The Management of Ecomed Pharma Ltd, winner of the Nigerian Healthcare Excellence Award- Pharmaceutical Manufacturing Company of the Year 2023, has refuted the claims on the production of the affected amoxycillin batch with number 4C639001. It stated that the substandard batch of the product was not manufactured by the pharma company, but was unscrupulously cloned by Divine Kings Pharmaceuticals- a pharma marketing firm in Lagos.
Meanwhile, the National Agency for Food and Drugs Administration and Control (NAFDAC) had earlier issued a public notice on the recall of the affected amoxycillin batch on safety reasons, urging the public and healthcare practitioners to desist from the purchase and administration of the affected products on patients.
The agency’s public alert further expatiated on the adverse effects of the recalled drug on patients, highlighting how reports of serious adverse drug reactions were received from a hospital that reported three cases of severe adverse drug reactions from patients administered with the batch of Deekins Amoxycillin 500mg capsule.
However, the Managing Director of Ecomed Pharma, Pharm. Ekene Christopher has cleared the air on the development, describing the affected Amoxycillin with batch number 4C639001, as fake, because it did not emanate from the company.
In an exclusive interview with Pharmanewsonline, the Ecomed boss said, “We want to reiterate here that the “Deekins Amoxycillin ” with batch number 4C639001 in circulation was not produced by Ecomed Pharma Ltd. It is a fake product cloned by Divine Kings Pharma with our name on it.”
He explained how his company alerted NAFDAC’s Pharmacovigilance section on the development and immediately initiated a recall of the product, due to the mischievous attachment of their name to the packs of the product by the adulterator.
“We instituted this recall because our name is on the packs, and there is urgent need to immediately stop distribution of the products which poses health danger to the public,” he stated.
Speaking further, Pharm. Christopher disclosed his business relationship with the CEO, Divine Kings Pharma, Mr Kingsley Ekeanyanwu, who has been arrested by NAFDAC for investigation, as a contract-manufacturing affiliation, which has been marred by Ekeanyanwu’s dishonest act. Having been in business relationship for about five years with Divine Kings Pharma, Christopher revealed that they manufactured few packs of Deekins Amoxycillin samples for Ekeanyanwu’s NAFDAC licence renewal in May 2024.
Pharm. Christopher told Pharmanewsonline that he later regretted his partnership with Ekeanyanwu’s on the contract-manufacturing of Deekins Amoxycillin, as complaints starting hitting him sometimes in November, about the severe adverse drug reactions of the adulterated version of the product on patients.
He said, “We produce products for Divine Kings Pharmaceuticals on contract and also for other companies. Around May, 2024, 20 packets of Deekins Amoxycillin with batch number 4C639001 were produced for renewal of NAFDAC licence, for the company, which the firm submitted to NAFDAC and was approved later.
“On 20th November, we received a call from Kowa Hospital about incidence of adverse reactions, including drowsiness,weakness and other related symptoms, on the product purportedly produced by Ecomed, “Deekins Amoxycillin ” with batch number 4C639001. We sent our Pharmacovigilance team, and also called the owner of the product, Mr Ekeanyanwu to inform him.
“My team met with the doctor in charge and also saw the patients who were feeling drowsy, at the time. We gave the doctor a form to fill and samples of the products were taken to our factory. We immediately instituted recall of Deekins Amoxycillin and also notified NAFDAC about what happened, and kept them updated.
“After 790 packets of Deekins Amoxycillin with batch number 40638001 were recovered from the premises of the Divine Kings Pharmaceuticals, the CEO could not give account of how he came about that quantity, because he submitted only the 20 packs of the sample produced for him to NAFDAC.
“NAFDAC has therefore arrested him for proper investigation, in order for him to explain how he and his friends he claimed that distribute for him at Onitsha came about the products he is selling.”
The Ecomed managing director however assured members of the public on the quality and safety of their products, saying they are known with good quality products, as many companies that work with them on contract- manufacturing can attest to it, with the inclusion of doctors, pharmacists, and patients that use their products.
Going forward on contract-manufacturing for other pharma companies, Christopher disclosed that Ecomed Pharma will exercise more caution in signing business deals with marketing companies, as they will always do their due diligence. “We need to review our processes in Ecomed Pharma, and do a lot of background checks on companies that we produce products for on contract, before signing any contract agreement,” he emphasised.
