Indian Cough Syrup: Toxic Samples Linked to Global Child Deaths
Indian Cough Syrup: Toxic Samples Linked to Global Child Deaths
In a disturbing revelation, more than 100 cough syrup samples from Indian pharmaceutical units have failed quality tests, with some found to contain the same toxins linked to the deaths of children in Gambia, Uzbekistan, and Cameroon. This alarming information comes from a government report.
The report from the Central Drugs Standard Control Organisation (CDSCO) categorized these substandard batches as “not of standard quality” (NSQ) due to issues such as the presence of diethylene glycol (DEG), ethylene glycol (EG), assay problems, microbial growth, pH imbalances, and volume discrepancies.
According to the report presented to the Ministry of Health and Family Welfare, out of 7,087 batches tested, 353 were classified as NSQ. Particularly concerning were nine batches found to contain diethylene glycol and ethylene glycol. These toxic substances were also identified in the cough syrups linked to the deaths of children globally, attributed to an “unsecured supply chain and failure to test the propylene glycol bulk for DEG/EG.”
The scrutiny of Indian cough syrups intensified after the World Health Organisation (WHO) in October 2022 suggested that the deaths of around 70 children in Gambia from acute kidney injury (AKI) could be linked to Indian-manufactured cough and cold syrups. Following reports connecting these syrups to 141 child deaths worldwide, various laboratories across India have been conducting extensive tests.
In response to these findings, the CDSCO, along with state drug control departments, has been inspecting cough syrup production facilities and propylene glycol distributors to trace the supply chain. Manufacturers have been made aware of the necessity to use pharma-grade propylene glycol.
Last May, the Drugs Controller General of India (DCGI) directed state drug controllers to prioritize the analysis of cough syrup samples intended for export in their state-run NABL-accredited labs and to issue test reports promptly. Additionally, starting in June, the Directorate General of Foreign Trade (DGFT) mandated that cough syrup exporters have their products tested at government laboratories and provide a certificate of analysis (CoA).
An inquiry by the United States Centers for Disease Control and Prevention and Gambian researchers indicated that the deaths in the small West African nation were likely caused by imported medications contaminated with diethylene glycol (DEG) and ethylene glycol (EG). This could lead to acute kidney injury clusters among children.
