The Pharmacy and Medicines Regulatory Authority (PMRA) has assured the public that Malawi has the necessary capacity to conduct rigorous medicine quality assessments for product registration and ongoing market surveillance, guaranteeing access to high-quality, safe, and effective medicines.
Among others, PMRA boasts of ISO/IEC 17025:2017 accredited laboratory attesting to Malawi’s capability and international recognition to test and assure the quality, safety and efficacy of medicines. ISO 17025 accreditation is a certification that recognizes a laboratory’s technical competence to carry out specific tests, calibrations, or measurements.
PMRA Director General Mphatso Kawaye made the remarks Tuesday in Lilongwe where the Authority addressed a media briefing to respond to findings of a study by Ethiopia’s Bahir Dar University on quality of medicines in Africa.
In particular, the Director General was commenting on an article published in the UK-based Guardian newspaper of 4th August, 2024, titled “Fifth of medicines in Africa may be sub-par or fake, research finds” which cited the Bahir Dar University study claiming that Malawi has one of the highest prevalence of substandard and falsified medicines in Africa.
“Using its Medicine Quality Control Laboratory which is ISO 17025 accredited, PMRA tests medicine samples prior to distribution and those samples collected through routine quality surveillance activities,” said Kawaye.
Among others, the Director General observed that the Bahir Dar University review referenced a 2015 Malawian study on anti-malarial medicines and used its findings to generalize the quality of all medicines in the country.
Said Kawaye: “The study which the article quoted only examined the quality of anti-malarial medicines which were: LA, Quinine, SP, DHA/SP, DHA/Pp, ATS/SmP, and ATS/SP. In addition, the study did not include samples from the government health facilities which constitute the largest proportion of anti-malarial medicines consumed in the country and whose brands are not found in the private sector.
“This means that the findings of this referenced 2015 study cannot be used to generalize the quality of all anti-malarial medicines let alone the quality of all medicines in the country.”
The DG further observed that the analytical method used for assessing LA in the 2015 reference study was modified from a published well validated method. However, the extent of the modification was quite significant and resulted into inferior validation parameters, rendering the method unsuitable for assessing quality of LA.
He cited an instance where samples from the same batch of LA gave significantly different results, which he said is not normal in medicines analysis especially considering that the samples were collected from regulated facilities.
“The failure rate of LA which had the highest number of samples in the 2015 study was largely due to analytical method problems. Had the analysis been as per the reference analytical method (Arun 2011), the failure rate could have been much different from the 88.4% that was reported in the 2015 Malawi study,” he said.
According to Kawaye, the Authority acknowledges the importance of studies conducted by institutions of higher learning whose recommendations inform both public health policy and medicines regulatory practice.
The Authority has since called for adherence to best research practices saying incorrectly done studies may raise alarm and grossly mislead the public to lose confidence in the public health sector. Further, such studies undermine the efforts by government institutions, partners and stakeholders in the health sector in ensuring access to quality health services.