14 December 2017

Kenya: Malaria Drug Duo-Cotecxin to Be Recalled From Kenyan Market

A commonly used antimalarial drug - Duo-Cotecxin - is set to be recalled from the Kenyan market for failing a laboratory quality test, the Health ministry has said.

This follows investigations by Nation in collaboration with the Code for Africa impactAFRICA Fund, which revealed that the drug of batch number 160621, which is widely in circulation across the country, failed an assay test, making it substandard and fake.

The drug samples that were purchased from a pharmacy outlet in Nairobi are manufactured by Chinese firm Zhejiang Holley Nanhu Pharmaceutical co. and are due for expiry in May 2018.

This means they would still be in circulation, posing grave health risks to consumers.

Batch withdrawn

"The specific batch number has to be withdrawn from the market and because of the expiry date - meaning it can readily be consumed- it has to be recalled," said Health Cabinet Secretary Cleopa Mailu in a telephone interview.

"Since Duo-Cotecxin is not locally manufactured, we are going to use the batch number (and even if it is in the private sector) to trace them and withdraw them, then take the matter up with the manufacturer since it seems to be a quality control issue at the manufacturing point," he said.

The label claim on the specific Duo-cotecxin batch showed the tablets had 40mg of Dihydroartemisinin and 320mg of Piperaquine phosphate known to treat malaria, but the lab test found the drug to only contain 67 per cent of Dihydroartemisinin.

Lab analysis

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

"The sample of Duo-Cotecxin 40/320 tablets was found to comply with the in-house specifications for identification of dihydroartemisinin and piperaquine phosphate, and assay of piperaquine phosphate, but was found not to comply with the specification for assay of dihydroartemisinin tablets," said Daru.

Quality Control

National Quality Control Laboratory Deputy Director Pius Wanjala said drug uniformity is usually given an international standard range within which it should fall in in order to conform.

"It's impractical to have the ingredients read the exact number on the label hence the range. In this case of Duo-Cotecxin, the drug is substandard as the ingredients have fallen outside the range. It can be dangerous," said Dr Wanjala.

This comes barely a month after a recently released WHO 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.

Reporting for this story was supported by Code for Africa's impactAFRICA fund and the Bill and Melinda Gates Foundation.


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