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Suspension of Indian drug part of cover-up by NMRA: Academy of Health Professionals

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Kumudesh

President, Academy of Health Professionals, Ravi Kumudesh, yesterday (22), alleged that the National Medicines Regulatory Authority’s (NMRA) decision to suspend several batches of Ondansetron Injection USP 8 mg/4 mL (Batch Nos: OD24021E, OD25009E, OD25024E, OD25023E), following suspicions of patient complications, and a few reported deaths, seemed to be a bid to cover-up the latest public health sector crisis.

Kumudesh said so responding to The Island queries.

Kumudesh pointed out that the Chief Executive Officer of the NMRA, and other responsible officials of the Ministry of Health, were on record as having said that the alleged bacterial contamination in the medicine in question was based on laboratory test results generated at the Microbiology Laboratory of the National Hospital, Kandy.

He, however, emphasised that the Kandy facility lacked legally mandated facilities, validated systems, or regulatory accreditation required to conduct pharmaceutical sterility testing in accordance with internationally accepted regulatory standards.

“The Academy of Health Professionals is aware that the Microbiology Laboratory of the National Hospital, Kandy, does not possess the required facilities,” Kumudesh said, urging the government to come clean in this matter.

Kumudesh said the regulatory action taken by the political authority was aimed at deceiving the public, and theAcademy of Health Professionals had raised the issues with Health Minister Dr. Nalinda Jayatissa, Health Secretary Dr. Anil Jasinghe, NMRA head Dr. Ananda Wijewickrama and Director General Health Services (DGHS) Dr. Asela Gunawardena.

Kumudesh pointed out that the Kandy facility was meant to meet requirements within the Kandy National Hospital and not a world standard testing lab. Kumedesh sought an explanation as to how the suspended Ondansetron Injection had been administered on 13 December to a person warded at the hospital where NMRA head is based, a day after the NMRA decided to suspend it.

Public health sector trade union activist Kumudesh said that the Health Ministry couldn’t turn a blind eye to the disclosure that post-mortem reports of two persons, who allegedly died after being given the same medicine by the National Institute of Infectious Diseases, did not identify the medicine as the cause of death. According to him, the National Institute of Infectious Diseases administered the same medicine to patients, on multiple occasions, in the wake of the controversy.

Kumudesh said that it would be the responsibility of the government to ensure a comprehensive technical, legal, and administrative investigation into, what he called, Ondansetron affair. Having lambasted all previous governments of waste, corruption and irregularities, at the expense of the hapless public, the NPP couldn’t, under any circumstances, side-step the issue. “In the interest of transparency, regulatory credibility, and the protection of public health, this should be properly investigated,” Kumudesh said.

The crux of the matter was that the very basis of NMRA’s suspension of Ondansetron batches seemed to be irregular and questionable, Kumudesh said.

The Academy of Health Professionals, in its letter to Dr. Jayatissa, sought the Health Ministry’s response to the following questions: 1. Who requested the Microbiology Laboratory of the National Hospital, Kandy, to conduct sterility testing on this medicinal product?

2. Under what legal provisions was such a request made, and on what basis was the laboratory authorised to accept and perform such testing?

3. Who conducted the test, and who issued the report? Did those individuals possess the requisite professional qualifications, regulatory authorisation, and legal mandate to do so?

4. Did the laboratory possess the required infrastructure, validated testing systems, quality assurance mechanisms, and specialised training necessary to perform pharmaceutical sterility testing in compliance with regulatory standards?

5. If patient complications were attributed to microbial contamination, were all related materials—including syringes, IV lines, infusion fluids, and other associated devices—systematically tested? If not, on what scientific basis was it concluded that the contamination originated exclusively from the medicine?

6. Given that the NMRA is legally empowered to suspend a medicine as a precautionary measure, even without laboratory confirmation, when serious safety concerns arise, what was the justification for relying on an irregular and non-regulatory laboratory test instead?

Kumudesh stressed that Ondansetron, and nine other injectable medicines that had been suspended, were all ordered by the State Pharmaceutical Corporation (SPC) from an Indian manufacturer, Maan Pharmaceuticals.

By Shamindra Ferdinando



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Maldivian President plants a sapling to mark 60 years of Sri Lanka–Maldives Diplomatic Relations

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President of the Maldives, Dr Mohamed Muizzu, who is on a State Visit to Sri Lanka at the invitation of President Anura Kumara Dissanayake, planted a sapling this afternoon (04) at Viharamahadevi Park in Colombo to commemorate 60 years of diplomatic relations between Sri Lanka and the Maldives.

Upon arrival at the Viharamahadevi Park in Colombo, President Dr Mohamed Muizzu was warmly received by President Anura Kumara Dissanayake. Children lined both sides of the pathway holding the national flags of the two countries and paid tribute to the visiting Maldivian President.

Among those present at the occasion were Deputy Speaker Rizvi Salih, Minister of Foreign Affairs, Foreign Employment and Tourism, Vijitha Herath and the Mayor of Colombo, Vraie Cally Balthazaar, along with several other dignitaries.

[President’s Media Division (PMD)]

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Sri Lanka and Maldives strengthen ties with productive bilateral talks

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Following the bilateral meeting between President Anura Kumara Dissanayake and President Dr. Mohamed Muizzu of the Maldives, who is currently on a State visit to Sri Lanka, official-level bilateral discussions between the delegations of the two countries were held this morning (04) at the Presidential Secretariat.

The discussions commenced after the formal welcome ceremony accorded to President Dr. Mohamed Muizzu earlier this morning within the Presidential Secretariat premises.

Extending a warm welcome to the Maldivian President, President Anura Kumara Dissanayake expressed his appreciation for accepting the invitation to visit Sri Lanka.

