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Officials of NMRA, SPC, and Health Minister under pressure to resign as drug safety concerns mount

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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past two years, more than 100 batches of medicines, imported from India, have been either temporarily, or permanently, withdrawn due to quality concerns,” he said.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



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Presidential Suite at Sri Jayewardenepura General Hospital opened to the public

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The special ward at Sri Jayewardenepura General Hospital, which had until now been reserved exclusively for the use of the Executive President, was opened for the public for the provision of medical treatment to the general public from Tuesday (24).

This decision was taken jointly by the Ministry of Health and the hospital administration, in accordance with instructions given by President Anura Kumara Dissanayake.

Constructed in 1984 with a grant from the Government of Japan, Sri Jayewardenepura General Hospital was originally established with a capacity of 1,000 beds. However, in line with the initial design, an additional special unit, designated as Room No. 1001, was included exclusively for the personal use of the Executive President.

Over the 42 years since the hospital’s establishment, this facility has been utilised only on a very limited number of occasions. Nevertheless, it has been maintained over the years in anticipation of a possible visit by a sitting President, without being made available for patient use.

With effect from today, this special unit will be utilised for the benefit of general patients receiving treatment at the hospital. This step has been taken in line with the Government’s policy of ensuring the more efficient use of public assets and resources to meet the healthcare needs of the people.

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Cabinet Sub-Committee appointed to streamline the Public Service meets for the second time

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The second meeting of the Cabinet Sub-Committee appointed to ensure the orderly functioning of the public service was held on Tuesday (24) afternoon at the Presidential Secretariat, under the patronage of Prime Minister Dr Harini Amarasuriya.

Extensive discussions were held on the immediate measures required to ensure the uninterrupted delivery of government services to the public and to address the challenges faced by public servants.

Attention was also drawn to maintaining the continuous operation of services under the Ministries of Public Administration, Provincial Councils and Local Government, Health, Education, and Justice. Accordingly, it was decided to ensure that examinations are conducted as scheduled and that essential medicines are supplied to hospitals without disruption.

The challenges in passenger transport services and the railway transport system, as well as future measures, were also discussed at length. Focus was also placed on the steps to be taken regarding the transportation of essential goods.

In addition, attention was given to introducing digital service systems to facilitate working from home and to enhance the efficiency of existing services. It was also noted that these activities would be supervised under the Ministry of Digital Economy.

Instructions were further issued to review the current energy management practices across all ministries and departments and to take steps to implement necessary policy changes.

Minister of Public Administration, Provincial Councils and Local Government A. H. M. M. H. Abeyaratne, Secretary to the Prime Minister Pradeep Saputhanthri, Chief of Staff to the President Prabath Chandrakeerthi, Secretary to the Ministry of Public Administration, Provincial Councils and Local Government S. Aloka Bandara, Secretary to the Ministry of Health and Mass Media Dr Anil Jasinghe, Secretary to the Ministry of Energy Professor T. M. Udayanga Hemapala, Secretary to the Ministry of Digital Economy T. R. W. S. Dhanapala, Secretary to the Ministry of Justice and National Integration Ayesha Jinasena, PC, Senior Additional Secretary to the President Roshan Gamage, and Chairman of the Ceylon Petroleum Corporation D. J. A. S. S. Rajakaruna, along with other committee members, were also present at the occasion.

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Energy Minister indicted on corruption charges ahead of no-faith motion against him

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Jayakody

… first NPPer to face charges under Section 70 of Bribery Act

Colombo High Court has issued summons on Energy Minister Kumara Jayakody to appear in court today (27) to serve indictment in a corruption case filed by the Commission to Investigate Allegations of Bribery or Corruption (CIABOC). Action has been taken under Section 70 of the Bribery Act. The losses suffered by the government have been estimated at Rs. 8,859,708.

National List (NL) MP Jayakody is the first NPP minister or politician at any level to be indicted for corruption. The NPP parliamentary group consists of 159 including 18 NL members.

The summons has been issued by High Court judge Rashantha Godawalage.

Although CIABOC previously in many instances arrested those who had been under investigation and produced them before Magistrate courts, Minister Jayakody has been directly summoned by the Colombo High Court.

The investigation into alleged corruption in procurement during the time Jayakody served the Ceylon Fertilizer Corporation (CFC) started after the change of government in 2015.

According to the CIABOC investigation, the alleged instance of corruption took place in early 2014 towards the tail end of Mahinda Rajapaksa’s second term. At that time Jayakody was CFC’s Procurement Manager, and the CIABOC dragged the investigation until its current leadership under overall speeding up of the cases recently completed the inquiry.

Parliament recently announced that the debate on no-faith motion moved against Minister Jayakody over alleged irregularities in the procurement of substandard coal for the country’s only coal-fired power station at Norochcholai.

SJB MP Mujibur Rahman said that the NPP, having campaigned on an anti-corruption platform during presidential and parliamentary polls in 2025 couldn’t under any circumstances shield minister Jayakody. The indictment of Jayakody over a corruption case that had happened in 2014 and the failure on his part to fulfill obligations as Energy Minister under the current dispensation couldn’t be considered separately, the Colombo District MP said.

The issue at hand is whether the NPP would try to protect Jayakody at the expense of the government, MP Rahman said. Once the NPPer is formally charged in a corruption case the government would find it extremely difficult to keep him in the cabinet, the former UNPer said.

SJB lawmaker S.M. Marrikar recently warned Minister Jayakody that he should be prepared to serve a jail term. The warning was issued at a media briefing that primarily dealt with the alleged irregularities in the procurement of coal and their decision to move a no-faith motion against the minister. Marrikar explained how the crisis coupled with the growing diesel shortage could compel the government to increase electricity tariffs by as much as 18 percent next week. MP Marikkar said that they were eagerly waiting to see who backs Jayakody at the expense of the government during the upcoming  vote on the no-faith motion.

There had been a previous case of a sitting minister being charged under the Bribery Act in respect of corruption perpetrated as a government servant. MP Rahman said that they intended to intensify the ongoing campaign against the government on the strength of the unprecedented corruption case and the outcome of the no-faith motion. “Of course, they have the numbers to defeat our no-faith motion. But, in doing so, they end up with egg on their face. That is the reality,” Rahman said, adding that those responsible for waste, corruption and irregularities whichever political parties they represented shouldn’t expect special status.

MP Rahman alleged that the CIABOC granted special status to Minister Jayakody. All those who had been indicted previously were first called to the CIABOC, recorded their statements and then arrested, handcuffed and produced in court. The media was afforded the opportunity to cover their humiliation, MP Rahman said, but in this case the powers that be paved the way for the accused to receive indictments directly from the Colombo High Court.

“Let us see whether the Bar Association of Sri Lanka responds to this development,” MP Rahman said.

By Shamindra Ferdinando

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