Production at Marion Biotech, a pharmaceutical company based in Noida, continues to be suspended following allegations that its cough syrup caused the deaths of 18 children in Uzbekistan last year, according to Shashi Mohan Gupta, Uttar Pradesh Deputy Commissioner (Drugs). The company remains under an order to submit a Corrective and Preventive Actions (CAPA) plan, and production remains halted as of the latest inspection. Gupta clarified that despite media reports suggesting a resumption of production, no such orders have been issued by the state government.
The controversy surrounding Marion Biotech emerged after reports indicated that the September 14 order by the state government allowed partial production to resume. However, Gupta and Noida drug inspector Vaibhav Babbar both affirmed that production has not restarted since the suspension order was issued in December 2022.
Marion Biotech faced severe consequences when the license for its manufacturing unit was revoked in December 2022. This action was taken after the Uzbekistan government discovered contamination of Marion Biotech’s ‘Dok1 Max syrup’ and ‘Ambronol cough syrup’ with diethylene glycol (DEG). DEG is an industrial solvent used as an antifreeze agent but is prohibited by WHO standards due to its lethality, even in small quantities.
Gupta emphasized that the company’s CAPA plan needs to be submitted and evaluated by the Drugs Controller General of India (DCGI) before any decision on lifting the production suspension can be made. Babbar echoed this sentiment, clarifying that the manufacturing plant has remained inactive and no production is taking place.
The episode highlights the stringent regulatory measures and safety standards enforced by authorities in response to health-related concerns. The case underscores the importance of adherence to global health standards in the pharmaceutical industry to ensure the safety and well-being of consumers. The suspension serves as a precautionary measure until the company can demonstrate corrective actions to address the issues raised during the investigation.
