The Ministry of Health has issued a statement addressing recent reports concerning the human immunoglobulin medication.
The statement, signed by Specialist Dr Ananda Wijewickrama, Chairman of the National Medicines Regulatory Authority (NMRA), clarifies the matter.
According to the statement, the Indian-manufactured immunoglobulin drug in question was granted registration in Sri Lanka in April 2023. This registration was issued by the NMRA following thorough evaluations of the medication’s clinical quality, safety, and pharmaceutical standards.
However, the statement notes that concerns were later raised through a complaint, prompting an investigation. Preliminary findings of that inquiry suggested potential quality issues with the medication. As a result, the Safety and Risk Assessment Subcommittee recommended temporarily suspending its use and informed the relevant medical supply division.
Subsequent investigations conducted locally confirmed that the medication met the required standards. This conclusion was also corroborated by quality assessments carried out by India’s Central Drugs Standard Control Organisation (CDSCO).
Upon reviewing all findings, the Safety and Risk Assessment Subcommittee, comprising medical specialists, determined that the medication could continue to be used. The relevant decision was formally communicated to the medical supply division.
Accordingly, the NMRA affirms that there is no cause for concern regarding the quality of the said immunoglobulin medication, and it can be safely used again, Dr Ananda Wijewickrama emphasised in the statement.
Meanwhile, many social media users have questioned whether this is the same immunoglobulin batch connected to the case involving substandard immunoglobulin for which former Health Minister Keheliya Rambukwella has been indicted. However, this is a separate matter. The batch involved in that case was supplied by a different company, which operated under the guise of being Indian but was in fact a local entity, and the purchase was made through an emergency procurement scheme. Therefore, the current stock is not related to the case involving Keheliya Rambukwella.
