- NMRA complains to CID over forged registration waiver doc for drug that failed quality
A batch of human intravenous immunoglobulin (IVIG) imported to the country from India in violation of the due procedure has been suspended from use, the National Medicines Regulatory Authority (NMRA) said on Tuesday (3).
In a media release issued on the matter, NMRA Chairman Prof. S.D. Jayaratne said that 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 Private Limited, India, was imported by Isolez Biotech Pharma AG (Pvt.) Ltd.
The NMRA said that 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 General Hospital on 22 August and 16 September, 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 a 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 ongoing.
The NMRA said that it had also filed a complaint in this regard before the Criminal Investigations Department (CID) on Tuesday (3).
When contacted by the NMRA, the India-based manufacturer has said that 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.