# Paracetamol: Regulation

How price caps and dose limits shape paracetamol sales

Source page: https://www.materialinsights.org/chemicals/paracetamol/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 |
|---|---|---|
| acute toxicity oral cat 4, skin sensitisation (supplier SDS, indicative) | not regulated | Overdose causes liver failure; dust explosion risk in milling. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **EU and UK** | Pack-size limits on OTC sales | limits demand per purchase |
| **US** | FDA limit of 325 mg per dose unit in prescription combinations (2011) | reformulation of combinations |

#### India

| Rule | Effect |
|---|---|
| **DPCO 2013 ceiling prices for paracetamol formulations (NLEM)** | caps formulation prices |
| **PLI scheme includes para-aminophenol as a chemical-synthesis KSM** | Meghmani 13,500 t/yr plant |
| **Export restriction March-May 2020** | showed India may curb exports in emergencies |

#### Trade measures

- Indian anti-dumping duty on Chinese paracetamol (2001, renewed 2013)

#### Supply risk

Production is concentrated in India and China, and India's PAP has depended on China. Governments treat paracetamol as an essential medicine.

## Other sections

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