Suspect drug company involved in another scandal: Health Ministry collects details of patientsView(s):
By Namini Wijedasa
The Health Ministry has started gathering details of all patients who were treated with the counterfeit Rituximab 500mg injection sold to the Medical Supplies Division (MSD) by Isolez Biotech Pharma AG, the company that sold fake human immunoglobulin to the government.
An MSD circular states that it is “collecting details of all patients who were treated with the above-mentioned products [Rituximab Inj 500 mg] and remaining on hand [sic] quantities of the product”. It asks the heads of all public-sector health institutions to promptly provide information about such patients and any remaining quantities of the drug.
Beyond this official communication, however, there is no transparency from the Health Ministry regarding the second drug sold by Isolez, despite this being a serious public health issue. There are unconfirmed reports that the MSD had paid more than Rs. 100 million to the company.
Last month, the National Medicines Regulatory Authority’s (NMRA) former Chief Executive Officer Vijith Gunasekera referred to a third medication that had been bought from Isolez based on what he claimed was a fake waiver of registration (WoR) containing what he claimed was his “forged” signature and stamp.
Meanwhile, medical laboratories have not yet revealed what was contained in the immunoglobulin vials administered to patients. Isolez owner Hewage Sudath Janaka Fernando was arrested and is in remand. He reportedly told the Criminal Investigation Department (CID) that his company manufactured the immunoglobulin locally with plasma from the National Blood Transfusion Service (NTBS). This is despite stating in documents submitted to—and endorsed by—the Health Ministry that the raw materials would be imported from India.
No action has been taken against health officials who made the payments to the company either for the immunoglobulin or the Ritumaxib (the name of the third medication has not been revealed). It remains unclear whether the Indian Credit Line was used for the purchases, as indicated in a letter written in October last year by Health Secretary Janaka Sri Indraguptha regarding immunoglobulin.
There is also no breakdown of how many waivers—genuine or forged—were issued by the NMRA since last year, when its board delegated sole authority for issuing waivers to the CEO, circumventing the established WoR Committee. The legality of this decision has been questioned, and the practice was stopped after the new CEO, Dr. Ananda Wijewickrama, was appointed. All WoR requests will now be vetted by the committee.
Rituximab 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, Tal-Khambhat, 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. This is just another case of forgery and counterfeit products.”
In early October, the MSD issued a circular titled “Report on Failing Sample—Rituximab Inj 500mg in 50ml Vial’. It said the NMRA had decided to withhold the medication that had been labelled as manufactured by Livealth Bio Pharma.
“The decision was taken due to the fact that the immunoglobulin labelled as manufactured by the above manufacturer was found to be falsified,” it said.
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