The Zambian government has recalled an Indian-made malaria drug, Shal’Artem, citing non-compliance with medicine control regulations due to insufficient active ingredients.
Health Minister Elijah Muchima announced the recall on Tuesday, following consultations with the Zambia Medicines and Regulatory Authority (ZAMRA).
Speaking in a ministerial statement to the National Assembly, Muchima disclosed that the drug, used to treat malaria in children, was found to have an average of 79.1 percent of Artemether – a key active ingredient – falling below the required standard of 90 to 110 percent as specified by the international pharmacopoeia.
The recalled batch bears the number 2390784 and has an expiry date of November 2025.
The product was flagged during routine post-marketing surveillance, with samples collected from a registered pharmacy in Lundazi district.
Testing at the ZAMRA National Drug Quality Control Laboratory in Lusaka confirmed its non-compliance with assay tests.
Manufactured by India’s Gopaldas Visram and Company Limited, the drug is imported and distributed in Zambia by Shalina Pharmaceuticals.
However, the Ministry of Health has not received any reports of treatment failure or adverse drug reactions related to Shal’Artem so far.
The health minister emphasised the government’s commitment to maintaining stringent standards to protect public health.
JN/APA