President Dissanayake noted that President Muizzu’s visit, taking place as the two nations mark 61 years of diplomatic relations, reflects the strong partnership, mutual trust and longstanding friendship between Sri Lanka and the Maldives. The President further expressed confidence that the visit would mark a new phase in bilateral relations.

The two leaders engaged in extensive discussions on ways to further expand and diversify multifaceted cooperation, including economic, cultural and social ties, in a manner that delivers mutual benefits to the people of both countries.

Key areas of focus included tourism promotion, educational cooperation, youth and sports development, challenges faced by both nations in the fisheries sector within the Indian Ocean region, education and vocational training, as well as defence training and broader security cooperation.

Representing the Government of Sri Lanka were Minister of Foreign Affairs, Foreign Employment and Tourism, Vijitha Herath, Minister of Labour and Deputy Minister of Finance and Planning, Anil Jayantha Fernando, Minister of Science and Technology, Krishantha Abeysena; Deputy Speaker Rizvie Salih, Secretary to the President, Dr. Nandika Sanath Kumanayake, Secretary to the Ministry of Defence, Air Vice Marshal Sampath Thuyacontha (Retired), Additional Secretary to the Ministry of Foreign Affairs (covering Europe, North America, East Asia and Oceania, Southeast Asia and Central Asia, South Asia, the Middle East and Legal Affairs) M. R. K. Lenagala, Sri Lanka’s High Commissioner to the Maldives, Mohamed Rizvi Hassan and Director (South Asia and SAARC) of the Ministry of Foreign Affairs, Foreign Employment and Tourism, Mahesha Jayawardena.

The Maldivian delegation included Minister of Foreign Affairs Iruthisham Adam, Minister of Economic Development and Trade, Mohamed Saeed, Minister of Fisheries, Agriculture and Marine Resources, Ahmed Shiyam, Minister of Homeland Security and Technology, Ali Ihusaan, Chief of Staff to the President, Abdulla Fayaz, Principal Secretary to the President on Foreign Relations, Mohamed Naseer; Chief Government Spokesperson, Mohamed Hussain Shareef, High Commissioner of the Maldives to Sri Lanka,Masood Imad; Minister of State for Foreign Affairs and Chief of Protocol , Mohamed Shahudy, Deputy Minister at the President’s Office, Mr Mohamed Hassaan and Minister Counsellor at the Maldives High Commission in Sri Lanka, Mr. Ismail Mamdhooh.

[President’s Media Division (PMD)]

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Maldives and Sri Lanka exchange seven MOUs

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Seven Memoranda of Understanding (MoUs), signed across several sectors between the Maldives and Sri Lanka, were formally exchanged this morning (04) at the Presidential Secretariat in the presence of President Anura Kumara Dissanayake and President Dr. Mohamed Muizzu of the Maldives.

Marking a new chapter in Maldives–Sri Lanka relations, the MoUs cover cooperation in the fields of health, sports, tourism, education and defence.

Accordingly:

1. MoU on Tourism Cooperation between the Democratic Socialist Republic of Sri Lanka and the Republic of Maldives was exchanged by Maldives Minister of Foreign Affairs, Ms Iruthisham Adam and Sri Lanka’s Minister of Foreign Affairs, Foreign Employment and Tourism,  Vijitha Herath.

2. MoU on Archiving Cooperation between the Department of National Archives of Sri Lanka and the National Archives of the Maldives was exchanged by Maldives Minister of Foreign Affairs, Ms Iruthisham Adam and Sri Lanka’s Minister of Foreign Affairs, Foreign Employment and Tourism, Vijitha Herath.

3. MoU on Training and Professional Development of Teachers and School Leaders between the Ministry of Education, Higher Education and Skills Development of the Maldives and the Ministry of Education, Higher Education and Vocational Education of Sri Lanka was exchanged by Maldives Minister of Foreign Affairs, Ms Iruthisham Adam and Sri Lanka’s Minister of Foreign Affairs, Foreign Employment and Tourism, Vijitha Herath.

4. MoU on Sports and Youth Development Cooperation between the Republic of Maldives and the Democratic Socialist Republic of Sri Lanka was exchanged by Maldives Minister of Foreign Affairs, Ms Iruthisham Adam and Sri Lanka’s Minister of Youth Affairs and Sports, Sunil Kumara Gamage.

5. MoU on Defence Cooperation between the National Counter Terrorism Centre of the Maldives and the Ministry of Defence of Sri Lanka was exchanged by the Maldives High Commissioner to Sri Lanka,  Masood Imad, and the Secretary to the Ministry of Defence, Air Vice Marshal Sampath Thuyacontha (Retired).

6. MoU between the Ministry of Defence and National Service of the Maldives and General Sir John Kotelawala Defence University of Sri Lanka was exchanged by the Maldives High Commissioner to Sri Lanka, Masood Imad and the Vice Chancellor of General Sir John Kotelawala Defence University, Rear Admiral Dammika Kumara.

7. MoU on Academic Cooperation between the University of Colombo of Sri Lanka and the Ministry of Health, Family and Welfare of the Maldives was exchanged by Maldives High Commissioner to Sri Lanka,  Masood Imad and the Vice Chancellor of the University of Colombo, Professor Indika Mahesh Karunathilake.

The state visit of President Dr Mohamed Muizzu, undertaken at the invitation of President Anura Kumara Dissanayake, aims to further strengthen economic, cultural and social ties between the two countries, while enhancing their multifaceted partnership.

Cabinet Ministers, government officials and members of the Maldivian delegation, representing both Sri Lanka and the Maldives, were present at the occasion.

[President’s Media Division]

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