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Sub-standard malaria drug set for recall

Health secretary Cleopa Mailu. FILE PHOTO | NMG
Health secretary Cleopa Mailu. FILE PHOTO | NMG 

Commonly used anti-malarial drug, Duo-Cotecxin, is set to be recalled from the Kenyan market for failing a laboratory quality test.

Tests on the drug, which is in circulation countrywide, show it is sub-standard as it does not have the ingredients it claims to have.

The laboratory tests were done as part of an ongoing investigation by the Business Daily in collaboration with the Code for Africa impact AFRICA Fund.

“Since Duo-Cotecxin is not locally manufactured we are going to use the batch number to trace and withdraw them then take the matter up with the manufacturer since it seems to be a quality control issue at the manufacturing point,” said Health secretary Cleopa Mailu in a telephone interview.

Samples that were subjected to the tests were purchased from a pharmacy in Nairobi’s central business district.

The drug is manufactured by Chinese company - Zhejiang Holley Nanhu Pharmaceutical co. and the specific batch number 160621 is due for expiry in May 2018, meaning it is still in circulation and poses a health risk to consumers.

The label on the Duo-cotecxin batch claims the tablets have 40mg of Dihydroartemisinin and 320mg of Piperaquine phosphate known to treat malaria, but the test found the drug only contains 67 per cent of the ingredient – Dihydroartemisinin.

Lab analysis was done by the Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry – The University of Nairobi – one of three such accredited facilities in the country.

Deputy director of National Quality Control Laboratory Pius Wanjala said drug uniformity is usually given an international standard range within which it should fall.

Dr Mailu said he was going to involve the Pharmacy and Poisons Board – the industry regulator – and issue a status update.

The recall comes barely a month after a recently released World Health Organisation report showed that one in every 10 medical products in low and middle-income countries – including Kenya – is substandard or falsified, meaning that people are taking medicines that are not working.

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