Sri Lanka clears continued use of Indian immunoglobulin drug

A statement has been issued by Sri Lanka’s Ministry of Health regarding reports circulating about the Human Immunoglobulin drug.

The statement, signed by the Chairman of the National Medicines Regulatory Authority (NMRA), Consultant Dr. Ananda Wijewickrama, addresses the matter in detail.

According to the statement, registration for the Immunoglobulin drug produced in India was granted in April 2023, following proper evaluations by the NMRA concerning the drug’s quality, safety through clinical assessments, and pharmaceutical standards.

However, the statement further notes that, after a complaint was received regarding the drug, an investigation revealed certain quality concerns. As a result, the Subcommittee on Safety and Risk Assessment informed the Medical Supplies Division to suspend its use.

Subsequent investigations carried out within the country later confirmed that the drug met the required standards.

Moreover, quality assessments conducted by India’s Central Drugs Standard Control Organization also verified that the drug complies with the appropriate standards, the statement adds.

Based on these findings, the Subcommittee on Safety and Risk Assessment, comprising medical experts, has decided that the drug may continue to be used. The Medical Supplies Division has been informed accordingly.

Therefore, there is no need for concern regarding the quality of the drug, and it can be used again, the NMRA Chairman, Consultant Dr. Ananda Wijewickrama, further stated in the release.