Regulatory authority, Kuhes tussle over study report

Pharmacy and Medicines Regulatory Authority (PMRA) has questioned Kamuzu College of Health Sciences (Kuhes) study which claimed that 14 percent of common medicines in Malawi are substandard and falsified.

This reaction follows our publication of Kuhes’ study findings in our edition of this paper, two weeks ago, which also quoted researchers themselves.

The authority’s director general Mphatso Kawaye said their study analysis showed that Kuhes’ findings were not supported by evidence.

PMRA argues that laboratory methods used to test the medicines were uncertified and lacked the World Health Organisation (WHO) confirmatory test.

Reads the response: “The investigators did not have impurity standards for the medicines that were included in the study and it was surprising how they could conduct the tests with the referenced methods when the same methods specified use of impurity reference standards to confirm validity of the tests.

“The laboratory did not validate the analytical methods; the laboratory did not have an out-of-specification handling procedure and lacked procedures of referring samples that failed quality control test to recognised laboratory for confirmatory testing, especially considering that the laboratory that tested samples under this study is not certified.”

But Kuhes head of pharmacy department Associate Professor Felix Khuluza shot back at PMRA, arguing that their lab-based findings can only be discredited through re-analysis of the samples in another laboratory.

“For that reason, I cannot respond to the authority’s position based on their opinion. I have confidence in the reliability of the results as the tests were conducted using scientifically proven techniques.”

Khuluza said their laboratory is equipped to conduct these tests for research having previously sent samples to other labs in Kenya, Germany and Taiwan for confirmatory tests.

The study sampled 23 public, faith-based and private health facilities in Malawi and focused on commonly used medicines based on the Malawi Treatment Guidelines.

PMRA raises questions on the sample size and questions how Kuhes’ research and ethics committee approved a study focusing on 23 health facilities in the Southern Region against 1 064 facilities to have a national meaning.

“It is not clear how such results were explorated to the whole country. It would have been different if the study title was limited to ‘selected medicines’ and ‘selected districts’ in Malawi,” further reads PMRA’s response.

But Khuluza said their study duly acknowledged the sample size limitation which may under or over-estimate the prevalence of substandard and falsified medicines.

He also said these findings are not different from other countries and WHO’s estimation.

Khuluza added: “It should also be noted that most medicines are supplied by same manufacturers through CMST across all districts in Malawi. Thus, I don’t think it’s scientifically necessary to collect samples from all districts when the likelihood of being from the same manufacturers is high.”

Similar studies were conducted by Kuhes in 2014 and in 2017 which revealed a higher prevalence rate of substandard and falsified medicines in Malawi.

Kawaye noted that while Kuhes has not yet responded to data quality issues they raised in their submission on March 30 2023, the investigators have continued to quote the same questionable data in a way that may “raise alarm and grossly mislead the public to lose confidence in the public health sector.”

But PMRA acknowledges there are substandard and falsified medicines in Malawi and will this year conduct a survey with WHO to establish the extent of this problem.

Kawaye said it recorded 20 cases from January to April 2024 where 18 were substandard medicine and two were falsified.

“Defective batches were recalled and regulatory investigations were conducted. Concerned manufacturers have been inspected for compliance to good manufacturing practices and they submitted acceptable corrective and preventive actions,” he said.

Medical experts describe substandard medicines as those “approved or registered,” but fail to meet quality standards or specifications.

Falsified medicines are fake products where manufacturers deliberately misrepresent the identity, contents, or source of the medicines.