Malaria Drug Quality

The American Enterprise Institute has raised concerns about the quality of drugs that might be purchased for large scale donor efforts. Roger Bate explained that for malaria, “only 7% of malarial drugs on the Global Fund’s list have undergone bioequivalence testing yet malaria kills more than a million people a year.” He goes further to note that, “Some of the drugs are “monotherapies,” single drugs which have been actively discouraged by WHO because they encourage drug resistance. The list contains further drugs which go against good medical practice, the specific advice of the WHO and even, according to insiders, against the technical advice of competent people at the Global Fund.” The head of Kenya’s malaria control program quotes as saying that their ministry “plans to buy untested Indian copies of Coartem.” Mr Bate is therefore concerned that, “Uganda and Nigeria are likely to do the same. And this is probably just the tip of the iceberg.”

As we have reported before, there are definite concerns about cost and availability of malaria drugs expressed by African countries. What can be said about quality? The Global Fund, one of the largest sources of money for malaria drug purchases, addressed the quality issue through its Board, which has issued guidelines for countries. These guidelines distinguish four categories od medicines: A, B, Ci and Cii. Of note, “The Global Fund does not endorse or warrant the fitness of any product on the Compliance List for a particular purpose,” These categories are defined as follows:

A – Products acceptable under the WHO Prequalification Program

B – Products authorized for use by a stringent regulatory authority

Ci – The manufacturer has submitted an application for approval of such product to the WHO Prequalification Program or a stringent regulatory authority

Cii – If the manufacturer of such product has not submitted an application for approval of such product to the WHO Prequalification Program or a stringent regulatory authority, such product is manufactured at a GMP compliant manufacturing site, as certified (after inspection) by the WHO or a stringent regulatory authority

Only one drug in the list is found in category A: Artemether-Lumefantrine by Novartis. Only one is ranked in category B: Artesunate-Mefloquine by Mepha. This list is available in the internet for all countries to review and use for planning. The so-called monotherapy drugs are in large part artemether rectal capsules for use in severe malaria only. Sulphadoxine-pyrimethamine is listed since it is the drug used for Intermittent Preventive Treatment/Therapy in Pregnancy.

For the past three months the international Roll Back Malaria Partners have been providing technical guidance to African countries as they develop their next proposal for the Global Fund, and these partners are using such guidance from WHO and GFATM to ensure that countries order quality medicines. Contrary to fears that Nigeria may be ready to buy cheap, poor quality alternatives, the Nigerian proposal development team is at this very moment basing all its procurement and costing estimates on Artemether-Lumefantrine (Coartem). A positive and synergistic aspect of the planning is that if high coverage of long lasting insecticide treated nets is achieved, demand for ACTs will actually decrease, which addresses in part the cost issue.

Finally, although major RBM partners are trying to address quality issues, there are still many areas of concern – what malaria drugs are being imported and sold through the private sector? – what malaria drugs are governments in endemic countries buying with their own funds? The RBM partnership has made a start to ensure malaria drug quality, but must continue advocacy until all organizations and agencies that purchase malaria drugs adhere to quality standards and more drugs are added to the prequalification list.

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