10th Parliament· 154 sittings on record · 30,475 speeches · latest 10 June 2026

Sitting of Tuesday, 21 October 2025

10th Parliament· 24 debates· 209 speeches· 62 speakers

Source: Hansard PDF (parliament.lk) ↗ ·No. 22635 ·English daily/uncorrected Hansard

Order of business

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  1. 22 Debate Debate: Regulations under National Medicines Regulatory Authority Act No. 5 of 2015 67 speeches
    • The Hon. (Dr.) Nalinda Jayatissa - Minister of Health and Mass Media and Chief Government Whip JJB

      AI summary Moved approval of regulations made under the National Medicines Regulatory Authority Act, published in Gazette Extraordinary No. 2446/34 of 21 July 2025 and presented to Parliament on 7 October 2025. He noted that the regulations were made after consultations with the NMRA, Consumer Affairs Authority and other stakeholders, and that Cabinet approval had been obtained before opening the debate.

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    • The Hon. (Dr.) Nishantha Samaraweera JJB

      AI summary Hon. (Dr.) Nishantha Samaraweera supported the Regulations under the National Medicines Regulatory Authority Act, noting that the NMRA regulates registration, importation, inspection, quality assessment and approval of medicines, a process that can take around 300 days. He said previous price control arrangements lacked a clear methodology and led to legal challenges and inconsistent determinations. He stated that the new Regulations provide a structured basis for maximum retail prices and ceiling prices, using factors such as CIF value, duties, logistics and distribution costs, with the aim of improving affordability in both public and private sectors.

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    • The Hon. Speaker procedural
    • The Hon. Ajith P. Perera SJB

      AI summary Hon. Ajith P. Perera supported the 2025 NMRA Regulations introducing Maximum Retail Price and Maximum Distribution Price mechanisms, while stressing that medicine quality assurance, regulatory capacity, and post-market surveillance must be strengthened alongside price controls. He highlighted shortages of essential medicines in state hospitals, including reported shortages at Kalutara General Hospital, and called for more efficient, transparent procurement, including accelerated e-procurement, to ensure timely supply. He welcomed assurances that the Suwaseriya ambulance service would retain its identity and purpose, urged clearer government communication on the matter, and requested priority for upgrading Panadura Base Hospital.

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    • The Hon. Deputy Speaker procedural
    • The Hon. (Dr.) Nalinda Jayatissa - Minister of Health and Mass Media and Chief Government Whip JJB

      AI summary The Minister explained the legal and procedural basis for the NMRA’s medicine price regulation, citing the NMRA Act and past court challenges, and sought Parliamentary approval for the regulations gazetted on 7 October 2025 following stakeholder consultation. He outlined the new framework for Maximum Retail Prices and Maximum Ceiling Prices, including appeal mechanisms, semi-annual reviews, and enforcement under Section 131. He also reported improvements in NMRA capacity, reduced file backlogs, increased testing, and ongoing certification upgrades, while addressing hospital medicine shortages as operational stock-management issues being met through central supply, local purchases, and procurement acceleration.

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    • The Hon. Presiding Member procedural
    • The Hon. (Dr.) Nalinda Jayatissa JJB

      AI summary The Hon. (Dr.) Nalinda Jayatissa proposed that Hon. Sanjeewa Ranasingha take the Chair. The motion was agreed to, after which the Deputy Speaker left the Chair and Hon. Sanjeewa Ranasingha assumed it.

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    • The Hon. Rohitha Abeygunawardhana NDF

      AI summary Rohitha Abeygunawardhana welcomed the NMRA Regulations, arguing that they should help prevent medicine shortages, ensure quality, and keep prices fair amid risks of profiteering and malpractice in the pharmaceutical sector. He asked the Health Minister to give special attention to deficiencies in Kalutara District hospitals, including Nagoda Hospital and rural facilities such as those serving estate communities, citing shortages and lack of basic infrastructure. He also urged Health Ministry action against unjustified private-sector medicine price increases and requested clarification on public confusion caused by reports about bans on professional designation stickers on vehicle windscreens.

