More than a hundred Indian cough syrups fail quality tests, contain toxins linked to deaths in Gambia, Uzbekistan, and Cameroon
The report submitted to the Ministry of Health and Family Welfare revealed that, out of the total 7,087 tested batches, 353 were classified as NSQ.
In a shocking revelation from the Central Drugs Standard Control Organisation’s (CDSCO) report, over a hundred Indian cough syrups fail quality tests. Some of these samples were reportedly contaminated with the same toxin linked to the deaths of children in Gambia, Uzbekistan, and Cameroon.
CDSCO classified these substandard samples as “not of standard quality” (NSQ) due to issues with diethylene glycol (DEG), ethylene glycol (EG), assay, microbial growth, pH, and volume.
Supply Chain and Testing Failures
The report submitted to the Ministry of Health and Family Welfare revealed that, out of the total 7,087 tested batches, 353 were classified as NSQ, and nine batches were notably concerning due to contamination with diethylene glycol and ethylene glycol.
The report claims that the failures related to DEG/EG were attributed to an “unsecured supply chain and failure to test the propylene glycol bulk for DEG/EG, among others.”
Global Concerns and Impact
The CDSCO, along with state drug control departments, has been inspecting cough syrup production facilities and propylene glycol distributors to track the supply chain.
After a few reports accused some Indian cough syrups of the death of 141 children worldwide, private and government laboratories have been running tests on various samples.
In 2022, the World Health Organisation (WHO) claimed that the deaths of around 70 children in Gambia from acute kidney injury could be linked to the Indian-manufactured cough and cold syrup. This claim further intensified the investigation of the Indian cough syrups.
Last year in May, the Drugs Controller General of India (DCGI) instructed the state drug controllers to direct their state-run NABL-accredited labs to prioritise the examination of cough syrup samples from manufacturers intended for export and to issue test reports without any delay.
Furthermore, since last June, the Directorate General of Foreign Trade (DGFT) has mandated that cough syrup exporters have their products tested at government laboratories and submit a certificate of analysis (CoA).
Inquiring on the case, the United States Centres for Disease Control and Prevention and Gambian researchers found out that the deaths in the minor West African nation can be credited to the imported medications contaminated with diethylene glycol (DEG) and ethylene glycol (EG), which caused the acute kidney injury (AKI) clusters among children.
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