High-value and heavily regulated on both sides, with a trade deal that just opened a $572 billion door.
Book a 30-minute callIndia's domestic pharmaceutical market is valued around $50 billion and growing 10 to 12 percent annually, but the more interesting India-inbound story for European partners is India's position as the world's largest generic and biosimilar manufacturer, contributing over half the global vaccine supply. European pharmaceutical and MedTech companies increasingly use India for contract manufacturing and R&D partnerships specifically to combine European quality systems with Indian production cost structures.
India's pharmaceutical exports crossed $30 billion in FY 2024-25, with Europe absorbing around 19 percent, a small fraction of what's now possible. The new trade agreement eliminates tariffs on over 90 percent of tariff lines, tariffs that ran as high as 27.5 percent on pharmaceuticals, and opens access to a $572.3 billion EU pharmaceuticals and medical devices market where India currently holds only a 2 to 3 percent share despite its manufacturing scale. That gap between capability and market share is the actual opportunity.
Pharmaceutical manufacturing and sale runs through CDSCO oversight, with select devices under dual BIS/CDSCO regulation (IS 15748 and related standards).
EU pharmaceutical market access requires separate regulatory approval pathways (EMA and national authorities) entirely independent of the new trade agreement's tariff cuts, tariff relief doesn't shortcut a marketing authorisation, the two processes run on completely different tracks.