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Medical Specialists lambast govt.’s attempt to restructure NMRA

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The Association of Medical Specialists (AMS) has written to Prime Minister Ranil Wickremesingh, expressing its grave concern over recent media reports of intended ‘administrative restructuring’ of the National Medicines Regulatory Authority (NMRA) for ‘establishing a system to import medicine, bypassing the NMRA’. These attempts are being pushed by unscrupulous elements with vested interests trying to blame the NMRA for the shortage of drugs in the country, the AMS has said in its letter signed by Dr LakKumar Fernando President-AMS, and Dr R Gnanasekeram General Secretary-AMS

The AMS has pointed out that NMRA was established through an Act of Parliament (NMRA Act No 5 of

2015) in 2015 to provide regulatory oversight for medicinal products. It was established as an apex body independent of the Department of Health with the sole objective of improving availability of quality assured medicines and medical devices to our people. By engaging in such NMRA ensures professionalism and transparency in the regulatory process. This is in line with global good regulatory practices and good governance, strongly encouraged, endorsed and supported by the World Health Organization.

The AMS letter to the PM further says: “It should be noted that the NMRA as a regulatory body have absolutely no role to play in the procurement of medicines to state or other agencies. As all of us are very well aware, the present drug shortage in the country is due to lack of foreign currency where main purchasing arm (SPC together with MSD) could not place necessary orders on time and NMRA has no responsibility in this matter.

“Therefore, we feel that these allegations are baseless and unfounded. Such allegations are fabricated intentionally to destabilize the well-established regulatory system of medicines in our country. In our opinion, blaming the medicines regulator on the current shortage of certain medicines and medical devices is baseless, irrational and totally unacceptable.

“Further, we are aware that the NMRA acted promptly and proactively in establishing a mechanism to accept donations of medicines in the present crisis. Unfortunately, the support received from some of the directorates of the ministry of health in this endeavor was not encouraging.

“It is very important to note that interfering with the independence of the National medicines regulator is a retrogressive step, which will only pave the way to undesirables to profiteer at the expense of general public who have already been hit hard by the spiraling economic downturn. Many attempts have been made to meddle with the independence of the NMRA in the recent past at the behest of politicians and businesses with vested interests. Continuing to do so will ultimately destroy the NMRA, compromising the safety and efficacy of medicines available to the public.

“Therefore, we urge the Hon. Prime Minister and the Hon. Minister of Health not to be misled by poor advice of various elements with vested interest. Instead, we urge you to take meaningful steps to solve the issue of dearth of medicines whilst strengthening the independence of the NMRA. At the same time, the Association of Medical specialists will not hesitate to take appropriate action if the independence and the autonomy of the NMRA is interfered with.”



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PM meets UN Resident Coordinator

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A meeting between Prime Minister Dr. Harini Amarasuriya and the United Nations Resident Coordinator in Sri Lanka,  Marc-Andreé Franche, was held on the 20th of December 2025 at the Prime Minister’s Office.

During the meeting, Mr. Marc-Andreé Franche commended the swift coordination in which the Government acted to rescue affected communities and provide relief following the recent natural disaster situation faced by Sri Lanka.

Comparing experiences from other countries around the world, he noted that the level of international support Sri Lanka has received during such a disaster is exceptionally high. He further emphasized that he would utilize both his professional capacity and personal commitment to the fullest extent to ensure that Sri Lanka receives the necessary assistance.

Expressing appreciation for the continuous support extended by the United Nations to Sri Lanka, the Prime Minister stated that the role played by both the political authority and public officials in the field during this disaster management effort was exemplary. She highlighted that the collective and coordinated efforts of all parties from district leadership to the ground-level officials have become part in this success.

The Prime Minister also affirmed that the Government remains committed to properly managing the international assistance received and to rapidly restoring normalcy to the lives of people in the affected areas.

The meeting was attended by the secretary to the Prime Minister Pradeep Saputhanthri and Secretary to the Ministry of Education  Nalaka Kaluwewa

[Prime Minister’s Media Division]

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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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Dr. Jayatissa visits India amidst Ondansetron controversy

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Minister Jayatissa meets Anupriya Patel, Minister of State for Health & Family Welfare

Amidst the ongoing controversy over the suspension of several batches of Indian manufactured Ondansetron Injection USP 8 mg/4 mL (Batch Nos: OD24021E, OD25009E, OD25024E, OD25023E) over safety fears, Health Minister Dr. Nalinda Jayatissa undertook a visit to New Delhi.

The Indian HC in Colombo said: ‘Dr. Jayatissa, the Minister of Health and Mass Media of the Government of Sri Lanka led a delegation to India from 17–19 December 2025 to participate in the 2nd WHO Traditional Medicine Global Summit held at Bharat Mandapam, New Delhi. The Summit was jointly organized by the World Health Organization and the Ministry of Ayush, Government of India.

The Summit was held under the theme “Restoring Balance: The Science and Practice of Health and Well-Being” and aimed to advance a global movement focused on restoring balance for individuals and the planet through the scientific understanding and practice of traditional medicine.

During the Summit, the Minister participated in the Ministerial Roundtable and delivered his remarks, highlighting Sri Lanka’s perspectives and rich traditions in Ayurveda and traditional healing.

During the visit, the Minister held bilateral meetings with Anupriya Patel, Minister of State for Health & Family Welfare, Government of India, and Prataprao Ganpatrao Jadhav, Minister of State (Independent Charge), Ministry of Ayush, Government of India. Discussions focused on strengthening cooperation in healthcare and traditional medicine, including regulatory collaboration, research linkages, and capacity-building initiatives.

On the sidelines of the programme, Minister Jayatissa also visited Apollo Hospitals to gain insights into the implementation of Public-Private Partnership (PPP) models and to explore best practices.

The visit reaffirmed the shared commitment of India and Sri Lanka to deepen collaboration in the fields of health and traditional medicine and to explore new avenues of partnership for the benefit of the people of both countries.’

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