Potent compounds, multipurpose plants and the rules that keep them safe
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
product-specific
product-specific
Process safety in multipurpose plants, containment of potent compounds, data integrity.
Main rules
Where
Rule
Effect
US
BIOSECURE Act (FY2026 NDAA, signed 18 Dec 2025): bars federal procurement, contracts and grants involving biotechnology companies of concern; OMB list due Dec 2026; grandfathering for 5 years
pushes US customers to diversify from WuXi
US
DoD 1260H list: WuXi AppTec added 8 June 2026 (after a brief Feb 2026 listing withdrawn the same day); preliminary injunction granted 7 Aug 2026 by the US District Court for the District of Columbia
legal uncertainty
EU and US
GMP inspections, data integrity (ALCOA)
inspection outcomes decide access
India
Rule
Effect
Revised Schedule M GMP; CDSCO; USFDA inspections of Indian sites
quality gate for CDMO work
PLI for pharmaceuticals (Rs 15,000 crore) and Promotion of Research and Innovation in Pharma (PRIP)
support for complex manufacturing and R&D (indicative)
Patents Act and trade secret protection
IP security is a key customer concern
Trade measures
US BIOSECURE Act (2025)
US Section 232 investigation on pharmaceuticals (2025)
Supply risk
Innovator supply chains rely heavily on WuXi and a few Western CDMOs. A forced exit from Chinese CDMOs would take years because of tech transfer and re-validation.