Parliamentary Committee on Health is calling for the amendment of the Pharmacy and Medicines Regulatory Authority (PMRA) Act to curb illegal drugs.
The calls follow results of an enquiry the committee instituted in August this year.
In its report presented to Parliament, it established that despite PMRA having strong regulatory frameworks, proliferation of substandard medicines remains rampant though on a minor scale.
The committee’s inquiry followed an article published by The Guardian newspaper on August 4 2024 which stated that Malawi has one of the highest prevalence of falsified and substandard medicines in Africa.
According to the article, based on a study by Ethiopia’s Bahir Dar University, it was reported that Malawi has 88.4 percent of poor quality and anti-malarial medicines.
But the Parliamentary committee observed that while Malawi has substandard and falsified medicines, the situaiton was not tas portrayed by The Guardian article.
Part of the report reads: “PMRA has demonstrated a strong regulatory framework, supported by international standards to ensure quality and safety of medicines in Malawi. However, challenges remain, including the presence of substandard medicines, though at a lower prevalence than suggested by the study.
“To address these challenges, the committee recommends enhancing regulatory oversight, improving sampling and testing methodologies, increasing public awareness and fostering stronger collaboration with stakeholders. These actions are crucial to strengthening medicine quality assurance and protecting public health in Malawi.”
The Bahir Dar University study, which only examined the quality of anti-malaria medicines in Malawi, stated that a fifth of medicines in Africa may be sub-par or fake.
PMRA director general Mphatso Kawaye in a statement following the article argued that since anti-malaria medicines were the only examined medicines and in private facilities, it was illogical to generalise the findings to all medicines.
He said in a published statement on pmra.mw that such studies have potential to cause alarm.
The committee has since recommended that the government should strengthen the National Medicines Quality Control Laboratory through continued investment in its capacity and infrastructure.
It suggests upgrading laboratory equipment to state-of-the-art standards and conducting regular training for laboratory staff on the latest testing methodologies and quality control procedures.
The committee has further recommended enhanced training for healthcare providers on identifying and reporting suspected substandard and falsified medicines.
It also advises PMRA to improve its sampling and testing methodologies by developing standardised protocols for sampling that include both private and public health facilities.
The committee’s chairperson Matthews Ngwale, in the report, further suggested that PMRA should enhance its general oversight role on inspection of all medicines.
The report recommended national regulations to be aligned with international guidelines such as those from the World Health Organisation (WHO) and International Council for Harmonisation to ensure that global best practices in medicine regulation are followed.
On August 12 2024, our sister newspaper The Nation reported that Malawi is not the worst on fake medicines, following an interview with professor of pharmaceutical biology at University of Tubingen in Germany, Lutz Heide.
He argued that substandard and falsified medicines affect all countries in the world, including high-income countries.
Heide said WHO estimated that, on average, 10.5 percent of all medicines in low and middle-income countries are substandard or falsified.
He said: “The medicines are sometimes with minor quality deficiencies, sometimes with major deficiencies. Also, Malawi is affected by this problem, but less than many other countries, e.g. in Western and Central Africa.”
From January 2014 to December 2015, Heide worked in the Pharmacy Department at Kamuzu College of Health Sciences under a contract with the German Development Cooperation.
He shared a study he conducted together with Felix Khuluza and Stephen Kigera titled ‘Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi’ published in 2017 by the American Society of Tropical Medicine and Hygiene.
The study found that although the observed presence of substandard and falsified medicines in Malawi required action, their low prevalence in public and faith-based health facilities was still encouraging.
