By Tabora Bojang
Medicine importers have complained to the National Assembly that they are seriously ‘constrained’ by new regulations by the Medicines Control Agency MCA, which they say ”places barriers on them and preventing them from bringing quality medical products from Turkey and other countries whose medicine labels are not provided in English.
The importers were invited by lawmakers to have an interface with Health Minister Dr Samateh and officials of the MCA in a bid to find solutions to the challenges they are facing.
Addressing the meeting, the public relations officer of the pharmaceutical importers association, Mahawa Njie, said many importers are now unable to import some products from many countries since the MCA is insisting that without label in English they will not be allowed.
“One such country is Turkey which has high quality products but are not labelled in English. Again, we cannot do anything about the MCA’s regulation that both the name and the address of the manufacturer and the marketing authorisation holder of any medical product must be indicated on the packet.
Most of the products coming from non-English countries come with a label of the marketing authorisation holder on the packet while those of the manufacturer can only be found inside the patient information leaflet. Despite this, the MCA said we are not allowed to import such products unless all those details are in the packet,” Njie lamented.
According to him, because some importers at times use middlemen for purchases and those middlemen work with different manufacturers they cannot sometimes provide dossiers for certain manufacturers using their own office addresses.
The importers further alleged that the MCA regulations are also making it difficult for them to bring specialised medicines such as anti-snake, diabetic and cancer medicines as well as medicines that provide food supplements.
“There is a food supplement brand that we can no longer import because the name and address of the manufacturer is not on the packaging even though the dossiers that we submit to MCA to register these products highlight the name and address of the manufacturer. Considering the size of the population of the Gambia, I don’t think we have the capacity to influence these multinational companies to change their product labelling,” Njie told NAMs.
Dr Ousianu Mahanera, the president of the Pharmaceutical Importers Association, lamented that importers face huge fines from MCA for even the slightest mistakes. “If the addressing does not match, before they [MCA] allow your products to enter the country, the importer is fined D100,000.”
He stated that they cannot also source medicines from neighbouring countries like Ghana and Senegal due to certain regulatory measures.
“If there is a shortage of any product in this country, we should be allowed to source it from our neighbouring countries for emergency purposes,” Njie told NAMs.
Dembo Kanteh, head of pharmacies at the MRC, said these “new administrative loopholes” have created significant challenges in relation to the work MRC have been doing in the past.
“MCA’s interpretation and description of medicines and related products in a broader sense differs from MRC’s observations. Once it is a product that we are using on a person, we believe those ones are necessary just for us to do the research that we are mandated to do,” Kanteh stated.
For his part, MCA director Essa Marenah, said the regulations put in by the MCA are legal requirements and they are not out of context.
He said some of the regulations such as manufacturers’ information on labels came as a result of several complaints by patients, doctors and the public to the MCA.
“Any medicine that is imported, we have to know who manufactured it and the patients have a right to know and the doctors have a right to know so that if something happens and it needs to be recalled, the manufacturer can be identified,” he said.
On the restriction of food supplements, Marenah said this is due to the absence of a tracking system, which makes it important for such information to be on the label.
He said it is true that some products may not have the names of manufacturers on the secondary packaging but may have it on the patient leaflet.
“But people will hardly break the packet to go and check the leaflet. They want to read it from the packet. So it is important for these things to be on the secondary packaging. If we want these products in our country there must be a mechanism in place for the regulator to rely on in case of a problem and if they are not labeled in English, it becomes a problem. In the past, MCA allowed products labelled in Turkish and French but we received a lot of complaints from the public, doctors and patients,” he said.
Lower Fulladu West lawmaker and member of the health committee, Gibbi Mballow, who was not pleased with the MCA’s responses confronted his colleagues to do the needful and avert these difficulties faced by importers.
“So many people are dying in this country because of the unavailability of these drugs. We want a solution. No importer is unwilling to comply but the process that they are going through is the problem and that is what we want to address. If Marenah is not advising you [ministers] correctly or trying to protect something then we are not going as a country. This country has no drugs.
There is an absolute shortage of drugs in this country,” Hon Mballow said.
