Quality assurance of pharmaceuticals: meeting a major public health challenge

Overview

Quality assurance of pharmaceuticals has become a major public health challenge. Diseases know no borders; to combat the effects of diseases, countries need medicines that are manufactured to the same standards of safety and effectiveness so that they can be relied on everywhere. And as international demand for medicines grows, substandard/spurious/ falsely-labelled/falsified/counterfeit (SSFFC) medical products have been found in both developing and developed countries. Such products are at best ineffective, resulting in the growth of drug resistance and prolonged or ineffective treatment for patients, and at worst they are dangerous, putting lives at risk, even resulting in death.

Medicines that are ineffective or harmful not only damage lives but also waste public resources. e Constitution of the World Health Organization (WHO) states that one of the Organization’s primary functions is “to develop, establish and promote international standards with respect to food, biological, pharmaceutical and similar products”. WHO provides global standards for pharmaceutical ingredients, good manufacturing practices (GMP), testing of products, regulatory guidelines for authorization of marketing, and correct storage and distribution practices.