The Government Analyst-Food and Drug Department (GA-FDD) has ordered the recall of Ramipril, a drug for hypertension or congestive heart failure that was found to be unregistered and circulating on the local market.
GA-FDD Director Marlon Cole told Guyana Times at the sidelines of a workshop on Tuesday, that the move was taken following a complaint the Department received on Sunday.
Cole claimed that an immediate investigation was launched following the complaint and it was later found that the drug, which is highly used, was unregistered.
GA-FDD Director Marlon Cole
“The reason for registration is to ensure that the drugs were assessed either by a competent and serious reference authority or by the Caribbean registration. So, immediately as we recognised that the drug was not registered or no marketing authorisation was given to it to be sold on our local market, we made a decision to have it recalled from circulation with immediate effect,” he explained.
Ramipril is used to treat mainly hypertension (high blood pressure). It is also used to reduce the risk of heart attack, stroke, or death.
The Director said the owner of the unregistered drug is cooperating with the Department and had indicated that it would conduct a recall with immediate effect.
Given this recent discovery, Cole told this newspaper that the department would take stringent steps to ensure that other similar situations were reported and addressed.
“We will examine pharmaceuticals and specifically look for prescription drugs and ensure that they are on our list as registered drugs. If that is not the case, and they are in circulation and have not been subjected to regulatory oversight, chances are that drug may be posing a public health risk,” he said.
The Director explained that in any regulatory system, there was always a need for a balance to be maintained between the availability of drugs that were safe and filtering out substandard drugs.
The assessment of these drugs looks at whether the bio-availability is sound, the active pharmaceuticals are indeed included, and the patient information is accurate, among other things.
“We also need to check if the drugs could be sold in our climate because it is possible that a drug could be marketed in a temperate climate and when it comes to a tropical zone, it loses its efficacy. So, those are some of the things that our officers have to be vigilant about,” he added.
Cole said that his team continued to work hard daily to ensure that everyone was compliant and that unregistered drugs did not reach consumers.
The GA-FDD Head addressed a workshop on Tuesday for drug importers which focused on strengthening function and regulatory capacity, with special emphasis on the Caribbean regulatory system in Guyana.
