functions of a regulatory authority.
NOTE: NMRA = National Medicines Regulatory Authority.
SOURCE: WHO, 2010a.

Governments in low- and middle-income countries need a strategy to act against falsified and substandard medicines. Any viable solution will include strengthening the drug regulatory system, including building the inspectorate, enforcing quality standards, and licensing in accordance with international standards. Without a competent regulatory authority to inspect wholesalers, distributors, and manufacturers, opportunities to corrupt the drug supply abound. Box 4-6 describes a patient safety disaster following the disbanding of the Pakistani national regulatory authority.

A 2012 Institute of Medicine report called for greater international investment in building food and drug regulatory systems in developing countries and for an international training and credentialing system for regulators (IOM, 2012). This committee supports these recommendations. It also recognizes that the magnitude of the task facing these agencies is overwhelming and that governments need to make drug quality a priority, and then empower their regulatory agencies to improve.

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