The Pharmacy and Poisons Board has denied media reports that it has recalled from the market the anti-malarial drug Duo-Cotecxin over safety concerns.
The board, however, said it is investigating a certain batch of the drug after concerns were raised over its quality.
“The Pharmacy and Poisons Board is undertaking investigations to ascertain the suspected quality defect on that specific batch No 160621. Meanwhile, the batch is under quarantine pending the conclusion of investigations,” a letter signed by the board registrar on Thursday said.
“We would like to assure all stakeholders that they shall be informed of the outcome of investigations once concluded,” it added.
A local media outlet on Thursday quoted the director of the inspection, surveillance and enforcement at the Pharmacy and Poisons Board Dr Jacinta Wasike as having withdrawn the suspect batch after it failed an assay test.
An assay is an analytic investigative laboratory test on medicine to qualitatively or quantitatively determine the presence, amount or its functional activity.
About 30 tablets are randomly selected and dropped into different jars before stirring.
Ten of these are then assayed individually. A tablet passes the test if 9 of the 10 tablets contain not less than 85 per cent and not more than 115 per cent of the labelled drug content.
The 10th tablet may not contain less than 75 per cent and more than 125 per cent of the labelled content.
The batch under probe was purchased from a pharmacy outlet in Nairobi.
They are manufactured by a Chinese firm Zhejiang Holley Nanhu Pharmaceutical co. and are due for expiry in May 2018.
The drug can be administered to adults and children over six years.
Questions about the quality of the drug were first raised in December last year prompting a lab test by the Drug Analysis and Research Unit, Department of Pharmaceutical Chemistry at the University of Nairobi.
Sample results revealed that 40 out of 320 tablets met the specifications for identification of dihydroartemisinin and piperaquine phosphate.
They, however, failed to comply with the specification for assay of dihydroartemisinin.
Dihydroartemisinin (also known as dihydroqinghaosu, artenimol or DHA) is a drug used to treat malaria.
Dihydroartemisinin is the active metabolite of all artemisinin (a terpene-based antimalarial substance used in Chinese medicine).