Healthy Skepticism Library item: 17776

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Publication type: Journal Article

Tide turns for drug manufacturing in Africa
Lancet 2010 May 8; 375:(9726):1597 - 1598
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60687-3/fulltext

Abstract:

With several efforts underway to increase the local production of drugs in developing countries, Tatum Anderson assesses the pros and cons of manufacturing medicines in Africa.
A drugs producer in Uganda has become the first in a least developed country (LDC)-a category reserved for the world’s poorest nations-to achieve a world-class seal of quality for its manufacturing standards.
The Quality Chemicals plant, in the Ugandan capital Kampala, is the first to get this far along the so-called WHO pre-qualification process; a stringent quality check imposed on manufacturers of drugs. There are around 37 manufacturers in sub-Saharan Africa. “There has been excitement”, says George Baguma chief marketing officer at Quality Chemicals. “We are the first in sub-Saharan Africa to get pre-qualification of a plant outside South Africa.”
The next step is to gain approval, or pre-qualification, for each malaria and HIV/AIDS drug the firm produces, before international agencies, such as UNICEF, are allowed to buy from the company.
It is an important milestone because of scepticism over domestic, or local manufacturing, in such countries, says Suerie Moon, an expert on local production at the Kennedy School of Government, Harvard University, MA, USA. “There is a lot of doubt in the global health community as to whether a firm in an LDC is capable of producing at WHO pre-qualification standards”, she says. “It sends a clear signal that it’s possible and is an important part of changing the way people think about local production.”
A World Bank report set the tone in 2005, concluding that in many parts of the developing world, producing medicines domestically made little economic sense and could even end up reducing access to medicines. The thinking was that few developing world producers could compete with those from India and China. And, crucially, from a public health point of view it does not matter where the drug comes from as long as it is safe, affordable, and of good quality.
Manufacturers, especially in poor nations, face a multitude of expenses that push up the cost of medicines beyond those from India and China said the report’s authors, Richard Laing from WHO and Warren Kaplan, assistant professor of international health at Boston University, MA, USA. Difficulties include unreliable water and electricity supplies. Companies are also often forced to import machinery, packaging, and active pharmaceutical ingredients (APIs) because there is little production of starting materials at home. Technical specialists are scarce too.
By contrast, India and China are pharmaceutical powerhouses with plentiful supplies of skilled professionals and decades of government support. The countries’ enormous populations have helped support industries too.
Andreas Seiter, a senior health specialist at the World Bank says that few factors have changed dramatically since 2005, particularly in Africa. “There is still a cost disadvantage for local manufacturing in Africa”, he says. “In Ghana, for instance, with energy costs and importing raw materials and no large volumes produced, they are not competitive with Indian and Chinese manufacturers.”
And it is not just about cost. Some say that the quality of drugs produced can be much lower than international standards and that countries are putting industrial agendas ahead of public health if they buy from inefficient local facilities rather than better-quality medicines abroad.
Others attribute Quality Chemicals’ success to one of India’s leading pharmaceutical companies, Cipla, which designed the plant (it is a carbon copy of Cipla’s facility in Goa, India, say insiders). Cipla sent its experts to train Ugandan staff and even applied for WHO pre-qualification certification on behalf of Quality Chemicals.
Why then, is there currently a flurry of global activity aimed at increasing local production in developing countries? WHO, several UN agencies, the European Union and non-governmental organisations, are looking at local production strategies; Michel Sidibé, executive director of UNAIDS, last year called for local production of antiretrovirals to be ramped up; and importantly, the African Union (AU) grouping of African Governments, is currently devising a fully costed business plan for the production of drugs for HIV/AIDS, tuberculosis, and malaria on the continent.
Pharmaceutical companies from Democratic Republic of the Congo to Ethiopia are being helped to reach international standards too. German development agency GTZ is even sending individual inspectors from the German regulator to Africa to do personal plant assessments. Although no substitute for a full WHO pre-qualification, the process helps identify improvements necessary to reach international standards.

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