In the back-and-forth between the Food and Drugs Authority (FDA) on the one hand and Tobinco Pharmaceuticals, on the other hand, regarding the importation of alleged "fake and substandard" medicines into Ghana in 2013, the state regulator's CEO, Dr Delese Darko, in 2017, in her acting capacity at the time, wrote to the company's lawyers describing the incident as "criminal."

In the letter, dated 6th February 2017 and addressed to Mr Alex Mantey Osei of Akufo-Addo, Prempeh & Co., the FDA CEO wrote: "Reference is made to your letter dated 31st January 2017 referenced AAPC/GYD/MO/2017/0007. The Food and Drugs Authority denies the allegations contained therein, and would say in response that its actions and activities have not occassioned your client any loss during the period in question." 

The letter continued: "The FDA would like to put on record, for the avoidance of doubt, that your client, in blatant disregard of national laws, and, in particular, the Public Health Act, 2012 (Act 851), endangered the health and safety of Ghanaians, and especially, the health of Ghanaian children by importing, distributing and offering for sale fake, substandard and unregistered medical products."

It added: "Please note that the law criminalises the above conduct and empowers the FDA to act swiftly and timeously in such instances to avert any danger posed to the public."

"We are of the firm belief that the FDA acting through its officers acted properly, diligently, in accordance with due process and in the reasonable belief that their failure to so act would jeopardise public health and safety," the letter noted, adding: "We wish to state emphatically that the FDA is not indebted to your client in any way, whether by way of contract or tort or at all."

After almost a decade of the incident, the high court cleared Tobinco Pharmaceuticals of any wrongdoing and awarded a judgment debt of GHS94 million.

The court, presided over by Her Ladyship, Audrey Kocuvie-Tay, in a ruling dated July 29, 2024, exonerared the company of any infringements contrary to claims of wrongdoing by the then-Chief Executive Officer of the Food and Drugs Authority (FDA), Dr. Stephen Kwabena Opuni.  

A statement released by the Corporate Affairs department of the pharmaceutical company said, “Tobinco Pharmaceuticals Limited (TPL) and its Group Chairman, Mr Samuel Amo Tobbin, never imported fake drugs into the country."

Between September and December 2013, Dr. Opuni reported Tobinco Pharmaceuticals Limited and its CEO Mr Samuel Amo Tobbin to the Economic and Organised Crime Office (EOCO) and caused the latter’s arrest on the premise that the Company had imported fake drugs.  

The Opuni-led FDA proceeded to lock warehouses belonging to the company across the country with the closure of the warehouses, leading to a rapid expiration of the company’s products. 

The FDA also banned Bliss GVS Pharma Limited, the then principal business partner of Tobinco Pharmaceuticals Ltd., from importing drugs into Ghana and labelled the stored drugs as fake, leading to the confiscation of the drugs from customers. 

Tobinco Pharmaceuticals Limited, in proving its innocence, commenced a legal action against the Food and Drugs Authority (FDA) on July 19, 2019, for abuse of statand duties and prayed the court for damages. 

The court, in its ruling, asserted that Tobinco Pharmaceuticals Ltd did not import fake drugs into the Ghanaian market. 

It also affirmed that the acts of the FDA and its Chief Executive Officer at the time constituted a misfeasance - an abuse of the FDA’s statutory powers and duties. 

The court also confirmed that because the company was fined after some of its drugs had expired in terms of registration, the FDA, led by Dr. Opuni failed or refused to register the drugs that had not expired in terms of registration. 

It upheld that the FDA’s former CEO, Dr. Opuni targeted the company without any reason, as his departure led to the registration of the drugs. 

Again, the Court acknowledged the coercion of Mr Tobbin and the Director of Bliss GVS Pharma, Mr. Kamath, to sign the “so-called” confession statements. 

The court again explained that a review of both documents confirmed that the wording was the same, with the only differences being the letterhead, names, and signatures of the signatories. 

Mr Samuel Amo Tobbin, reacting to the ruling, said: “It is a positive feeling and a welcome news for a court of competent jurisdiction to affirm my innocence. It’s a very great feeling.” 

He said Tobinco Pharmaceuticals Ltd had always produced and marketed its drugs professionally to its valued Ghanaian and African customers, and would never endanger their health, adding that the Company would continue to produce quality drugs and other medical supplies to promote quality healthcare.