World Health Organization steps up action against substandard and counterfeit medicines
Asian and African Countries Move to improve the quality of their medicines
Geneva, 11 November 2003 - The World Health Organization (WHO) will launch an action plan against substandard and counterfeit medicines with six countries from the Greater Mekong sub-region this week. The plan follows similar initiatives begun in Africa and will continue to expand in response to countries’ increasing call for assistance to improve the quality of their medicines.
Counterfeit and substandard medicines are frequently detected in Cambodia, China, the Lao People’s Democratic Republic, Myanmar, Thailand and Viet Nam and the problem seems to be increasing. Products most commonly counterfeited in this region include antibiotics and those used in the treatment of tuberculosis, malaria and HIV/AIDS. The use of poor quality or counterfeit medicines has little or no therapeutic effect and in poor settings often leads to death.
“Combating low quality or illegal medicines is now more important than ever. Expanding access to safe, effective treatment for AIDS and other illnesses is no longer an option, it is an imperative," says Dr LEE Jong-wook, WHO Director-General.
At a meeting from 11-13 November 2003 in Hanoi, Viet Nam, WHO and the six countries will kick-start joint activities to combat counterfeiting of medicines in the region, to promote advocacy activities directed at key decision-makers, health professionals and the general public and to strengthen inspection and post-marketing surveillance. Substandard medicines are thought to account for 8.5% of medicines on the market in Thailand. Eight per cent of randomly collected samples in Viet Nam and 16% in Myanmar failed laboratory testing for quality assessment. From these batches, Rifampicin (used to treat tuberculosis) showed the highest failure rate at 26% followed by Cotrimoxazole (an antibiotic used mostly for children) at 24%.
In 2001 it was estimated there were 2800 illegal medicine sellers in Cambodia and 1000 unregistered medicines on the market. In the Lao People’s Democratic Republic 2100 illegal drug sellers are said to exist.
With more complex combination medicines now being recommended for drug-resistant malaria, there is a strong possibility that more substandard and counterfeit medicines will enter the market in malaria-endemic countries. Even in terms of older, more traditional antimalarials, the quality of the medicines is often poor.
A recent WHO survey of the quality of antimalarials in seven African countries revealed that between 20% and 90% of the products failed quality testing. The antimalarials in question were chloroquine-based syrup and tablets, whose failure rate ranged from 23% to 38%; and sulphadoxine/pyrimethamine tablets, up to 90% of which were found to be below standard. The medicines were a mixture of locally produced and imported products.
Samples were submitted by Gabon, Ghana, Kenya, Mali, Mozambique, Sudan, and Zimbabwe.
The reason why many of the antimalarials tested were substandard seems to stem from pervasive poverty. Poorly equipped laboratories, under-funded regulatory authorities, poor handling and manufacturing practices mostly contributed to the results of the tests.
“Many tools exist to improve medicines’ quality control and supply systems,” explains Dr Vladimir Lepakhin, head of Health Technology and Pharmaceuticals at WHO. “The problem is one of resources. Most of the countries with the lowest quality pharmaceuticals are also the ones with the highest disease burden and the poorest economies”.
The findings of the report have provided a basis from which to address potential problems in the transition to the combination artesimin-based medicines for drug-resistant malaria and has given impetus to the fight against poor quality and counterfeit medicines in Africa. WHO is now running a series of training workshops in several African countries assisting manufacturers to upgrade their standards, and regulatory authorities (the national bodies meant to assure the quality and safety of medicines) to improve their practices in the screening and testing of local and imported products.