Pharma starting materials and intermediates: Regulation
Why switching a starting material supplier takes years
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.
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.