Asian Drug Import, Local Production, and Regulatory Capacity in Tanzania, 1970–2005

Abstract

By the mid-2000s, the contribution of Tanzania’s pharmaceutical industry to local drug circulation was low compared to imports, with the latter mostly coming from India. The situation had mainly stayed the same since independence in 1961, despite a political desire to develop a local, self-sustaining drug supply pipeline. However, global developments affecting the pharmaceutical industry in the late 20th century around drug quality, safety, and availability to the majority of the poor of the Global South would later galvanize different actors, led by the World Health Organization (WHO), to respond. Among the interventions was the introduction of a set of evolving regulations, codes, and guidelines known as Good Manufacturing Practices (GMP). An archive located at the Tanzania Medicine and Medical Devices Authority (TMDA) provides a first-hand account, presented here for the first time, of the entanglements between selected local manufacturers and the regulator as GMPs were introduced into the country in the late 1980s. The TMDA archive’s files offer insights into the response of local manufacturers in this early period of GMP’s implementation. The archive facilitates a study of how the introduction of GMPs should be seen in connection with global economic and political events when, around 1990, the country’s socialism-inspired policy of health and drugs provision was challenged by mandatory global free markets that rescinded governments’ monopoly within the sector. The paper argues that while GMPs were a vital regulation to ensure drug quality and safety, their introduction caught local manufacturers off guard and stifled local drug production capacity while offering a favourable opportunity for imports, mainly from India, to dominate the markets, as the same rules did not initially apply to them locally. However, GMPs did offer an opportunity for the country’s drug regulatory infrastructure to be strengthened.