COA-FS now COA Mixture as product gains FDA authorisation as medicine
 
 

COA-FS now COA Mixture as product gains FDA authorisation as medicine

COA-FS now COA Mixture as product gains FDA authorisation as medicine
“This is the day I will never forget”. Those were the words of Professor Samuel Ato Duncan when he addressed a gathering of people who had come to witness the relaunch of COA Mixture, formerly COA-FS.

Prof Duncan’s “this is the day I will never forget” comment was in relation to the day Ghana’s Food and Drugs Authority (FDA) ordered a recall of batches of his product, COA-FS from the market.

Prof Duncan has resilience running through his body; a kind of resilience that has manifested in his product’s efficacy, therefore at this gathering, he did not only lament – he told a different story from that unforgettable day.

As all businesses will do, Prof. Duncan respected the regulator’s decision, collaborated with them and on this day, relaunched what is now known as COA Mixture.
This was after the FDA had granted the company a new Market Authorization Certificate to sell the product which has now been upgraded to be sold as medicine and not food supplement as it used to be.

COA Mixture is now produced in a revamped state-of-art research and manufacturing centre.

The revamped production facility has changed from COA Herbal Centre to COA Research and Manufacturing Company Limited (COA RMCL).

The facility was commissioned at Wusorkrom in the Abura-Asebu-Kwamankese District of the Central Region.

On March 31, 2020, the FDA recalled two batches of COA FS from the market after tests proved they were contaminated with some microbial substances.

The FDA directive also led to the suspension of the Marketing Authorization Certificate of COA, forcing the company to put production on hold to pave way for major rehabilitation of the entire factory to correct the identified anomalies.

Subsequently, the company complied with the recall order and safely disposed of the said contaminated products under the strict supervision of the FDA and the police.

As a result, the company undertook a capital intensive rehabilitation work at the factory, with installations of state-of-the-art equipment to turn it into a fully-fledged research and manufacturing centre.

FDA then issued COA with the necessary certificates and approvals indicating their satisfaction with all the measures taken since the suspension of production.

The FDA issued COA with a certificate, indicating it was satisfied with the safe disposal of the contaminated products before conducting a Good Manufacturing Practices (GMP) assessment exercise at the factory in May, 2020 and issued a report indicating it was satisfied.

The FDA finally reviewed and approved a Corrective and Preventive Action (CAPA) plan presented by COA, after which it conducted a GMP training for all COA RMCL staff.

It was after all the rigorous processes that FDA finally issued COA with a letter on September 10, 2020, revoking the suspension of production.

It was at the launch of the state-of-the-art research centre that Prof Duncan disclosed a huge loss of GHS 1,680,000 occasioned by the recall of the products.

The New Research Centre
But, the story is not all gloomy as the temporarily suspension afforded the company time to employ the services of scientists for further research as well as training and grooming for technical and non-technical staff, supervised by the FDA.

The total restructuring, he said, went beyond just the products as the company’s laboratory was improved to reduce human interface in the company’s operations.
Over GHS10,000,000 was injected with the results being the registration of COA not as a food supplement but medicine.

National Chairman of the New Patriotic Party (NPP), Freddie Blay, who was the Special Guest of Honour for the occasion, extolled the achievements of Prof Duncan, entreating him to make the new product an exportable one.

He reiterated the effectiveness of alternative medicine and most importantly, why COA mixture must be consumed on a large scale.

Deputy Central Regional Minister, Thomas Adjei-Baffour, sharing in the good news charged the Executive President to strictly abide by all recommendations in order to recapture the lost glory and put Ghana on the international market.
 
 

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