Unregistered drugs a widespread issue – GA-F&DD

…department to take legal action against defaulters

The Government Analyst Food and Drug Department (GA-F&DD) will be moving against those suppliers who would have supplied institutions in the public health care system with unregistered drugs.
According to the GA-F&DD Director, Marlon Cole, the department has received complaints from patients who have received unregistered drugs, and those complaints indicate that this is a widespread problem.
“We have environmental officers in all the regions who are appointed Food and Drug Inspectors and carry out our mandate on our behalf. We have regional coverage there. We have persons that would go to the Customs Department and refer entries we would have an interest in. So we have some protection at ports,” he explained.
Cole further explained that inspections are carried out at storage bonds and places where these drugs are distributed by the department’s own city inspectors. And then, of course, he noted the mechanisms in place for consumers to lodge complaints…for instance, in the case of wrong labelling.
“We will be taking legal action against some importers who are knowingly and deliberately releasing and distributing unregistered drugs into the national health care system. We have been receiving complaints about drugs that are not safe and efficacious after they’ve been used, and we are heavily dependent on those reports emanating out of the health care system,” he explained.
“In addition, we would be embarking on our pharmaceutical vigilance system in addition to doing some surveys,” Cole explained. “But the problem with unregistered drugs is widespread, and we’re tackling it in the same way we’re dealing with food.”

Drugs
Last year, the Public Health Ministry introduced a new system for procuring of drugs and medical supplies, with the aim of enhancing the efficiency and effectiveness of the drug supply chain in the country.
This was accompanied by several changes in the bidding documents, which were intended to create a more level playing field among competitors. Following the massive shortage of drugs in the country, the then Public Health Minister, Dr George Norton, admitted that the change in the procurement system is probably the likely cause for the drug shortages being experienced.
Previously, Public Health Minister Volda Lawrence had said that, in 2016 and 2017, several firms were awarded contracts to supply pharmaceuticals to the health sector, but failed to deliver.
The International Pharmaceutical Agency (IPA) was one of those companies that failed to supply all of the drugs it was expected to deliver, because it was not qualified to import some specialised pharmaceuticals.
In January 2016, IPA was awarded two contracts to supply the GPHC with pharmaceuticals and medical supplies. On one of the contracts — for $36.5 million — the company delivered only 80 per cent of the pharmaceuticals, because it was not qualified to supply the remainder.
The remaining 20 per cent of drugs consisted of narcotics, including morphine, which required special certification for importation. It is understood that in order for a firm to import narcotics-type pharmaceuticals, it must be registered in order to be granted a licence.
But the company was not registered to import those categories of drugs, and was therefore denied a licence by the GA-FDD.
It has been argued that pre-qualification (a practice from which Government has moved away) could have prevented a company that is not registered to provide specialised drugs from getting the contract.