..Counterfeit drugs, inferior condoms & forgery mentioned
The Herald’s continuous digging into the GH¢93,905,760.79 judgment debt awarded to Tobinco Pharmaceutical Limited, has unearthed a damning docket prepared by the Economic and Organised Crime Office (EOCO) for the criminal prosecution of the owner, Samuel Amo Tobin, for counterfeiting anti-malarial medicines which had endangers the lives of many people, especially children.
The docket was prepared in March 2015 by the then EOCO boss, Kweku Mortey Akpadzi, with the complaints in the case as officials of the EOCO and the Food and Drugs Authority (FDA). It alleged forgery of Ministry of Health documents against Tobinco Pharmaceutical Limited.
The Herald is informed the docket was submitted to the Attorney-General’s Department, specifically the then Director of Public Prosecution (DPP), Cynthia Jane-Naa Korshie Lamptey, who is currently the Deputy Special Prosecutor in the Office of the Special Prosecutor, but she failed to prosecute the matter.
EOCO officials, revealed how a delegation of pastors of the Church of Pentecost numbering almost 20, stormed their offices in 2013 to plead on behalf of Mr Tobin, whose police statement The Herald has sighted, in which he admitted the importation of the untested medicines.
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Despite the damning dockets, the company in a letter dated January 31, 2017, sneakily engaged the services of lawyers in the law firm of the President, Nana Akufo-Addo, to claim compensation alleging unlawful destruction of unexpired drugs belonging to the company by Dr Stephen Kwabena Opuni, ex-Chief Executive Officer of the FDA.
The lawyers of Tobinco Pharmaceuticals Ltd, 24 days after the inception of the Akufo-Addo administration, had resurrected the 4-year standoff between FDA and Tobinco, accusing Dr Opuni of savagery and “brute harassment” of Tobinco officers in the “unlawful destruction of its imported medicines”.
Tobinco’s lawyers in their letter in which they demanded compensation, stated that Dr Opuni, had “categorically threatened to bring our client’s CEO down”, and “finish him like Semanhyia”, etc..”
Excerpts of the docket sighted by The Herald, revealed that between 2012 and 2013, Tobinco Pharmaceutical Limited, imported and distributed across the country 52,690 units of GSUNATE PLUS SUPPOSITORIES 25mg and 50mg – Anti malaria medicines for children from an Indian manufacturer called Bliss GVS Ltd.
The manufacturer, did not subject the medicines to clinical trials before exporting them to Ghana.
The Chief Officer of Tobinco Pharmaceuticals Company Limited, was fully aware that the anti-malaria medicines for children, have not been subjected to clinical trials, as a result, the company did not register the drugs with the Food and Drugs Authority before importing and distributing them across the country contrary to section 118 of the Public Health Act, 2012 Act 851.
It said that “as a result of the above actions of the company, the efficacy and safety of the GSUNATE PLUS SUPPOSITORIES have not been ascertained, thereby posing a threat to public health and safety which is in breach of section 73 (c) of the Criminal code of Ghana, 1960 (Act 29) and section 133 of the Public Health Act, 2012 Act 851”.
The facts said that “Tobinco Pharmaceutical Limited counterfeited three drugs – Foligrow Syrup, Funbact-A and Jeditone as Folegrow Syrup, Combact –N and Geditone respectively, which the company invoiced to customers as though the medicines were the original ones. These actions contravene sections 113 and 123 of the Public Health Act 851.
It disclosed that “Between 2012 and 2013, Tobinco Pharmaceuticals Company Limited imported 3,906 units of GSUNATE PLUS SUPPOSITORIES 25mg as free samples which the Company distributed across the country without the permission or license of the Food and Drugs Authority in contravention of section 121 (I) of the Public Health Act, 2012 Act 851.”
Additionally, the ECOCO docket disclosed that, “Tobinco Pharmaceuticals Company Limited imported into the country 66 types of pharmaceutical products in commercial quantities without permit or license of the Food and Drugs Authority contrary to section 122 (I) of Public Health Act, 2012 Act 851”.
Furthermore, the docket revealed that “ Tobinco Pharmaceutical Company did not register all the medicines that they have imported without license or permit of the Food and Drugs Authority contrary to section 118 of the Public Health Act, 2012 Act 851.
