News
Officials of NMRA, SPC, and Health Minister under pressure to resign as drug safety concerns mount
Mounting concerns over drug safety and regulatory oversight have triggered strong calls from medical professionals and trade unions for the resignation of senior officials at the National Medicines Regulatory Authority (NMRA) and the State Pharmaceutical Corporation (SPC), following patient deaths, allegedly linked to the administration of Ondansetron injections.
Medical and civil rights groups say the incident has exposed deep systemic failures in Sri Lanka’s drug regulatory framework, with critics warning that the collapse of quality assurance mechanisms is placing patients’ lives at risk.
The Medical and Civil Rights Professional Association of Doctors (MCRPA), and allied trade unions have accused health authorities of gross negligence and demanded the immediate resignation of senior NMRA and SPC officials.
MCRPA President Dr Chamal Sanjeewa said the Health Ministry, NMRA and SPC had collectively failed to ensure patient safety, citing, what he described as, a failed drug regulatory system.
“These are not isolated incidents. Over the past two years, more than 100 batches of medicines, imported from India, have been either temporarily, or permanently, withdrawn due to quality concerns,” he said.
The controversy intensified after the NMRA announced the temporary withdrawal of several batches of Ondansetron Injection USP 8 mg/4 ml (Ondanman 8), manufactured by Maan Pharmaceuticals Ltd., India, following reports of serious adverse reactions and at least one confirmed death at the Infectious Diseases Hospital (IDH). Social media reports have also claimed two deaths at the National Hospital, Kandy, though these have not been officially confirmed.
The NMRA subsequently ordered hospitals nationwide to suspend the use of 10 injectable medicinal products until their manufacturing processes are verified to meet required safety and quality standards.
NMRA Chairman Dr Ananda Wijewickrema said the decision followed recommendations made by the authority’s Safety and Risk Evaluation Subcommittee on 16 December, 2025, in response to continuing reports of adverse drug reactions, including fatal cases.
An urgent circular was issued to PTC Medical (Pvt.) Ltd.,
instructing the company to immediately withhold all parenteral products manufactured by MAAN Pharmaceuticals Ltd of India, pending further investigations. PTC Medical is the market authorisation holder for the products in question.
Dr Wijewickrema clarified that while the reported death at IDH occurred after the administration of Ondansetron, a direct causal link to the drug has not yet been conclusively established. However, he said the precautionary withdrawal was necessary in the interest of patient safety.
Further laboratory testing is currently underway at the National Medicines Quality Assurance Laboratory (NMQAL) to assess the quality, safety and efficacy of the affected products.
Dr Sanjeewa added that the drugs currently under suspension included essential medicines such as antibiotics, Ondansetron for vomiting, Haloperidol for psychiatric and seizure-related conditions, and Iron Sucrose for iron deficiency. Most of the affected products, he said, were imported between 2024 and 2025.
He also criticised the continued use of senior officials allegedly responsible for regulatory lapses, arguing that accountability must extend to the political leadership.
“The Minister says these medicines were imported under previous governments. But the same officials responsible for this criminal mishap are still in office. If he continues to be served by errant officials, the Minister, too, must bear responsibility,” Dr Sanjeewa said, calling for the resignation of Health and Mass Media Minister Dr Nalinda Jayatissa.
The MCRPA announced that it would lodge a formal complaint with the Criminal Investigation Department (CID) today (18), seeking a criminal probe into the matter.
Medical associations have also raised alarm over regulatory changes that allow medicines approved under Indian Pharmacopoeia (IP) standards to be used in Sri Lanka without mandatory local retesting.
Dr Sanjeewa said that after the current government assumed office, provisions were introduced permitting the direct use of IP-approved medicines in the state hospital system, bypassing additional local quality testing.
“This has created a dangerous loophole. Imported medicines must be retested locally before they are administered to patients,” he said, urging authorities to urgently reinstate local verification procedures.
Deputy Minister of Health Hansaka Wijemuni told the media that investigations were ongoing into the specific batch of Ondansetron under scrutiny, following reports of two deaths that raised safety concerns.
Suspicion intensified after a patient died on 12 November. A medical specialist at the National Hospital, Kandy, conducted laboratory tests and shared findings that prompted the NMRA to immediately suspend the relevant batch nationwide.
The Government Medical Officers’ Association (GMOA) confirmed that the use of the affected Ondansetron batch had been suspended across the country.
GMOA Spokesman Dr Chamil Wijesinghe said investigations at the National Hospital, Kandy, identified the drug as a quality failure after several patients developed adverse reactions.
Sri Lanka records between 80 and 100 cases of substandard or low-quality medicines annually, he said, stressing the need to determine whether such failures arise from manufacturing defects, poor storage and transportation, or inadequate regulatory screening at entry points.
“When medicines enter the country, NMRA laboratories are responsible for testing them. If quality failures are detected later, serious questions arise about whether proper checks were conducted in the first place,” Dr Wijesinghe said.
by Sujeewa Thathsara and Chaminda Silva
News
President proposes; Speaker disposes
AKD’s request to Harsha:
Speaker Dr. Jagath Wickramaratne has frustrated an attempt by Chairman of the Committee on Public Finance (CoPF) Dr. Harsha de Silva, MP, to intervene to settle the continuing dispute over the appointment of a new Auditor General.
Dr. De Silva yesterday told The Island he had recently written to all members of the Constitutional Council (CC) drawing their attention to the urgent need to address the issue at hand. The AG’s position remains vacant since 08 Dec, 2025. AG W.P.C. Wickremanayake retired in April and since then there have been a couple of Acting appointments. The CC has declined to endorse any of President Dissanayake’s nominees as the AG.