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    • The Hon. Presiding Member procedural
    • The Hon. (Dr.) Nihal Abeysinghe JJB

      AI summary Hon. (Dr.) Nihal Abeysinghe supported the Health Ministry’s medicine price-control regulations, arguing that a transparent pricing formula is necessary because Sri Lanka relies heavily on imported medicines and patients cannot assess pharmaceutical quality or resist arbitrary pricing. He said the formula should account for CIF costs, levies, and supply-chain margins while ensuring timely access to safe, quality medicines at fair prices, particularly for chronic and emergency patients. He also called for expanded local manufacturing, stronger laboratory quality assurance, rational prescribing and public awareness, and continuous monitoring to prevent high out-of-pocket health costs.

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    • The Hon. Presiding Member procedural
    • The Hon. Gayantha Karunathilleka SJB

      AI summary Hon. Gayantha Karunathilleka supported the NMRA Regulations on medicine quality, maximum retail prices and distribution controls, while raising concerns that the health system has not fully recovered from the 2022 economic crisis. He cited continuing shortages of medicines, dialysis consumables, suture materials, testing supplies, imaging services, oncology drugs and functioning equipment, with specific references to the National Hospital, Kandy, Karapitiya Teaching Hospital and ambulance availability. He urged the Minister to verify and address these problems, reduce burdens on poor and elderly patients, and preserve the established name, number and branding of the 1990 Suwaseriya ambulance service.

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    • The Hon. Presiding Member procedural
    • The Hon. (Dr.) Janaka Senarathna JJB

      AI summary Dr. Janaka Senarathna noted that the objectives of the National Medicines Regulatory Authority Act, No. 5 of 2015, including fair pricing and access to medicines and devices, have not yet been fully realized after ten and a half years. He emphasized strengthening health system inputs—financing, workforce, infrastructure, and governance—citing renewed nurse recruitment, the rollout of Primary Medical Care Units, and the need to reduce catastrophic household health expenditure. He called for continued investment in the health system alongside full implementation of the NMRA pricing framework to protect households and improve access.

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    • The Hon. Presiding Member procedural
    • The Hon. Kathiravelu Shanmugam Kugathasan ITAK

      AI summary Hon. Kathiravelu Shanmugam Kugathasan discussed the Personal Data Protection (Amendment) Bill, outlining proposed changes to timelines for data subject requests, fees, Data Protection Officers, impact assessments, cross-border transfers, guidelines, and the definition of public authorities. He noted that the amendments aim to reduce administrative burdens, align with international practice, and provide clarity for investors, while raising concerns about extending response times and reducing some mandatory oversight requirements. He asked whether the Data Protection Authority has sufficient expertise, infrastructure and funding, how its independence, accountability and reporting to Parliament will be ensured, and whether cross-border transfers, national databases, digital identity systems, penalties, redress mechanisms and implementation timelines are adequately addressed.

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    • The Hon. Presiding Member procedural
    • The Hon. Kathiravelu Shanmugam Kugathasan ITAK

      AI summary Kathiravelu Shanmugam Kugathasan noted that the matter was being taken up at the Second Reading stage. No substantive argument, proposal, or question was recorded in the provided extract.

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    • The Hon. Presiding Member procedural
    • The Hon. Kathiravelu Shanmugam Kugathasan ITAK

      AI summary Kathiravelu Shanmugam Kugathasan noted that the matter before Parliament was being taken up for its Second Reading.

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    • The Hon. Presiding Member procedural
    • The Hon. Kathiravelu Shanmugam Kugathasan ITAK

      AI summary Kathiravelu Shanmugam Kugathasan stated that he spoke because the matter was listed for Second Reading. No further substantive argument, proposal, or question was recorded in the provided excerpt.

