A day after the World Health Organization (WHO) warned against the use of two Indian cough syrups for children that have been linked to deaths in Uzbekistan, Uttar Pradesh drug department suspended production licence of the manufacturer of the drug, Marion Biotech, even as the test results of its controversial cough syrup are awaited.
A team of central agencies and the Uttar Pradesh drug department on Thursday carried out a fresh inspection at Marion Biotech's office here, a day after the World Health Organisation (WHO) issued a medical product alert on Ambronol and Dok-1 Max syrups, both manufactured by the firm.
The Central Drugs Standard Control Organisation (CDSCO), India's central regulatory body for pharmaceuticals and medical devices, had in December initiated a probe in connection with the death of 18 children in Uzbekistan allegedly linked to Marion Biotech's cough syrup.
The Health Ministry of Uzbekistan claimed these children had consumed the cough syrup. The central and state teams had earlier carried out an inspection at the firm's office on December 29 and taken six samples of Dok-1 Max for testing, while on Thursday they took four samples of Ambranol, the official told a news agency. During the December 29 inspection, the firm representatives could not produce documents related to the production of 'Dok-1 max' cough syrup, prompting the government to order halting of its production immediately, the official added.
"The production licence of the firm remains suspended, as was ordered on December 29. Now the suspension order has been issued in writing to the firm on January 10 and has been acknowledged by the firm," he said.
"On Thursday a fresh inspection was done during which four samples of Ambranol cough syrup were taken for testing. Documents related to Ambranol production were also examined," he said. On the status of the test results, the officer said the samples were taken by the central agencies and their results are yet to arrive.
Marion Biotech did not sell 'Dok-1 Max' and Ambronol in India and its only export has been to Uzbekistan, according to records and as per estimates, the company exported around 1 lakh Dok-1 Max syrups in 45 days. On Wednesday, the WHO also issued a 'medical product alert', referring to two substandard (contaminated) products, identified in Uzbekistan and reported to it on December 22, 2022. According to WHO, substandard medical products are those that fail to meet quality standards or specifications and are therefore "out of specification." "The two products are AMBRONOL syrup and DOK-1 Max syrup. The stated manufacturer of both products is MARION BIOTECH PVT. LTD, (Uttar Pradesh, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," the WHO stated.
"Laboratory analysis of samples of both products, undertaken by national quality control laboratories of the Ministry of Health of the Republic of Uzbekistan found both products contained unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants," it said.