PRESS STATEMENT:
ZAMMSA HAS NOT DISTRIBUTED ANY DEFECTIVE MEDICINES
Lusaka, 13th November 2023 – The Zambia Medicines and Medical Supplies Agency (ZAMMSA) would like to correct the distortion circulating in some sections of the media where it is being alleged that we have distributed defective erythromycin to the public health facilities across the country.
Contrary to this reports, the medicine in question, Erythromycin, which is one of the 58 products contained in the recently procured Health Centre Kits supplied by Missionpharma to ZAMMSA, has been effectively quarantined awaiting further tests and investigations.
Facts of the matter are that on the 30th of September, 2023, ZAMMSA received a consignment of 7050 Health Centre kits supplied by Missionpharma. This was the second consignment from the 42,000 Health Centre kits to be supplied by Missionpharma to the Ministry of Health through ZAMMSA. As per standard operating procedure, the health center kits were submitted to the Zambia Medicines Regulatory Authority (ZAMRA) National Drug Quality Control Laboratory (NDQCL) for compliance and pre distribution testing.
On the 25th of October 2023, ZAMRA shared results that indicated that Erythromycin Stearate Tablets BP 250mg Batch No. TK293 was found non-compliant with respect to the dissolution test conducted. ZAMMSA immediately informed the supplier Missionpharma on this development and it was agreed on a third-party independent laboratory to be used for retesting of samples from batch TL293.
The Research Institute of Industrial Pharmacy (RIIP) at the Centre for the Quality Assurance of Medicines (CENQAM) in South Africa, a WHO pre-qualified lab, has since been nominated to conduct the third tests.
Out of the 7050 kits, 983 were found to have compliant erythromycin in them. To ensure that we have no delays in the subsequent distribution of medicines in the country, it was resolved as resolved that the non-compliant product, Erythromycin, be removed from the remaining 6,067 kits. This was with the aim of not further delaying the distribution and significantly impact the availability of commodities at Health Facilities countrywide.
This exercise has since commenced and the kits are being distributed without the non-compliant. Missionpharma has also sent a representative to witness and supervise the initial process of removal of erythromycin from the Health Centre kits for a period of one week and thereafter handover.
It is important to note that all the removed Erythromycins are being kept under kept under quarantine. In the event that the test results for the remaining batches meet the standard, the product will be distributed as per kit allocation.
The results from the third party-testing will determine the next course of action guided by the terms and conditions in the contract. The general publics should know that ZAMMSA is doing everything by the book and in accordance with standard operating procedures.
There is no need to panic. The results will be shared with the public once they are conclusive. The Government through the Ministry of Health and ZAMMSA is committed to ensuring the safety of all medicines and medical supplies.
This whole episode is credence that systems ensuring that we have quality, safe and efficacious medicines are working in Zambia.
Signed:
Bradley Chingobe,
Senior Manager Public Relations.
Zambia Medicines and Medical Supplies Agency