Regulator defends Malawi medicines

The Pharmacy and Medicines Regulatory Authority (PMRA) has dismissed reports suggesting that Malawi may have a high prevalence rate of substandard medicines.

The regulator was reacting to an article published in the August 4 2024 edition of The Guardian newspaper of the United Kingdom which quoted a study by researchers at Bahir Dar University in Ethiopia as having suggested that Malawi had the highest prevalence rate of substandard and falsified medicines at 88 percent.

The research also quoted another study done by a Malawian researcher at the University of Ghana in 2015 pointing to the 88 percent prevalence rate, which is way above the 10.5 percent World Health Organisation (WHO) estimates for most low income countries.

But reacting to the story at a press conference in Lilongwe yesterday, PMRA director general Mphatso Kawaye said their findings show that Malawi has a four percent prevalence rate, which means it is better than most African countries.

He said: “Results from routine quality surveillance activities over the past four years indicate that the prevalence of substandard medicines in the country is currently at around four percent.”

Kawaye said the 2015 study cannot be relied upon because it only focused on anti-malarial medicines from private outlets.

He said: “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 medicine brands are not found in the private sector. This study, therefore, cannot be used to generalise the quality of all anti-malarial medicine used in the country.”

Kawaye also assured the public that the PMRA medicine quality control laboratory is an accredited one with the requisite capacity and international recognition to test and assure the quality of medicines.

However, while PMRA puts the prevalence rate for substandard medicines at four percent, a 2022 Kamuzu University of Health Sciences (Kuhes) study points to an average of 14 percent across all sampled medicines; namely antibiotics, anti-hypertensive and anti-malarial with anti-diabetics on 5.7 percent.

Individually, antibiotics, which are commonly prescribed in Malawi, had a prevalence rate of 25 percent just like anti-hypertensive drugs.

This is latest report after two others were made in 2014 and 2017 that claimed high prevalence rates of substandard medicines. In 2014 and 2017 for antibiotics the prevalence rate was 45 percent and 13 percent respectively. This means for antibiotics Malawi has moved from better to worse now.

After The Nation published the reports in May this year, PMRA also mounted a defence and queried the findings from Kuhes, particularly faulting the methodology.

Ironically, yesterday, both Kawaye and Ministry of Health director of Health Technical Support Ser vice Godfrey Kadewere made reference to the Kuhes study as reflecting the reality over the Ethiopian university study.

Quizzed on the U-turn, Kawaye said they still have reservations with the reports, but “all the same the findings are not so much away from the WHO’s 10.5 percent”.

Speaking at the same briefing, politician Clement Stambuli, who in a letter to the Speaker asked Parliament to look into this issue, wondered why PMRA was overall defensive instead of spending energy to improve the situation.

In a telephone interview, health rights activist Maziko Matemba said it was comforting that PMRA has come in the open to explain its position amidst all these reports.

Earlier this week, a German pharmaceuticals expert said the prevalence of fake medicines was a global problem contrary to a study indicating that “Malawi was found to have the highest proportion of substandard and falsified medicines”.

Figures by the University of Tübingen indicate that globally, “the expenditure for such poor-quality medicines amounts to $30 billion (around K54 trillion) per year, and the annual number of deaths resulting from substandard and falsified medicines is estimated to be 74 000 to 169 000 in childhood pneumonia, and 31 000 to 116 000 in malaria”.