Uganda: Stiffer Regulation Needed On Fake Drugs

Carlos Odora | 21 May 2008
New Vision
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.