‘FDA Protecting Public Interest Not Targeting Businesses’

Delese Mimi Darko

 

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—the Industrial Support Services Directorate—which has as its sole purpose, the provision of technical support to both macro and micro industries, to help them meet the FDA’s regulatory requirements.

According to the statement, FDA’s 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.

“At the heart of the FDA’s 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,” the statement pointed out.

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—a critical medication used to stop bleeding during childbirth.

“This action was not an attack on the business but a necessary step to protect the lives of mothers and infants across the country.

“The 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,” the statement further pointed out.

It continued that such measures, though sometimes seen as stringent, are vital to preventing potential health crises.

It said recent criticisms suggesting that the FDA’s actions are anti-business overlook the broader picture.

“The FDA’s 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—it is a moral obligation.

“The consequences of lax regulation can be dire, including preventable illnesses, loss of life, and long-term public health risks,” it stressed.

Again, the statement pointed out that the FDA’s commitment to upholding high standards has earned its recognition on the global stage.

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.

“This milestone is a testament to the Authority’s dedication to excellence and positions Ghana as a leader in pharmaceutical regulation within the region.

“With 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,” it added.

The statement also indicated that this recognition not only benefits the local industry but also enhances Ghana’s ability to compete on the global market, including within the Africa Continental Free Trade Area (AfCFTA).

Additionally, it provides the public with assurance regarding the quality of approved medicines and offers local manufacturers relief from certain international regulatory requirements.

It said while some businesses may view FDA regulations as overly strict, these standards are in place to protect the public.

“The FDA’s 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,” it stated.

In addressing recent concerns, the FDA also clarified misconceptions regarding WHO’s involvement in the suspension of manufacturing activities of certain facilities.

The Authority explained that the inspections leading to these suspensions were part of its routine Good Manufacturing Practices (GMP) inspections.

“WHO officials were only observers, and the decision to suspend manufacturing activities of non-compliant facilities was based on the FDA’s adherence to its internal guidelines and international best practices, not external influence,” the statement noted.

In a related matter, the FDA has expressed its dissatisfaction with the GH¢93,905,760.79 judgement debt awarded to Tobinco Pharmaceutical Limited following a legal dispute.

The case, which dates back to 2013 when Tobinco’s products were seized and safely disposed of by the FDA, culminated in a High Court judgement in July 2024.

The FDA, however, stands firm in its belief that its actions were justified and has indicated its intention to appeal the judgement.

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.

The FDA indicated that it considers this responsibility critical, and will continue to uphold its mandate, even in the face of challenges.

A Daily Guide Report

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