# Pharmaceutical excipients: Regulation

How poisoned cough syrups changed excipient testing rules

Source page: https://www.materialinsights.org/chemicals/excipients/regulation/

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). |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **Global** | Pharmacopoeia monographs (USP-NF, Ph. Eur., IP); IPEC-PQG excipient GMP | quality and documentation requirements |
| **US** | 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.

## Other sections

- [Summary](https://www.materialinsights.org/chemicals/excipients/index.md)
- [Overview](https://www.materialinsights.org/chemicals/excipients/overview/index.md)
- [Correlation](https://www.materialinsights.org/chemicals/excipients/correlation/index.md)
- [Production route](https://www.materialinsights.org/chemicals/excipients/routes/index.md)
- [Production](https://www.materialinsights.org/chemicals/excipients/production/index.md)
- [Feedstocks](https://www.materialinsights.org/chemicals/excipients/feedstocks/index.md)
- [Cycles](https://www.materialinsights.org/chemicals/excipients/cycles/index.md)
- [Trading](https://www.materialinsights.org/chemicals/excipients/trading/index.md)
- [Movement](https://www.materialinsights.org/chemicals/excipients/movement/index.md)
- [Characteristics](https://www.materialinsights.org/chemicals/excipients/characteristics/index.md)
- [Emissions](https://www.materialinsights.org/chemicals/excipients/emissions/index.md)
- [Relationships](https://www.materialinsights.org/chemicals/excipients/links/index.md)