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Currently, tablets and syrups of the drug Doc-1 Max are withdrawn from sale in all pharmacies of the country in the prescribed manner.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.
The 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.
Drugs Standard Control Organisation initiates probe
The Central Drugs Standard Control Organisation (CDSCO) has initiated a probe in the issue, official sources said.
Hasan Harris, legal representative of Marion 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 will come, we will look into it. For now the manufacturing has stopped," Harris said.
Sources said the Drugs Controller General of India has sought more information regarding the incident from the Uzbek regulator.
An inspection jointly conducted by the central drugs regulatory team of north zone and state drugs regulatory team was also taken during which samples were lifted.
Earlier this year, death of 70 children in Gambia was linked to cough syrups manufactured by Haryana-based Maiden Pharmaceuticals following which the Haryana-based unit was shut for violation of manufacturing standards.
However, later the samples tested in a government laboratory in India were found to be complying with specifications.
India's drug regulator had told the World Health Organisation (WHO) earlier this month that the global health body drew a premature link between the deaths of children in Gambia and the four India-made cough syrups which adversely impacted the image of the country's pharmaceutical products across the globe.
In a letter to Dr Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, Drugs Controller General of India (DCGI) Dr V G Somani had said that a statement issued by the global health body in October in the wake of the deaths "was unfortunately amplified by the global media which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products".
In the letter, Somani said the samples of four made-in-India cough syrups linked to the deaths of 66 children in Gambia, which were tested in a government laboratory in the country, were found to be complying with specifications.
The DCGI had said that India has been committed to rigorous monitoring and oversight to ensure that the highest standards of manufacture are maintained in quality control of drugs and cosmetics.
(With agency inputs)
