[Ip-health] Uganda: Stiffer Regulation Needed On Fake Drugs

[Philip Coticelli]

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New Vision
Opinion
21 May 2008
Posted to the web 22 May 2008

Carlos Odora
Kampala

Although malaria is preventable and curable, it is reported to claim 320
lives daily in Uganda. Recently, however, efforts to reduce these deaths
have improved with more widespread use of insecticide-treated nets, indoor
spraying with insecticides and better access to effective new Artemisinin
combination medicine. Many people still access medicines from private
pharmacies and shops.

A new study in the peer reviewed journal, PLoS ONE, reveals worrying data
about the quality of these medicines across Africa. If progress against
malaria is to be sustained, governments must do more to improve the quality
of malaria medicines.

In conducting the research for the PLoS ONE study, I worked with Africa
Fighting Malaria to collect a range of anti-malaria medicines in pharmacies
in Kampala. Similar collections were repeated in the main cities of Ghana,
Nigeria, Tanzania, Kenya and Rwanda. This study is the first of its kind to
test malaria medicine quality across Africa's high-malaria burden region,
the highest in the world.

We sampled 210 drugs randomly from pharmacies in the cities and drug shops
in sub-urban areas. Of these, 35% did not pass the quality tests either
because they did not have the correct levels of active ingredient or failed
dissolution tests which would not provide the biological activity required
to combat the parasites. Furthermore, across these countries, 21 different
brands of Artemisinin mono-therapy were found. The mono-therapy has been
specifically proscribed by the World Health Organisation and should not be
used because of the danger of drug resistance developing. Thus, these
results are not good for people who rely on these types of drugs or for
public health officials.

The researchers did not test whether the drugs collected were simply poorly
made, sub-standard medicines or complete fakes. Certainly, some fakes were
found with zero active ingredient. Raising the standards of legitimate drug
makers and stamping out the fakes should be the priority of governments in
the region.

Until recently, fake malaria drugs have been a problem largely confined to
Southeast Asia, where a sampling two years ago found 53% of the drugs
substandard. Drug experts opined that Asia was facing "an epidemic of
counterfeits." Southeast Asia is also the hotspot for drug resistance where
Artemisinin resistance has already been found. It is unfortunate that fakes
and sub-standards are finding their way to Africa. Drug resistance may
develop if bad quality drugs and fakes continue to be used. This could be
disastrous in the region where malaria has the greatest impact in human
welfare and economies.

With more money from donors being made available to fight malaria, the trend
in fake drugs merchandising is likely to surge, as more dubious players are
attracted to make a quick buck. This situation can only be abated if
governments move fast to close the gaps by strengthening on their regulation
capacities to make sure that drugs manufactured locally and those imported
in are subjected to stringent quality test in order to protect the consumer.

Improving the capacity to detect fake Artemisinin combination therapies and
regulating the use of the mono-therapies is vital if governments are to
protect drug integrity. It is also key to ensuring that the biological
benefits are reaped adequately over the maximum period knowing that there
will not likely be a substitute sooner in the next decade as effective in
combating malaria.

While government medicines are procured under strict scrutiny and only
deteriorate during the supply and chain management, the medicines availed to
the public through the private sector need to be thoroughly scrutinised
using stringent criteria so as to protect current users from being robbed of
their scarce resources.

*The writer is a Fellow, Africa Fighting Malaria.*