Study raises questions over WHO-approved drug quality

Almost one-fifth of sampled WHO-approved anti-infectives manufactured in China failed quality tests run by researchers.

Sampling of more than 2,500 drugs over a four-year period showed that almost 18 per cent of drugs manufactured in China and approved by the World Health Organization (WHO)  failed quality tests. The reasons for the finding are unclear but a high prevalence of counterfeits is a possibility.

"It is possible that more of the failures originating in China are counterfeit products, but this cannot be ascertained without greater help from the manufacturers themselves," Roger Bate, one of the authors of the study, wrote in Research and Reports in Tropical Medicine.

The finding has raised concerns that WHO-approved drugs sold in mid-income countries for treating malaria, tuberculosis and other diseases may lack efficacy. More worryingly, use of substandard medicines has been linked to development of drug-resistant malaria parasites.

A separate study, published in the same edition of the journal by many of the same authors, found almost eight per cent of artemisinin-based antimalarial drugs sampled in Nigeria and Ghana had too little of the active pharmaceutical ingredient (API).