In calling an unregistered product ‘fake,’ the Ghanaian FDA has sparked a media war with industry, but are critics using this as an excuse to knock the regulators whilst importers gain undeserved sympathy? in-Pharmatechnologist’s Dan Stanton believes so.
Indian drugmaker, Bliss GVS, has become embroiled with the Ghanaian Food and Drugs Authority (FDA) over products - including a suppository form of anti-malarial drug Gsunate - it supplied to local pharmaceutical firm Tobinco.
The FDA says the drugs are ‘fake’ and must be destroyed and has imposed a blanket import ban on all Bliss products. The company in response says the products are not fakes but quality pharmaceuticals that simply have not been registered as a result of administrative delays caused by the agency itself.
The argument has led to the criticism of the Agency by groups including the Pharmaceutical Society of Ghana and local think-tank IMANI , and with the FDA hitting back, Dr. Derrick Owusu-Ampofoa - a Consultant from Ghanaian industry business and organization advisory firm CDC - released a statement last week calling for the end of hostilities in a “media war” which has “the potential to damage the nation’s international image and also create a state of fear and panic, among the populace.”
He admitted “issues of counterfeit and sub-standard drugs in the country are worrying” but playing “the triangular blame game” was not helping the issue.
What’s in a name?
Having spoken with the two protagonists, it is apparent to this journalist that the language the FDA used has complicated the issue. “There were delays at the FDA, and from our own partner (Tobinco),” Bliss spokesperson Gagan Sharma told me, and “some of those registrations were not completed. Therefore the FDA has said these products are fake.”
But Eric Karikari-Boateng, Head of Laboratory Services Department at the FDA, defended the terminology telling us the agency “subscribes to the World Health Organisation’s definition for such groups of Drugs.
“SSFFC - Substandard, spurious, fake, falsely labeled and counterfeits are all in one group and this is the definition that we use.”
In-Pharmatechnologist.com also spoke with a number of other regulators about the terminology used in this case, and how they define a ‘fake’ drug.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), the US Food and Drug Administration and the European Medicines Agency about the terminology used in this case, and what defines a ‘fake’ drug.
Spokesman Nick Spears told us that under the UK agency's rules drugs like Gsunate Plus - which has a different delivery route than the approved product - would need to be registered and would be defined as unlicensed until it had been reviewed. He added however that the MHRA would not define such products as fake because “they are not pretending to be something that they are not."
As for the European Medicines Agency, spokesperson Rebecca Harding said “the Agency does not have a definition of ‘fake’ medicines,” as such, instead referring to such products as ‘falsified medicines,’ of which it said there is no definition in the EU.
Across the pond US FDA spokesperson Stephen King said in this example the “products would be considered unapproved drug products,” whereas ‘fake’ drugs - also known as ‘counterfeit’ - are defined by the following formulation range:
- Drugs containing ingredients that can cause health problems, and therefore known to produce a ‘toxic effect.’ One example he cited was a recent counterfeited batch of Procrit containing non-sterile tap water, and therefore causing an infection in the bloodstream.
- Counterfeits that substitute one drug for another, causing “unintended effects.”
- Ineffective treatments due to the products containing only some active ingredient, as counterfeiters look to copy the real drug posing safety risks due to formulation errors.
- Drugs with no active pharmaceutical ingredients (API), such as was the case in a recent haul of fake Pfizer’s Xanax in Zurich, Switzerland .
Therefore, under these guidelines, it is evident the products were not fake as Gsunate Plus is made up of Artesunate and Amodiaquine, a combination which is listed on the WHO’s List of Essential Medicine .
Though the Ghanaian FDA acted sincerely in its attempt to regulate the unlicensed imports, it has allowed its critics to use its failure in definition as a springboard to attack some of the Agency’s genuine misgivings.
The agency may have missed this linguistic nuance, but Karikari-Boateng had the final word: “Whether the product is unregistered or fake, any good company with morals would not export a product to a country without a valid Marketing Authorization.”