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NMRA laboratory lacks SLAB accreditation

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Dr. Sanjeewa

Drug controversy:

 “Setting up state-of-the-art drug testing facility will cost Rs 5 billion”

 Activists call for legal action against politicians, bureaucrats

Serious questions have been raised over Sri Lanka’s drug regulatory system following revelations that the National Medicines Regulatory Authority’s (NMRA) quality control laboratory is not accredited by the Sri Lanka Accreditation Board (SLAB), casting doubt on both the reliability of local test results and the adequacy of oversight of imported medicines.

Medical and civil rights groups warn that the issue points to a systemic regulatory failure rather than an isolated lapse, with potential political and financial consequences for the State.

Chairman of the Federation of Medical and Civil Rights Professional Associations, Specialist Dr. Chamal Sanjeewa, said the controversy surrounding the Ondansetron injection, which was later found to be contaminated, had exposed deep weaknesses in drug regulation and quality assurance.

Dr. Sanjeewa said that the manufacturer had confirmed that the drug had been imported into Sri Lanka on four occasions this year, despite later being temporarily withdrawn from use. The drug was manufactured in India in November 2024 and in May and August 2025, and imported to Sri Lanka in February, July and September. On each occasion, 67,600 phials were procured.

Dr. Sanjeewa said the company had informed the NMRA that the drug was tested in Indian laboratories, prior to shipment, and passed all required quality checks. The manufacturer reportedly tested the injections against 10 parameters, including basic quality standards,

pH value, visual appearance, component composition, quantity per phial, sterility levels, presence of other substances, bacterial toxin levels and spectral variations.

According to documents submitted to the NMRA, no bacterial toxins were detected in the original samples, and the reported toxin levels were within European safety limits of less than 9.9 international units per milligram.

Dr. Sanjeewa said the credibility of local regulatory oversight had come under scrutiny, noting that the NMRA’s quality control laboratory was not SLAB-accredited. He said establishing a fully equipped, internationally accredited laboratory would cost nearly Rs. 5 billion.

He warned that the failure to invest in such a facility could have grave consequences, including continued loss of life due to substandard medicines and the inability of the State to recover large sums of public funds paid to pharmaceutical companies for defective drugs.

“If urgent steps are not taken, public money will continue to be lost and accountability will remain elusive,” Dr. Sanjeewa said.

He added that if it was ultimately confirmed that the drug did not contain bacterial toxins at the time it entered Sri Lanka, the fallout would be even more damaging, severely undermining the credibility of the country’s health system and exposing weaknesses in health administration.

Dr. Sanjeewa said public trust in the health sector had already been eroded and called for legal action against all politicians and public officials responsible for regulatory failures linked to the incident.

by Chaminda Silva ✍️



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Fuel crunch looms

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Govt. tells fuel distributors to maintain stocks to ensure uninterrupted supplies

by Saman Indrajith and Norman Palihawadane

The government had instructed private fuel distributors to maintain minimum stocks and ensure uninterrupted supplies to the market, Energy Minister Anura Karunathilaka told Parliament yesterday (06).

Karunathilaka said the Ministry of Energy Secretary had notified the relevant companies of the requirement, following a reduction in supplies by some private distributors, amid higher international fuel prices.

The Minister said private companies had informed the government that they were facing losses because international prices had risen while fuel was being sold, locally, at prevailing prices. As a result, some companies had reduced the volumes released to the market.

The reduced supplies had increased the burden on the Ceylon Petroleum Corporation (CPC), whose share of the diesel market had risen from about 54% to 82%, the Minister said.

“The CPC currently holds an 82% share of the market,” he said, adding that it had increased its supplies, compared with February, to compensate for the reduction by private distributors.

Karunathilaka said the government could not, under the existing agreements with private companies, specify the quantities they should supply to individual filling stations. However, it could require them to maintain minimum stocks in the country.

The Minister said the Energy Ministry had already instructed companies that had failed to maintain the required stocks to take steps to prevent supply disruptions.