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    • The Hon. Presiding Member procedural
    • The Hon. Kathiravelu Shanmugam Kugathasan ITAK

      AI summary Kathiravelu Shanmugam Kugathasan addressed amendments to data protection legislation, noting changes on risk consultation, cross-border data transfers, DPA guideline-making powers, and the narrowed definition of public authority. He said the amendments may reduce bureaucracy, strengthen privacy protections and improve investor clarity, but asked the Minister to clarify concerns about DPA capacity and independence, parliamentary transparency, cross-border safeguards, sensitive data, enforcement access, implementation timelines, and regulatory coordination. He urged Sri Lanka to draw on international practices for personal identifiers and data protection while supporting digital development.

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    • The Hon. Presiding Member procedural
    • The Hon. Ruwan Wijeweera JJB

      AI summary Hon. Ruwan Wijeweera supported the regulations under the National Medicines Regulatory Authority Act, No. 5 of 2015, stating that they form part of government efforts to improve health services and address issues such as overcrowding, long waiting lists, and access to medicines. He emphasized the NMRA’s role in procurement oversight, pricing through Maximum Retail Price and Maximum Ceiling Price mechanisms, quality assurance, and post-dispensing pharmacovigilance. He referred to COPE findings on past irregularities, including misuse of Waiver of Registration procedures and alleged corrupt procurement of human immunoglobulin, and called for strengthening the NMRA as an independent authority. He also cited a 2025 WHO report commending Sri Lanka’s steps to improve transparency, accountability, and corruption-risk assessment in medicine regulation.

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    • The Hon. Presiding Member procedural
    • The Hon. Wasantha Pushpa Kumara JJB

      AI summary Hon. Wasantha Pushpa Kumara supported the NMRA Act reforms, stating that the amendments and Gazette No. 2446/34 of 21 July 2025 empower the NMRA to set maximum ceiling prices and pricing formulas for medicines imported or manufactured in Sri Lanka. He argued that this would allow price caps across pharmacological groups and reduce costs for the public, framing the measure as part of the Government’s wider welfare-oriented reforms in health, education, transport and justice. He also referenced the establishment of the Criminal Proceeds Investigations Division as part of efforts to address misuse of state resources and recover public assets.

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    • The Hon. Presiding Member procedural
    • The Hon. Chanaka Madugoda SLPP

      AI summary Hon. Chanaka Madugoda supported bringing NMRA-related regulations to Parliament in the context of continuing shortages of essential medicines, equipment, specialists and staff in public hospitals, noting delays in surgeries and diagnostics and congestion at facilities such as Karapitiya Hospital. He urged progress on domestic pharmaceutical production, including the Oyamaduwa “Suwa Siripura” project, and on digitizing NMRA and SPC operations and certifying medical supplies. He also called for urgent government intervention to pay arrears and regularize non-permanent workers at the Pulmudai Mineral Sands Company, who he said have gone unpaid for over a year and are on a fast.

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    • The Hon. Presiding Member procedural
    • The Hon. Muneer Mulaffer - Deputy Minister of Religious and Cultural Affairs JJB

      AI summary The Deputy Minister rejected claims that the Health Minister advised patients to buy unavailable medicines privately, stating that funds and mechanisms exist for hospitals to procure medicines during shortages. He defended the Government’s health policy and the regulations under the NMRA Act as measures intended to improve access to medicines and reduce public hardship, while criticizing past handling of substandard medicines. He also linked the debate to broader calls for national unity, urging against religious or ethnic division and calling for peace and development.

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    • The Hon. Chaminda Lalith Kumara JJB

      AI summary Chaminda Lalith Kumara supported the NMRA regulations, stating that they form part of the Government’s efforts to strengthen health services under the Health Minister and President. He criticized the Opposition for past failures on staffing, drug quality, and hospital administration, and cited current measures such as hospital development committees, staff appointments for new facilities, and stronger regulation of private-sector health services. He also called for regulation of laboratory testing standards due to inconsistent results and urged Opposition support for bringing health services closer to communities.

