Delese Mimi Darko<\/strong><\/p>\n\u00a0<\/p>\n
The Food and Drugs Authority (FDA) has reaffirmed its commitment to protecting public health and safety, dismissing claims that it seeks to target or destroy individual businesses.<\/p>\n
The FDA, in a statement, said it had established a dedicated unit\u2014the Industrial Support Services Directorate\u2014which has as its sole purpose, the provision of technical support to both macro and micro industries, to help them meet the FDA\u2019s regulatory requirements.<\/p>\n
According to the statement, FDA\u2019s mandate is to regulate and monitor the manufacture, importation, exportation, distribution, sale, and use of food, drugs, cosmetics, and medical devices, ensuring that all products on the market meet stringent safety and quality standards.<\/p>\n
\u201cAt the heart of the FDA\u2019s mandate is the safety and well-being of the public. Every regulatory action the FDA undertakes is driven by this mission, underscoring its role as a guardian of public health,\u201d the statement pointed out.<\/p>\n
It said for instance, in 2023, the FDA took decisive action against Entrance Pharmaceuticals, a subsidiary of the Tobinco Group of Companies, for importing unregistered and substandard oxytocin\u2014a critical medication used to stop bleeding during childbirth.<\/p>\n
\u201cThis action was not an attack on the business but a necessary step to protect the lives of mothers and infants across the country.<\/p>\n
\u201cThe FDA detained and safely disposed of the products, and the company was sanctioned for non-compliance with regulatory requirements. Additionally, Tobinco Group of Companies faces several outstanding fines for other infractions, which remain unpaid. The Authority is therefore pursuing further regulatory sanctions to ensure compliance,\u201d the statement further pointed out.<\/p>\n
It continued that such measures, though sometimes seen as stringent, are vital to preventing potential health crises.<\/p>\n
It said recent criticisms suggesting that the FDA\u2019s actions are anti-business overlook the broader picture.<\/p>\n
\u201cThe FDA\u2019s primary duty is to the public. Ensuring that the food people eat, the medicines they take, and the products they use are safe and of high quality is not just a regulatory responsibility\u2014it is a moral obligation.<\/p>\n
\u201cThe consequences of lax regulation can be dire, including preventable illnesses, loss of life, and long-term public health risks,\u201d it stressed.<\/p>\n
Again, the statement pointed out that the FDA\u2019s commitment to upholding high standards has earned its recognition on the global stage.<\/p>\n
In 2022, the FDA Drug Laboratory achieved prequalification from the World Health Organisation (WHO), becoming the first laboratory in West and Central Africa to do so.<\/p>\n
\u201cThis milestone is a testament to the Authority\u2019s dedication to excellence and positions Ghana as a leader in pharmaceutical regulation within the region.<\/p>\n
\u201cWith this prequalification, the FDA Laboratory can now perform tests that are globally recognised, allowing Ghana to participate in international tenders and ensuring that locally manufactured medicines meet international standards,\u201d it added.<\/p>\n
The statement also indicated that this recognition not only benefits the local industry but also enhances Ghana\u2019s ability to compete on the global market, including within the Africa Continental Free Trade Area (AfCFTA).<\/p>\n
Additionally, it provides the public with assurance regarding the quality of approved medicines and offers local manufacturers relief from certain international regulatory requirements.<\/p>\n
It said while some businesses may view FDA regulations as overly strict, these standards are in place to protect the public.<\/p>\n
\u201cThe FDA\u2019s role is not to stifle business but to ensure that products are safe, effective, and of the highest quality. This balance between regulation and business growth is crucial for sustainable development and public confidence,\u201d it stated.<\/p>\n
In addressing recent concerns, the FDA also clarified misconceptions regarding WHO\u2019s involvement in the suspension of manufacturing activities of certain facilities.<\/p>\n
The Authority explained that the inspections leading to these suspensions were part of its routine Good Manufacturing Practices (GMP) inspections.<\/p>\n
\u201cWHO officials were only observers, and the decision to suspend manufacturing activities of non-compliant facilities was based on the FDA\u2019s adherence to its internal guidelines and international best practices, not external influence,\u201d the statement noted.<\/p>\n
In a related matter, the FDA has expressed its dissatisfaction with the GH\u00a293,905,760.79 judgement debt awarded to Tobinco Pharmaceutical Limited following a legal dispute.<\/p>\n
The case, which dates back to 2013 when Tobinco\u2019s products were seized and safely disposed of by the FDA, culminated in a High Court judgement in July 2024.<\/p>\n
The FDA, however, stands firm in its belief that its actions were justified and has indicated its intention to appeal the judgement.<\/p>\n
The FDA has reiterated its commitment to protect public health and safety by not just enforcing regulations but also ensuring that the public has access to safe and high-quality products.<\/p>\n
The FDA indicated that it considers this responsibility critical, and will continue to uphold its mandate, even in the face of challenges.<\/p>\n
A Daily Guide Report<\/strong><\/p>\n\n\t<\/div>\n","protected":false},"excerpt":{"rendered":"
Delese Mimi Darko \u00a0 The Food and Drugs Authority (FDA) has reaffirmed its commitment to protecting public health and safety, dismissing claims that it seeks to target or destroy individual businesses. The FDA, in a statement, said it had established a dedicated unit\u2014the Industrial Support Services Directorate\u2014which has as its sole purpose, the provision of […]<\/p>\n","protected":false},"author":1,"featured_media":89768,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[14],"tags":[],"class_list":["post-211758","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health"],"yoast_head":"\n
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