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NMRA mulls recalling drugs with calcitriol metabolite from the market

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After unregistered products found during raid

by Suresh Perera

The National Medicines Regulatory Authority (NMRA) is contemplating withdrawing all pharmaceutical drugs with calcitriol, an active form of Vitamin D3 prescribed largely to kidney patients, following the discovery of stocks of six unregistered imported products during a raid at Dehiwala last week.

“We will have to take a fresh look at medicines with this key metabolite to ensure that the unregistered drugs had not sneaked into the marketplace”, says Amith Perera, NMRA’s Chief Food and Drugs Inspector.

He said that a stock of a combination of six unregistered drugs with the calcitriol hormone were found during a swoop on a luxury house by officers of the regulatory body.

Calcitriol is used to treat hyperparathyroidism (overactive parathyroid glands) and metabolic bone disease in people who have chronic kidney failure and are not receiving dialysis.

The drug, which comes under different brand names, is also prescribed by some doctors to treat Covid-19 patients and those suffering from arthritis as it is an active form of Vitamin D3.

Asked whether the NMRA sealed the complex where the unregulated drugs were discovered, Perera said the medicines were placed inside a room of the house and sealed.

He said a company licensed to import six other drugs was registered under the address. As a result, the stock of ‘expired’ drugs found stored within the building was in order as an importer was authorized under the law to accept products beyond their shelf life and store them to be destroyed under NMRA supervision.

State Minister of Production, Supply and Regulation of Pharmaceuticals, Prof. Channa Jayasumana inspected the drugs in the raided complex on Wednesday and directed the NMRA to withdraw the relevant medicines from the market.

He was shown on television taking a closer look at the medicines and, at one point saying, “these are given to kidney patients”.

When the State Minister asked a company official present how the drugs were imported without authority, he replied, “we have paid taxes”.

The NMRA believes the unregistered drugs may have been imported under the ‘food supplements’ category by changing the HS code description.

The regulatory authority will be filing legal action against the company, Perera said.

When asked for comment, the company’s Chairman said he was “at a meeting” and promised to call back. However, he didn’t return the call.

Meanwhile, pharmacists complained of difficulties to secure the required approvals via the NMRA’s online portal.

The process is so complicated that we cannot even get our annual licenses renewed online, they said. “Many pharmacies are operating without renewing their licenses as a result and could face a load of trouble if there’s an issue”.

Online applications are repeatedly, “rejected”, perhaps due to a glitch in the system, and the situation is so grave that even the transport of pharmaceuticals has to be done without renewing the permit, they pointed out.

The NMRA should first put its house in order before venturing out to supervise pharmacies, they suggested.

An official of the regulatory body promised to look into the complaint.



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India should be kept out of PC polls, matters related to 13 A – Mano

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Mano

Leader of the Tamil Progressive Alliance (TPA), Mano Ganeshan, MP, said that India shouldn’t intervene here regarding the long-delayed Provincial Council polls.

The former Yahapalana Minister of National Co-existence, Dialogue and Official Languages (2015-2018), Ganeshan, who represents the main Opposition Samagi Jana Balawegaya (SJB) in the current Parliament, stressed that New Delhi’s intervention wouldn’t do any good for them or for us.

Lawmaker Ganeshan said so when The Island asked him whether the TPA would ask India to pressure the NPP government to conduct PC polls, last held in 2014, during Mahinda Rajapaksa’s second term. Ganeshan said: “India shouldn’t get involved in the issue at hand . Such a strategy is also in their interest, particularly in the context of the evolving global order. India should not be perceived as a pro-Tamil state, but rather as a state that supports Sri Lanka as a whole.”

Ganeshan said that the Indian state bears a moral responsibility in this matter. “That responsibility arises from the fact that India’s diplomacy and military intervention played a decisive role in neutralising the Tamil armed struggle in Sri Lanka. Although India’s mission remained unfinished, it nevertheless lost nearly two thousand soldiers in the process. There was also a prelude to this involvement, when Tamil militant groups received training in India. Consequently, the Indian connection became a sensitive issue for both the Sinhalese and Tamils of Sri Lanka.”

