The Uzbekistan government has alleged that 18 children have died in the central Asian nation following the consumption of cough syrup produced by an Indian pharmaceutical firm Marion Biotech.
"To date, 18 out of 21 children with acute respiratory disease have died as a result of taking Doc-1 Max syrup manufactured by the Indian company Marion Biotech Pvt Ltd," the Uzbekistan Health Ministry said in a statement.
"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 Union Health Ministry sources didn't respond, still, they maintained that a file was placed before Health Minister Manuskh Mandaviya, who also heads the Department of Pharmaceuticals as the Minister for Chemicals and Fertilisers. Noida-based Marion Biotech also didn't respond.
Factors behind tragic deaths of children
The press statement from the Uzbekistan Health Ministry identifies two factors behind the tragedy -- excess doses of the medicine in kids who don't require the drug and contamination of ethylene glycol -- one of the two toxic chemicals found in the Gambian case.
"All children were given the drug without a doctor's prescription. 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 the recommendation of pharmacy sellers. This was the reason for the deterioration of the condition of patients," the Uzbek Ministry said.
"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," Uzbekistan authorities said.
The World Health Organisation in October flagged the presence of ethylene glycol and diethylene glycol as toxic contaminants in four cough syrup samples (made by Maiden Pharmaceuticals, Haryana) that are reportedly linked to the deaths of 70 children in The Gambia. But this was not the first time EG and DEG were found in cough syrups made in India, as there have been many similar cases in the past with fatal consequences.
Experts say that cough syrups sometimes contain "unacceptable levels" of Diethylene Glycol and Ethylene Glycol. The syrup becomes harmful if there is even a slight difference in their quantity.
Noida facility raided; samples sent for testing
After Uzbekistan Health Ministry's allegations, a joint inspection of the manufacturer's Noida facility is being carried out by teams of the Uttar Pradesh Drug Control Department, Central Drugs Standard Control Organisation (CDSCO) and the Noida Police. The Central Drugs Standard Control Organisation (CDSCO) is in contact with the national drug regulator of Uzbekistan regarding the matter.
"Immediately on receipt of the information, joint inspection of the NOIDA facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report," said the Union health ministry on Thursday.
The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing.
Meanwhile, Marion Biotech Pharma company has said that it has sent samples of the said cough syrup for testing and has also halted the production of the product.
An investigation by the Noida police and other officials at pharma company Marion Biotech Pvt Ltd is underway. Hasan, the Legal Head of Marion Biotech, expressed grief over the deaths on behalf of the company and said that an inquiry in the matter was being conducted by the government.
Marion Biotech is a licensed manufacturer and holds license for manufacturing of Dok1 Max syrup and Tablet for export purpose granted by Drugs Controller, Uttar Pradesh.
Centre faces backlash
Meanwhile, Congress on Thursday slammed the Centre and demanded the "strictest" action against the Uzbekistan government's claim that 18 children died in the Central Asian nation after consuming cough syrup made by an Indian manufacturer.
Taking to Twitter, Congress General Secretary Jairam Ramesh said: "Made in India cough syrups seem to be deadly. First it was the deaths of 70 kids in Gambia & now it is that of 18 children in Uzbekistan. Modi Sarkar must stop boasting about India being a pharmacy to the world & take strictest action."
