Medicines not manufactured for Guyana’s climatic zone will be seized

DIRECTOR of Government Analyst Food Drugs Department, Marlon Cole, is advising importers and retailers that only medicines which have undergone the requisite stability testing and are intended for use in Guyana’s climate will be allowed into the country.

The Government Analyst –Food and Drug Department (GA-FDD), in a press missive Monday, said medicines that are not manufactured to be sold in Guyana’s climatic zone (IVb) will no longer be accepted into the country or be accepted for resale.

Cole explained that during the formulation process, manufacturers determine the medicine’s, stability, shelf-life and expiry date according to the climatic zone.
Therefore, he said 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, he said, can sometimes be located on the outer package of the product or in the information leaflet.
In addition, the GA-FDD Director noted that zone differences often result in products being labelled in or 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 1971and Regulations of 1977, stipulates 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,” Cole said.

He explained that inspectors of the GA-FDD recently visited in excess of 11 pharmacies in Georgetown and other outlying areas where out-of-zone and foreign language (Turkish) labelled medicine were seized and removed from approximately 10 of those pharmacies.

He said that the department is expected to continue this exercise to curb this practice and enforce our labelling laws.
“No waivers will be granted for the importation of any medicines that is intended for use and sale outside of Zones IVa or IVb. 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 director added.

The GA-FDD, he said, is now an accredited Conformity Assessment Body (CAB) and is therefore bound to uphold the necessary standards for document and trade facilitation.
“There will be no facilitation of any medicines that puts our status at risk. 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,” he said.

The climatic zones are as follows: 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) and IVb- hot/ very humidity (e.g. Guyana, India and Brazil). Information on zoning can be found on the World Health Organisation (WHO) website,www.pharmaguideline.com/2010/12/different-climatic-zones-for-stability.html.