Mozambique’s medicines regulator has ordered the suspension and market withdrawal of several malaria, HIV and HIV/syphilis rapid diagnostic tests after international and national health bodies flagged serious flaws in the manufacturer’s quality controls.
The National Medicine Regulatory Authority (ANARME) said the affected products, made by Indian firm Meril Diagnostics, pose a risk of incorrect results that could lead to misdiagnosis and inappropriate treatment.
“All pharmacies, health facilities, hospitals, and distributors are prohibited from selling or using the aforementioned tests and must withdraw them and return them to their respective suppliers, in accordance with ANARME guidelines,” the regulator said in a statement on Thursday.
The suspension covers malaria rapid diagnostic tests for malaria, HIV and HIV/syphilis combo tests and the HIVFIND home self‑test.
ANARME said the decision followed alerts from the World Health Organisation and Mozambique’s National Institute of Health, which identified “critical failures” in the company’s quality management system.
The regulator also urged members of the public who possess any of the products to discontinue use immediately and seek alternative diagnostic tools authorised by health authorities.
The rapid tests in question are widely used across Mozambique for frontline screening of malaria, HIV and syphilis, particularly in primary‑care settings where laboratory access is limited.
JN/APA