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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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Police detain Bathiudeen’s wife, father-in-law and another suspect over domestic aide’s death

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Former Minister Rishad Bathiudeen’s wife, father-in-law and another suspect have been detained for interrogation in connection with the death of the 16-year old domestic aide.

“They are being held for 72 hours for further questioning”, police said.

The suspects taken into custody were identified by police as that 46-year old Sheyabdeen Ayesha, her father  70-year-old Mohammed Sheyabdeen and the broker who brought the girl to work as a domestic aide in Bathiudeen’s house.

The victim, a resident of Dayagama Estate off Talawakelle, was admitted to the Colombo National Hospital on July 3 with severe burn injuries. She died on July 15.

Police have already recorded the statements of more than 20 persons in connection with the girl’s death.

Police have also questioned two women aged 22 and 32 from the Dayagama area, who earlier served as domestic workers at the former Minister’s house.

One of the women had claimed she was sexually harassed by Bathiudeen’s brother-in-law from 2015 to 2019 at the former Minister’s residence in Colombo.

Subsequently, police also arrested the 44-year old Sheyabdeen Ismadeen, brother-in-law of the former Minister.

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Contamination fears propel Lanka Sathosa to recall Chinese-made canned fish stocks

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After procurement from Colombo port for Rs. 50mn

by Suresh Perera

A substantial stock of “confiscated” canned fish Lanka Sathosa procured from the Colombo port at a cost of around Rs. 50 million has been recalled from the market following public complaints that the Chinese-manufactured products were unfit for human consumption.

The five 20-foot container loads of 425g ‘Kitchen King’ Mackerel canned fish of the Scomber japonicus species, which were lying in the Colombo port as “abandoned cargo” after forfeiture by the Customs in October last year, was purchased by Lanka Sathosa recently to be sold at a concessionary price through its chain of supermarkets.

“We have now withdrawn the whole stock from our supermarket shelves as there were customer complaints that the canned fish was not fit for consumption”, says Lanka Sathosa Chairman, Rear Admiral (Retd) Ananda Peiris.

The products were injected into the market after clearance by the Food Control Unit of the Health Ministry following quality testing by the Sri Lanka Standards Institution (SLSI), he said.

“As there’s a shortage of canned fish in the marketplace, we promptly distributed the stocks to our supermarkets island-wide to be sold at Rs. 290 each. We have now asked the outlets not to sell them to customers because of the quality issue that has emerged”, the Chairman noted.

“We have no option now other than to return the consignment and seek a refund from the Ports Authority”, he said.

Onions, potatoes, lentils and other food commodities, which are either confiscated by the Customs or remain uncleared by importers, are generally procured by Lanka Sathosa to be sold at concessionary prices to customers, Peiris explained.

“In terms of a Cabinet decision, the consignments are auctioned only if we don’t procure them”.

The stock of canned fish had been forfeited as the owner had not cleared it for three months, he said.

“Lanka Sathosa appears to have opened a can of worms as the 9,200 packs of canned fish had arrived aboard a vessel, which sailed into Colombo on October 29 last year, a source knowledgeable of the operation, said.

Listing out the relevant reference and batch numbers of the consignments, the source said the Chinese products were manufactured on 09/10/2020 with a 09/10/2023 ‘expiry date’.

This means the stocks had been in the Colombo port for the past nine months, and had turned rancid despite a 2023 ‘expiry date’, the source asserted.

Consumer Affairs Authority (CAA) officers had raided the Lanka Sathosa outlet at Moneragala following complaints that canned fish was being hoarded.

“We found stocks in storage, but was told by officers there that instructions were received to withhold the sale of the ‘Kitchen King’ products until they were re-labeled”, CAA’s Executive Director, Thushan Gunawardena said.

As the importer was not in favor of Lanka Sathosa marketing the products under its original brand name, a sticker was affixed to obscure it, Peiris clarified.

Under Section 10 of the Consumer Protection Act, re-labeling a product constitutes an offence, Gunawardena pointed out.

Acting on a complaint, public health inspectors have taken a sample of the canned fish from the Mawanella outlet for testing, the Lanka Sathosa chief further said.

Responding to questions raised by the CAA, the SLSI said its officers had collected samples from the five containers following requests by the Ports Authority and Lanka Sathosa.

As the original importer had not submitted any documents to the SLSI so far, the need for sample collection didn’t arise, it said.

The CAA has further queried whether the SLSI was aware of the purpose the test results were required at the time samples were received.

The SLSI has clamped down on the import of substandard canned fish with an intolerable level of arsenic, particularly from manufacturers in China.

In a news report headlined “SLSI cracks the whip on substandard Chinese canned fish imports”, The Sunday Island of March 21, 2021 quoted the institution’s Director-General, Dr. Siddhika Senaratne as saying that fish harvested for canning has a high arsenic content as the sea in China is heavily polluted and dirty due to lax environmental laws.

“It is true that there is a scarcity of canned fish in the market because supply cannot meet the demand. However, this does not mean we should allow our people to be poisoned through arsenic-laden imports”, she was quoted saying in the news report.

With the SLSI stipulating a maximum arsenic tolerance standard of 1.0 milligram per kilogram of fish, a filtering mechanism is now in place to shut out substandard imports, she assured at the time.

Asked whether the consignment of Chinese canned fish procured by Lanka Sathosa was earlier detained due to its high arsenic content, Dr. Senaratne declined comment saying she’s “not allowed to talk to the media”.

“The DG wouldn’t want to be dragged into another controversy”, an official remarked, referring to the furore over her claim of toxins in foodstuffs, which she, however, declined to identify at the time.

At a time canned fish imports from China have been off the shelves since SLSI’s rigid monitoring of tolerable arsenic levels began, industry players expressed consternation on how a stock, which had been lying in the Colombo port for months, was suddenly given the nod for procurement by Lanka Sathosa.

With the scarcity of canned fish products in the market pushing up demand, will an importer abandon his consignments unless there was something rotten somewhere?, they asked.

“It is too far-fetched to imagine that they got the documentation wrong as these importers are seasoned campaigners in the game”.

It is apparent that Lanka Sathosa had not done its homework before jumping at the idea of procuring the consignment because Chinese-made canned fish had remained virtually out of bounds for many months because of fears of contamination, they said.

Importers didn’t want to risk their investments as a high arsenic level meant the consignments were either destroyed or ordered to be re-exported, they added.

“That’s why local products now dominate the market with a brand from Thailand also no longer available”.

 

 

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United States gives Sri Lanka 500,000 coronavirus rapid tests

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The United States had donated 500,000 Rapid diagnostic tests to Sri Lanka worth Rs. 300 million to help the country fight Coronavirus, the US Agency for International Development said.

“By enabling rapid detection of the virus, these tests donated by the American people will save lives and protect public health in Sri Lanka,” USAID Mission Director to Sri Lanka and Maldives, Reed Aeschliman said in a statement.

“This donation builds on previous U.S. support to the Sri Lankan government’s pandemic response and reflects our strong, long-standing partnership.”

US has also given 1.5 million moderna vaccines to Sri Lanka.

The tests are simple to use and enable fast, decentralized access to direct testing. They do not require additional equipment or specialized laboratory access, which helps achieve high testing coverage.

The United States has also given of 200 ventilators to Sri Lanka’s health system.

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