Paracetamol: Regulation

How price caps and dose limits shape paracetamol sales

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.