Indian drug regulator has asked Noida-based Marion Biotech Pvt Ltd to stop all manufacturing activities following the allegation that cough syrups supplied by the company resulted in 18 children dying of acute respiratory disease in Uzbekistan.
According to Union Health Ministry, the Central Drugs Standard Control Organisation (CDSCO) stopped all manufacturing activities of Marion yesterday night following an inspection of the facility by CDSCO and UP drug administration. "In view of the reports of contamination in cough syrup Dok-1 Max, all manufacturing activities of Marion Biotech at Noida unit have been stopped, while further investigation is ongoing," the ministry said.
Union health minister Mansukh Mandaviya had earlier stated that the Indian drug regulatory agency is in regular touch with the national drug regulator of Uzbekistan on the issue.
Following the inspection, the drug regulator sent the sample cough syrup taken from the manufacturing premises of Marion to Regional Drugs Testing Laboratory, Chandigarh for testing.
The Ministry of Health of Uzbekistan had in a press release on December 27 said that an internal inquiry conducted by the regulatory agencies of that country found that the deceased children, before admission to hospital treatment, took Dok-1 Max syrup manufactured by Marion Biotech for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children. It also mentioned that the preliminary laboratory studies conducted by them found that the particular series of Dok-1 Max syrup contained ethylene glycol, a substance that is toxic.
Uzbekistan has withdrawn the tablets and syrups of the drug Dok-1 Max from sale in all pharmacies of the country.
Noida-based Marion Biotech had got tablets and syrup Dok-1 Max registered in Uzbekistan in 2012. The drug was imported into Uzbekistan by a local company Quramax Medical LLC.
Uzbekistan is the second country after Gambia to link child deaths to India-made cough syrups. In the case of Gambia, the CDSCO had said the test results of sample did not show any evidence of contamination of the medicinal product.
