• Notes irregularities in procedure 

While the source of a batch of the human blood-based drug, intravenous immunoglobulin (IVIG), which was recently withheld from use, is still unknown, the Sri Lanka Medical Association (SLMA) emphasised that the relevant authorities should expeditiously reveal the truth behind the importation of the said drug.

IVIG is a pooled antibody, and a biological agent used to manage various immunodeficiency states and a plethora of other conditions, including autoimmune, infectious, and inflammatory states. A batch of IVIG, of which there was no information about the manufacturer – imported to Sri Lanka in violation of due procedure – had been suspended from use last week.

Speaking at a media briefing yesterday (10), SLMA President Dr. Vinya Ariyaratne said that the SLMA and other professional bodies representing medical professionals had been pointing out issues pertaining to the procurement of drugs, and suggesting solutions to these throughout the past one and a half years, but that it was unfortunate that such recommendations had not been implemented in full.

"This is a very serious and dangerous issue. The process from manufacturing this drug to giving it to a patient is a very planned and careful procedure. How did this drug come to Sri Lanka? Did it come through ports or airports? The National Medicines Regulatory Authority (NMRA) now says that they did not give approval to import this drug. Even if approval was given, and the drug came through the ports, the Customs would contact the NMRA for verification purposes. We strongly believe that there have been irregularities in this entire procedure. They should be investigated immediately."

Speaking further, Dr. Ariyaratne said that the drug in question had not been registered under the NMRA, and that the Health Ministry had not yet discovered its place of manufacturing. "This has been imported without registration. So, this should have been brought in either under a waiver of registration, or emergency purchases. It is the authorities' responsibility to reveal the truth behind this matter. It should happen expeditiously," he said.

The use of the controversial batch of IVIG had temporarily been halted as investigations were ongoing. The NMRA stated last week that it had filed a complaint in this regard with the Criminal Investigations Department. When contacted by the NMRA, the India-based manufacturer had stated that it did not produce this drug anymore. The NMRA asserted that this drug had been imported and used in the country without its approval.