GA-FDD set to utilise importers/distributors’ feedback to help regularise drugs import

Apr 29, 2014 News

The way forward in terms of the registration and regulation of pharmaceuticals utilised locally is expected to be improved in the very near future. Although this process is a mandated responsibility of the Government Analyst Food and Drugs Department (GA-FDD), the input of distributors and importers of such products will have some bearing on the way it is carried out.

The recent workshop in session.

This development is in fact a direct result of a recent training workshop, which was spearheaded by the GA-FDD, for the country’s distributors and importers of pharmaceuticals. The workshop which was venued at Cara Lodge, Quamina Street, Georgetown, was conducted earlier this month and yielded heartening results. At least this is according to a report issued by the GA-FDD Director, Marlan Cole.
“The feedback from those present was positive as they voiced their support and concerns to the Department,” Cole in a statement disclosed.
At the interactive forum Cole said that concerns discussed included: the reduced therapeutic effects of medications prior to the expiry date; maintenance of cold chain storage for critical medicines held at the port of entries for extended periods; registration of medicines imported by hospitals and inability or difficulty to secure source documents necessary to complete registration.
The participants also amplified the need to immediately halt the issuing of permits to allow the import of unregistered medicines. They further deliberated on the importance of translating foreign labels by manufacturers and determining the authenticity of the translation.
According to Cole, the Department noted the concerns of the importers/distributors and considered discussions at the forum as “a collective effort to improve the medicines’ registration process to ensure safe and efficacious medicines are available to the Guyanese society.”
Aside from the importers and distributors, the workshop saw the attendance of representatives from both the Pharmacy and Medical Councils.
The Ministry of Health was represented by its Director of Communicable Disease Control Programme, Dr Morris Edwards, who acted in the capacity of Chief Medical Officer. Dr Edwards in his presentation sought to highlight the importance of the pharmaceutical industry even as he alluded to the Ministry of Health’s Strategic Plan, Health Vision 2020, which has as a stated goal “citizens of Guyana are among the healthiest in the Caribbean and South America.”
Cole, on the other hand, deliberated extensively on the current situation in Guyana whereby there is a questionable percentage of medicines available that are registered by the GA-FDD. In fact he indicated that registration of medicines is very important in ensuring the quality of imported medicines.
His deliberations saw him making reference to the Food and Drug Regulations 1977, as well as those of 1978 and 1986, all of which he noted are still very relevant in the local regulation process.
Moreover, the GA-FDD Director in his informed presentation categorically emphasised that the current system of issuing permits for unregistered medicines would not continue and therefore “importers must work with the Department to prevent counterfeit and substandard medicines from reaching the local markets by registering their products.”
He insisted too that since the enforcement of the registration, requirement will not be selective; all importers of medicines to be used and traded on the local market must comply with the requirements as stipulated by the Food and Drug Regulation.
In his presentation too he made reference to the similarities of the registration requirements in other Caribbean countries namely Jamaica, Trinidad and Barbados. All medicines imported into the named territories are registered prior to importation and the suppliers in Barbados, for instance, are pre-qualified by the World Health Organization.
Cole noted that while there will be a move towards change, it is not expected that it will occur overnight.
The workshop also saw presentations on issues relating to Registration Requirements, Quality Assurance, Packaging and Labelling of Products, Record Keeping and Quality Control.
The seminar concluded with remarks by Mr Trevor Thomas, Deputy Permanent Secretary of the Ministry of Health, who endorsed the workshop and indicated the Government’s commitment to all efforts of regularization in the industry.