The Hon. (Dr.) Jagath Gunawardana

¶ 01 Hon. Presiding Member, I am grateful for the opportunity to speak on the Private Member’s Motion presented by the Hon. (Dr.) Kavinda Heshan Jayawardhana: “Formulation of a programme to ensure the proper functioning of the National Medicines Quality Assurance Laboratory.”

¶ 02 The National Medicines Quality Assurance Laboratory is an institution under the National Medicines Regulatory Authority (NMRA). The NMRA’s primary objective is to ensure that medicines and medical devices provided to the public are of quality, efficacy, safety, and accuracy. Although that is its core mandate, we all know it was not properly fulfilled during certain periods under previous governments.

¶ 03 The Laboratory, established under the NMRA with considerable technical support, exists to provide the technical inputs required to implement the national quality certification system for medicines and medical devices. It was set up in 1990, so it has operated for about 35 years. Its primary role is to conduct the laboratory testing necessary to determine quality, safety, and efficacy. It is an institution with a highly organized workflow, analyzing different points in the supply chain for both locally manufactured and imported medicines and devices, including pre-marketing and post-marketing stages. It tests and analyzes samples collected from government and private institutions, including unregistered drugs, complaint samples, tender samples, and surveillance samples.

¶ 04 The laboratory comprises major units: Chemical, Microbiological, Biological, Standardization, and Equipment. Despite this organized framework, in past periods it did not achieve its expected objectives.

¶ 05 Hon. Presiding Member, although NMRA was established to ensure the quality, safety, and efficacy of medicines, during certain previous administrations there were large-scale frauds and irregularities in medicines and devices. Notably, through a “special pathway” that bypassed normal protocols, NMRA issued registration exemptions and quality certificates even without proper registration or adequate technical committee recommendations. This allowed substandard medicines to enter the country, placing many patients at risk. The so-called special pathway sidelined minimum verification and quality checks.

¶ 06 Further, serious malfeasance occurred in the procurement and supply of medicines such as Human Immunoglobulin and Rituximab, endangering patients’ lives. The society knows about the substandard drug scandal involving emergency procurements and the alleged role of a former Health Minister and senior officials. Private interests enabled suppliers without proper registrations to bring in poor-quality drugs, risking lives and eroding public trust in the health system—some patients paid with permanent disability or even their lives.

¶ 07 The people changed this situation by electing a democratic government, and we now have a political culture without fraud, corruption, or irregularity. That change has been transmitted across all institutions, including the NMRA. Since this government took office, substantial reforms have been implemented within NMRA and its quality laboratory: resources improved, infrastructure upgraded, around 15 additional drug analyst positions created, lab capacity increased fourfold, and more equipment procured. Both pre- and post-marketing sample testing are now conducted efficiently, and we aim to provide technical summaries for all imported medicines. We are proceeding accordingly.