INSUBCONTINENT EXCLUSIVE:
importing and distributing substandard antibodies using forged documents and distributing them to state hospitals.Magistrate Lochana
Abeywickrama had further directed the CID officers to produce the suspects before the court before November 16.The order was delivered when
13).Earlier this month, the National Medicines Regulatory Authority (NMRA) had said a batch of human intravenous immunoglobulin (IVIG)
imported to Sri Lanka from India in violation of the due procedure was suspended from use.In a media release, NMRA chairman Prof
Jayaratne had said forged documents were found to have been submitted for Customs clearance when importing the drug which later failed the
quality tests.The product, manufactured by Livealth Biopharma Pvt Ltd
India, was imported by a local medicine supplier called Isolez Biotech Pharma AG (Pvt) Ltd.The NMRA had said the situation came to light
following reports of allergic reactions after the drug was administered to several patients under treatment at the Colombo National Hospital
and the Matale District Hospital on August 22 and September 16, respectively.As doubts were cast about the quality of the drug, the NMRA had
received several reports that sounded the alarm
It was uncovered that the relevant vials containing human IVIG, an antibody produced by blood plasma cells, had not been registered with the
NMRA prior to being imported.Additionally, it had been observed that not only the due procedure had not been followed when the batch of
vials was brought into the country, but the Waiver of Registration (WOR) was also not obtained
The NMRA has found that the document submitted as the WOR had been forged using NMRA letterhead and the signature of a senior official.When
contacted, the India-based manufacturer has told the NMRA that it no longer produces this drug
The medicines regulator asserted that this drug had been imported and used in the country without its approval.On Wednesday (Oct
12), it was revealed that measures were taken to suspend and cancel all medicine supplying orders given to Isolez Biotech Pharma, as per a
directive from Health Minister Keheliya Rambukwella.
