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India initiates proceeds against Doc-1 Max manufacturer in connection with death of 18 children in Uzbekistan

India’s SK Todays News reported on December 29 that the Central Drugs Standard Control Organization (CDSCO) said it has initiated a probe in connection with the death of 18 children in Uzbekistan “allegedly linked to a cough syrup manufactured by an Indian firm.”

Official sources reportedly 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 the north zone and the state drugs regulatory team was also taken during which samples were lifted.

Recall, the Health Ministry of Uzbekistan said on December 27 that 18 out of 21 children have died after taking the medicinal syrup manufactured by the Indian pharmaceutical company for relief of cold and flu symptoms.

The syrup, which is manufactured by the Indian company Marion Biotech, was imported to Uzbekistan by Quramax Medical LLC, the ministry said.

According to the ministry, the chemical ethylene glycol was found in a batch of syrup during laboratory tests.

The press service of the Uzbek ombudsman says the chief physician of the Samarkand Regional Children's Multidisciplinary Medical Center said in a letter dated December 15 to the head of the regional health department that the 21 children who took Doc-1 Max "showed signs of kidney damage and kidney failure."

The patients were from the Jizzaq, Samarkand, Navoi, and Qashqadaryo regions.  All 21 children were under 6 years old; 15 of them were under 3 years old.  The three children who recovered have been discharged from the hospital.

According to SK Todays News, Mr. Hasan Harris, the 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.

Manufacturing of that product has reportedly been halted as of now and other processes are underway.  

SK Todays News further noted that earlier this year, the 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 down for violation of manufacturing standards.  However, later the samples tested in a government laboratory in India were found to be complying with specifications. 

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