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Over 100 Indian cough syrup samples fail quality tests, linked to deaths
The Central Drugs Standard Control Organisation (CDSCO) report identified these substandard batches as "not of standard quality" (NSQ) due to the presence of diethylene glycol (DEG), ethylene glycol (EG), assay discrepancies, microbial growth, pH imbalances, and volume inconsistencies.
- By Newsdesk
- New Delhi
- Jul 24, 2024
A government report, cited by The Economic Times, has revealed that cough syrup samples from more than 100 pharmaceutical units across India failed quality tests. Some of these samples contained toxins linked to fatal incidents in children from Gambia, Uzbekistan, and Cameroon.
The Central Drugs Standard Control Organisation (CDSCO) report identified these substandard batches as "not of standard quality" (NSQ) due to the presence of diethylene glycol (DEG), ethylene glycol (EG), assay discrepancies, microbial growth, pH imbalances, and volume inconsistencies.
Presented to the Ministry of Health and Family Welfare, the report noted that out of 7,087 batches tested, 353 were found to be NSQ. Particularly concerning were nine batches that contained diethylene glycol and ethylene glycol.
The report attributed the DEG/EG failures to "an unsecured supply chain and the failure to test the propylene glycol bulk for DEG/EG, among other factors."
Following global reports linking Indian-made cough syrups to 141 child deaths, extensive testing has been conducted by various laboratories across the country.
Child Deaths in Gambia
The scrutiny of Indian cough syrups increased after the World Health Organization (WHO) reported in October 2022 that around 70 children in Gambia died from acute kidney injury (AKI), potentially linked to Indian-manufactured cough and cold syrups.
In response, the CDSCO, along with state drug control departments, has been inspecting cough syrup production facilities and propylene glycol distributors to trace the supply chain. An official noted, "The manufacturers have been sensitized on the use of pharma-grade propylene glycol."
Last May, the Drugs Controller General of India (DCGI) directed state drug controllers to have their state-run NABL-accredited labs prioritize the analysis of cough syrup samples intended for export and to issue test reports promptly.
Additionally, since June, the Directorate General of Foreign Trade (DGFT) has mandated that cough syrup exporters have their products tested at government laboratories and provide a certificate of analysis (CoA).
An investigation by the United States Centers for Disease Control and Prevention and Gambian researchers suggested that the deaths in Gambia were likely caused by imported medications contaminated with diethylene glycol (DEG) and ethylene glycol (EG), leading to acute kidney injury (AKI) clusters among children.