New mission targets biologics, biosimilars, and clinical research as India tackles rising chronic diseases
The Union Budget 2026 sharpens India’s biopharma ambitions. Finance minister Nirmala Sitharaman announced Biopharma SHAKTI, a five-year, INR 10,000 Cr mission to scale research, manufacturing, and innovation in biotechnology and pharmaceuticals.
Building a Domestic Biologics Ecosystem
Can India move from generics leadership to biologics scale?
The mission—Strategy for Healthcare Advancement through Knowledge, Technology and Innovation—aims to create a robust ecosystem for domestic production of biologics and biosimilars.
- Focus areas include advanced R&D, manufacturing capacity, and translational innovation.
- The push positions India as a global biopharma manufacturing hub, not just a volume producer.
Biologics, the FM noted, are central to longevity and quality of life, especially when made affordable at scale.
Institutions, Trials, and Regulation
What if clinical research moved as fast as manufacturing?
Under Biopharma SHAKTI, the Centre will build a biopharma-focused network by:
- Setting up three new National Institutes of Pharmaceutical Education and Research (National Institute of Pharmaceutical Education and Research).
- Upgrading seven existing institutions.
- Creating a network of 1,000 accredited clinical trial sites across India.
The government will also strengthen the Central Drugs Standard Control Organisation to align regulatory processes with global standards—critical for faster approvals and trust.
Addressing India’s NCD Burden
Why does biopharma matter now?
Sitharaman linked the initiative to the surge in non-communicable diseases (NCDs)—including diabetes, cancer, and autoimmune disorders—which are driving higher mortality.
- NCDs now account for over 63% of total deaths, up from 37.9% in 1990.
- These conditions contribute to roughly 5.87 Mn deaths annually, driven largely by lifestyle shifts.
Biologics and biosimilars are increasingly central to managing these chronic diseases effectively.
India’s Gap in Biologics
Can SHAKTI close the biologics deficit?
India ranks third globally in pharmaceutical production by volume and leads in generics and vaccines. Yet, it trails in biologics.
- Despite 95+ approved biosimilars domestically, India held only ~3.2% of the global biosimilars market in 2025.
- Biopharma SHAKTI targets this gap by strengthening trials, talent, and regulation together.
Industry View: Fixing the Foundations
Will this accelerate clinical research quality?
According to Indian Society for Clinical Research president Seema Pai, the initiative addresses long-standing gaps in trial readiness, skilled manpower, and globally aligned regulatory practices.
- She expects faster, higher-quality clinical research outcomes.
- The emphasis on collaboration—academia, industry, policymakers, and patients—could lift India’s global credibility.
Think of it as upgrading the entire pipeline, not just the final factory.
TL;DR
Budget 2026 launches Biopharma SHAKTI, a INR 10,000 Cr mission to scale biologics, biosimilars, institutions, and clinical trials as India tackles rising chronic diseases.
AI summary
- INR 10K Cr biopharma mission over five years
- Focus on biologics and biosimilars
- New and upgraded NIPERs plus 1,000 trial sites
- Stronger drug regulation via CDSCO
- Targets rising NCD burden
