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Foreign language-labeled drugs seized from pharmacies’ shelves
A few of the pharmaceutical drugs that were seized.
Kaieteur News – Inspectors from the Government Analyst–Food and Drug Department (GA-FDD) recently visited 11 pharmacies in Georgetown and outlying areas where a quantity of out-of-zone and foreign language-labeled medicine were seized and removed.
Speaking with Kaieteur News, Director of GA-FDD Marlon Cole disclosed that the drugs were found to be outside of the country’s climatic zone hence, why it was confiscated.
He added that the owners of these pharmacies were given notices to not import or distribute these drugs.
The GA-FDD, in a release, advised that importers and retailers who are engaged in the practice of importing, distributing and marketing medicines that are not manufactured to be sold in the country’s climatic zone (IVb) should take warning.
The climatic zones are as follow: Zone I- temperature (e.g. Canada and Germany); II-Mediterranean/sub-tropical (e.g. Chile and Turkey); III –Hot/dry (e.g. Chad and Iraq); IVa- Hot/humid (e.g. Jamaica and Pakistan); and IVb-Hot/very humid (e.g. Guyana, India and Brazil).
During the formation process, manufactures determine the medicine’s stability, shelf-life and expiry date according to the climate zone.
However, parameters such as the medicine’s stability, quality, efficacy or safety cannot be guaranteed if it is sold outside the intended zone. 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.
In addition, the zone differences often results in the product being labeled in the language of the respective countries for which it is manufactured to be distributed.
Notably, the Laws of Guyana – Food and Drug Act of 1971 and Regulations of 1977, impose that “products for our market must be labeled in English and any product that is labeled in a foreign language is in contravention to our laws.”
GA–F DD outlined that no waivers would be granted for the importation of any medicine that is intended for the use and sale outside of zones IVa and IVb.
The department noted that declarations must be clear to GA –FDD regarding the intended zone or be stated on the label. The label must be in English before it could be allowed in Guyana.
The GA-FDD made it clear that it is now an accredited Conformity Assessment Body (CAB) and is therefore bound to uphold the necessary standards for document and trade facilitation.
“There would be no facilitation of any medicines that puts its status at risk. Waivers would therefore be prohibited and greater scrutiny would be given to medicines emanating from countries outside of Zone (Iva or IVb) which could potentially put the health of the population at risk. Only medicines which have undergone the requisite stability testing and are intended for use Zone IVa or IVb countries would be allowed to be imported into the country.”
The Director further stated that Public Health Officers in the hinterland regions are also expected to be conducting this exercise at the various health clinics.
GA-FDD said it is expected to continue this exercise to curb this practice and enforce the labeling laws.
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