Maintaining that it did not submit expired HIV testing kits to the Ministry of Public Health, Caribbean Medical Supplies Inc. (CMSI) has said that it subcontracted a Kenyan firm to supply the kits and if there is any malpractice it would take the firm to court.
“CMSI and its officers categorically deny being involved in any fraudulent conduct or knowingly providing any tampered or expired rapid HIV testing kits to the ministry,” a press release from the company, dated March 30, said.
“If the allegations are true and the provided kits were tampered with and are expired, CMSI shall take appropriate steps, including action against the Kenyan supplier,” it added.
CMSI supplied 400 HIV test kits to the ministry from the Uni-Gold brand.
On January 31 this year, Michael Roche, Vice President of Sales and Marketing for Trinity Biotech, the company which manufactures the kits and which is based in Ireland, wrote to Health Minister Volda Lawrence expressing concern.
“It is with great concern that Trinity Biotech brings to your attention that counterfeit Uni-Gold HIV kits have been supplied to you, the MOPH of Guyana during January 2020,” said the letter, a copy of which was seen by this newspaper.
Roche provided photos as evidence of the expired items supplied, and he pointed out that not only are the counterfeit supplies from an unauthorised distributor, but they are all expired.
“The conclusions to draw from this evidence are: the Uni-Gold HIV kit box has been recreated without authorisation from Trinity Biotech and the components within repack-ed. The kit box expiry date for these 400 kits has been altered illegally. It has been extended by 17 months beyond its actual true expiry date. The product supplied by Caribbean Medical Supplies Inc. to you was already 6 months out of date when you received it. The product supplied to you no longer has a product guarantee from Trinity Biotech since the kits have expired,” the letter stated.
Risk
Roche informed the minister that the company on the said day of sending the correspondence, also wrote to the WHO and to the company which had originally and legitimately purchased batches of the kit with the same number.
He warned that the kits posed a risk to patient health and urged that they be immediately removed from testing centres.
Roche highlighted that it was not the first time he was writing her ministry to let them know that CMSI were not authorized to distribute their products or is any way affiliated with their exclusive distributor, the Trinidadian firm Transcontinental Medical Products Limited. “I would like to reiterate to you now, our authorized exclusive distributor for Guyana is Transcontinental Medical Products Ltd,” Roche said.
It is unclear what action the minister took but two weeks later, on 14th February this year, Permanent Secretary at the Ministry of Health Collette Adams wrote to CMSI Country Manager Devendra Rampersaud.
Rampersaud has told this newspaper that he received the correspondence and had been working with the ministry.
The company’s release echoed this position, as it said that “CMSI stands ready to assist the ministry, GA-FDD [the Government Analyst-Food and Drug Department] and any other authority in relation to this issue”.
In giving a background to the issue, CMSI said that it was in 2015 awarded a contract for the delivery of several pharmaceutical and healthcare products, including rapid HIV testing kits. But before delivery of these kits, the ministry told the company that it did not want them in the said year and not to deliver them.
However, all of the other pharmaceuticals were all delivered in accordance with the contract.
But the company said that its name was put into disrepute, since annual Auditor General’s reports since 2015 made reference to the kits not being delivered, although the company had made repeated requests to the ministry to complete the contract. “The yearly reports of the Auditor General of Guyana, along with news reports, cited this non-completion and caused significant damage to the reputation and image of CMSI. Alternative pharmaceuticals were also offered in lieu of these kits since there seemed to be no immediate need for the kits and completion of the contract was CMSI’s main concern,” the release said.
It was, according to CMSI, its insistence to the ministry that saw the last request for the kits with the specific December 2020 expiry date. “The Ministry specifically requested that the kits have an expiration date of December, 2020,” the company said while adding that its “ordinary supplier was unable to fill this order and suggested a supplier in Kenya.
Due diligence
CMSI said it contacted the Kenyan supplier and completed its routine due diligence of the company. When this was received they confirmed the banking information, paid the supplier and obtained the kits.
The kits were shipped and delivered to the ministry’s Diamond, East Bank Demerara Bond “in the original packaging as supplier by the Kenyan company.
CMSI said that it believed that all was well, until in February of this year when it was told by the ministry that the manufacturer of the kits had complained that the kits were expired and the date of expiration tampered with.
“CMSI did not know at that time or any time prior to early February 2020 that there was any defect, fault or abnormality with the kits nor that there was any allegation regarding tampering and expiration of the kits. At that point, no kits were issued by the ministry for distribution to testing sites. And investigation was then launched by the ministry,” it said.
The company said that it has held several meetings with the ministry and has provided documents showing how the kits were obtained. The company said that it agreed that the kits should be removed from circulation.
But given the delivery of the kits to the ministry, the company said it has been unable to have an independent test done to prove or disprove the allegations that they were expired or had been tampered with.
And in accordance with this country’s Food and Drug Act, it gave the GA-FDD the name of the Kenyan supplier from which it received the kits.
“From the outset of learning of possible (tampering) with the kits, CMSI indicated its intention to fully cooperate with the investigation by the Ministry and was informed that when its input was required, officers of CMSI would be contacted by the ministry of another authority to assist. Despite this, CMSI was not contacted to provide statements or other documents related to the investigation at any time,” the company said.
But last week, the company’s Chief Executive Officer was charged by the GA-FDD for supplying tampered goods.
And while the company denies all the allegations, it said that it could not go into full detail since the matter is now sub judice. However, it added that it will defend its name and prove that the allegations are wrong as it maintained that it is a transparent and reputable company and provides pharmaceuticals to not only Guyana but the Caribbean. “The current state of affairs is therefore met with regret and is unsatisfactory. It is hoped that a positive resolution benefitting the ministry and general public can eventually be garnered,” the company said.
