Cough syrup deaths: What is ethylene glycol and the controversy behind it

New Delhi, Dec 30: The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe into the claims of Uzbekistan that at least 18 children died after consuming cough syrup manufactured by an Indian firm, reports said.

The Health Ministry of Uzbekistan on Wednesday cited two factors behind the tragedy - excess doses of the medicine in kids who don't require the drug and contamination of ethylene glycol. It claimed that the children who died had consumed cough syrup 'Doc-1 Max' manufactured by Noida-based Marion Biotech.

"It was found that the deceased children, before admission to hospital treatment, took this drug at home for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children," the ministry said in a statement. ''Preliminary laboratory tests have shown that this series of Doc-1 Max syrup contains ethylene glycol - the deadly chemical which was held responsible for deaths in the Gambia - was found," it added.

"This substance is toxic, and about 1-2 ml/kg of a 95% concentrated solution can cause serious changes in the patient's health, such as vomiting, fainting, convulsions, cardiovascular problems and acute kidney failure," said media reports, quoting the ministry statement.

The Uzbek ministry further added that it had dismissed seven employees for negligence for not analysing the deaths in a timely manner and not taking the necessary measures. It said it had taken disciplinary measures against some 'specialists', without specifying what role the specialists had. It also informed that they are withdrawing the Doc-1 Max tablets and syrups from all pharmacies.

Ops at Marion Biotech unit halted

Earlier in the day, Union Health Minister Mansukh Mandaviya said that all manufacturing activities at Marion Biotech's Noida unit have been stopped in view of reports of contamination of its cough syrup Doc-1 Max as India begins a probe into the cough syrup-linked deaths in Uzbekistan.

"Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing," Mandaviya said.

The action against the firm also came a day after samples of the cough syrup were taken from the manufacturing premises in Noida and sent to the Regional Drug Testing Laboratory (RDTL) in Chandigarh for testing. Marion Biotech does not sell Doc-1 Max in India and its only export has been to Uzbekistan, an Uttar Pradesh government official had said.

Hasan Harris, legal representative of Mario Biotech, said the governments of both countries are looking into the matter and inquiring. ''There is no problem from our end and no issue in testing. We have been there for the past ten years. Once the government report comes, we will look into it. For now the manufacturing has stopped,'' Harris said.

The Gambia incident

The Uzbek incident comes months after similar claims were made after the death of 70 children in Gambia was linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals, following which the unit was shut down for violation of manufacturing standards.

The World Health Organisation (WHO) too had claimed that these cough syrups had 'unacceptable' amounts of diethylene glycol and ethylene glycol. However, earlier in December, India's drug regulator DCGI said that the samples tested in a government laboratory in India were found to be complying with specifications.

What is ethylene glycol?

Ethylene glycol is an organic compound with the formula (CH₂OH)₂. It is an odourless, colourless, flammable, viscous liquid. It is mainly used for two purposes, as a raw material in the manufacture of polyester fibres and for antifreeze formulations. In addition to its use in antifreeze, ethylene glycol is used as an ingredient in hydraulic fluids, printing inks, and paint solvents. It is also used as a reagent in making polyesters, explosives, alkyd resins, and synthetic waxes, notes 'britannica.com' website.

According to the Centre for Disease Control and Prevention (CDC), ethylene glycol is mostly used as an automotive antifreeze and as a raw material for manufacturing polyester fibres. It is also found in several products such as hydraulic brake fluids, stamp pad inks, ballpoint pens, solvents, paints, cosmetics and plastics.

How toxic is it?

According to the WHO, diethylene glycol and ethylene glycol are toxic to humans and can be fatal if consumed. Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death.

As per CDC, central nervous system depression, nausea, vomiting, intoxication, euphoria, stupor, respiratory depression, and reduced excretion of urine can occur due to ethylene glycol intoxication. "Severe toxicity may result in coma, loss of reflexes, seizures (uncommon), and irritation of the tissues lining the brain," it adds.