Government spends K1.8 billion on drugs tests in 6 years


By Cathy Maulidi:

Malawi has spent over K1.8 billion on drug tests in six years as the country’s laboratories are yet to get certified by the International Organisation for Standardisation (IOS) to perform the task, The Daily Times has learnt.

At the moment, Malawi cannot test drugs such as antiretroviral medicines (Abacavir and Lamivudine tablets), anti-tuberculosis medicines (Rifampicin, Isoniazid and Pyrazinamide) and anti-malarials such as Artemether/Lumefantrine, commonly known as LA.


According to Director General of Pharmacy and Medicines Regulatory Authority, Mphatso Kawaye, for six years now, Malawi has been sending the drugs to Kenya and Ghana for testing.

Kawaye said annually, the country spends about $300,000 (approximately K307 million) sending the drugs outside for testing.

“From 2017 to 2019, we were sending to CePAT Lab in Ghana and from 2020 to date, we do send to a Kenyan laboratory called Mission for Essential Drugs Supply.


“The concept of sending the drugs outside the country for testing is not based on us having no capacity. We have capacity in terms of qualified equipment, qualified staff and utilisation of traceable reference standards.

“The only problem is that we are not yet ISO-certified or World Health Organisation pre-qualified,” Kawaye said.

He added that Global Fund’s policy on who is qualified to test medicines procured by the fund says that only laboratories that are accredited can test and that is where Malawi falls short as it is not accredited.

Kawaye said the board is working hard to have the country’s laboratory certified by ISO by the end of this year.

“We completed a mock audit in December 2022 by the Sadc Accreditation Service and now we are working on observations that the auditors made. We should be able to express interest for the final audit by July this year,” he said.

Meanwhile, Chairperson for the Health Committee of Parliament, Mathews Ngwale, has asked government to fast-track the process of having the country’s laboratory certified to save forex that is spent on tests done outside the country.

“Already, we are struggling with forex issues and we should save the little that we have,” Ngwale said.

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