# Chiral and specialty building blocks: Regulation

How a 1992 FDA policy made single-handed drugs the norm

Source page: https://www.materialinsights.org/chemicals/chiral_building_blocks/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 by compound | varies; many not regulated | Product quality risk (wrong enantiomer, metal or solvent residues) matters more than transport hazard. |

#### Main rules

| Where | Rule | Effect |
|---|---|---|
| **US** | FDA policy on stereoisomeric drugs (1992); ICH Q6A, Q11 (starting materials), Q3C (solvents), Q3D (metals) | single-enantiomer development and strict impurity limits |
| **EU** | EU GMP Part II for APIs; REACH for intermediates over 1 t/yr | supplier audits and registration costs |
| **US** | BIOSECURE Act (section 851 of the FY2026 NDAA, signed 18 Dec 2025): bars US federal contracts and grants involving listed Chinese biotechnology companies of concern; OMB list due by Dec 2026 | pushes sourcing to non-Chinese CDMOs |

#### India

| Rule | Effect |
|---|---|
| **PLI scheme for key starting materials, drug intermediates and APIs (2020, about Rs 6,940 crore, indicative)** | incentives for local KSM and intermediate production |
| **Revised Schedule M (GMP) under the Drugs and Cosmetics Rules (indicative)** | higher quality requirements for pharma plants |
| **MSIHC Rules 1989; state pollution board consent** | effluent and solvent controls |

#### Trade measures

- US tariffs and supply-chain rules on Chinese pharmaceutical inputs (indicative)

#### Supply risk

High dependence on China for many advanced intermediates and resolving agents (indicative). Pharmaceutical supply chains are treated as strategic by the US, EU and India.

## Other sections

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