Malawi’s drug regulatory and testing authority Pharmacy, Medicines and Poisons Board (PMPB) falls short of international drug testing standards as it is not accredited by UN’s World Health Organisation (WHO) and lacks capacity to conduct some tests on drugs.
The lack of accreditation and PMPB’s inability to conduct some tests force the board to refer some drug samples to foreign laboratories, thereby costing the country more and delaying the release of some procured drugs to hospital.
In an interview on Tuesday, PMPB registrar Godfrey Kadewere said they are not accredited because they do not have facilities and resources necessary to get WHO endorsement.
“We have limited capacity in the sense that we cannot conduct biological tests on drugs, but this does not mean that our laboratory cannot be used. We test things which we can test,” said Kadewere.
He said the board has in the past sought services of WHO accredited laboratories in Zimbabwe to test some of the drugs supplied into the country.
“Our laboratory has no capacity to carry out biological tests. We can do all physical tests on medical products such as IV [intravenous] fluids, but we can’t detect if there is any growth of things like bacteria in those fluids.
“Mind you, those products are classified as sterile, meaning that they do not contain any growth in them,” said Kadewere.
He said it would improve efficiency in the country’s drug distribution chain if Malawi had its own internationally accredited laboratory.
The registrar said the board is making efforts to get WHO accreditation because some donors, especially the Global Fund, want their drugs to be tested in WHO accredited laboratories only.
WHO had not yet responded to our questionnaire on Thursday as we went to bed.
