Bliss GVS Pharma denies Ghanaian products are fake

Indian drugmaker Bliss GVS Pharma has refuted claims by Ghana's Food and Drugs Authority (FDA) that it has been distributing fake antimalarial drugs in the country.

The company's local distributor Tobinco Pharma has also applied for an injunction to prevent the FDA from destroying the suspect Gsunate product, saying it needs time to have it analysed and certified as genuine.

The Gsunate brand includes several products based on artesunate, which forms the basis of the recommended combination therapy for malaria, and in this case the product in question is Bliss GVS Pharma's suppository formulation.

On October 4, the Ghanaian government published a statement on its website - originally run by the Ghana News Agency - saying it had "with immediate effect banned the importation and distribution of all medicinal products manufactured by Bliss GVS Pharma."

It said the efficacy and safety of the Gsunate Plus Suppositories product had not been maintained and the product was not registered in Ghana, whilst alleging that a company representative had indicated the product was fake.

In response, Bliss GVS Pharma issued a statement saying that "all our products have been subjected to stringent quality standards and meet the required accreditations in India," adding: "it is unfortunate that the FDA released a statement classifying our products as fake."

Meanwhile, Tobinco has said that some of the products under scrutiny had previously been registered with the FDA but had lapsed, and the company insists it is in the process of re-registering them.

If it turns out that the product is actually genuine but has been distributed illegally, it once again brings to the fore the problems that can occur by a lack of consensus on the definition of a counterfeit medicine.

As a reminder, the World Health Organization defines a counterfeit medicine as "one which is deliberately and fraudulently mislabeled with respect to identity and/or source".

It will be interesting to see how the Bliss GVS/Tobinco versus FDA story plays out in the coming days. A court case is scheduled for October 16 to hear the case for an injunction on the destruction of the goods.