All you need to know about cough syrups linked to deaths in Gambia

Healthcare authorities in India went into a tizzy after a domestic pharma company’s products were potentially linked to acute kidney injuries and 66 deaths among children in Gambia, according to the World Health Organisation (WHO).

The African nation has announced a callback of the controversial cough syrups. Maiden is also reported to be looking at a callback.

What action has been taken

Investigations have been launched at several levels into the deaths even as India is awaiting the “one to one causal relation of death” due to the cough syrups made by Maiden Pharmaceuticals, a Sonipat, Haryana-based pharma company.

“While all required steps will be taken, as a robust regulatory authority, WHO has been requested to share with CDSCO (Central Drugs Standard Control Organisation) at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc,” an official told PTI.

Gambia is recalling the cough and cold syrups and has launched a door-to-door campaign to get the product from households, pharmacies, healthcare centres and hospitals, reports said on Thursday.

Are these cough syrups sold in India?

The Union Health Ministry said in a press release on Thursday that Maiden Pharma had the licence to only export the four drugs that are now linked to the deaths in Gambia. “Four drugs, out of 23, named Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup, are not sold in India,” stated the press release.

It further said Maiden has manufactured and exported these products only to Gambia.

According to a Business Standard report, the company had come under the scanner of the Jharkhand drugs controller in 2013-14 for allegedly selling substandard paracetamol syrups.

What Indian authorities did

Indian authorities quickly responded to the WHO announcement and launched an investigation into the said cough syrups.

“Samples have been sent to a central pharmaceutical laboratory for testing,” Anil Vij, Haryana Health Minister, told reporters. “Strict action will be taken if anything is found wrong.”

Also read: WHO alert for 4 Indian cough syrups as 66 children die in Gambia

A director of Maiden Pharmaceuticals said they are trying to find out from its buyer in Gambia details related to the deaths of children.

“We are trying to find out the situation because it cropped up only today morning,” Naresh Kumar Goyal told Reuters. “We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India.”

What ingredients were found harmful

The WHO has said that four Maiden products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — may be potentially linked to the deaths in Gambia.

A laboratory analysis of the cough syrups confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury. Diethylene glycol is a colourless, practically odourless, and hygroscopic liquid with a sweetish taste.

A high amount of diethylene glycol could cause gastrointestinal symptoms such as nausea, vomiting, abdominal pain, and diarrhoea. Some patients may develop early neurological symptoms like altered mental status, central nervous system depression, coma and mild hypotension.

Also read: WHO yet to provide ‘one to one causal relation of deaths’ in Gambia due to Indian cough syrups

It could later lead to acute kidney failure, oliguria, increasing serum creatinine concentrations, and later anuria. In the final stage, it could cause progressive lethargy, facial paralysis, dysphonia, dilated and nonreactive pupils, quadriplegia, and coma leading to death.

Ethylene glycol is an odourless, colourless, flammable, viscous liquid with a sweet taste, but toxic in high concentrations.

Ethylene glycol has relatively high mammalian toxicity as it is oxidised to glycolic acid, which is, in turn, oxidised to oxalic acid, which is toxic. These and their byproducts first affect the central nervous system, then the heart, and finally the kidneys, finally leading to death.

Most governments and health authorities across the world advise against the use of the cough syrups for children below 12 years of age and in adults with kidney issues.