Notice of release of August 2024 registration exam results
The Pharmacy and Medicines Regulatory Authority (PMRA) is pleased to announce release of results of registration examinations for pharmacists, pharmacy technologists and pharmacy assistants which were administered on 1st and 2nd August, 2024.
For more details click 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.
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
PMRA hails Air Cargo Malawi’s pharma service launch
The Pharmacy and Medicines Regulatory Authority (PMRA) has commended Air Cargo Malawi Limited for launching a pharmaceutical service describing the development as a positive step towards improving healthcare outcomes for the country.
The new pharma service will see Air Cargo Malawi Limited in partnership with Emirates Airlines commence transportation of pharma products from Europe, the UAE, India and China to Malawi. Previously, Emirates did not allow Air Cargo Malawi to carry pharmaceutical products due to safety concerns as pharma products are considered high risk.
Speaking when he presided over the launch, PMRA Director General Mphatso Kawaye noted that the service launch is a significant milestone in ensuring the availability and quality of pharmaceutical products in the country.
“The launch of this service is a testament to the critical role that effective logistics plays in ensuring the availability and quality of pharmaceutical products, which subsequently assure key actors in the health sector that patients get the right treatment outcomes,” said Kawaye.
He described the pharmaceutical industry in Malawi as a very important partner in the implementation of the Health Sector Strategic Plan (HSSP III), Malawi 2063 and Sustainable Development Goals (SDGs), all of which place much emphasis on universal health coverage with quality, available, equitable and affordable health care, on one hand, and efficient drug supply chain management through monitoring of quality of medicines and medical supplies, on the other.
Kawaye observed that the medicines regulatory environment in the country places immerse responsibility on pharmaceutical wholesalers as authorized importers of medicines, to make sure that the right medicine transportation requirements are met.
Added Kawaye: “Although the regulatory environment has placed this responsibility in the hands of the pharmaceutical wholesalers as importers, the quality assurance of products in transit including cold chain products is unfortunately not within their sphere of control.”
He then expressed optimism that the coming of Air Cargo Malawi Pharma Service will fill the gap and provide sustainable support to the importer in complying with the law as it relates to storage and transportation of temperature controlled pharmaceutical products.
He called on players in the pharmaceutical sector to complement the Air Cargo pharma service by ensuring that appropriate regulatory procedures are adhered to, both before and after the shipment of consignments.
Said Kawaye: “Let us realize that our proactive participation on the regulatory side partnered with Air Cargo Pharma’s expertise on the pharmaceutical handling side will create a highly efficient transportation solution for our temperature sensitive pharmaceutical products and contribute towards timely access to quality medicines for Malawians.”
PMRA hails Air Cargo Malawi’s pharma service launch
The Pharmacy and Medicines Regulatory Authority (PMRA) has commended Air Cargo Malawi Limited for launching a pharmaceutical service describing the development as a positive step towards improving healthcare outcomes for the country.
The new pharma service will see Air Cargo Malawi Limited in partnership with Emirates Airlines commence transportation of pharma products from Europe, the UAE, India and China to Malawi. Previously, Emirates did not allow Air Cargo Malawi to carry pharmaceutical products due to safety concerns as pharma products are considered high risk.
Speaking when he presided over the launch, PMRA Director General Mphatso Kawaye noted that the service launch is a significant milestone in ensuring the availability and quality of pharmaceutical products in the country.
“The launch of this service is a testament to the critical role that effective logistics plays in ensuring the availability and quality of pharmaceutical products, which subsequently assure key actors in the health sector that patients get the right treatment outcomes,” said Kawaye.
He described the pharmaceutical industry in Malawi as a very important partner in the implementation of the Health Sector Strategic Plan (HSSP III), Malawi 2063 and Sustainable Development Goals (SDGs), all of which place much emphasis on universal health coverage with quality, available, equitable and affordable health care, on one hand, and efficient drug supply chain management through monitoring of quality of medicines and medical supplies, on the other.
