India can strengthen its position as a truly global pharma hub by leveraging recent regulatory gains, trade negotiations, and supply-shortage opportunities in Brazil and Germany while systematically reducing API dependence on China and moving up the value chain into complex generics and biosimilars. The window is open: Brazil is signaling faster approvals and deeper cooperation, Germany is pushing supply diversification amid persistent shortages, and India’s compliance metrics and export momentum have materially improved in FY25, creating a credible springboard beyond a heavy U.S. tilt.
Where momentum stands
India’s pharmaceutical exports reached about $30.5 billion in FY25, up 9.3% year-on-year, underscoring sustained global demand for Indian-made medicines despite trade headwinds. The U.S. remains the single-largest destination at roughly 30–37% of India’s pharma exports, prompting policymakers and industry to diversify for resilience and market balance. Recent export dashboards show Europe, Africa, and Latin America collectively accounting for a large share of outbound shipments, with Brazil among the top five markets in May 2025.
Why Brazil and Germany now
Brazil is courting Indian manufacturers: diplomatic readouts indicate exploration of fast-track pathways for medicines already authorized by major regulators, growing local presence of Indian firms, and ANVISA’s newly enhanced cooperation footprint in India, lowering friction for dossier reviews and inspections.
On-the-ground momentum is visible—Indian sites continue securing ANVISA GMP and plant approvals, enabling faster product registrations and launches in Latin America’s largest pharma market. Germany, meanwhile, faces stubborn medicine shortages despite new legislation (ALBVVG) and supplementary measures, creating room for reliable suppliers that can meet quality, stockpiling, and multi-sourcing criteria.
The demand signal from Germany
German reforms emphasize diversification of supply chains, stockpiling, and greater flexibility in pricing and contracting—particularly for generics and pediatric/antibiotic categories that faced severe shortages, which favors partners who can assure steady volumes and rapid response. Shortages have persisted, with hundreds of molecules under strain, and the health minister’s public stance has kept supply security at the forefront of policy, opening doors to credible non-EU suppliers that can meet strict standards. India already supplies close to $1 billion of pharma products to Germany annually, indicating a base to scale from with targeted filings and local partnerships.
Policy tailwinds and trade lanes
Commerce Minister Piyush Goyal has mapped out an export-led agenda, signaling record overall exports in 2025 and underscoring how FTAs can unlock market access for value-added healthcare goods. Negotiations with the EU are reported as advancing, with officials signaling a two-phase closure approach and broader alignment on market access—both important for smoother entry into Germany and the wider single market. On Brazil, leaders have publicly discussed regulatory alignment and industry expansion, creating political cover for technical agencies to accelerate cooperation.
But fix the weak link: APIs
India still relies on China for an estimated 65–80% of APIs and key starting materials, a strategic vulnerability that can undercut credibility as a dependable global supplier during shocks. The recent fall in API prices eases margin pressure and offers a tactical window to invest in backward integration and alternative sourcing without immediate cost spikes. Sustained API resilience—via domestic capacity, diversified imports, and KSM investments—will be essential to convert short-term export wins into durable “hub” status.
Compliance edge is emerging
India’s footprint of global-standard facilities continues to expand, with hundreds of FDA, WHO-GMP, and EDQM-approved plants and a measurable reduction in major compliance observations over the past decade. This compliance uplift, coupled with targeted ANVISA inspections and certifications, is precisely what Brazil and Germany require to trust large, multi-year tenders and shortage-reduction plans. Regulatory convergence dialogues—like those spotlighted at iPHEX—can further reduce duplication and accelerate approvals across agencies.
Expert advice: actionable plays
- Build regional presence: For Germany, complement filings with EU-based packaging/stockholding and partnerships to align with diversification and stockpiling rules; for Brazil, deepen ANVISA-facing capabilities and local distribution to capitalize on fast-track pathways.
- Climb the value curve: Focus on complex generics, sterile injectables, and selected biosimilars to meet shortage-sensitive and specialty needs; sector roadmaps and analyses show sizeable global headroom this decade.
- De-risk APIs: Use the current dip in API prices to accelerate backward integration, KSM investments, and second-source qualification programs across portfolios.
- Dual-ready compliance: Institutionalize “multi-agency by design” quality systems, drawing on guidance and convergence forums that cut timelines and reduce rework for ANVISA, EMA, and FDA.
- Target shortage lists: Prioritize antibiotics, pediatric formulations, and oncology injectables aligned to German policy signals, ensuring supply commitments, safety stocks, and pricing mechanics fit ALBVVG updates.
What politicians said
Piyush Goyal has repeatedly linked export growth to FTA-led market openings, arguing that new agreements will unlock scale, quality, and innovation across healthcare manufacturing and services. In Brazil, President Lula signaled openness to the expansion of Indian producers, while India proposed closer collaboration on regulatory reliance and knowledge-sharing—political alignment that supports technical fast-tracks. In Germany, Health Minister Karl Lauterbach has underscored the severity of shortages and moved to make Germany more attractive for suppliers, reinforcing a policy environment that rewards reliable, diversified sourcing.
Engagement ideas to make this resonate
- Launch a “Brazil–Germany Market Readiness Tracker” highlighting ANVISA approvals, EMA/FDA inspection outcomes, and plant certifications to demonstrate readiness and reliability for buyers.
- Run a “Diversify Beyond the U.S.” poll using fresh export splits to invite stakeholder views on the next high-potential corridors (e.g., Germany, Netherlands, Brazil).
- Publish a shortage playbook for Germany mapping ALBVVG requirements to Indian capabilities and case studies where rapid supply alleviated bottlenecks.
- Visualize export gains by region with recent Pharmexcil data to show traction beyond the U.S. in Europe and Latin America.
Verdict
India can absolutely consolidate status as a truly global pharma hub if export diversification to Brazil and Germany is paired with API resilience, complex-product depth, and systematic regulatory convergence. The combination of policy tailwinds, compliance upgrades, and shortage-driven demand offers a timely, credible pathway from “pharmacy of the world” to a broader, innovation-leaning, reliability-led global hub.
