The Government Analyst–Food and Drug Department (GA-FDD) is advising the public that only medication manufactured for sale in Guyana’s climate zone and packaged with English instructions should be imported, sold or consumed.
“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 department announced yesterday.
According to a release from the GA-FDD, recent visits from inspectors to more than 11 pharmacies in Georgetown and other outlying areas resulted in the seizure of out of zone and foreign language (Turkish) labeled medicine.
These medicines were seized and removed from approximately 10 of the pharmacies inspected.
The GA-FDD has stressed that during the formulation process, manufacturers determine the medicine’s stability, shelf-life and expiry date according to the climatic zone.
“Parameters such as the medicine’s, stability, quality, efficacy or safety, cannot be guaranteed if it is sold outside the intended zone,” they warn while explaining that the climatic zone for which a product is manufactured can be located on the outer package of the product or in the information leaflet.
Additionally zone differences can result in products being labeled 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 Guyana’s market must be labeled in English and any product that is labeled in a foreign language is in contravention of local laws, the department reminded.
Guyana’s Climate Zone is listed as Zone IVb-hot/very humid. Other zones include Zone I- Temperate (e.g. Canada and Germany), II – Mediterranean/ Subtropical (e.g. Chile and Turkey), III- Hot/ dry (e.g. Chad and Iraq), IVa – hot/humid (e.g. Jamaica and Pakistan.)
The department has stated that it will continue this exercise to enforce local labelling laws and has directed that further information on zoning can be found on the World Health Organization (WHO) website, www.pharmaguideline.com/2010/12/different-climatic-zones-for-stability.html.
They maintain that no waivers will be granted for the importation of any medicines that are intended for use and sale outside of Zones IVa or IVb and advised importers 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.
Further noting that it is now an accredited Conformity Assessment Body (CAB), the GA-FDD stressed that it is bound to uphold the necessary standards for document and trade facilitation and will not facilitate the importation of any medicines that puts this status at risk.
“Waivers will 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,” they explained.
