Malaria drug recalled for low active ingredients
By Alice Lubasi
Health Minister ELIJAH MUCHIMA says the recall of a drug used to treat malaria in children, is because the product had low amount of active ingredients.
Dr. MUCHIMA says the drug known as Shal’Artem or Lumefantrine powder, which bears a batch number 2390784 with an expiry date of November 2025 was not compliant.
The Minister says the recall has been done in consultation with the Zambia Medicines and Regulatory Authority- ZAMRA.
In a Ministerial statement to the National Assembly, Dr. MUCHIMA said during the routine post marketing surveillance activities, the product was sampled from a registered private pharmacy outlet in Lundazi district.
He said the drug was analysed at the ZAMRA national drug quality control laboratory in Lusaka, where it was found non-compliant with respect to the assay test.
The Health Minister explained that according to the international pharmacopoeia, the acceptance criterion for assay for this product ranges between 90 to 110 percent.
Dr. MUCHIMA said in this instance, the product assay was found at an average of 79.1% in respect of Artemether, which fell below the acceptance criteria and therefore it should be withdrawn from the market.
He said so far, the Ministry has not received cases through ZAMRA of treatment failure or adverse drug reactions following use of Shal’Artem which is manufactured by Gopaldas Visram and company Limited of India and is imported and distributed by Shalina Pharmaceuticals in Zambia.
