Counterfeit and Substandard Medical Products: Zambia’s Legal Response

Abstract

The presence of counterfeit and substandard Medical Products is a problem of growing concern in African countries, and Zambia has not been spared. Their use causes medical complications among patients and in some cases, death. They also add to the challenges faced by an already burdened health care system. This article explores Zambia’s regulatory framework for the control of Counterfeit and Substandard Medical Products. This study examines the extent to which the Zambian law, namely, the Medicines and Allied Substances Act, protects the general public from Substandard and Falsified Medical Products. Further, it identifies the challenges faced by the Zambian regulatory authority for pharmaceutical products, the Zambia Medicines Regulatory Authority (ZAMRA), in controlling of the import, manufacture and sell of Counterfeit and Substandard Medical Products. The study adopted a qualitative research approach through a systematic review of literature. This was done by following a key word search on literature that is relevant or related to regulation of counterfeit and substandard products. The study found that the Medicines and allied Substances Act has empowered ZAMRA to protect the Zambian public from counterfeit and substandard medical products. However, it faces various challenges which include an insufficient availability of financial resources and low staffing levels. The study recommends that the Zambian government should provide incentives and policies to support investment in the pharmaceutical industry. It also recommends for an increase in the financial and human resources availed to ZAMRA, in order to solve the challenges that it faces.