But, whatever had happened, the national issue should be settled among us. ” The solution must be found and settled within Sri Lanka itself. We do not need Western interventions in this regard.”

” In recent years, whenever we in the Tamil Progressive Alliance (TPA) have met Indian dignitaries—including the Prime Minister, the External Affairs Minister, and, most recently, the Vice President—the subjects of the 13th Amendment and Provincial Councils have never featured on our agenda.”

The 13th Amendment is part of Sri Lanka’s Constitution. Therefore, it is for Sri Lankans themselves to decide whether to retain, improve, fully implement, reform, or even repeal it, Ganeshan said.

MP Ganeshan found fault with those who represented the Northern and Eastern provinces for failing to utilise the goodwill and influence India enjoyed with successive Governments of Sri Lanka to pursue an amicable political settlement. The parliamentarian said that they should acted after the end of the war in May, 2009. Unfortunately, they failed to effectively use the Provincial Council framework to consolidate their political position and advance further, thereby earning the confidence of both India and successive Sinhala-majority governments, MP Ganeshan said.

Responding to another query, MP Ganeshan said: “

We should keep the ethnic issue separate from bilateral relations with India, while deepening economic connectivity and cooperation on the basis of mutual benefit and a win-win partnership.”

By Shamindra Ferdinando

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US boost for SLAF

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Helicopters from the US. (Pic courtesy SLAF)

Sri Lanka has taken delivery of 10 TH-57 ‘Sea Ranger’ multi-role helicopters provided by the United States of America to the Sri Lanka Air Force. Air Forces headquarters said that the helicopters arrived here by sea.

The SLAF has said: “The arrival of these aircraft marks a significant milestone in the longstanding defence cooperation between Sri Lanka and the United States and represents a valuable contribution towards enhancing the operational and training capabilities of the Sri Lanka Air Force.

“The helicopters are currently undergoing configurations and technical preparations at SLAF Base Ratmalana. Following the completion of requisite inspections, acceptance procedures and test flights, the aircraft will be inducted into service and deployed for operational duties.

“The TH-57 fleet is expected to significantly strengthen the Air Force’s aviation training capacity while enhancing the ability to support a broad spectrum of national requirements. The aircraft will primarily be employed for pilot training, humanitarian assistance and disaster response (HADR) operations, search and rescue (SAR) missions and other public service commitments undertaken by the Sri Lanka Air Force.”

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TPA demands House committee to probe Tilvin’s claim PC polls cannot be held due to fund constraints

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Harsha

Referring to the recent declaration made by JVP General Secretary Tilvin Silva that the Provincial Council elections couldn’t be held this year as funds allocated for that purpose were utilised to provide Ditwah cyclone relief, Tamil Progressive Front (TPA) leader Mano Ganeshan, MP, has asked Dr. Harsha de Silva, MP Chairman, Committee on Public Finance, to inquire into the issue at hand and take action deemed appropriate.

The text of MP Ganeshan’s letter: “I write with reference to a statement reportedly made by Tilvin Silva, General Secretary of the Janatha Vimukthi Peramuna (JVP), the principal constituent party of the National People’s Power (NPP) Government.

According to media reports, Silva stated, in substance, that funds allocated and set aside for the conduct of Provincial Council Elections had been utilised by the Government for disaster-rebuilding and related purposes.

While he is reported to have made further remarks, I confine my attention to the above statement, which raises a serious matter concerning public finance and parliamentary oversight.

To the best of my knowledge, Parliament has not approved any transfer or reallocation of funds, earmarked for Provincial Council Elections, to any other expenditure head or purpose. If the statement, attributed to Mr. de Silva, is accurate, it may indicate that such funds have been utilised without the requisite parliamentary authorisation.

In view of the above, I respectfully request that the Committee on Public Finance inquire into this matter and ascertain whether any transfer, reallocation, or expenditure of funds allocated for Provincial Council Elections has occurred in a manner inconsistent with parliamentary approval and financial regulations.

I would be grateful if the Committee could examine the facts and take any action deemed appropriate within its mandate.”

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