The World Health Organization on Wednesday recommended not using two cough syrups made by an Indian pharmaceutical firm after the company’s product was linked with deaths in Uzbekistan.
On December 27, Uzbekistan’s health ministry had said that 18 children died after consuming Dok 1 Max syrup manufactured by Noida-based company Marion Biotech Limited. Two days later, the Indian government had said that samples of the medicine have been sent for testing.
On Wednesday, the global health body recommended not using Dok 1 Max and Ambronol, both produced by the Noida-based company, on account of their “substandard” quality.
In a medical product alert, it said that Ambronol and Dok 1 Max “contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants” as per laboratory analysis carried out by authorities in Uzbekistan.
Syrups are ideally not supposed to contain even traces of ethylene glycol, which is found in industrial grade of glycerine not permitted for medicinal uses. Ethylene glycol and diethylene glycol can cause vomiting, convulsions, affect the circulatory system and cause acute renal failure.
“The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death,” the global health body said. “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.”
The World Health Organization also said that it was important to detect and remove the two cough syrups from circulation to prevent harm to patients.
Production licence of Marion Biotech suspended
A drug official in Uttar Pradesh on Thursday told PTI that an order about suspending Marion Biotech’s production licence had been issued to the firm on January 10.
During an inspection by central agencies and the Uttar Pradesh drug department on December 29, the company representatives could not produce documents related to the production of Dok 1 Max cough syrup, Gautam Buddh Nagar district Drug Inspector Vaibhav Babbar said. The decision to suspend the firm’s licence was taken after that.
On December 29, Marion Biotech had said that it has stopped manufacturing the Dok 1 Max cough syrup. The legal department head Hasan Harris claimed that there were no problems on the company’s part in testing the cough syrup.
In October, the World Heath Organization had issued another global alert for medicines manufactured in India. The alert was for four cough syrup brands manufactured by Haryana-based Maiden pharmaceuticals.
Laboratory analysis of the syrups “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the health body had said.
This was after authoritiesin the west African country linked 66 deaths, most of them due to acute kidney failure, to the four medicines – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
However, the Drugs Controller General of India VG Somani had claimed on December 13 that the global health body drew a premature link between the deaths of children in The Gambia and the cough syrups.
Somani had said that the samples of the syrups were tested in government laboratory and found to be complying with specifications. Test reports also showed that the syrups were not contaminated with diethylene glycol or ethylene glycol.
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