…Insists Its operations threatens “public, health and safety”.
The Food and Drugs Authority (FDA) has suspended the operations of Entrance Pharmaceutical and Research Centre, owned by Tobinco Pharmaceuticals Ltd, for non-compliance with the World Health Organisation (WHO) guidelines for Good Manufacturing Practices.
The Herald, has sighted a letter authored and signed by the Chief Executive Officer (CEO) of the FDA, Dr Mimi Delese A. A Darko dated July 1, 2024, in which she told the Managing Director that “the safety, quality, and efficacy of the general and beta-lactam pharmaceutical products manufactured at your facility are a threat to public, health and safety”.
“You are, by this letter, directed to suspend all production activities and submit a Corrective and Preventive Action Report (CAPA) within fifteen (15) days upon receipt of this letter”, the FDA boss demanded from the producers of the Foligrow blood tonic and multivitamin, Entracin, Entradol, Zinvite, Lufart, Artenate, Tobin’s Baby Grip water, Entrance Antacid, Tobvital Multivitamin, Lonart, Coldrilif, Tobcee Syrup, Antralyn baby among others.
The suspension, followed a routine inspection of the facility owned by Entrance Pharmaceutical and Research Centre “located at 16 Okpoi Gonno 1 Light Industrial Area, Accra, by the Food and Drugs Authority from 24th to 26th June 2024 to ascertain the level of compliance to Good Manufacturing Practices (GMP)”, where “certain deficiencies were observed”.
Interestingly, as of last week Friday, officials of the FDA, were in the premises of the Pharmaceutical and Research Centre, inspecting the operations of the company to ensure it had put in the required WHO standards.
FDA, The Herald, picked has had the WHO on its neck to ensure that the health, life and safety of Ghanaians, including children were not compromised by the Tobinco and its sister company.
The company, was said to have initially resisted the directive of the FDA and refused to shut down its operations.
FDA in its 10-page report, noted that the activities of Entrance Pharmaceutical and Research Centre, lacked the required “safety, quality, and efficacy of the general and beta-lactam pharmaceutical products manufactured at your facility are a threat to public, health and safety”.
“The deficiencies of the facility which have been categorized into 5 ‘Critical’, 39 ‘Major’ and 5 ‘Other’ deficiencies have rendered the facility non-compliant with the WHO guidelines for Good Manufacturing Practices” adding, “Please treat as urgent and comply”.
The management of the FDA, is expected to update the WHO on its latest findings at the company.
The Herald’s continuous investigations into the Accra High Court’s order for the FDA to pay a whopping GH¢94 million to Tobinco Pharmaceuticals Ltd, for the unlawful destruction of unexpired drugs belonging to the company, continues to unearth more dirt confirming that Tobinco is not deserving of any amount.
A crucial document in the custody of The Herald, dated 6, February 2017, had the current FDA CEO, insisting that Tobinco’s conduct was criminal by the law specifically the Public Health Act 2012, Act 851, but it remains unclear, why she did not enter the witness box to testify in favour of the Authority over the 2013 incident.
Mrs Darko’s damning letter was in response to one written to her by Akufo-Addo, Prempeh & Co, the law firm of the President, Nana Akufo-Addo, and dated January 31, 2017, in which Dr Stephen Kwabena Opuni, was severely condemned for taken action against drugs imported into the country by Tobinco Pharmaceuticals Ltd owned by Samuel Amo Tobin.
Akufo-Addo, Prempeh & Co, through one Alex Mantey Osei, acting as the lawyers of Tobinco Pharmaceuticals Ltd, 24 days after the inception of the Akufo-Addo administration, 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 lawyer 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..”
However, in her response to the letter, Delese Darko, who per documents available to The Herald, revealed was the brain behind the 2013 detection of Tobinco’s unregistered products, fired back on behalf of the FDA, saying it “denies the allegation contained therein, and would say in response that its actions and activities have not occasioned your client and loss during the period in question”.
“The FDA would like to put on record, for the avoidance of doubt, that your client, in blatant disregard of national law, 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”.
She went on to tell the lawyer to “please note that the law criminalizes 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.”
“We wish to state emphatically that the FDA, is not indebted to your client in any way, whether by way or contract or tort or at all”, concluded Mrs Dako’s letter. She was then acting as CEO of the FDA.
Meanwhile, analysts have waded into theGH¢94 million awarded to Tobinco, saying it stifles the work of the FDA.
It was explained that the FDA, has always safely disposed of unregistered and or expired products pursuant to section 132(2) without court orders and has done so to date. It does so with guidelines pursuant to section 148(2) (f) – guidelines for the destruction of drugs.
The judgement, it is suspected will open the pandora’s box for all disposals made without the order of a court since the FDA’s inception to attract judgments, following the court’s orders as captured by the entry of judgment.
The FDA (acting through authorized officers) has powers under section 135 titled to enter any premises where an officer believes that a regulated product is preserved, stored or conveyed; (d) seize and detain for the period that the officer considers necessary an article by means of or in relation to which it is believed a provision of Act 851 has been contravened.
The FDA’s power, includes the power to detain unregulated items on the premises of the proprietor or importer. Section 132(1) – the FDA has authority to order the closure of premises.
Hence, the public must be interested in knowing whether the FDA, acting through its officers in the period under review acted in the interest of public health and safety, or unlawfully as described by the entry of judgment.
The paper’s findings had been that, the FDA, is simply on its way to paying a dubious judgment debt it should have fought with the arsenals at its disposal, including documents authored by the FDA boss, Delese Darko.
Additionally, The Herald discovers that, although the issues Tobinco, led by Samuel Amo Tobbin, complained of happened in 2013 during the Dr Opuni administration at the FDA, he rather went to court in 2019, six clear years under the current Delese Darko administration and after Alhaji Hudu Mogtari.
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.
Lawyer Philip Addison of Addison Bright Sloane, Barristers, Solicitors, Consultants, formerly of Akufo-Addo’s law firm, represented Tobinco in the case presided by Justice Audrey Kocuvie-Tay.
More to come!
