Contrary to the common belief that when imported medicines arrive at the ports, they are tested before they are released into the supply chain for distribution, that is not the case at all.

In fact, current information is that medicines which arrive at the ports and are registered in Ghana are not tested before they are released into the supply chain.

But why is that so? Wait a minute! Every importer takes the full responsibility of the quality of products which it imports into the country. So the products need to be registered in Ghana before they arrive in the country.

The registration process takes care of all the conceivable issues (quality, stability, color change, hardness, consistency etc) about the product to guarantee its safety and efficacy when it traverses the supply chain after the registration green light over a specified period, usually five years in Ghana before the registration is due for renewal.

Although, the registration process can be time consuming, it is not advisable to import any medicine into the country when the medicine is not yet registered.

In any case, one needs an authorization from the regulator before you import so how can you import without a permit.

During the registration process, samples are submitted, as well as technical dossiers which contain the results of tests conducted on the finished products as well as clinical data. These data are reviewed and when they are found to conform to our national standards, approval will be given for registration in the country. Otherwise, the application will be suspended while the applicant is asked to provide more data or information to support the application. Incomplete application documentation or queried application is what often delays the medicine registration process. In order to assist the registration process, the regulator has issued registration guidelines to aid applicants.

The registration application is accompanied by the payment of prescribed fees for both imported and locally produced products. In case of imported products, an inspection of the manufacturing facility is mandatory. The manufacturing facilities of locally produced products are subjected to annual inspections. A registration application can be rejected if a manufacturing facility does not meet the set standards upon the inspection; usually the standards are WHO cGMP (World Health Organization current Good Manufacturing Practices).

The registration process is complex, time consuming, expensive and without it the economic activities of the importers and the manufacturers are held in abeyance. It is important, therefore for the registration process to be transparent so that anxious importers can monitor and participate in the process because it is the harbinger to an economic activity.

The principle of taking total responsibility for the medicines brought into the country by the importer is the same in most developed countries. In Ghana,medicine imports are restricted to Tema, Takoradi and KIA ports, in order for the regulator to have control on the import process. Any importation of medicines into the country through any other port is illegal.  All local manufacturers are also required to register all new products they formulate. Products are registered for a specific period, usually five years in Ghana, after which you can renew the application by going through a similar process or an abridged form, depending upon the product in question, reputation of the manufacturers etc.

Looking at the volumes and frequency of medicine imports, testing them before release from the ports will create congestion at the ports and slow the port clearing process which has economic consequences for the importers. The current approach of non-testing before clearing from the ports however facilitates the process. Testing is also a very expensive undertaking and the regulatormay have difficulty coping with that demand, not to mention the capacity to test every imported product locally. Assuming the regulator decides to test every medicine import, who will bear the cost?

However, there are mechanisms in place to monitor the medicines in the supply chain to ensure that they meet the safety and efficacy standards; these are known as the safety monitoring mechanisms. These safety systems are Post Marketing Surveillance (PMS) and pharmacogilance (PV) reports. The PMS is a process whereby the regulator picks samples of medicines at random from the market place for analysis for quality evaluation. Reports of adverse medicines reactions when they are reported to the clinics/hospitals/pharmacies are captured and reported to a central point, the PV Center. These reports also give pointers to medicines in the supply chain which may have quality issues and problematic from which the regulator will act by further investigating the medicine in question.

When medicines fail the safety monitoring checks in the market place, regulatory sanctions are applied in various forms. The sanctions include batch product recall, total product recall, fines, prosecution of importer, suspension of registration of the supplier and manufacturer, publication of the name of the quality control officer responsible for the substandard product in circulation etc.

The national medicines quality monitoring framework is not complete unless the sanctions are applied. Sanctions are part and parcel of the quality monitoring framework just like the Ghana Revenue Authority allows self tax assessment but you will be penalized if you submit false tax data. So please relax and allow the regulator (FDA) to do its work to the logical conclusion. ’’The space looks empty but that space is not free because it is a regulated space’’; summarises Ghana’s medicine monitoring framework.

Reports are common about suppliers providing quality samples and appropriate documentation during the registration process, only to put in spurious products when they start supplies into the supply chain. It is only the vigilance of the regulator and consumers which can check this practice. This behavior is not restricted to Ghana alone, even the US suffers such unprofessional acts. But in the US and other developed countries, WOE onto you when such unprofessional acts are observed. The regulator descends hard on the miscreants because lives are involved and also to discourage others from doing same.

[Pharm Nii Louis Nortey is a  Pharmaceutical Policy Analyst]