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

¶ 01 Hon. Presiding Member, first I will briefly respond on another matter mentioned—about a programme started in March 2018 under your administration—Comprehensive Sexuality Education—implemented jointly by the Ministry of Education’s School Health and Nutrition Unit, the Ministry of Health, and UNFPA. Detailed documents are placed in the Library.

¶ 02 Now to the questions:

¶ 03 1. On ensuring standard medicines via NMRA: When a product applies for registration, first the manufacturing site—domestic or foreign—must be registered. Inspections assess manufacturing techniques, environment, and compliance with Good Manufacturing Practices in line with WHO-approved procedures. Only thereafter is the product dossier evaluated for quality, safety, and efficacy. A qualified expert committee reviews and, upon approval, registration proceeds. We also obtain pre-shipment samples for first consignments before loading, test initial batches before market or hospital distribution, and obtain reports from WHO-qualified labs. This is a lengthy process—typically about 300 working days. When we assumed office, timelines had stretched to 400–500 days; we have reduced them to around 300.

¶ 04 2. On establishing an international-standard laboratory: Before that, note our gap in post-marketing surveillance. We are working to establish a PMS system by networking laboratories capable of conducting required tests. Accreditation processes to meet international standards are underway. When we took over, the NMRA lab was severely understaffed. NMRA now has about 230 staff, 110 recruited this year. We are upgrading the NMRA lab to international standards and also exploring a separate, independent national laboratory capable of testing both pharmaceuticals and foods for the country and the region. Discussions are ongoing.

¶ 05 3. On uninterrupted supply: The 2026 Budget allocates Rs. 185 billion for medicine procurement—the largest ever. We have strengthened NMRA staffing and are systematising its digitisation. Through the SPC and SPMC, and via local manufacturers, we procure medicines. From a priority list of about 860 drugs, roughly one-third are sourced locally; we aim to increase this. We are also addressing gaps where no local agents exist and working to reduce monopolies. Price regulation measures are being advanced.

¶ 06 On the Troponin-I issue: hospitals may procure reagents from two companies; disputes often arise when a clinician prefers one reagent over another. This matter is before court; it will be resolved judicially.

¶ 07 Thank you.