By: Kebba AF Touray
The National Assembly Select Committee on Health, has recommended legal action by the Government of the Gambia, against Maiden Pharmaceutical Company, for their alleged manufacture and importation of contaminated syrups into the country, that was alleged to have been responsible for Acute Kidney Injury (AKI) and deaths of at least 70 children in the Gambia. The committee made this and other recommendations in its report on AKI, after conducting inquiries with the relevant authorities in the country.
Tabling the said report before members, the Chairperson of the Committee Amadou Camara, said the objective of their engagement with the relevant stakeholders on AKI was meant to establish the root causes of the reported death of at least 70 children, the effect of the contaminated medical syrups linked to the deaths, and the impact to access primary health care services in emergency cases especially for children. He said the objective of the inquiry include the establishment of culpability of the suspected importer and pharmacy linked to the contaminated drugs and how the pharmacy license scheme is administered, and to identify and address gaps to prevent future happening of such nature.
The findings he said includes but is not limited to “Stop Step” Pharmacy, who order their products mainly from UK, Germany and India; “Malak Chemist” where 119 products were registered, with 11 pending and 766 listed; “Kairaba” Pharmaceuticals who have not sold any product from Maiden Pharmacy or any medications linked to AKI. The Medicines Control Agency is faced with the challenge of testing drugs due to lack of a toxicology lab and Atlantic Pharmacy has signed an agreement with the Maiden Pharmaceuticals. All four contaminated products linked to AKI where duly listed with MCA among other findings.
Some of the recommendation made by the legislative select committee on health on its inquiries on the Acute Kidney Injury includes but is not limited to the followings: urgent need for a functional national medicines quality control laboratory (NMQC Lab), and also recommends for government through the Health Ministry, to intensify efforts to compete this task as quickly as possible, bearing that it is a requirement under Section 50 of the Medicines and Related Product Act 2014; need for urgent establishment of a functional pharmaco-vigilance (PV) unit at the MCA and recommends for its immediate establishment in January 2021; for the MCA to blacklist Maiden Pharmaceutical products and ban all their products in the Gambia market; for Government to pursue legal action against Maiden Pharmaceuticals for exporting contaminated drugs to the Gambia with the Atlantic brand name; for the relevant government ministries and departments to revisit their initial emergency responses to the AKI tragedy in collaboration with relevant CSOs and CBOs to address the issues of the victims and their families; ensure that all medicines are registered before importation into the Gambia, as this will require MCA to conduct site visit to inspect the manufacturing sites.
That where site visit is not feasible, the MCA can liaise with Gambian Embassy / High Commission at the exporting country, to assign an agent for the site visit and submit a report accordingly. For medicines from less stringent regulatory countries, the MCA shall assign WHO accredited laboratory to conduct the pre-shipment inspection and QC testing of each consignment and be further verified by MCA agents at ports of entry.
All products should be subjected to screening before release into the market for distribution and use, as this will ensure that what is ordered is what is delivered to avoid what happened in the case of Atlantic Pharmacy.
Revisit MCA’s SOPs for importation to ensure that those suspected to be substandard, falsified and counterfeit items are quarantined for further investigations including QC testing at the cost of the importer.
Random sampling of each imported medicines should be conducted, and the result kept at the MCA, as this practice will keep importers on their toes, and ensure that at least 5 percent of all randomly sampled medicines are annually tested (eg. 25 percent each 6 months) at the cost of the importers.
All premises (wholesale pharmacies, retail pharmacies and drugstores) shall maintain a real-time electronic database, tracing all medicines from importer to user, as this will help tracing and recall of medicines as well as for easy retrieval of information.
Provide compensation to the families of deceased and surviving children, and should include free medical care for the surviving children with AKI until they obtain full cure and recovery.
The Medicines and Related Products Act should be amended to gibe clear and direct powers to the MCA to regulate and impose sanctions on the sector without having to seek the approval of the Minister of Health. This is to prevent interference and ineffectiveness of the Agency and its decisions
The Pharmacy Council Act should be amended to give clear and direct powers to the pharmacy council of the Gambia to regulate and impose sanctions without having to seek the approval of the Minister of Health.
The Ministry of Health should become more vigilant and play an effective oversight over the MCA and PCG to ensure that they are effectively exceeding their functions, without interfering in their operations.
“Therefore, the select committee recommend for the government through Ministry of Health to speed up reviewing of laws and regulations governing the pharmacy and drug regime in the Gambia and table it before the National Assembly,” he said.