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    • The Hon. Presiding Member procedural
    • The Hon. (Dr.) Namal Sudarshana - Deputy Minister of Women and Child Affairs JJB

      AI summary Hon. (Dr.) Namal Sudarshana moved that Hon. (Prof.) Sena Nanayakkara take the Chair. The motion was seconded, agreed to, and the change of Chair was effected.

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    • The Hon. Harshana Rajakaruna SJB

      AI summary Hon. Harshana Rajakaruna cautioned that proceeding with NMRA pricing regulations while litigation by the Pharmaceutical Importers’ Association is pending could create complications. He argued that CIF-based cost-plus pricing is unsuitable, citing WHO guidance, Institute for Health Policy views, and past NMRA pricing practices that used IMS data, while stressing the need to balance consumer protection with fairness to importers. He also urged that the 1990 Suwaseriya ambulance service be strengthened and expanded, not politicized or altered, despite statements suggesting possible changes to its colour or number.

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    • The Hon. (Dr.) Sandaruwan Madarasinghe JJB

      AI summary Hon. (Dr.) Sandaruwan Madarasinghe supported the NMRA regulations, arguing that Sri Lanka inherited a weakened medicines regulatory and procurement system marked by substandard imports, shortages, unused laboratory capacity, procurement delays, and data-system failures. He said improved two-year forecasting by hospital committees, MCP-based price reductions, and development of a stronger national quality laboratory were needed to ensure supply, quality, and affordability. He also stated that the Government would strengthen the 1990 Suwaseriya ambulance service, replace ageing imaging equipment, and act against rising narcotics trafficking, including recent large heroin and methamphetamine seizures linked to southern sea routes.

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    • The Hon. (Mrs.) Nilanthi Kottahachchi, Attorney-at-Law JJB

      AI summary Hon. (Mrs.) Nilanthi Kottahachchi stated that past political and official misconduct had undermined public trust in medicines through the supply of substandard drugs, and said those responsible are now subject to legal action and asset freezes. She linked current health sector reforms to restoring quality and public confidence, noting international recognition through Sri Lanka’s Health Minister chairing the WHO South-East Asia Regional Committee. She highlighted plans to expand primary care access to about one facility per 5,000 people within three kilometres and supported maximum retail price controls to ensure affordable, quality medicines in a patient-centred and equitable health system.

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    • The Hon. Amila Prasad SJB

      AI summary Hon. Amila Prasad expressed support for reducing medicine prices but raised concerns about the technical basis and implementation of the proposed NMRA pricing regulations. He questioned whether WHO guidance, IHP concerns, and the Senaka Bibile principles had been adequately considered, and asked whether the regulations had consensus among importers, distributors, and retailers as envisaged under Section 118 of the NMRA Act. He warned that CIF-based, brand-oriented price caps and unclear margin allocation across the supply chain could disrupt supply, reduce quality options, and require stronger local quality-control capacity.

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    • The Hon. R. M. Gamini Rathnayake JJB

      AI summary Hon. R. M. Gamini Rathnayake supported the NMRA regulations, framing them as part of a patient-centred health policy grounded in the right to health. He said the regulations aim to improve affordability while maintaining quality and ensuring continuity of supply for essential health services and medicines.

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    • Hon. R.M. Gamini Ratnayake JJB

      AI summary Hon. R.M. Gamini Ratnayake argued that health care should cover the full continuum of services and that patient safety and quality control must be strengthened through the proposed regulations. He said household out-of-pocket health spending in Sri Lanka has risen to an excessive level despite free health care, making medicine price regulation necessary. Referring to the National Medicines Regulatory Authority Act, No. 5 of 2015, and Gazette Extraordinary No. 2446/34 of 21 July 2025, he supported empowering the NMRA to set maximum retail prices for medicines and urged the Opposition to support the measure.

