A batch of human immunoglobulin IV imported to the country from India in violation of the due procedure has been suspended from use, the National Medicines Regulatory Authority (NMRA) said today (Oct. 03).
In a media release issued on the matter, the NMRA chairman Prof. S. D. Jayaratne 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 Isolez Biotech Pharma AG (Pvt) Ltd.
The NMRA 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.
While 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 immunoglobulin, an antibody produced by blood plasma cells, had not been registered with the NMRA prior to being imported.
Additionally, it was 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.
Accordingly, the use of the controversial batch of human immunoglobulin has temporarily been halted as investigations are on.
The NMRA said it also filed a complaint before the Criminal Investigation Department (CID) today.
When contacted by the NMRA, the India-based manufacturer has said it does not produce this drug anymore, the medicines regulator clarified, asserting that this drug had been imported and used in the country without its approval.
