Our drugs are not fake — Tobinco

Tobinco Pharmaceutical Company has stated that its stocks of drugs being destroyed by the Food and Drugs Authority (FDA) are not fake.
“Our drugs that were and are being destroyed by the FDA are not fake drugs,” it said in a statement signed by Mr Bernard Boateng, Head of Technical and Regulatory Affairs of the company.

The FDA has over the past two weeks cautioned the general public not to patronise a product of Tobinco, Gsunate Plus, an anti-malarial medicine for children.

A statement signed by the Chief Executive of FDA, Dr Stephen Opuni, said Gsunate Plus Suppository was not registered by the FDA and, therefore, the authority could not guarantee that the drug could be used for the treatment of malaria in children.

The FDA has also ordered the recall of some 100 drugs imported and distributed by Tobinco. It is investigating how the drugs were imported into the country without official documentation and approval.

But Tobinco, in its statement, promised the public that it would continue to maintain the quality and integrity of its products as it resolved certain issues with the FDA.

“We must state that some of the medicines which are being destroyed were passed under our previous registrations by the FDA, while some are in the process of registration and cannot be described as “fake”,” it said, stressing that the company was not “in violation of the provisions of the Public Health Act 2012, Act 851, subsection 123, fake (counterfeit) products.

It said what had led to the recent state of affairs with regard to registration of products with the FDA was a misjudgment and delayed action on Tobinco’s part and had nothing to do with the integrity of the products.

“A penalty imposed by the authority in connection with the registration issues has been duly paid and further discussions are ongoing,” it said.

The statement explained that since product registration was for a period, after which the product must be re-registered upon the submission of the relevant supporting documentation, samples and payment, “we have duly been pursuing re-registration in respect of all the products we distribute. Indeed the requisite registration payments have been made and documentation is being prepared for the attention of FDA.”

Daily Graphic/Ghana