The president of the Pharmaceutical Society of Ghana (PSGH), James Ohemeng Kyei, has said that there is a breakdown in the regulatory system of the Food and Drugs Authority (FDA), the state agency responsible for ensuring pharmaceutical products sold in Ghana are safe.
He said the kneejerk reaction of the FDA to the importation and distribution products it says are unwholesome, was a clear indication that there is a “systemic regulatory failure and lack of technical assessment and input into regulatory decision-making” at the FDA.
The Authority in recent times has blacklisted a number of pharmaceutical companies and recalled drugs distributed in the country, saying those drugs were fake and had not been certified as required by law.
It blacklisted an Indian drug company whose products were said to have been exported to Ghana without certification in India.
But Mr. Kyei, speaking on Joy FM’s Super Morning Show Friday, said the FDA was derelict in its duties and must be investigated by the appropriate state agencies.
“If the FDA’s regulatory system is functioning effectively, all applications to the FDA for registration of imported finished pharmaceutical products must be accompanied by quality assurance certificates issued by the competent medicines regulatory authorities (counterparts of the FDA) in the exporting country; the fact that medicines can be cleared from the harbor without these (documents) means that there is a breakdown in the regulatory system,” he stated.
Citing the Gsunate Plus anti-malaria drug which the FDA said had not been registered and yet had been imported into the country and distributed nation-wide, Mr. Kyei, said “If the products were not registered, how were they cleared from the harbor and distributed throughout the country”?
He said the FDA must come clean with Ghanaians because its modus operandi and the explanations thereof, left much to be desired.
“I think that we need to demand from our public officials, core values of transparency, probity and accountability,” he asserted.
The PSGH President said it was unacceptable for the FDA to dither and wait for drugs it claims are fake to be distributed across the country, only for it to expend scarce resources to retrieve them.
He likened the behavior of the FDA to a proverbial bird which muddies the water in the stream and goes out to ask, “Who is responsible for muddying these waters”?
“This is what the FDA authorities are doing,” he said, stressing that “after allowing the products to be cleared from the port, then they will issue alert, ‘don’t buy this drug, don’t use this medicine,’ what is happening”?
He rejected suggestions that the medicines in question may have been imported into the country through unapproved routes and could not have been detected by the officials of the FDA at the entry points.
He said if that were the case, the FDA should tell Ghanaians the routes through which those drugs were imported into the country and take steps to punish such companies.
Reacting to the comments of the PSGH President, a Senior Regulatory Officer at the FDA, Mr Samuel Asante Boateng said the FDA deserved commendation not condemnation for the work it was doing.
He said the World Health Organisation had lauded the regulatory framework of the FDA and that the system was working perfectly.
According to him, if drug importers conceal unregistered drugs to bring them into the country, the FDA cannot stop such drugs from entering the market.
What the Authority can do, he said, is to track such medicines in pharmacy shops and hospital stores and recall them.
That is not an inefficient system, he maintained.