The Minister attributed the queues reported at some filling stations to reduced supplies from private distributors, as well as normal variations in fuel distribution. He also said demand for CPC fuel had increased because private companies generally did not provide fuel to dealers on credit, while the CPC offered a three-day credit facility.

“We expect that, as the Ceylon Petroleum Corporation takes on this additional burden, the problem will ease to some extent by Wednesday or Thursday,” Karunathilaka said.

He said instructions had also been issued to increase supplies to CPC filling stations. A special discussion on the issue is scheduled for today (07), with officials of the Energy Ministry and CPC expected to participate,

along with President Anura Kumara Dissanayake.

Meanwhile, Petroleum Dealers’ Association officials have called for an early solution to the supply issue. Association Chairman D.V. Shantha Silva said queues had been reported at many filling stations, mainly those operated by private distributors.

He said the situation was not due to an overall shortage of fuel, but was linked to reduced orders by Lanka IOC, Sinopec and R.M. Parks amid concerns over losses incurred on fuel sales.

The Ceylon Petroleum Private Tanker Owners Association has urged motorists to refrain from panic buying, saying there was no nationwide disruption to fuel supplies.

The government earlier increased fuel prices and introduced a per-litre diesel subsidy following concerns raised by distributors over rising international prices.

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Gnansara Thera to be assigned to prison printing section: Officials

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Bodu Bala Sena General Secretary Ven. Galagodaaththe Gnanasara Thera, who was taken into custody to serve the remainder of his prison sentence, was produced before the Colombo High Court yesterday by prison officials in connection with a warrant issued by the court. He appeared before the court in layman’s clothes. Pic by Nishan S. Priyantha.

by Norman Palihawadane

Bodu Bala Sena General Secretary Ven. Galagodaatte Gnanasara Thera, who has been ordered by the court to serve the remainder of his prison sentence, is to be assigned to the prison ‘printing work party’, prison officials said yesterday.

The monk was produced before the Colombo High Court yesterday by prison officials in connection with a warrant issued by the court.

He appeared before the court in civilian attire.

Prison sources said arrangements were being finalised for his detention and that he would subsequently be assigned to the printing work party.

The Thera initially objected when prison officials instructed him to change from his robes into the attire worn by convicted prisoners.

He later agreed to wear the prescribed prison clothes, sources said.

The Supreme Court, in September, annulled the presidential pardon granted to Gnanasara Thera in 2019. He had been serving a six-year prison sentence imposed following his conviction for contempt of court but had served only about nine months when then President Maithripala Sirisena granted him a presidential pardon in May 2019.

Following the Supreme Court ruling, the Thera was required to serve the remainder of his sentence. He was subsequently reported missing, prompting the Court of Appeal to issue an open warrant for his arrest.

The Court of Appeal on Monday ordered the authorities to enforce the remainder of his prison sentence.

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Speaker rejects Ajith Perera’s privilege complaint

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Speaker Dr. Jagath Wickramaratne yesterday ruled that a privilege complaint submitted by SJB Kalutara District MP Ajith P. Perera did not constitute a prima facie breach of parliamentary privilege.

The ruling was made in response to a notice of privilege submitted by Perera on October 02.

Perera alleged that his parliamentary privileges had been breached over the failure to take formal action or reach a final decision on a written request submitted on August 03 by 18 Opposition MPs seeking the appointment of a Special Select Committee to investigate delays in the judicial system and prison overcrowding.

He had also requested that the matter be referred to the Committee on Ethics and Privileges for investigation and recommendations.

In his ruling, Speaker Wickramaratne said the Speaker, as the Presiding Authority and guardian of the powers, rights and privileges of Parliament, could not be subjected to a privilege complaint or disciplinary inquiry by a committee subordinate to the Chair in respect of actions taken in an official capacity.

He said that, under the Standing Orders, the Speaker was required to independently determine whether a prima facie case of breach of privilege existed.

Referring a complaint against the Speaker to a committee functioning under the Speaker’s authority would, therefore, create a procedural contradiction, he said.

Accordingly, the Speaker ruled that Perera’s notice did not constitute a prima facie breach of parliamentary privilege and disallowed the request to refer the matter to the Committee on Ethics and Privileges.

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