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    • The Hon. Presiding Member procedural
    • Hon. (Dr.) S. Sri Bavanandarajah JJB

      AI summary Hon. (Dr.) S. Sri Bavanandarajah supported strengthening the National Medicines Regulatory Authority under the relevant regulations to address rising medicine costs and improve access to essential drugs. He proposed introducing maximum retail and ceiling prices through a transparent pricing formula, modern digital price surveillance, stronger enforcement, and fast-tracked registration for quality local pharmaceutical production. He also called for greater transparency in NMRA approvals and pricing decisions, independent audits, and an internationally standard quality control laboratory to prevent distribution of substandard medicines.

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    • The Hon. Presiding Member procedural
    • Hon. (Dr.) S. Sri Bavanandarajah JJB

      AI summary Hon. (Dr.) S. Sri Bavanandarajah called for stronger consumer awareness by making approved medicine lists and Maximum Retail Prices easily accessible online and in pharmacies. He urged closer coordination between the NMRA, State Pharmaceuticals Corporation and State Pharmaceuticals Manufacturing Corporation to ensure islandwide supply of affordable essential drugs, including through bulk purchasing and generic substitution. He requested support for legislative and administrative measures to strengthen the NMRA’s independence, modernize its operations and improve medicine price regulation.

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    • The Hon. Presiding Member procedural
    • Hon. (Dr.) S. Sri Bavanandarajah JJB

      AI summary Hon. (Dr.) S. Sri Bavanandarajah concluded by emphasizing that savings on medicine directly benefit household welfare. He stated that reforms undertaken now would provide future relief to thousands of Sri Lankans.

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    • The Hon. Presiding Member procedural
    • Hon. Imran Maharoof SJB

      AI summary Hon. Imran Maharoof welcomed the regulations under the National Medicines Regulatory Authority Act to regulate medicine prices and supply, while stressing the need to ensure quality medicines and minimum essential health services. He requested that the Kinniya and Muttur hospitals in Trincomalee, currently under the Provincial Council, be brought under the Central Government and asked the Health Minister to visit Kinniya, Muttur, Thambalagamuwa and Pulmoddai hospitals to address deficiencies. He also urged Government action on unpaid salaries for about 83 Lanka Mineral Sands Company employees who had been protesting for five days over arrears reportedly outstanding for around 15 months.

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    • The Hon. Presiding Member procedural
    • Hon. Imran Maharoof SJB

      AI summary Hon. Imran Maharoof stated that 83 employees had raised their grievances with Ministers, Secretaries, and officials but had not received a solution. He requested that the Government take proper action to pay their outstanding salary arrears.

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    • The Hon. Presiding Member procedural
    • Hon. Ruwanthilaka Jayakody JJB

      AI summary Hon. Ruwanthilaka Jayakody supported the approval of regulations under the National Medicines Regulatory Authority Act, No. 5 of 2015, arguing that medicines are essential and that price control and availability are matters of public welfare. He alleged that past failures in procurement and supply, including incidents involving substandard or fraudulent medicines for cancer patients, reflected corruption by politicians and officials and called for accountability. He said a national medicines policy, drawing on the principles associated with Professor Senaka Bibile, is necessary to address the pharmaceutical “mafia,” and stated that the Government is acting to reduce medicine prices and prevent the supply of substandard drugs.

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    • The Hon. Presiding Member procedural
    • Hon. K. Kader Masthan SLLP

      AI summary Hon. K. Kader Masthan welcomed the proposed medicine price regulation but argued that continuing medicine shortages in hospitals and private pharmacies must be addressed urgently. He warned of impending health-sector staffing gaps, particularly from retiring RMOs, and called for timely appointments and alternatives to prevent harm to rural communities in areas such as Vavuniya, Mannar and Mullaitivu. He urged reforms to procurement and petty-cash procedures for rural hospitals, stricter enforcement against unstaffed NMRA-registered pharmacies and unregistered clinics, action on an alleged misuse of a Health Ministry vehicle, and resolution of delayed Bachelor of Pharmacology admissions.

