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

¶ 01 Hon. Presiding Member, we are glad Parliament is debating the quality of the lab that tests medicines. But we must remember it was people in this very House who created a special pathway to import untested medicines—water bottles instead of drugs—killing patients, and then used their majority to defeat the no-confidence motion. That was the country we had.

¶ 02 There is now significant change, and we are grateful. Speaking about the NMRA: some do not like the NMRA precisely because it regulates medicines. Some think they can set up any factory and manufacture as they wish and give it to our people. That is how the immunoglobulin scandal occurred—blood allegedly put in, but what came out was water. We support local industry, but only with standards and processes in line with international norms. That is the difference today.

¶ 03 On the NMRA lab: Hon. (Dr.) Kavinda Jayawardhana’s Motion is good; we are already implementing it. The lab’s history goes back to 1990. Over 35 years, there has been development, but within this past year we doubled the number of tests, doubled the workforce, and for the first time placed the NMRA on a pathway to obtain international accreditation. We are rapidly developing the lab.

¶ 04 Financially, NMRA has adequate deposits. But lab development requires specific stepwise processes recognized internationally, and we are following those. Sri Lanka produces about 250 medicines locally but still needs about two-thirds by import. Not everything can be tested in one lab; some samples must go to accredited labs recognized globally and by NMRA. We aim to obtain ISO 17025 accreditation to deliver internationally accepted results and increase testing throughput. Beyond the NMRA lab, we have the MRI lab, SPC’s lab, and others. A strong third-party lab under the Ministry of Science and Technology is essential, because self-confirmation for disqualifications is not ideal.

¶ 05 We recruited 15 drug analysts and 24 assistant analysts this year. As for the NMRA Board composition concerns, membership is as per the 2015 Act; pharmacists and requisite expertise are being recruited where needed.

¶ 06 We have facilitated local pharma, but we will not permit arbitrary registrations. Regarding the NMRA Chairman, he is a competent doctor appointed before our government took office and continues to serve; any “issues” appear to arise from refusal to bend rules for certain imports or factories.

¶ 07 On quality assurance workflow: we perform pre-shipment and pre-delivery sampling for first-time imports; warehouse sampling at MSD; samples after distribution to institutions; and complaint-driven sampling, sometimes via third-party labs. A technical committee decides whether to continue or withhold batches. It is a complex, multi-layered process designed to avoid errors, built over time by many experts. We appreciate the Motion; our lab development roadmap with annual targets is available and shared with all health institutions.

¶ 08 On shortages raised: as a clinician involved in cardiology units, I have rarely seen some of the “reversal” drugs cited being absent; currently, a historic volume of antibiotics is available in hospitals compared to previous periods; bypass surgeries have not been halted. Regarding prices paid, I will provide details later. Procurement is through MSD/SPC for bulk; smaller items are handled via institutional procurements and petty cash allocations—that is where certain suture and needle items fall, not national shortages.

¶ 09 We have moved from an era of water in place of medicine to progressively improving quality. We thank Hon. (Dr.) Kavinda Jayawardhana for the Motion.