Indian Pharma Makes Changes After Cough Syrup Kills Uzbek Children

@dreamstime

The deaths of several children in Uzbekistan caused by Marion Biotech’s Dok-1 Max cough syrup have prompted the Indian government to make significant reforms in the pharmaceutical sector.

In December 2022 the deaths of 18 children after taking Dok-1 Max were reported, but the cases didn’t receive much publicity — despite Marion Biotech then losing its license to sell that drug in March 2023. Sales of the syrup continued, and in August 2023 details emerged about 65 more child deaths from the same syrup. Local media reported that during the trial prosecutors said that officials had received a $33,000 bribe to not test the drug.

As a result, 21 managers and employees of Quramax Medikal LLC, the Pharmaceutical Industry Development Agency and the Indian State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment were put on trial.

The Indian Ministry of Health conducted inspections of all pharmaceutical plants in the country and, as it turned out, in addition to a lack of testing of incoming raw materials detected at 162 plants, less than 25% of the existing 8,500 small pharmaceutical plants meet the requirements of WHO international standards.

India has introduced new standards in 2024 to which every company operating in the pharmaceutical industry will have to adhere. According to Tafsilar news agency, the new decrees gave large factories no more than six months to bring everything in line with international standards, while smaller factories were given a year.