The World Health Organisation (WHO) yesterday has recommended that two cough syrups manufactured by the Noida-based company Marion Biotech should not be used for children in Uzbekistan.
"Cough syrups made by India's Marion Biotech should not be used for children, after the products were linked to 19 deaths in Uzbekistan," WHO said in a statement.
"The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH (Uttar Pradesh, India). Laboratory analysis found both products contained unacceptable amounts of diethylene glycol and /or ethylene," it said.
Back in December 2022, the health ministry of Uzbekistan claimed that as many as 18 children have lost their lives in the country after consuming medicines manufactured by an Indian pharmaceutical company.
Medical alert by WHO
"This WHO Medical Product Alert refers to two substandard (contaminated) products, identified in Uzbekistan and reported to WHO on 22 December 2022. Substandard medical products are products that fail to meet quality standards or specifications and are therefore out of specification," the WHO said in an alert released on its website.
"Both of these products may have marketing authorizations in other countries in the region. They may also have been distributed, through informal markets, to other countries or regions," the WHO alert added.
The UN health agency added that 'the substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death.'
Previously WHO claimed that four "contaminated" and "substandard" cough syrups, allegedly produced by Maiden Pharmaceuticals Limited in Haryana's Sonepat included Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
This comes months after WHO issued an alert for four "contaminated" cough syrups manufactured by an Indian drugmaker, Maiden Pharma, that have been "potentially linked" with acute kidney injuries and 66 deaths among children in Gambia.
The Uttar Pradesh Food Safety and Drug Administration department has suspended the production licence of Marion Biotech company linked to Uzbekistan's deaths of 18 children.
"We have suspended the production license of Marion Biotech company after not providing enough documents, show-cause notice was also given by the state licensing authority depending upon the documents asked during the inspection which they didn't provide," said Gautam Buddh Nagar Drug inspector Vaibhav Babbar.
What happened in December?
Back in December, Uzbekistan claimed that an Indian cough syrup was responsible for the death of 18 children a sthey consued the product manufactured by an Indian pharmaceutical company.
The company in question is Marion Biotech Private Limited, which was registered in 2012 in Uzbekistan.
What has the health ministry said?
According to the health ministry, the children who died had consumed the Dok-1 Max Syrup produced by Noida-based Marion Biotech.
So far, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup, the ministry said.
"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 statement noted.
"Since the main component of the drug is paracetamol, Doc-1 Max syrup was incorrectly used by parents as an anti-cold remedy on their own or on the recommendation of pharmacy sellers. And this was the reason for the deterioration of the condition of patients," it added.
The preliminary laboratory studies have shown that this series of Doc-1 Max syrup contains ethylene glycol.
"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," the ministry pointed out.
The ministry has also asked parents to be attentive to the health of their children, and to purchase medicines in pharmacies only by prescription.
How has the government responded?
Following the incident, a total of seven responsible employees were dismissed from their positions for being negligent and inattentive to their duties.
Disciplinary measures were applied to a number of specialists.
Currently, tablets and syrups of the drug Doc-1 Max are withdrawn from sale in all pharmacies of the country in the prescribed manner.
Gambia spurious cough syrup incident
This incident in Uzkekistan comes months after the World Health Organization (WHO) issued an alert for four "contaminated" cough syrups manufactured by an Indian drugmaker, Maiden Pharma, that have been "potentially linked" with acute kidney injuries and 66 deaths among children in Gambia.
(With PTI Inputs)