(GENTAMICIN SULPHATE 80MG/2ML)
DUE TO REPORTS OF SUSPECTED ADVERSE DRUG REACTIONS
Presented to the National Assembly
by Dr. Chitalu Chilufya MP, Hon. Minister of Health
Mr. Speaker, I wish to thank you for giving me this opportunity to render a Ministerial Statement
to inform the general public through this August House on the status of the quaratined
GENTAMED injection (Gentamicin sulphate 80mg/2ml) due to reports of suspected Adverse
Drug Reactions (ADRs).
In 2013, the Medicines and Allied Substances Act, No. 3 of 2013 was enacted which
established the Zambia Medicines Regulatory Authority (ZAMRA) as a body corporate with the
overall mandate of assuring the quality, safety and efficacy of medicines being made available
to the Zambian public. This is done through a robust registration process, import/ export
controls, post-marketing surveillance, control of premises and pharmacovigilance activities.
Pharmacovigilance activities include receipt, collation, causality assessment and provision of
feedback on received ADRs and medicines quality problems (MQPs). Pharmacovigilance
system is intended to facilitate the early detection of medicines that might cause Adverse Drug
Reactions or have quality problems.
Mr. Speaker, allow me to highlight the details of the reported suspected adverse reactions due
to GENTAMED injection (Gentamicin sulphate 80mg/2ml). From January, 2019 to date ,
ZAMRA received thirty two (32) suspected Adverse Drug Reactions (ADRs) reports across the
country, disaggregated as follows: Levy Mwanawasa University Teaching Hospital (6), Kabwe
Central Hospital (7), Choma General Hospital (10), Livingstone Central Hospital (7), Chipata
Central Hospital (1) and Mumbwa District Hospital (1) on GENTAMED Injection (Gentamycin
The common complaints, as reported on the reporting forms included headache, dizziness,
heart palpitations and vomiting following administration of GENTAMED Injection. This medicine
was imported into the country for supply to public health facilities. A total of 492,000 units of
GENTAMED Injection were received by Medical Stores Limited (MSL) in September last year
(2018). So far, 279,900 units have been distributed across the country and the remainder
(212,100) has been quarantined at Medical Stores Limited.
GENTAMED Injection from the suspected batches was sampled and are undergoing analysis
in-country and some samples have since been sent to North-West University, South Africa for
quality analysis. As a precautionary measure, ZAMRA recommended that the product be
quarantined until investigations are concluded.
Arising from the recommendation, the Government through Ministry of Health directed all public
health facilities to quarantine the medicine in order to allow for investigations.
However, I wish to assure the nation that there are sufficient safe quantities of gentamicin
injection at Medical Stores Limited to replace what has been quarantined.
Mr. Speaker, the House may wish to note that the ZAMRA Technical Committee on
Pharmacovigilance and Clinical Trials have undertaken Causality Assessment to ascertain
whether the reactions were indeed caused by the Gentamed injection. The Committee after
considering all the evidence including, interviewing doctors, nurses, anaesthetists , some
patients and audit of records at health facilities were reports originated, concluded that it was
certain that the reactions were caused by Gentamed injection. In this regard, the affected
batches of Gentamed injection will be recalled and the supplier required to replace the
Mr. Speaker, Government remains committed to providing quality health services to the
Zambian population. To this effect Government has, in line with the provisions of the Medicines
and Allied Substances Act No.3 of 2013, commenced the construction of a National Medicines
Quality Control Laboratory (NMQCL) which is now 70% complete and is expected to be
completed in August, 2019. The procurement of the state of the art equipment to be installed in
the NMQCL has been completed and will be delivered and installed immediately the
construction works are completed. One of the key functions of the NMQCL is to verify the
safety, quality and efficacy of medicines and allied substances which are manufactured or
imported into the country by persons who are authorised or licenced under the Medicines and
Mr Speaker, the House may also wish to note that Government through Ministry of Health has
embarked on a transformation agenda that aims at attaining Universal Health coverage by
building a robust and resilient health system using Primary Health Care Approach across the
continuum of care covering promotive, preventive, curative, rehabilitative and palliative health
services provided as close to the family settings as possible. One of the pillars of a robust and
resilient health system is the provision of quality, safe and efficacious essential medicines and
medical supplies to the Zambian population. To this effect I wish to assure the House and the
nation at large that Government through Ministry of Health is on the ground and will continue to
intensify post marketing surveillance for both public and private marketed health commodities.
Mr Speaker I thank you.