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