India drugs regulator orders quality checks on cough syrup ingredient

People wait for their turn to buy medicine outside a pharmacy in Amritsar, India on March 28, 2020. (AFP/File)
Short Url
Updated 09 December 2023
Follow

India drugs regulator orders quality checks on cough syrup ingredient

  • Syrups made by three Indian firms have been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon in over a year 
  • Drugmakers have denied allegations their products were responsible for the deaths, which have cast a shadow over quality of Indian exports 

NEW DELHI: India’s drugs regulator has ordered that the source and quality of an ingredient used to make cough syrups be checked and verified as a “top priority,” in the wake of the deaths of at least 141 children globally. 

In one of the world’s worst such waves of poisoning, cough syrups made by three Indian manufacturers have been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since the middle of last year. 

The drugmakers have denied allegations that their products were responsible for the deaths, which have cast a shadow over the quality of exports from India, often dubbed the “world’s pharmacy” due to its supply of life-saving drugs at low prices. 

In a letter this week, India’s Drug Controller General Rajeev Singh Raghuvanshi directed state and regional authorities to carry out inspections and verify the source and quality of propylene glycol (PG) either produced domestically or imported by cough syrup makers. 

He also directed drugs inspectors to submit a supply chain verification report for PG manufacturers and importers 

The direction was issued to rule out “possible quality issues” related to toxins diethylene glycol (DEG) and ethylene glycol (EG) in cough syrups and the diversion of industrial grade PG, Raghuvanshi said in a letter dated Dec. 6 and seen by Reuters. 

PG is a colorless, viscous liquid that does not react with other substances, making it an ideal solvent for syrupy medicines. Reuters has reported that some Indian drugmakers were buying key ingredients from suppliers who were not licensed to sell pharmaceutical-grade products. 

DEG and EG are used as industrial solvents and antifreeze agents and can be fatal when consumed even in small amounts. 

The syrups linked to the deaths of the children were found to contain high levels of DEG or EG in tests done by the World Health Organization and other authorities. 

Raghuvanshi has requested details including the number of cough syrup batches manufactured across India in 2023, the PG used and whether it was tested before use. 

Raghuvanshi also issued an advisory on Dec. 5 asking all drugmakers to purchase and use only pharmaceutical grade ingredients in their products. 

India has introduced mandatory testing for cough syrup exports since June and stepped up scrutiny of drugmakers, finding a string of deficiencies in recent inspections including poor documentation and a lack of self-assessment. 


Trump renews push to annex Greenland

Updated 9 min 51 sec ago
Follow

Trump renews push to annex Greenland

  • President Donald Trump doubled down Sunday on his claim that Greenland should become part of the United States, despite calls by Denmark’s prime minister to stop “threatening” the territory

COPENHAGEN: President Donald Trump doubled down Sunday on his claim that Greenland should become part of the United States, despite calls by Denmark’s prime minister to stop “threatening” the territory.
Washington’s military intervention in Venezuela has reignited fears for Greenland, which Trump has repeatedly said he wants to annex, given its strategic location in the Arctic.
While aboard Air Force One en route to Washington, Trump reiterated the goal.
“We need Greenland from the standpoint of national security, and Denmark is not going to be able to do it,” he said in response to a reporter’s question.
“We’ll worry about Greenland in about two months... let’s talk about Greenland in 20 days.”
Over the weekend, the Danish prime minister called on Washington to stop “threatening its historical ally.”
“I have to say this very clearly to the United States: it is absolutely absurd to say that the United States should take control of Greenland,” Prime Minister Mette Frederiksen said in a statement.
She also noted that Denmark, “and thus Greenland,” was a NATO member protected by the agreement’s security guarantees.
’Disrespectful’
Trump rattled European leaders by attacking Caracas and grabbing Venezuelan president Nicolas Maduro, who is now being detained in New York.
Trump has said the United States will now “run” Venezuela indefinitely and tap its huge oil reserves.
Asked in a telephone interview with The Atlantic about the implications of the Venezuela military operation for mineral-rich Greenland, Trump said it was up to others to decide.
“They are going to have to view it themselves. I really don’t know,” Trump was quoted as saying.
He added: “But we do need Greenland, absolutely. We need it for defense.”
Hours later, former aide Katie Miller, the wife of Trump’s most influential adviser, drew ire by posting an image of Greenland in the colors of the US flag, captioning it “SOON.”
Greenland’s Prime Minister Jens-Frederik Nielsen called Miller’s post “disrespectful.”
“Relations between nations and peoples are built on mutual respect and international law — not on symbolic gestures that disregard our status and our rights,” he wrote on X.
But he also said “there is neither reason for panic nor for concern. Our country is not for sale, and our future is not decided by social media posts.”
Allies?
Stephen Miller is widely seen as the architect of much of Trump’s policies, guiding the president on his hard-line immigration policies and domestic agenda.
Denmark’s ambassador to the United States, Jesper Moeller Soerensen, offered a pointed “friendly reminder” in response to Katie Miller’s post that his country has “significantly boosted its Arctic security efforts” and worked together with Washington on that.
“We are close allies and should continue to work together as such,” Soerensen wrote.
Katie Miller was deputy press secretary under Trump at the Department of Homeland Security during his first term.
She later worked as communications director for then-vice president Mike Pence and also acted as his press secretary.

Meanwhile, France reiterated on Monday its support of the sovereignty ​and territorial integrity of Denmark and Greenland following renewed threats by US President Donald Trump to take over Greenland.
When asked about France’s ‌reaction, Foreign ‌Ministry spokesman Pascal ‌Confavreux ⁠told ​TF1 ‌TV: “It is solidarity with Denmark...Greenland belongs to Greenland’s people and to Denmark’s people. It is up to them to decide ⁠what they wish to do. Borders ‌cannot be changed ‍by ‍force.”