New Liberian drug authority shows its teeth

The newly-formed regulatory authority in Liberia has taken its first enforcement action, recalling three antimalarial medicines which were identified as counterfeit.

The Liberia Medicines and Health Products Regulatory Authority (LMHRA), which was established in September 2010 (see also Liberia sets up regulatory authority to tackle substandard drugs), carried out testing on samples of the three products in the capital Monrovia and concluded that they contained no active pharmaceutical ingredients (API).

"Counterfeit and substandard medicines, such as the three recalled products, have the potential to create serious health threats to those counting on their medicinal properties to help combat diseases such as malaria," said Dr. Clavenda Bright Parker, chair and acting managing director of the LMHRA.

The LMHRA tested 56 samples of the antimalarial medicines, of which 32 failed visual inspection or testing by thin-layer chromatography. Screening of the medicines samples was conducted by the LMHRA in cooperation with the Promoting the Quality of Medicines programme, an initiative set up by the US Pharmacopeial Convention (USP) with the support of the US Agency for International Development.

"TLC tests showed that what appeared to be the three front-line antimalarial medicines - Artesunate 50 mg Tablet (Batch Number 07015FX); Colquine, quinine sulphate syrup 60 mL (Batch Number ECQ-10001); and Colquine, quinine sulphate suspension 60 mL (Batch Number ECQ-10001) - were counterfeit and contained no antimalarial ingredients," said USP in a statement.

The same batch number was found on the two recalled medicines identified as Colquine, an indicator of product tampering.

The LMHRA has ordered all pharmacies, medicines stores, hospitals, clinics and individuals that have purchased or hold stocks of the recalled medicines to send them to its offices in Monrovia for incineration.

Earlier sampling studies carried out by the PQM found substandard medicines rates of 44 per cent, with up to 80 per cent of chloroquine- and amodiaquine-based antimalarials showing high levels of impurities. The majority of samples of another popular antimalarial - sulfadoxine-pyrimethamine - failed basic disintegration tests.