The Hon. (Dr.) Hansaka Wijemuni - Deputy Minister of Health

¶ 01 Mr. Speaker, on behalf of the Minister of Health and Mass Media, I provide the following answers.

¶ 02 (a) (i) The quality failure of a medicine is determined based on laboratory test results of the relevant medicine. Such quality non-conformities cannot be deliberately created by the National Medicines Regulatory Authority (NMRA). No such deliberate incidents have been recorded at the NMRA. (ii) During the past five years, among life-saving/high-cost medicines requiring storage at 2–8°C, only two batches of Tenecteplase Injection 40 mg, namely TNV1B24A08 and TNV1B24E07, have been temporarily withheld from use pending a regulatory decision by the NMRA.

¶ 03 (b) (i) Reports of adverse reactions and issues including specifications are most often made via hospitals. In such instances, decisions such as withholding or withdrawal from use are made by the NMRA based on laboratory reports and related evidence. These are not decisions taken at hospital level. (ii) The State Pharmaceuticals Corporation is informed of quality issues reported at regional hospital level. However, in awarding tenders, consideration is given only to NMRA-recommended product withdrawals/batch withdrawals/rejections. In cases of product withdrawal, tenders are not awarded; in other instances mentioned above, tenders may be recommended subject to conditions (e.g., pre-shipment sample testing, performance reports for the first lot supplied to Medical Supplies Division). (iii) For 2025 and 2026 to date, details of medicines for which use has been suspended, withdrawn, or recalled—by batch and product—are provided in the annex. After review, suspensions may be lifted (e.g., when a marketing authorization holder voluntarily suspends use pending decision, later revoked), or confirmed as batch/product withdrawals. Summary totals (Jan 2025–Feb 2026): Suspensions 28; Rejections 8; Batch withdrawals 18; Product withdrawals 3; Voluntary suspensions lifted 2; Regulatory decisions revoked 2; Other actions 24.

¶ 04 (c) (i) No information has been recorded to date that NMRA-withdrawn medicines are being sold in the private market. (ii) Complaints regarding such irregularities can be lodged with the NMRA Market Surveillance and Compliance Division. (iii) No such complaints were recorded in 2024.

¶ 05 (d) Does not arise.