India has launched an inquiry into the Noida-based drugs manufacturer after deaths of 18 children in Uzbekistan were linked to a cough syrup that was madeby the firm, Marion Biotech, the Union Ministry of Health and Family Welfare said in a statement.
This is the second Indian pharma company to come under the radar, after Haryana-based Maiden Pharma was pulled up for child deaths in Gambia because of alleged contaminated cough syrups.
According to the officials at the Ministry, there have been reports from Uzbekistan concerning contaminated cough syrup, ‘Dok1 Max’, made by the Uttar Pradesh-based company.
“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 Central Drugs Standard Control Organisation (CDSCO) team and further action as appropriate would be initiated based on the inspection report,” the statement from the Centre said.
Under directions of Union Minister, Mansukh Mandaviya, the CDSCO is in regular contact with the national drug regulator of Uzbekistan regarding the matter since December 27, officials said.
Marion Biotech is a licensed manufacturer for Dok1 Max syrup and tablet for export purpose granted by Drugs Controller, Uttar Pradesh. The company’s website throws up an error message.
The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh, for testing, according to people familiar with the matter.
Production of the cough syrup is currently suspended, Ministry officials said adding that it is currently not sold in India.
The Uzbekistan Health Ministry, in a statement, said that 18 out of 21 children diagnosed with acute respiratory disease died from taking the cough syrup Dok-1 Max. With paracetamol being one of the active ingredients in Doc-1 Max, the ministry said that parents incorrectly used it as an anti-cold remedy on the recommendation of local pharmacies. The ministry report there said, primary laboratory studies have shown the presence of ethylene glycol, which is toxic, in the syrup. (Ethylene glycol is commonly found in industrial-grade glycerine, which should not be used in pharmaceutical products.)
Gambia Child Deaths
Earlier this year, Maiden Pharma faced similar allegations in Gambia.
A preliminary investigation conducted by the police in Gambia found that the death of 69 children from acute kidney injury was linked to using four cough syrups manufactured by Maiden Pharma. Following the incident, Indian authorities had halted all production at Maiden Pharmaceuticals, but on December 15, the government informed the Parliament that the control samples of four cough syrups linked to the death of children in Gambia were found to be of standard quality.
A senior health ministry official said, Maiden Pharma will have to follow good manufacturing practices and is currently awaiting clearance for re-opening of facilities.
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