EOCO established that “the efficacy and safety of the unregistered medicines have not been ascertained, thereby posing a threat to public health and safety which is in breach of section 73 (c) of the Criminal Code of Ghana, 1960 (Act 29).
It said, “In spite of the Food and Drugs Authority’s detention notices on the unregistered medicines, the Company went ahead and distributed most of the medicines to the public in breach of Food and Drugs Law 1992 (PNDCL 305B) and section 135 (1)(d) of the Public Health Act, 2012 Act 851”.
The docket argued that “Every importer of pharmaceutical products and medical devices e.t.c is required under the law to re-register with the Authority any of the products or devices that has outlived its registration period. Tobinco Pharmaceutical Company Limited imported and distributed 52 types of pharmaceutical products in commercial quantities which had expired registration in contravention of section 118 of the Public Health Act, 2012 Act 851.
In spite of the detention notices placed on these medicines that have expired registration, the Company distributed them to the public in contravention of the Food and Drugs Law 1992 (PNDCL 305B and section 135 (1)(d) of Public Health Act, 2012 Act 851.
The docket said that “Between 2012 and 2013, Tobinco Pharmaceutical Company Limited forged documents of the Ministry of Health to import medical devices in commercial quantities – HIT MAN CONDOMS in order to escape registration and avoid the payment of registration fees in contravention of section 159 of the Criminal Code of Ghana, 1960 (Act 29).
“Mr Paul Sekyi, official of the Ghana Supply Company Ltd (clearing agent), aided the company to clear the condoms from the Port with the permit of the Ministry of Health in contravention of section 20 of the Criminal Code of Ghana, 1960 (Act 29).
It revealed that “the condoms were tested by the Food and Drugs Authority and the result showed that, the condoms were substandard, therefore cannot protect the public from sexually transmitted diseases and unwanted pregnancy, thereby in breach of section 73 (c) of the Criminal code of Ghana, 1960 (Act 29) and section 113 of the Public Health Act, 2012 Act 851”.
It said that “in spite of detention notices placed on the condoms by the Food and Drugs Authority, the Company distributed the condoms to the public contrary to the Food and Drugs Law 1992 (PNDCL 305B) and section 135 (1) (d) of the Public Health Act, 2012 Act 851”.
The docket also revealed that “on 21st day of November, a combined team of officials from the Economic and Organized Crime Office and Food and Drugs Authority acting on intelligence that Tobinco Pharmaceutical Company Ltd. had concealed some unregistered pharmaceutical products and medical devices in a warehouse at No 16 Okpoi Gono Street were obstructed by Mr. Samuel Amo Tobin, the CEO of the Company who incited a mob of his employees who attempted to lynch the officerd. These actions are in breach of section 205 of the Criminal code of Ghana, 1960 (Act 29)
In 2019, Tobinco sued FDA and asked the court to award cost against the FDA and declare its action as unlawful.
Tobinco, was represented by Mr Philip Addison, of Addison Bright Sloane, Barristers, Solicitors, Consultants, Accra.
In reaching a decision, the court presided over by Justice Audrey Kocuvie-Tay, declared that the wanton destruction of Tobinco’s unexpired products without obtaining any order from the court was unlawful.
The court again declared that “the unlawful lockup of Tobinco’s warehouses by the FDA and bad media publicity by the FDA resulted in the massive expiration of Tobinco’s products between June 2014 and August 2015.”
Interestingly, Mr Tobbin, who has had various brushes with the FDA’s strict regulations, including the importation and distribution of Oxytocin used to induce labour or strengthen uterine contractions, or to control bleeding after childbirth, sought damages and interest on medicines confiscated from Tobinco Pharmaceuticals starting from 2015 during the tenure of Hudu Mogtari, who replaced Dr Opuni.
Remarkably, Delese Darko, who took over from Mogtari and had also been at the FDA long before Dr Opuni and Alhaji Mogtari, did not defend the institution’s actions. Neither was Opuni and Mogtari subpoenaed by Justin Agbeli Amenuvor, FDA’s private lawyer, to give evidence in favour of the FDA to save the state from the GH¢93,905,760.79 million payment.
Strangely, the judgement suggested the FDA, called only one witness, without giving his or her name, but said that during cross-examination the witness “admitted that merely because a consumer experienced adverse effects from taking medications, it does not make the drug fake”.
