# Pharma starting materials and intermediates: Regulation

Why switching a starting material supplier takes years

Source page: https://www.materialinsights.org/chemicals/ksm_intermediates/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 |
|---|---|---|
| varies: acute toxicity, skin sensitisation, aquatic toxicity (e.g. para-aminophenol is acute tox 4, muta 2, aquatic chronic 1) | varies | Nitration and hydrogenation are runaway and explosion hazards; effluent is high in COD and salts. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **EU** | REACH registration for intermediates over 1 t/yr | documentation cost |
| **US** | ICH Q11 defines KSM selection; FDA scrutinises KSM justification | changing KSM supplier needs change control |

#### India

| Rule | Effect |
|---|---|
| **PLI scheme for bulk drugs (2020): 41 products, 20% incentive on sales for fermentation products in early years, 10% for chemical synthesis** | subsidy for import substitution |
| **Scheme for Promotion of Bulk Drug Parks: three parks with central grant support (2020)** | common utilities and effluent plants |
| **MSIHC Rules 1989; Factories Act; state pollution control board consent** | hazard and effluent controls |

#### Trade measures

- MIP on penicillin G, 6-APA, amoxicillin (Jan 2026, one year)
- DGTR anti-dumping probes (Sept 2026): penicillin G (China), 6-APA (China and EU), amoxicillin trihydrate (China)

#### Supply risk

India's most acute pharmaceutical supply risk. 53 critical APIs were identified by the Department of Pharmaceuticals for PLI support because of high Chinese dependence.

## Other sections

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