How poisoned cough syrups changed excipient testing rules
What this tab covers How it is regulated and what could disrupt supply: hazard classification, rules in the EU, US and India, anti-dumping duties and other trade measures, and supply-risk notes.
Hazards
Classification
UN number
Key risks
mostly not classified; combustible dust
not regulated
Dust explosions in spray dryers and mills; contamination with toxic impurities (e.g. diethylene glycol in glycerine or propylene glycol).
FDA guidance on testing glycerin and propylene glycol for DEG and EG (2023)
after fatal contaminated syrup cases
India
Rule
Effect
Mandatory DEG and EG testing of excipients and cough syrups for export (2023) after deaths in Gambia and Uzbekistan linked to Indian syrups
stricter excipient testing
Factories Act and state safety rules; Sigachi explosion (June 2025) prompted inspections (indicative)
process safety focus
Supply risk
Generally low, but single-source branded grades and contamination risks are real. The DEG contamination cases (2022-2023) showed the cost of weak excipient quality control.