Kawaye observed that the medicines regulatory environment in the country places immerse responsibility on pharmaceutical wholesalers as authorized importers of medicines, to make sure that the right medicine transportation requirements are met.
Added Kawaye: “Although the regulatory environment has placed this responsibility in the hands of the pharmaceutical wholesalers as importers, the quality assurance of products in transit including cold chain products is unfortunately not within their sphere of control.”
He then expressed optimism that the coming of Air Cargo Malawi Pharma Service will fill the gap and provide sustainable support to the importer in complying with the law as it relates to storage and transportation of temperature controlled pharmaceutical products.
He called on players in the pharmaceutical sector to complement the Air Cargo pharma service by ensuring that appropriate regulatory procedures are adhered to, both before and after the shipment of consignments.
Said Kawaye: “Let us realize that our proactive participation on the regulatory side partnered with Air Cargo Pharma’s expertise on the pharmaceutical handling side will create a highly efficient transportation solution for our temperature sensitive pharmaceutical products and contribute towards timely access to quality medicines for Malawians.”
PMRA, NAC call for vigilance against false claims about HIV cure
The Pharmacy and Medicines Regulatory Authority (PMRA) and the National AIDS Commission (NAC) have called for vigilance against increasing spread of social media claims about supposed permanent cure for HIV.
PMRA Director General Mphatso Kawaye and NAC Chief Executive Officer Dr. Beatrice Matanje made the call in Lilongwe on Wednesday when the two organizations addressed the media.
The call follows recent joint investigations by NAC and PMRA, in collaboration with Malawi Police Service (MPS), which have uncovered disturbing trend where some unscrupulous individuals are tampering with labels of known medicines and later advertise the falsified medicines as “Gammora HIV Cure”, falsely claimed to be permanent cure for HIV.
PMRA and NAC stress that there is no cure for HIV and that consistent treatment with Anti-retroviral drugs (ARVs) is the only effective way to manage HIV. They have since advised people living with HIV to consult healthcare professionals and avoid taking medication without prescriptions.
Read the full joint statement here.
Parliament praises PMRA’s commitment to fighting corruption
The Legal Affairs Committee of Parliament has commended Pharmacy and Medicines Regulatory Authority (PMRA) for demonstrating serious commitment to the fight against corruption within the organization.
Committee Vice Chairperson Hon. Yusuf Nthenda made the remarks in Lilongwe on Friday when PMRA Institutional Integrity Committee (IIC) appeared before the parliamentary committee to appraise it of the progress the IIC has made in the implementation of anti-corruption activities in line with the National Anti-Corruption Strategy (NACS II).
Nthenda applauded PMRA Management’s commitment to allocating adequate funds for IIC activities, citing it as a tangible demonstration of the seriousness and resolve required to combat corruption effectively.
“We can only contain corruption if we are serious in our fight against the vice. PMRA has demonstrated that they are serious and as a Committee we are satisfied with the progress they have made so far,” he said.
The Committee has since urged PMRA to ensure it has in place a whistleblower protection policy to facilitate safe and confidential channel for employees to report corruption.
In his remarks, PMRA Director General Mphatso Kawaye assured the Committee of management’s resolve to supporting activities of the IIC. He reiterated the Authority’s commitment to pursuing zero tolerance to all forms of corruption, strengthen PMRA’s institutional integrity, foster a culture of transparency and accountability, and ultimately contribute towards promotion of good governance in the pharmaceutical sector.
On her part, PMRA IIC Chairperson Irene Dzanjalimodzi expressed her committee’s commitment to implementing the recommendations and guidance provided by the Legal Affairs Committee. She assured that the IIC will utilize this expert advice to ensure effective implementation of its future anti-corruption activities.
PMRA established its IIC in February, 2023 to spearhead anti-corruption efforts within the organization. The objectives of the PMRA IIC are to ensure increased knowledge on corruption prevention mechanisms to members of staff and stakeholders; strengthened measures for the prevention and detection of corruption; and enhanced reporting mechanisms for suspected corrupt practices.