Malawi has capacity to assure quality of medicines
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.
Press release – PMRA statement on study claiming Malawi has highest prevalence of substandard medicines
Lilongwe, Tuesday, 20th August, 2024: The Pharmacy and Medicines Regulatory Authority (PMRA) wishes to inform stakeholders and the general public that it is aware of the article published in The Guardian newspaper of 4th August, 2024, titled “Fifth of medicines in Africa may be sub-par or fake, research finds.” The article cites a study by researchers at Ethiopia’s Bahir Dar University, which suggests that Malawi has one of the highest prevalence of substandard and falsified medicines in Africa.
Read full statement here.
Malawi has capacity to assure quality of medicines
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.
Malawi has good quality medicines
The Pharmacy and Medicines Regulatory Authority (PMRA) is following with concern the ensuing debate around a study by the Bahir Dar University in Ethiopia suggesting the country has highest proportion of substandard medicines.
The Authority assures stakeholders and the public that, contrary to the study report, the medicines being consumed in the country are of good quality. The Malawi 2015 study that was included in the Bahir Dar University review has serious methodological issues that the Authority will address during a press conference slated for Monday at 09:00 a.m. in Lilongwe.
The Authority has a robust system for routine quality surveillance of medicines on the Malawi market whereby samples are collected from both public and private health facilities and tested by the Authority’s National Medicines Quality Control Laboratory.
The PMRA laboratory is ISO 17025 Accredited, indicating that as a country we have the requisite capacity and international recognition to test and assure the quality of the medicines which we consume in the country.
Based on the data that we have collected through the medicines quality surveillance and testing program, the prevalence of substandard medicines in Malawi is currently estimated at 4%. We are, therefore, assured of good quality medicines in the country.
The Authority will continue to engage the public with scientific facts on the matter as will do at the Monday, 19th August, 2024 press briefing.
WHO alert on falsified Oxymorphone hydrochloride 40mg tablets
The Pharmacy and Medicines Regulatory Authority (PMRA) is informing stakeholders and the general public that the World Health Organisation (WHO) has issued an alert concerning one batch of falsified (contaminated) Oxymorphone Hydrochloride 40mg tablets. The falsified product was detected in the unregulated supply chain in Finland and reported to WHO in July 2024 by the Finnish Medicines Agency (FIMEA).
Oxymorphone Hydrochloride is a semi-synthetic opioid used to treat moderate to severe pain.
The falsified product imitates Oxymorphone Hydrochloride marketed by AUROLIFE PHARMA LLC., who have confirmed that the product, subject of this Alert, is falsified and was not produced by their company.
PMRA is assuring stakeholders and the general public that Oxymorphone Hydrochloride is not registered with the Authority, making it very unlikely for the falsified product to be available in the country.
However, in case anyone has the affected product, PMRA recommends that they should not use it and report to the Authority immediately.
PMRA urges pharmaceutical importers, retailers, healthcare workers, and consumers to report any suspected falsified medicines or adverse drug reactions to any healthcare facility and to the PMRA by dialing *360# for free on TNM and Airtel networks.
The Authority remains steadfast in ensuring that medicines and allied substances being used in the country are of acceptable quality, safe and efficacious in line with our mandate as provided for under the PMRA Act, 2019.
Full details of the alert are available on: Medical Product Alert N°3/2024
For media enquiries, please contact PMRA Public Relations Officer on +265 899 567 365 or email at jjosiah@pmra.mw