Asked whether he had taken up the issue with the CC following President Anura Kumara Dissanayake soliciting his support in this regard, MP de Silva said that he had written to CC members as agreed with the President.
The former UNPer and one-time State Minister said: “I did so, giving due respect to CC’s independence, underscoring the critical importance in them working with the President to resolve the crisis. I alluded to the need to have transparency in public financial management during this post-cyclone period where large amounts of funds are being transacted on multiple fronts, both domestic and foreign.”
Responding to another query, Dr. De Silva emphasised that he had clarified that the President must send the names of qualified and experienced persons to the CC for consideration. “However, these letters were returned to me by the Speaker, without being delivered to members of the CC. The Speaker didn’t give an explanation. Thus, except for members who are MPs who had been copied via email by my committee office, others never received my letter of concern. Even though I questioned, in Parliament, the basis of his refusal to forward my communication to the members of the CC of which he is Chairman, no answer was given.”
The CC consists of Dr. Jagath Wickramaratne, Speaker and Chairman of the 10-member body. Dr. Harini Amarasuriya, Prime Minister, Sajith Premadasa, Leader of the Opposition, Bimal Rathnayake, Aboobucker Athambawa, Ajith P. Perera, Sivagnanam Shritharan, and three civil society members namely Dr. Prathap Ramanujam, Dr. Dilkushi Anula Wijesundere and Dr. Dinesha Samararatne. None of the President’s nominees could obtain CC’s approval as all of them were rejected by the CC.
The present CC was introduced by the 21st Amendment to the Constitution which was endorsed on 31 October 2022.
Both the Bar Association of Sri Lanka (BASL) and the Transparency International Sri Lanka Chapter recently requested President Dissanayake, in writing, to propose a suitable person to the post of AG. The BASL, in another statement that dealt with the forthcoming vacancies in the CC due to three civil society members completing their terms, declared its concern over possible attempts by the President and the NPP government to fill the vacancies with rubber stamps.
The three civil society members will complete their terms on 18 January. In terms of Article 41E of the Constitution, the CC meets at least twice every month, and may meet as often as may be necessary. The Chairman presides at all meetings of the CC and in the absence of the Chairman, the Prime Minister, and in the absence of the Prime Minister, the Leader of the Opposition presides at the meetings of the CC.
Asked whether the CC could be disrupted due to the end of civil society members’ terms, an authoritative official pointed out that in case new appointments were not made the current members could continue.
The Parliament has not so far called for applications to fill the forthcoming vacancies.
by Shamindra Ferdinando ✍️
News
Sri Lanka loses Rs.7.5 bn due to coal tender irregularities: FSP
The NPP government’s coal procurement process has once again come under scrutiny following allegations by the Frontline Socialist Party (FSP) that substandard coal has been imported for power generation and that tender procedures were manipulated to favour a specific supplier.
Addressing the media after a party meeting in Maharagama on Saturday, FSP Education Secretary Pubudu Jagoda said a test report issued by the government laboratory at the Lakvijaya Power Plant had confirmed that the latest coal shipment unloaded in Sri Lanka did not meet the required quality standards. According to the report, the coal’s calorific value ranged between 5,600 and 5,800 kilocalories per kilo, below the 5,900–6,200 kCal/kg range specified in tender requirements.
Jagoda warned that lower calorific value coal would require higher volumes to generate the same amount of electricity, increasing costs significantly. Preliminary estimates, he said, indicated an additional financial burden of around Rs. 7,500 million, which might eventually be passed on to consumers through higher electricity tariffs.
The FSP also accused the government of tailoring procurement rules to benefit the Indian supplier, which has deposited bonds for long-term coal supply for the upcoming season. Jagoda alleged that tender conditions had been altered to accommodate the company, pointing to changes in coal reserve requirements. Under the 2021 Sri Lanka Coal Registration Document, suppliers were required to maintain a minimum reserve of one million metric tonnes with a gross calorific value of 5,900 kCal/kg. This threshold, he said, had been reduced to 100,000 metric tonnes in the 2025 document which is a 90% reduction raising serious concerns.
He further cited past allegations against the Indian company, including findings in a 2016 Auditor General’s report that the company violated procurement guidelines regarding a rice supply contract with Sathosa in 2014. Jagoda also referred to legal issues involving individuals linked to the company, and the suspension of a representative by the International Cricket Council in 2019 over match-fixing allegations.
Beyond company-specific concerns, Jagoda criticised what he described as systemic manipulation of the coal tender process. He questioned why the coal tender, typically called in February or March, was delayed until July, despite electricity being declared an essential service. He also alleged that the tender submission period had been progressively shortened from the internationally accepted six weeks to five weeks, and now reportedly to three giving an unfair advantage to suppliers with existing stock.
The Ministry of Energy has recently issued an amended tender to procure 4.5 million metric tonnes of coal for the Lanka Coal Company for the 2025/26 and 2026/27 periods, following the cancellation of an earlier tender.
Jagoda warned that delays and irregularities could lead to coal shortages, higher spot market purchases, increased electricity costs, and even power cuts if hydropower generation falls short. He called for urgent investigations into the procurement process, insisting that the burden of alleged mismanagement and corruption must not be transferred to the public.
by Chaminda Silva ✍️
News
CID summons SJB MP for criticising education reforms
SJB Gampaha District MP Prasad Siriwardhana has been summoned to the CID today (12) for questioning in connection with a statement he made on a private television channel regarding education reforms.
He was earlier asked to report to the CID on 10 January to make a statement. However, as Siriwardhana had notified the authorities that he was unable to appear on that day, he was subsequently asked to come today.
Siriwardhana is one of the critics of the shortcomings of the education reforms introduced by the NPP government.
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