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    • The Hon. Presiding Member procedural
    • The Hon. (Prof.) Chrishantha Abeysena - Minister of Science and Technology JJB

      AI summary Minister Chrishantha Abeysena supported regulations under the National Medicines Regulatory Authority Act to impose maximum price ceilings for medicines by generic category, arguing that excessive mark-ups and brand-driven practices have burdened patients and undermined the health sector. He said price control must be accompanied by stronger quality testing, better laboratories, support for domestic manufacturers, and action against officials or practices that delay registrations or create shortages. He also addressed wider health workforce issues, opposing expansion of private medical colleges on the grounds of limited internship capacity and fiscal constraints, and called for balanced strengthening of doctors, nurses, pharmacists and allied health cadres.

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    • The Hon. Deputy Chairperson of Committees procedural
    • Hon. M.S. Abthul Wazeeth SLMC

      AI summary Hon. M.S. Abthul Wazeeth used the debate on Regulations under the NMRA Act to raise health service deficiencies in several areas of Ampara District, requesting the upgrading of Irakkamam Grade “C” divisional hospital and the establishment of an obstetrics unit there. He called for completion and full operation of the Ayurvedic Research Hospital in Nintavur, citing its intended research and indigenous medicine role. He also sought action on staff shortages and facility upgrades in Pottuvil, including appointment of public health midwives, upgrading Komari PMCU, returning its ambulance, improving Savalai PMCU, providing additional staff, accommodation, safety measures such as elephant fencing, and moving towards 24-hour service.

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    • The Hon. Deputy Chairperson of Committees procedural
    • Hon. R.M. Samantha Ranasinghe JJB

      AI summary Hon. R.M. Samantha Ranasinghe supported the Regulations under the NMRA Act, describing them as necessary to control medicine prices and address long-standing problems in access to drugs. He argued that profiteering, corruption, politicization, staff shortages, outdated hospital equipment, and drug shortages had harmed patients, especially poorer families. He said concerns about shortages or substandard medicines should not prevent regulation, and stated the government would work to improve health services and implement the price-control measures.

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    • The Hon. Deputy Chairperson of Committees procedural
    • Hon. Hector Appuhamy SJB

      AI summary Hon. Hector Appuhamy supported the medicines pricing formula under the NMRA Act but raised concerns about reported shortages of essential medicines, local hospital purchasing arrangements, diagnostic equipment shortages, and possible conflicts of interest within the NMRA, including whether its Chairman should engage in private channeling. He asked the Health Minister to clarify governance and ethical issues at the NMRA and to ensure that pricing and procurement systems do not worsen shortages or disadvantage public hospitals. He also requested urgent interventions for several hospitals in his district, including reopening closed clinics, completing unfinished facilities, replacing mortuary equipment, providing staff and quarters, opening the Kalpitiya hospital building, and upgrading Puttalam District Hospital to a National Hospital.

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    • The Hon. Deputy Chairperson of Committees procedural
    • Hon. (Dr.) Najith Indika JJB

      AI summary Hon. (Dr.) Najith Indika supported the regulations under the NMRA Act, arguing that medicine price control is needed through a fair and scientific process while maintaining reasonable margins for suppliers and protecting patients. He said current shortages stem largely from past procurement failures and the economic crisis, and noted that the government has increased tender awards substantially and expanded local purchasing limits for hospitals as an interim measure. He also defended the new MRP and MCP mechanisms, stating that consultation requirements under Section 118(4) had been met and that quality procurement is being prioritized following past controversies.

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    • Hon. (Dr.) Nalinda Jayatissa - Minister of Health and Mass Media and Chief Government Whip JJB

      AI summary Hon. (Dr.) Nalinda Jayatissa concluded the debate by thanking Members for supporting regulations intended to ensure fair medicine prices, noting that the Gazette defined MRP and MCP and would guide registration and re-registration based on fair pricing. He rejected concerns that companies would leave the market or that price controls would lead to substandard medicines, citing past experiences and stating that the NMRA’s primary duty is to ensure quality. He also acknowledged district-level shortages and procurement delays, said reforms were being proposed to improve timely supply while preventing fraud and corruption, and requested approval of the regulations, which was agreed to.

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