How WHO Regulations Forced FDA to Suspend Tobinco’s Entrance Pharmaceutical from Production
The Food and Drugs Authority (FDA) has halted the operations of Entrance Pharmaceutical and Research Centre, owned by Tobinco Pharmaceuticals Ltd, due to non-compliance with World Health Organization (WHO) guidelines for Good Manufacturing Practices (GMP).
A letter from the FDA’s Chief Executive Officer, Dr. Mimi Delese A. A Darko, dated July 1, 2024, addressed to the Managing Director of Entrance Pharmaceutical, indicated that the safety, quality, and efficacy of the general and beta-lactam pharmaceutical products manufactured at the facility posed a threat to public health and safety.
Dr. Darko directed the company to suspend all production activities and submit a Corrective and Preventive Action Report (CAPA) within fifteen days of receiving the letter. This directive impacted products such as Foligrow blood tonic, Entracin, Entradol, Zinvite, Lufart, Artenate, Tobin’s Baby Grip water, Entrance Antacid, Tobvital Multivitamin, Lonart, Coldrilif, Tobcee Syrup, and Antralyn baby, among others.
The suspension followed a routine inspection by the FDA from June 24 to 26, 2024, at the Entrance Pharmaceutical and Research Centre located at 16 Okpoi Gonno 1 Light Industrial Area, Accra. The inspection revealed several deficiencies, and as of last week, FDA officials were on-site to ensure compliance with WHO standards.
The FDA’s action was reportedly prompted by pressure from the WHO to ensure the health, life, and safety of Ghanaians, including children, were not compromised by Tobinco and its sister company. Initially, Tobinco resisted the FDA’s directive and refused to cease operations.
In its 10-page report, the FDA detailed that the activities at Entrance Pharmaceutical lacked the required safety, quality, and efficacy, categorizing the facility’s deficiencies into five ‘Critical’, 39 ‘Major’, and five ‘Other’ deficiencies, rendering the facility non-compliant with WHO GMP guidelines.
The management of the FDA is expected to update the WHO on its latest findings regarding the company.
Continued investigations by The Herald into an Accra High Court order requiring the FDA to pay GH¢94 million to Tobinco Pharmaceuticals Ltd for the unlawful destruction of unexpired drugs have unearthed more evidence suggesting that Tobinco is undeserving of any compensation.
A crucial document dated February 6, 2017, shows the current FDA CEO, Mrs. Darko, stating that Tobinco’s conduct violated the Public Health Act 2012, Act 851. It remains unclear why she did not testify in favor of the FDA during the 2013 incident. Mrs. Darko’s response was to a letter from Akufo-Addo, Prempeh & Co., the law firm of President Nana Akufo-Addo, dated January 31, 2017, which condemned Dr. Stephen Kwabena Opuni for actions against drugs imported by Tobinco Pharmaceuticals Ltd, owned by Samuel Amo Tobin.
Akufo-Addo, Prempeh & Co., through lawyer Alex Mantey Osei, acting for Tobinco Pharmaceuticals Ltd, rekindled the four-year standoff between the FDA and Tobinco, accusing Dr. Opuni of harassment and demanding compensation. They claimed that Dr. Opuni had threatened the company’s CEO, stating he would “finish him like Semanhyia.”
In her response, Mrs. Darko, who was behind the 2013 detection of Tobinco’s unregistered products, denied the allegations, stating that the FDA’s actions were in line with national law and the Public Health Act 2012 (Act 851). She emphasized that Tobinco’s importation, distribution, and sale of fake, substandard, and unregistered medical products endangered public health and safety, particularly that of Ghanaian children.
Mrs. Darko asserted that the FDA acted properly and diligently, adhering to due process, to avert any danger posed to public health.
