NEW DELHI, Jan 12: The World Health Organization (WHO) has issued an alert
against taking two India-made cough syrups following the death of 18 children
in Uzbekistan after consuming the medicines last month.
The Indian Government has since stopped the production at the manufacturing
unit of Marion Biotech in Noida, Uttar Pradesh. The licence has also been suspended.
Uzbekistan also banned any imports of the drugs - AMBRONOL and Dok-1 Max.
The WHO declared the drugs produced by the Indian company as “substandard.”
The alert, issued on Thursday, follows tests conducted by the quality control
laboratories of Uzbekistan. The analysis found “unacceptable amounts of diethylene
glycol and /or ethylene glycol as contaminants” in the cough syrups. These adulterants
can prove fatal.
“Both of these products may have marketing authorisations in other countries
in the region. They may also have been distributed, through informal markets,
to other countries or regions,” WHO said.
The drugs are “unsafe and their use, especially in children, may result in
serious injury or death”, it said.
An Uzbek statement had said on December 27 that Dok-1 Max tablets and syrup
have been sold in the country since 2012. "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,"
it said.
66 deaths in Gambia
In an earlier incident, 66 children died in Gambia under similar circumstances
in October last. It was reported that the cough and cold drugs manufactured
by Maiden Pharmaceuticals in Haryana damaged kidneys.
The WHO had then sounded a global alert and linked four India-made cough syrups
to the deaths. The four cough and cold syrups are Promethazine Oral Solution,
Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip Cold Syrup.
It said tests on samples of the syrup showed that they contained unacceptable
amounts of toxic substances diethylene glycol and ethylene glycol.
However, the Indian Government claimed later that the medicines were of “standard
quality”.
Gambia is reportedly prosecuting Maiden Pharmaceuticals after weeks of investigation.
Vietnam and Indonesia have banned India-made drugs due to lack of standard.
The US Food and Drugs Administration (FDA) has also banned some India- made
medicines due to quality control issues, according to BBC.
