Zimbabwe manufacturing

Ensuring the achievement of quahty health services dehvery to the pubhc in a safe, accessible and effective manner through the control of the manufacture, distribution, storage, and dispensing of both human and animal medicines throughout Zimbabwe at a sustainable cost. Corporate Strategy and Plan 1999-2001. 

In all 10 countries, licensing of manufacturing, product assessment and registration, GMP inspection, import controls and control of product quality are determined by legislation. Licensing of importation and wholesale trade is not required in Cuba and Cypms, however. In Zimbabwe, a licence is required for wholesale trade. 

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Human resources management systems for inspection differ among countries. In Australia, the same group of personnel is responsible both for licensing of manufacturers and for GMP inspection. In Cypms, Tunisia, Venezuela and Zimbabwe, GMP inspectors also carry out other dmg regulatory functions. One of the results of such an arrangement is that the different functions must compete for the employees time. Cuba, Estonia and Tunisia employ both full-lime and part-time inspectors for both functions. Other countries have full-time employees only. 

Information on implementation of GMP inspection plans is available in only some of the countries. Where data exist, they indicate that plans were successfully followed or even exceeded their targets. This applies to Cuba, Malaysia, the Netherlands, Uganda, Venezuela and Zimbabwe. For Cyprus, however, inspections of domestic plants fell short of the planned values. Cyprus has 10 domestic manufacturers, and nine inspections were planned, but in 1997 only seven were carried out. The Netherlands has 86 manufacturers and 28 inspections were planned in 1998 all of them were carried out. Venezuela has 41 manufacturers and 23 inspections were planned in 1997, of which 35 were carried out. So a low implementation rate does not necessarily indicate a low inspection rate. Enforcement measures are available in case of non-compliance in Cyprus, Estonia, Malaysia, Tunisia, Uganda, Venezuela and Zimbabwe. In Cuba, no enforcement measures are specified for failure to comply with GMP standards. Comparatively speaking, there is less likely to be a workplan for inspection of distribution channels than there is for GMP inspection. Only four countries — Cyprus, Estonia, Uganda and Venezuela — carry out inspection of distribution channels based on such a plan. 

Jua Kali can bring in under-developed regions with possible long term environmental damage. E. Muleya (Midlands State University, Zimbabwe) has analysed the effluent from battery manufacturers, specifically the levels of zinc and cadmium. High levels of some metals were found in boreholes but, thankfully, not in tap water. Simple effluent treatment technology to remove heavy metals (for example via precipitation with lime) was proven to be effective and should improve the situation. 

The area of study was a battery manufacturing concern in the heavy industrial sites of Gweru, Zimbabwe, along Bristol Road. 

I wish to thank Midlands State University, Zimbabwe, for providing the funds to undertake this research. I would also wish to thank the battery manufacturing concern for allowing us to take samples for this research in their premises, and for allowing us the use of their laboratory. 

The western United States was once covered by a large, landlocked sea. The water evaporated, leaving huge deposits of sodium carbonate, a soluble salt that is a valuable chemical raw material. While most nations must manufacture sodium carbonate from other chemicals, the United States meets a large proportion of its needs by mining. Other minerals are concentrated elsewhere, of course. Most of the known deposits of nickel are in New Caledonia and Zimbabwe. Most of the chromium is in Botswana and Turkey. Each country must rely on imports of one kind or another. 

The perception that the industry has not been working hard to improve, is not borne out by the facts. An initiative named Responsible Care which is the chemical industry s commitment to continuous improvement in all aspects of health, safety and environmental protection was launched in Canada in 1984. It was adopted by the USA in 1988 and has been spreading around the world since then. Apart from North America and Europe which are discussed below, Japan, Australia, New Zealand, Brazil, Mexico, Argentina, India, Zimbabwe and other countries have adopted it [5]. The European Chemical Industry Council (CEFIC) has drawn up guidelines which are given in Figure 1.1 [5]. In the UK, where the Chemical Industries Association (CIA) makes participation in the Responsible Care initiative a condition of membership, discharges of red list substances (compounds of mercury and cadmium, DDT, malathion, triphenyl and tributyl tin, etc.) fell by 40% between 1990 and 1992 whilst special wastes (compounds of arsenic, antimony, barium, mercury, nickel, vanadium, etc.) disposed of off site fell by 9% [6]. The Chemical Manufacturers Association (CMA) in the USA also makes participation a condition of membership and one of its Pollution Prevention Code requirements is very relevant to this book ... 

According to a report by Roskill Information Services published in 2003, the lithium market is characterized by a high degree of consolidation. Actually, three major producers—Sons of Gwalia in Australia, Tanco in Canada, and Bikita Minerals in Zimbabwe—represent the major lithium mineral producers, while Sociedad Quimica y Minera de Chile SA (SQM) and Sociedad Chilena de Litio (SCL) control the world s supply of lithium carbonate, and Chemetall GmbH of Germany and FMC Corp. of the USA dominate the manufacture of lithium metal and hthium chemicals. 

Despite the deteriorating industrial and economic conditions, however. Plus 5 Pharmaceuticals was established in 1996. The start-up used venture capital funding (UNIDO, 2007 2011b), a testament to Zimbabwe s financial system s capability at the time, despite deindustrialization, and also to the continuing vibrancy of the pharmaceutical sector. The country continued to rely on locally manufactured medicines (Turshen, 2001), and Zimbabwe appears to have sustained some alignment of industrial and health policy goals through this tumultuous period. 

Yet even in this era, aligned industry, health and social development policies did create some positive feedback mechanisms, enhancing local manufacturers innovative capabilities. This environment was instrumental in the country being one of the first in Africa to locally manufacture anti-retroviral medicines (ARVs) to address the HIV/AIDS pandemic (Banda, 2013). As Chapter 15 describes, in 2002 Zimbabwe issued a compulsory licence allowing its local manufacturers to produce ARVs. 

While Zimbabwe s experience shows that African countries can manufacture drugs for their local health system, and illustrates some ways in which health and industrial policies can be aligned, it is also a grim history of how economic crisis drives loss of industrial development opportunities in pharmaceuticals. 

Tanzania has a shorter history of pharmaceutical manufacturing than the two countries just discussed. In the colonial period during World War II, facilities for manufacturing simple medicines were established to counter the risk of blockade. However, after the war, these closed, and the country reverted to imports. The mainland, then called Tanganyika, did not, unlike Zimbabwe and Kenya, have a large colonial settler population in the pre-independence period, and the level of industrialization at independence was correspondingly small. 

However in this case, purposive support for local manufacturing was provided. The Extended Support Programme funded by the European Union and DFID (the UK Department For International Development) supported local manufacturers CAPS Pharmaceuticals and Varichem in Zimbabwe to manufacture and supply medicines to the local health system during the era of economic collapse (Table 13.1). This example shows that donor-funded programmes can support local industry and operate as an effective industrial policy tool. Table 13.1 shows that CAPS and Varichem were contracted to supply more than US 4 million worth of drugs to the programme. The contract value shows the values... 

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