Conflicted MCA Shuts Down Innovarx Global Health

Medicines Control Agency HQ (c) MCA Facebook

By Yusef Taylor, @FlexDan_YT

The Gambia’s Medicines Control Agency (MCA) has shutdown one of The Gambia’s most prominent pharmaceutical companies Innovarx Global Health on 2nd February 2024. However, our research has shown that after the firing of the MCA Executive Director and Deputy Executive Director the new MCA Director is a conflicted officer working with Stop Step Pharmacy.

The Acute Kidney Injury (AKI) outbreak which struck back in mid-2022 until early 2023 resulted in the death of over 70 children and more tightening on the implementation of the Medicines Control Act. The worse happened when children died after consuming poisonous medicines manufactured by Maiden Pharmaceuticals and distributed by Atlantic Pharmaceuticals. This was made possible by using an alternative method to Drug Registration called Listing which was not provided for in the act.

After the outbreak and the public backlash, the laws started to take effect. In a classic case of be careful of what you wish for the lack of testing facilities in the country and the huge demand for medicines meant less drugs were being allowed into to pharmacies across the country impacting supply.

The problem was that after listing became frowned upon as an unauthorised method of approving medicines for distribution in the country many drugs now had to be tested to be approved for distribution in pharmacies. Without a testing facility in the country this affected numerous pharmacies who had already listed drugs through the MCA and had them in their inventory or shelves for sale. Innovarx happens to be one of them.

Conflicted MCA Staff

The Pharmaceutical Industry is riddled with conflict of interest starting with the MCA Officers who are meant to regulate the industry and at the same time work for the Pharmacies they are mandated to regulate. This was unearthed in the AKI Presidential Taskforce which highlighted that eleven MCA Officers were conflicted including the fired Deputy MCA Director Madam Jah Sowe who was also the Supervising Pharmacist for Malack Chemist and Value Pharmacy from 2016 to date.

It’s important to note that the MCA Director who was also fired, Madam Markieu Janneh Kaira was not identified as conflicted. What is also true is that the new MCA Director is also conflicted. According to the AKI Presidential Report Mr Marena was the Director of Evaluation, Registration and Inspection at the MCA which is a crucial role of the MCA and at the same time he was serving as Supervisor for Stop Step Pharmacy from 2004 to date.

Another noteworthy conflicted officer is Mr Tijan Jallow who is a Regulating Officer with the MCA and the Supervising Chemist for Atlantic Pharmaceuticals responsible for imported the poisonous drugs. Mr Jallow has not been dealt with at all, highlighting that even after the damning AKI Presidential Task Force Report the Ministry of Health has not weeded out the 11 Conflicted MCA Officers.

It’s important to note that all conflicted staff working at the MCA and a Pharmacy at the same time are competitors to Innovarx Global Health and all other pharmacies in the country. This raises the question on how such officers can remain neutral in conducting their job.

MCA Closes Down Innovarx

Innovarx is owned by Dr Ismaila Badgie a young Pharmaceutical Entrepreneur who sources his medicines from the United States. He is a returning Gambian Diaspora whose innovative pharmaceutical business has seen significant public support from Gambians inside and outside the country.

Soon after MCA closed down Innovarx our reporter got two statements issued by the MCA and Innovarx. MCA issued a very strong statement on 3rd January 2024 announcing “the closure of INNOVARX effective the 2nd February 2024 due to serious noncompliance with the MCA legal provisions”. However, the MCA statement signed by Executive Director Mr Essa Marena claims that on 1st February 2024 “serious noncompliance issues were uncovered and the Chief Executive Officer, Dr Ismail D. Badgie was informed accordingly but refused to cooperate with the MCA Inspectors”. In addition to this MCA says “Inspectors were obstructed from carrying out their work by [Dr Ismaila D. Badgie] and they had to report the matter to Bakau Polic Station and were given two Police Officers to accompany them to Innovarx”.

In a statement issued the following day Innovarx refutes this highlighting that they are “deeply concerned and disheartened by the misleading and defamatory allegations directed at our company and our CEO, Dr. Ismail Badjie”. Contrary to MCA’s claims Innovarx say that they “cooperated with the MCA inspectors and steadfastly maintained the integrity of our operations, including the storage and transportation conditions of our medicines”.

MCA claim that “in the presence of the Police Officers Dr. IsmailD. Badgie refused for MCA Inspectors to confiscate his medicines that are neither registered nor listed with MCA and were illegally imported into the Gambia without MCA approval. Most of these smuggled medicines were not manufactured in the United States of America as claimed but in India, China and Taiwan, and all were not tested prior to dispensing to the general public which poses potential danger. The MCA Inspectors also informed Dr. Ismail D. Badgie that they were going to close down his premise and he should report to MCA Office which he refused to comply with. The Police Officers were later recalled by their Station Officer and MCA also withdrew its Inspectors due to security reasons”.

The MCA states that the following day of 2nd February 2024 they visited Innovarx with Police Officers and managed to convince them to shut down and confiscate a significant amount of their medicines. At this stage MCA say “Dr Badgie had no choice but to allow MCA to proceed and MCA had closed INNOVARX and seized all the illegally imported medicines that are deemed by the law to be substandard and falsified for the interest of public health safety. So many expired medicines were also found on the shelves within the dispensary where the patients are served at INNOVARX”.

According to the statement issued by Innovarx “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”.

Innovarx stresses that “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. [Innovarx] 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”.

Amendment to Medicines Act

To ensure more safer drugs from countries with tighter regulations can be approved for distribution in the country an amendment was passed by Parliament and sponsored by the Chairperson of Parliament’s Select Committee on Health, Disaster, Refugees and Humanitarian Relief, Hon Amadou Camara.

The Act titled “Medicines and Related Products Act (Amendment) 2023” sought to “provide and alternative mechanism to the registration of medicine and related products manufactured in the United Kingdom, United States, and countries in the European Union and for connected matters”. The very short act which proposed only one amendment was passed back in 2023 and states;

“Section 26 of the Principal Act is amended by inserting after subsection (4) the following new subsection:

(5) Notwithstanding sub-section (4), the Agency may adopt a mechanism other than registration permitting a person to import, distribute, sell, supply, or exhibit for sale any medicine or related product manufactured or produced in the United Kingdom, United States of America, or a country in the European Union.

The challenge now is the issue of how the law is being applied. Manufacturing a drug from the above stated countries is not necessarily the same as sourcing and that appears to be the nuance in this case. Innovarx drugs are sourced from the US with the same safety requirements however, their drugs are manufactured outside the US which is what MCA is clamping down on.