The Food and Drugs Authority (FDA) in Ghana has recently made headlines by ordering the closure of a pharmaceutical production facility owned by Tobinco Pharmaceuticals Ltd., a well-known company in the country. The facility in question, Entrance Pharmaceutical and Research Centre, is a subsidiary of Tobinco, and the shutdown has sparked widespread discussion and concern.
The FDA, which is responsible for ensuring the safety and quality of food and drugs in Ghana, conducted a routine inspection of Entrance Pharmaceutical’s facility in Accra from June 24 to June 26, 2024. During this inspection, the FDA found a number of serious problems with how the facility was operating.
Specifically, the FDA identified a total of 49 deficiencies, which are basically issues that show the facility wasn’t following the rules set by the World Health Organization (WHO) for Good Manufacturing Practices (GMP). These practices are crucial because they ensure that the medicines produced are safe, effective, and of high quality.
Out of the 49 issues, 5 were labeled as “critical,” meaning they posed a significant risk to public health. Another 39 were considered “major,” and the remaining 5 were categorized as “other.” These problems ranged from poor quality control during drug production to incomplete documentation and problems with how the facility managed its operations.
Due to the severity of these issues, the FDA determined that the facility was not complying with WHO guidelines, which are internationally recognized standards for pharmaceutical production. As a result, the FDA issued a letter on July 1, 2024, ordering Entrance Pharmaceutical to immediately suspend all production activities. The letter also demanded that the company submit a detailed plan within 15 days explaining how it would fix these problems.
The FDA’s letter highlighted that the issues found at the facility were serious enough to potentially endanger public health, meaning that the medicines being produced could have been unsafe for people to use.
Entrance Pharmaceutical produces a wide range of products, including well-known brands like Foligrow blood tonic, Entracin, and Tobin’s Baby Grip water. With the production halt, these products will no longer be available until the company can prove that it has resolved the issues and can safely resume operations.
The FDA has also informed the World Health Organization about its findings, which is a standard procedure when a facility fails to meet international standards.
This isn’t the first time Tobinco Pharmaceuticals has clashed with the FDA. Back in 2019, Tobinco sued the FDA, accusing the authorities of unlawfully seizing and destroying their drugs. The High Court in Accra eventually ruled in favor of Tobinco, ordering the FDA to pay the company about GH¢94 million in compensation.
Despite this past legal battle, the FDA has maintained that its actions were necessary to protect public health. In a letter from 2017, the FDA’s Chief Executive Officer, Dr. Delese Darko, defended the authority’s decision, stating that Tobinco had violated national laws by importing fake drugs, putting the lives of Ghanaians at risk.
Source: Ghana Web
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