All manufacturing activities at Noida-based pharmaceutical firm Marion Biotech, which was linked to the deaths of children in Uzbekistan, have been stopped, Union Health Minister Mansukh Mandaviya said on Friday.
The Indian drug maker’s Dok-1 Max cough syrup contained ethylene glycol, a toxic substance, Uzbekistan’s health ministry had said on Tuesday. Syrups are ideally not supposed to contain even traces of ethylene glycol, which is found in industrial grade of glycerine that is not permitted for medicinal purposes.
Uzbekistan’s health ministry had said that 18 children in Samarkand city died after consuming the syrup.
Mandaviya said on Friday that a team of the Central Drugs Standard Control Organisation carried out an inspection in view of reports of contamination of the medicine. Following this, all manufacturing activities of Marion Biotech at its Noida unit have been stopped and further investigation is underway, he said.
The development came a day after a legal representative of Marion Biotech said the company regretted the deaths and has halted production of the Dok-1 Max cough syrup. “There is no problem from our end and no issue in testing,” Hasan Harris claimed. “Once the government report will come, we will look into it.”
The Indian drug regulator reviewed the company’s Noida facility and has been in regular touch with its Uzbekistan counterpart since December 27, the health ministry said on Thursday.
The allegations from Uzbekistan came two months after the World Health Organization issued a global alert advising regulators to stop the sale of four cough syrups made by Haryana-based Maiden Pharmaceuticals.
The Gambia linked 66 child deaths, most of them due to acute kidney failure, to Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup. Last week, a parliamentary committee in The Gambia said Maiden Pharmaceuticals should be held accountable for exporting what it described as contaminated medicines.
However, the Drugs Controller General of India on December 13 wrote to the World Health Organization, saying that it had drawn a premature link between the deaths of the children and the cough syrups. The authority said that samples of the syrups were tested in a government laboratory and found to be complying with specifications.
Maiden Pharmaceuticals had also denied the allegations.
At a press briefing on Thursday, Indian foreign ministry’s spokesperson Arindam Bagchi described the country’s pharmaceutical industry as “a reliable supplier to countries across the world” and said such incidents were taken “very seriously”.
He added that consular assistance is being provided to some who are facing legal action from Uzbek authorities.
The Dok-1 Max tablets and syrups, which have been sold in the country since 2012, were withdrawn from all pharmacies in Uzbekistan after the deaths. A number of specialists are also facing disciplinary action.
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