Ghana FDA defends blanket ban after calling Bliss' anti-malaria drug 'fake'

Last week Indian drugmaker Bliss GVS​ told in-Pharmatechnologist.com it was 'baffled' by the accusation it had supplied fake malaria drugs to Ghana and said the blanket ban imposed on all of its products by the Food and Drugs Authority of Ghana (FDA) was 'harsh.'

Earlier today the regulatory agency issued its response. Eric Karikari-Boateng, head of the laboratory services at the FDA Ghana, told in-Pharmatechnologist.com the actions were fully justified, explaining that: “With respect to whether the product are unregistered or fake, ​I would like to draw your attention to the fact that any good company with morals would not export a product to a country without a valid marketing Authorization, and nothing, I mean nothing, can justify this.”​

The drug that has been at the centre of the spat is Gsunate Plus, an anti-malarial therapy made up of Artesunate and Amodiaquine, which the FDA says had not undergone clinical trials in its suppository form.

On its website, the FDA reported Bliss’ Director had been “lured into the country”​ by the Bureau of National Investigations (BNI), and arrested for importing fake drugs into the country (the original story​ has been removed but a copy of the statement by the FDA can be found at newsite AllAfrica.com​).

Karikari-Boateng told us: “Nobody forced Mr S N Kamath [the Director] of Bliss GVS to sign a letter that he manufactures and export fake drugs to Ghana, he did that on his own accord.”​

Regulatory Delays​

However, Bliss GVS spokesperson Gagan Sharma previously told us the products are not fake, but rather had not completed the registration process due to delays from its Ghanaian partner, Tobinco Pharmaceuticals, and the FDA itself, and thus sanctions against the company (who export a significant amount of products to the country) were “harsh.”​

In response Karikari-Boateng expressed his surprise as to why there has been controversy with the decision to undertake a blanket ban on Bliss imports as “changing the route of administration of an already approved drug would have to be supported with clinical data,”​ as is the case with other regulatory bodies.

With regards to delays, “the FDA does not intentional delay applications of its client, the clock simply stops when there are issues on Quality, Safety and Efficacy to be addressed by the applicant,” ​he added.

“It is not different from how we work here in Ghana. Our Timelines are clearly stipulated in our guidelines so the issue of we delaying does not come into play at all.”​

Not a Witch Hunt​

Sharma had said the ban of Bliss’ products had left the firm “quite baffled,” ​but Karikari-Boateng was adamant the FDA’s actions were defendable and were not a witch hunt against the drugmaker.

“[Bliss GVS] exported over 100 unregistered products to Ghana and distributed them to private and Government Hospitals,”​ he said. “When the company was asked by the FDA to provide Pharmaceutical dossiers to support the application of these products, the company responded by submitting Dossiers which have been forged.​

“When this was detected, Bliss GVS and Tobinco requested that the dossiers should be given back to them which the FDA declined.”​

Industry’s response​

In an interview with Ghanaian radio station Joy FM​, James Ohemeng Kyei - President of the Pharmaceutical Society of Ghana (PSGH) - said there is a “systemic regulatory failure and lack of technical assessment and input into regulatory decision-making”​ at the FDA.

Regarding Gsunate Plus and the ban on Bliss, he asked “if the products were not registered, how were they cleared from the harbor and distributed throughout the country?​

“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?”​

Furthermore, discontent with the FDA was demonstrated in a petition presented to the FDA by Ghana-based think-tank and research institute IMANI, who undertook a survey of the pharmaceutical industry in light of the Gsunate incident.

“Of the 68 importers, distributors, marketers and manufacturers whose views were sampled, all of them felt that the FDA’s quality of service, responsiveness, and general excellence of delivery needed ‘substantial improvement,’”​ it said.

When asked for comment on this report, Karikari-Boateng said: “I would not waste my time to talk about it.”​ Questioning the research methods involved, he added: “How can one arrive at a valid conclusion without assigning reasons for the questions that the research was to answer.”​

In-Pharmatechnologist.com did not receive any response to questions from either IMANI or the PSGH.