Pharmaceutical and Analytical Quality Control Services: Ownership or Outsourcing—A South African Case Study

Abstract

This investigation aimed to determine whether outsourcing quality control (QC) of medicines or ownership of a quality control facility was the best option for effective medicines regulation by the regulatory authority of South Africa. The study commenced with a review of the importance of laboratory assessment of the quality of medicines, particularly for third world countries, which often serve as targets for the dumping of substandard and counterfeit medicines. It was found that the ultimate determinant of quality drugs in a developing country market is ready access to a QC laboratory. A medicines regulatory authority (MRA) should never operate in a framework where financial constraints limit access to QC services. This, however, is often the case in developing countries. The South African MRA has a system whereby QC monitoring of medicines is outsourced to private service providers. Outsourcing can prove cost-effective if competition exists in a market. However, when few providers are available, their services may be too costly for a third world MRA. In addition, a conflict of interest may arise if these laboratories also offer their services to private pharmaceutical companies. The findings of this study support the contention that outsourcing QC is not the best option for controlling the quality of medicines by MRAs in developing countries.