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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past two years, more than 100 batches of medicines, imported from India, have been either temporarily, or permanently, withdrawn due to quality concerns,” he said.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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Athapaththu and Dilhari muscle Sri Lanka past Malaysia in mismatch

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Kavisha Dilhari scored a quick unbeaten 44 and then picked up two wickets [Asian Cricket Council]

The quarter-finals of the Asian Games women’s competition, putting top-notch teams against teams without much experience of playing at the highest level, were expected to be mismatches. It took till the third game – Bangladesh vs China was washed out and Thailand gave Pakistan a fright for a proper one-side affair, though, as Sri Lanka bashed 160 after opting to bat, and their bowlers then stopped Malaysia 86 runs short.

Fresh off their appearance in the final of the Women’s T20 Asia Cup, Sri Lanka were always expected to dominate, but it didn’t quite start the way they wanted, with Imesha Dulani run out for another low score in the third over – she hasn’t topped 25 in eight innings since her century against Pakistan on July 31.

Chamari Athapaththu,  however, stitched together an 80-run stand off just 53 balls with Hasini Perera for the second wicket, scoring 56 runs in 27 balls to Perera’s 23 in 26 in the collaboration. After the two batters fell, Kavisha Dilhari played a similar role to Athapaththu in the stand with Harshitha Samarawickrama, scoring 36 in 19 in a stand worth 62 in 37 balls.

Athapaththu top-scored with 63 in 37 balls, while Dilhari’s unbeaten 44 came off just 27 balls. For Malaysia, offspinner Nurin Imanina impressed with 3 for 29 from her four overs, picking up all the wickets to fall to bowlers.

In reply, Malaysia were three down inside the powerplay, with Dilhari picking up two of the wickets to fall on her way to returns of 2 for 4 from three overs. Athapaththu chipped in with two wickets of her own to finish with 2 for 3 from two overs, while Mithali Ayodhya got 2 for 15 from three.

It’s not like there was no resistance from Malaysia: Winifred Duraisingam scored 28, though it took her 47 balls to do it, while Mahirah Izzati Ismail scored 24, another slow effort, taking her 42 balls.

Scores:
Sri Lanka Women  160 for 4 in 20 overs  (Athapaththu 63, HasinMithali Ayodhya 2-15i Perera 23, Kavisha  Dilhari 44*, Harshitha Samarawickrema 25; Nurin Imanina 3-29) beat Malaysia Women 74 for 7 in 20 overs (Winifred Duraisingam 28, Mahirah Izzati Ismail 24; Mithali Ayodhya 2-15, Kavisha Dilhari 2-04, Chamari Athapaththu 2-03, ) by 86 runs

[Cricinfo]

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Bid for Basil’s extradition nears final stage: Police

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Basil Rajapaksa

Govt. is finalising extradition proceedings against Basil to have him stand trial here in respect of several cases

By Norman Palihawadane

The process of having former Minister Basil Rajapaksa extradited from the US to Sri Lanka was being finalised, Police Headquarters sources disclosed yesterday.

The government has formally sought assistance from the United States government to extradite former Minister Basil Rajapaksa, as multiple courts have reissued arrest warrants over his failure to appear before them in connection with two separate criminal cases, a senior police officer told The Island.

The officer, speaking on condition of anonymity, said matters pertaining to obtaining US government authorities’ assistance to extradite Rajapaksa were now being finalised.

Police headquarters sources said law enforcement agencies were currently evaluating red notices, which request the location and provisional arrest of a person pending formal extradition.

The CID and Police Headquarters earlier initiated steps to seek INTERPOL assistance to secure Rajapaksa’s return to Sri Lanka to face court proceedings relating to the two cases in which arrest warrants have been issued against him.

Rajapaksa is believed to be residing in Los Angeles, United States.

The Matara Chief Magistrate’s Court on July 21, 2026, reissued an arrest warrant for Rajapaksa after he failed to appear before court for the second time in connection with a case involving the alleged purchase of a 1.5-acre coconut estate on Eliyakanda Road in the Brown’s Hill area of Matara.

The case relates to the purchase of the property for Rs. 60 million.

The case was filed by the Police Financial Crimes Investigation Division and names Basil Rajapaksa and several other accused, including Ayoma Galappaththi, identified in court reports as the sister of Rajapaksa’s wife, Tissa Galappaththi, and Muditha Jayakody.

However, officials acknowledged that seeking US assistance would only begin a formal international process and would not automatically result in Rajapaksa’s arrest or return to Sri Lanka. Sri Lankan authorities would need to submit court orders, details of the alleged offences, and other supporting documents through the appropriate diplomatic and judicial channels. Any request would then be considered by the relevant US authorities under American law and applicable legal arrangements.

Sources at the Foreign Ministry said sealed correspondence had been exchanged between Sri Lanka’s Ministry of Foreign Affairs and the Legal Department of the US State Department relating to corruption allegations against members of the Rajapaksa family residing in the United States.

The legal foundation for any extradition is the bilateral treaty between Sri Lanka and the United States signed in Washington on September 30, 1999. The treaty applies the principle of dual criminality, meaning authorities must show that the underlying conduct amounts to a crime in both countries. Rajapaksa’s status as a United States citizen would not, on its own, make him immune from a valid request under the treaty’s provisions.

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High blood pressure, diabetes lead to about 80% of deaths in Sri Lanka

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Non-communicable diseases (NCDs) account for 80% of all deaths in Sri Lanka, with high blood pressure and diabetes among the leading causes, Secretary to the Ministry of Health and Mass Media, Dr. Anil Jasinghe, said early this week.

Dr. Jasinghe pointed out that the two conditions were interrelated and could lead to a range of serious health complications, with heart attacks being among the most severe consequences.

Dr. Jasinghe made these remarks while attending the commencement of construction of a modern Cardiac Care Complex at the Anuradhapura Teaching Hospital on Wednesday (16).

The Health and Mass Media Ministry Secretary said:

“The main issue is that these two diseases are interconnected and cause a range of complications in a person’s health. Looking at the current situation in Sri Lanka, only around 50% of those suffering from high blood pressure are under effective control. Similarly, only around 25% of diabetic patients are under proper control. As a result, this has now become a major problem in society.

“The most serious complication associated with both these diseases is Myocardial Infarction (MI), or a heart attack. This has also become the

leading complication. So, how do we control this modern epidemic? This is the biggest challenge before us.

“While establishing modern facilities across the country, our health system must also recognize the changes that have taken place in the demographic structure of our population and disease patterns. Accordingly, our health system must be adapted to suit these changing circumstances.

“Under the policies of the government led by the President and the guidance of the Minister of Health, the Ministry of Health and Mass Media is currently implementing a major programme in this regard. Its three main components are Arogya, Cluster Systems and High-End Care Institutions, which need to be developed to suit the requirements of our health system.”

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