For a number of weeks the Ghanaian FDA has been issuing warnings of fake drugs - including anti-malarial drug, Gsunate Plus - supplied to local pharma firm Tobinco Pharmaceuticals by Indian drugmaker Bliss GVS Pharma.
Last week the FDA announced that Bliss’ Director, Shibroor Kamath, had admitted the Gsunate Plus suppository was fake after being “lured into the country by the Bureau of National Investigations (BNI).”
However, speaking with in-Pharmatechnologist.com, Gagan Sharma - head of Bliss’ International Business Division - said the FDA’s terminology is incorrect, as the issue stems from delays in re-registration of a few products.
“There were delays at the FDA, and from our own partner (Tobinco),” he told us, and “some of those registrations were not completed. Therefore the FDA has said these products are fake.”
However, he continued, “the user fees had already been paid to the Food and Drugs Board (FDB - predecessor to the FDA) and unfortunately the FDA has taken a stand.”
Product registration is for a period, after which the product must be re-registered upon the submission of the relevant supporting documentation, samples and payment,a statement by Tobinco said, adding:
“What has led to the recent state of affairs with regards to registration of products with the Food and Drugs Authority is a misjudgment and delayed action on our part, and has nothing to do with the integrity of the products,” the company said.
Gsunate Plus is a suppository made up of Artesunate and Amodiaquine, a combination listed on the WHO’s List of Essential Medicine as a recommended curative treatment for malaria.
In a step described as “harsh” by Sharma, the FDA has banned all imports of Bliss products into the country, and, according to the website GhanaWeb today, is demanding all Bliss products currently stocked by hospitals, pharmacies and distributors to be returned to the suppliers, on threat of sanctions.
“We wanted to work with the FDA but haven’t been able to,” he said. “We are quite baffled as to what the FDA has against us.”
The confiscated drugs are being destroyed which is having a detrimental effect on both Bliss and Tobinco.
“As of now, we have not yet quantified the losses because of the destruction of the stocks by the FDA Team,” said Sharma. “Ghana is one of our big markets and therefore there has been some significant impact.” However he remained confident that these problems could be resolved with product recommendations due in the next couple of weeks.
The Ghanaian FDA did not respond to requests for comment by both telephone and email from In-Pharmatechnologist.com.