Weeks after the Uzbek Health Ministry linked the deaths of 18 Samarkand children to a syrup manufactured by Noida-based Marion Biotech, the World Health Organisation Wednesday raised an alert over two products by the firm. This prompted another round of inspections on Thursday by the country’s apex drug regulator and the state drug controller to collect samples for the second medicine. After the incident was first highlighted by Uzbekistan, drug regulators had conducted two inspections at Marion’s manufacturing unit, sent a show cause notice for “deviations” from good manufacturing practices and halted all production. The Indian Express had reported that some of the “deviations” included specifications for conducting certain tests that were not followed, pressure differences between areas that weren't maintained, and some gauges used to record pressure differences that weren’t working. The samples collected Thursday were sent to the Regional Drug Testing Laboratory in Chandigarh. “The licence of the firm was suspended on January 9 after they failed to reply to the show cause notice. Further, prosecution will be launched against the company under the drugs and cosmetics act based on whether the contaminants are found in the control samples,” said a senior official aware of the matter. The control samples — samples from the same batch exported to Uzbekistan — are stored by the company as part of quality control measures. “Now, the samples of the second medicine as per the WHO alert have also been collected and sent for testing,” the official said. The WHO alert on Wednesday states that the contaminants were found in four batches of Ambronol syrup set to expire between August 2024 and December 2025 and 17 batches of Dok-1 Max set to expire between August 2024 and July 2025. The WHO alert urged people to not use the two anti-phlegm syrups and asked regulatory authorities to “detect and remove these substandard products from circulation to prevent harm to patients”. The alert says that the products were found to have the contaminant di-ethylene glycol or ethylene glycol when tested by Uzbekistan's national quality control laboratory. The advice to regulatory authorities from the WHO states that all medical products should be obtained from authorised or licensed sellers and their authenticity and physical condition must be checked. It also urged manufacturers of syrups that use propylene glycol, polyethylene glycol, sorbitol, glycerine, or glycerol to test for these contaminants before use in medicines. These solvents are the most likely source of the contaminants in the syrups. This advice comes after the WHO has had to raise three medical product alerts in the last four months where the syrups were found to have ethylene glycol or di-ethylene glycol, including syrups manufactured by another Indian firm exported to the Gambia. At least 18 of 21 children admitted to hospitals in Samarkand reportedly died of kidney damage and failure, with an Uzbek health ministry statement linking the deaths to one of the syrups mentioned in the WHO alert – Dok-1 Max. As per the statement, preliminary laboratory studies indicate the presence of ethylene glycol in the particular batch of the syrup. It, however, goes on to say that the syrup was incorrectly used by parents as an anti-cold remedy without prescription and in higher doses than appropriate for the ages. The action is similar to the one taken in case of the Gambia deaths against Maiden Pharma, where the production was halted for lapses in paper work and good manufacturing practices. Although India maintains that they have not received any data from the Gambia or the WHO to establish causal link between the deaths of the 70 children and the four syrups manufactured by Maiden, Gambia’s parliamentary panel has said that the Indian company was culpable and that legal action must be initiated. "The presenting symptoms and progression of the cases was noted to be consistent with poisoning through diethylene glycol. The children were also noted to may have been exposed to the two products," WHO said in a statement to The Indian Express. "Amounts of diethylene glycol and/or ethylene glycol above the acceptable limits were found in the tested samples,” it said. “The three levels of WHO (HQ, Regional Office and Country Office) are collaborating with the authorities in Uzbekistan,”
