Over 100 Indian cough syrup samples fail quality tests, linked to deaths

Some of these collected samples contained the same toxins found in cough syrups linked to the deaths of children in Gambia, Uzbekistan, and Cameroon

Cough syrup samples from over 100 pharmaceutical units in the country did not pass quality tests, according to a government report cited by The Economic Times.

The report indicates that some of these samples contained the same toxins found in cough syrups linked to the deaths of children in Gambia, Uzbekistan, and Cameroon.

The Central Drugs Standard Control Organisation’s (CDSCO) report classified these substandard batches as “not of standard quality” (NSQ) due to issues with diethylene glycol (DEG), ethylene glycol (EG), assay, microbial growth, pH, and volume.

The report, presented to the Ministry of Health and Family Welfare, found that out of 7,087 batches tested, 353 were deemed NSQ. Nine batches were particularly problematic due to the presence of diethylene glycol and ethylene glycol.

According to the report, 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.”

Following reports that connected India-produced cough syrups to 141 child deaths globally, various laboratories, both government-run and private, across the country have been performing tests.

Children deaths in Gambia

The scrutiny of Indian cough syrups intensified after the World Health Organisation (WHO) in October 2022 indicated that the deaths of around 70 children in Gambia from acute kidney injury (AKI) might be linked to cough and cold syrups manufactured in India.

In response, the CDSCO, with assistance from state drug control departments, has been inspecting cough syrup production facilities and propylene glycol distributors to trace the supply chain.

The report quoted an official as saying, “The manufacturers have been sensitised on the use of pharma-grade propylene glycol.”

In May last year, the Drugs Controller General of India (DCGI) instructed state drug controllers to direct their state-run NABL-accredited labs to prioritise the analysis of cough syrup samples from manufacturers intended for export and to issue test reports promptly.

Additionally, starting last June, the Directorate General of Foreign Trade (DGFT) required cough syrup exporters to have their products tested at government laboratories and to provide a certificate of analysis (CoA).

An inquiry by the United States Centres 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), which contributed to acute kidney injury (AKI) clusters among children.