Innovarx reacts to its closure

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Innovarx Global Health has issued a press release describing the Medicine Control Agency press release as misleading and defamatory. See below the press release issued by Innovarx:

PRESS RELEASE FEBRUARY 4TH 2024

Re: Medicines Control Agency (MCA) Notice on Closure of Innovarx Global Health

Dear Stakeholders,

We acknowledge the claims made by the Medicines Control Agency (MCA) regarding our operations at Innovarx Global Health. We also recognize the importance of complying with legal provisions to ensure the safety and efficacy of medicines available to the public. However, we are deeply concerned and disheartened by the misleading and defamatory allegations directed at our company and our CEO, Dr. Ismail Badjie.

In an effort to maintain the trust that our customer base places in our company, its products, and services, we wish to clarify and explain a few important points related to the aforementioned matter. At this time, we are deliberately choosing not to engage in a public dispute with the regulator as we continue to consult with all relevant stakeholders. Our focus is on ensuring that our facility is reopened to serve the people of The Gambia.

We are deeply grateful for the outpouring of support and for the personal testimonies shared about our impact on the lives of individuals in The Gambia. Your voices reinforce our commitment and drive our efforts to resume operations as swiftly as possible.

– Inspection: We cooperated with the MCA inspectors and steadfastly maintained the integrity of our operations, including the storage and transportation conditions of our medicines. This is particularly crucial for our insulin products, which require stringent cold-chain storage conditions.

– Regulation Compliance: Regarding Listing and Regulation, 100% of the medications dispensed by Innovarx are sourced from the United States of America (USA). Each product that was confiscated complied with U.S.

Food and Drug Administration (FDA) guidelines, which mandate a QR code on the bottle/package to enable tracking and tracing throughout its entire supply chain, from the point of manufacturing at a U.S. FDA-approved facility in countries such as India to its distribution points within the USA. Additionally, all medications currently in the possession of the MCA feature this QR code, ensuring full traceability.

– Medicine Confiscation and Public Safety: The decision by the Medicines Control Agency (MCA) to close Innovarx and confiscate medications valued at $80,000—medications that are essential to saving lives—raises serious concerns. We affirm that all FDA-approved medications were sourced from the USA and were deemed “illegal” by the MCA, not due to quality issues but owing to technicalities arising from recent amendments to documentation requirements. The cited amendment significantly restricts the importation of U.S. FDA-approved products into the Gambian market, directly impacting Innovarx Global Health as the sole importer of these medications from the U.S. Additionally, the pharmacy’s electronic prescription processing and drug utilization review systems are robustly designed to prevent the dispensing of expired medications to patients. Innovarx is also recognized for its fully digitized operations—a unique distinction in The Gambia, aimed at enhancing patient safety and ensuring transparent, trackable, and personalized instructions on medication labels.

Innovarx stands ready to engage in constructive dialogue with the MCA and other higher authorities to resolve these matters.

We are champions of the healthcare industry’s essential role in the future progression of The Gambia – its potential for building collaborations, for enabling companies and individuals to attain their personal goals, and for being a source of hope for the future and continued economic development for the country. As we often remind our employees, change is not the responsibility of one man or one woman, it is the responsibility of a group of dedicated individuals focused on created a community that enables individual residents of The Gambia to possess the ability to play a role in the improvement of their health.

Sincerely,

The Management of Innovarx Global Health