Photo Of The Officials At The National Assembly Committee Room
By Ramatoulie Jawo
The Pharmaceutical Importers Association, on Monday, outlined the various challenges they face when importing drugs into The Gambia. These concerns were raised during their appearance before the National Assembly Select Committee on Health, Refugees, Disasters, and Humanitarian Relief to discuss the difficulties in drug importation and propose solutions.
The meeting brought together officials from the Ministry of Health, the Medicines Control Agency (MCA), the Medical Research Council (MRC), and representatives from the pharmaceutical import sector.
Mahawa Njie, Public Relations Officer of the Pharmaceutical Importers Association, highlighted that many importers are currently restricted from importing certain products due to regulatory issues. One of the key challenges he mentioned was related to the language requirements on drug packaging.
“Many of us as Importers as of today are unable to import some products from SRA countries that are products that are coming from India and the reason being is the regulation says the primary and secondary container of every medicine intended for human use shall bear clearly written and legible legal English language. And we all know Turkish products are multinational products, and they are manufactured in their language and these are products that are of high quality, and they are equally affordable,”he said.
He proposed a solution to allow Turkish products to enter the country with a translated leaflet and sticker labels, making it easier for Gambians to understand the generic names and have access to an English version of the instructions.
Another issue Njie raised concerned the details of manufacturers and marketing authorization holders on packaging. He pointed out that while the marketing authorization holders’ information is typically on the packet, the manufacturer’s name and address are often only available inside the leaflet, which makes importation problematic under current regulations.
“Most of the products that are coming from SRE countries, most of them come with the marketing authorization holders on the packets. However, the name and address of the manufacturer can be found inside the packet in the leaflet, but with the regulation one can not import because if the name and address of the manufacturer and that of marketing authorization holders is not on the packet. I am not allowed to bring, but the name and address of the marketing authorization holders can be found on the packet and the name and address of the manufacturer can equally be found in the leaflet,”he highlighted.
Njie urged the committee to consider allowing imports of products where the manufacturer’s details are provided inside the leaflet, and the marketing authorization information is present on the packet.
Despite these challenges, Njie commended the pre-shipment analysis conducted by the MCA for products from countries like India, Pakistan, and China, which ensures that they meet quality standards before export. However, he mentioned that inconsistencies in addresses on product packaging and invoices, due to the involvement of middlemen, create further obstacles.
“But the problem that we are facing is sometimes the address that is on the packing of the product and the address on the invoice might not be the same,”he added.
Another critical issue he highlighted was the limited availability of specialist medicines, such as vaccines, anti-snake venom, diabetic medications, cancer treatments, and dialysis medicines, which are often imported in small quantities. Njie urged the committee to simplify the registration process for these products by allowing them to be registered with minimal documentation, such as a certificate of analysis or a good manufacturing practice certificate.
“The other problem we are also facing is the problem of specialist products when I talk about specialist products, this is vaccines, antiradald, anti-snake antivenom medicine, diabetes medicines, cancer medicines and dialysis medicine. These medicines that one can only import in small volumes, we want this Committee to consider the registration of this product with minimum documentation that is to say if we can register them with certificate of analysis, or a certificate of pharmaceutical or GMB certificate so that the products can be available into the country,”he said.
He expressed that it deeply saddens them to see Gambians rushing to their local pharmacies, only to be informed that a specific medication is unavailable for one reason or another.
In response to concerns raised by the Pharmaceutical Importers Association about specialist products manufactured in non-SRA countries, Essa Marenah, the executive director of the Medicine Control Agency, emphasized that their position is clear: these products must be registered, as required by law.
“You can not go in for listing on that because that is not in line with the law depending on the level of risk the documentation requirement is based on level of risk if those products are WHO prequalified products manufactured for example in India, but they are WHO pre-qualified, or they registered by any stringent regulatory authorities, “he said.
Dr. Ahmadou Lamin Samateh, Minister of Health, has urged the Importers’ Association to consider increasing supply volumes to help tackle the ongoing challenges related to drug availability.
“Anyone who goes into a business should also first of all study the laws of the country. What do they allow an individual to do, I think the mindset also needs to be changed on the other side? When people want to start something, let them also look at what is prevailing because otherwise they go and start something, and they want the laws to adjust to them,”he said.
He highlighted the need for clear and easily understandable drug labelling, not only for clinicians but also for patients. He warned that poor labelling could result in confusion and potentially harm patients.