GA-FDD seizes climate-unsuitable, incorrectly-labelled drugs from 11 pharmacies

The Government Analyst – Food and Drug Department (GA-FDD) has seized and removed a quantity of climate unsuitable and foreign labelled drugs from 11 pharmacies in Georgetown, the Department said in a statement.
The Department also used the opportunity to remind the general public, especially importers and retailers engaged in the importation, marketing and distribution of medicines not locally produced of the relative laws associated with them. It also reminded of the zoning of medication for specific climates.
The climatic zones are as follows: Zone I – Temperate (eg Canada and Germany), II -Mediterranean/Subtropical (eg Chile and Turkey), III – Hot/dry (eg Chad and Iraq), IVa – hot/humid (eg Jamaica and Pakistan) and IVb – hot/very humidity (eg Guyana, India and Brazil). Information on zoning can be found on the World Health Organisation (WHO) website.
The GA-FDD reminded that during the formulation process, manufacturers determine the medicine’s, stability, shelf-life and expiry date according to the climatic zone. Therefore, parameters such as the medicine’s stability, quality, efficacy or safety, cannot be guaranteed if it is sold outside the intended zone. It noted that the climatic zone for which a product is manufactured can sometimes be located on the outer package of the product or in the information leaflet.
The Department said that zone differences oftentimes result in products being labelled in the language of the respective countries for which the medicine is manufactured to be marketed or distributed. The Laws of Guyana – Food and Drug Act of 1971 and Regulations of 1977, stipulate that products for the local market must be labelled in English and any product that is labelled in a foreign language is in contravention of the stipulated laws.
“Inspectors of the GA-FDD recently visited in excess of eleven (11) pharmacies in Georgetown and other outlying areas where out of zone and foreign language (Turkish) labelled medicine were seized and removed from approximately ten (10) of those pharmacies. The department is expected to continue this exercise to curb this practice and enforce our labelling laws,” the Department related in a statement.
It added that no waivers will be granted for the importation of any medicine that is intended for use and sale outside of Zones IVa or IVb. It reminded that declarations must be clear to the Department regarding the intended zone or be stated on the label. The label must also be in English before those medicines can be allowed entry into Guyana.
The Department said that only medicines which have undergone the requisite stability testing and are intended for use in Zone IVa or IVb countries will be allowed to be imported into Guyana.
The GA-FDD is now an accredited Conformity Assessment Body (CAB) and is therefore bound to uphold the necessary standards for document and trade facilitation. GA-FDD said there will be no facilitation of any medicine that puts that status at risk, adding that waivers will therefore be prohibited and greater scrutiny will be given to medicines emanating from countries outside of Zone Iva or IVb which can potentially put the health of the population at risk.