Health Ministry blunders again: Two more drugs bought from firm that allegedly forged papers
The Health Ministry had ordered two more medications from the same company that had supplied its Medical Supplies Division (MSD) with counterfeit human immunoglobulin which triggered adverse patient reactions in three major hospitals, it has been revealed.
The local company, Isolez Biotech Pharma AG, had secured these tenders—as it did with human immunoglobulin—by purportedly using “fake” waivers of registration (WoR) containing the “forged” signature and stamp of the chief executive officer of the National Medicines Regulatory Authority (NMRA).
One of the medicines is a monoclonal antibody called “Rituximab” used to treat certain autoimmune diseases and types of cancer. It was immediately withheld from use when a hospital reported the batch to the NMRA after noticing that the information printed on the box was similar to that on the immunoglobulin packages.
The manufacturer name on the Rituximab was printed as “Livealth Bio pharma [sic] (PVT) Ltd., Int. Company no 69/1, GIDC, Kansari, TalKhambhat, Dist. Gujarat”.
As with the human immunoglobulin claimed to have been manufactured by it, a Livealth spokesman told the Sunday Times: “Please note again that these are not our products,” he said. “This is just another case of forgery and counterfeit products.”
The company name was wrongly spelled, and Livealth had no affiliation with the relevant marketing entity named on the box: CURIMED LIFESCIENCE. The human immunoglobulin packages contained the same errors and also named the marketer as
CURIMED LIFESCIENCE.
The NMRA confirmed at a news conference that 2,025 vials of Rituximab were immediately withheld from use. Its CEO, Dr. Vijith Gunasekera, said the waiver of registration addressed to the Controller General of Import and Export under his name, signature, and seal was fake. He distributed copies of this document at the news conference held on Wednesday.
The NMRA also found evidence of another medication that had been ordered from Isolez, Dr. Gunasekera said, adding that it has not yet been supplied. He did not name this drug. The NMRA did not know what quantities of these medications had so far been given to patients.
Meanwhile, the Maligakanda Magistrate on Friday ordered the Criminal Investigation Department (CID) to arrest and produce in court before tomorrow suspects who had supplied counterfeit medication to state hospitals on the basis of forged documents. Nobody has been taken into custody yet. Several complaints were lodged with the CID this week, including by the NMRA CEO and an advisor to Health Minister Keheliya Rambukwella.
The NRMA is now expeditiously limiting “as much as possible” the issuance of waivers of registration.
As with the human immunoglobulin claimed to have been manufactured by it, a Livealth spokesman told the Sunday Times: “Please note again that these are not our products,” he said. “This is just another case of forgery and counterfeit products.”
WoRs allowed medicines and devices to be imported with minimal or no regulatory oversight. Limiting waivers would be the regulator’s first move “because it is from this that a lot of problems were caused”, NMRA board member Manoj Gamage admitted.
“When we follow our usual procedure, the space for such irregularities to occur is less,” he told journalists. He maintained that WoRs became common owing to last year’s economic collapse, which led to a lack of funds to secure medications, thereby necessitating quick approval to avoid shortages.
The NRMA has decided “to reduce WoRs as much as possible”. In the event the regulator had to issue one, it would thoroughly check all documents beforehand. “We are saying with responsibility that we will do everything within our scope for this not to happen in the future,” Mr. Gamage reiterated.
Separately, the MSD this week notified the State Pharmaceutical Corporation (SPC) that it would hereafter only accept medical supplies on the basis of SPC-verified certified certificates of analysis; certified customs declarations; original import licences; original customs assessment notices; and “certificate” [sic] copies of the NMRA’s registration certification, or WoR.
(See related story on Page 8)