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21 September 2026

India’s Pharma Sector Must Turn Manufacturing Scale Into Original Innovation, CII-EY Roadmap Says

India ranks third globally in pharmaceutical production by volume but 11th by value. A new roadmap argues that leadership by 2047 will depend on trusted quality, original therapies, responsible use of AI and wider patient access rather than market size and exports alone

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Key Details

Launched by the Confederation of Indian Industry and EY-Parthenon India, Vision 2047: India—Building the Innovation Powerhouse of Tomorrow proposes four connected shifts for India’s pharmaceutical and life-sciences sector.

Priority

What It Would Involve

Defend trust

Consistent quality, revised Schedule M compliance, traceability, resilient supplies of critical inputs and climate-ready manufacturing

Differentiate through science

Original drugs, biologics, biosimilars, precision medicine, genomics and cell and gene therapies

Leapfrog through technology

Governed pharmaceutical data, validated AI, digital manufacturing and real-world evidence

Democratise access

Affordability, healthcare financing, faster diagnosis and treatment, and measurable patient outcomes

The report’s evidence shows both the scale of India’s starting position and the distance to higher-value leadership:

  • India supplies around 20% of global generic medicine demand and exports pharmaceuticals to 191 countries.

  • The industry ranks third globally by production volume but 11th by value.

  • The report cites a projection that India’s pharmaceutical market could increase from US$60 billion in FY2026 to US$130 billion by 2030.

  • China supplied at least 70% of India’s imports for 25 bulk drugs, with dependence reaching 100% for some products.

  • India had 11,855 active biotechnology start-ups in 2026 and 95 incubation centres supported by the Biotechnology Industry Research Assistance Council.

  • India accounts for only about 3.2% of global biosimilar revenue, despite having established manufacturing and product-development capabilities.


India’s Scale Advantage Has Yet to Become Value Leadership

India’s pharmaceutical strength rests on affordable generics, vaccines and high-volume manufacturing, but price erosion in major generic markets limits the scope for sustained higher-value growth.

The report frames the next transition as moving from efficient manufacturing towards discovering, developing and owning more of the underlying science—including original medicines, intellectual property, reusable research platforms and advanced therapies.

India already has capabilities in novel antibiotics, biosimilars, antibody-drug conjugates, peptides, precision oncology, and cell and gene therapies. The challenge is to turn individual successes into a repeatable innovation pipeline.


Quality and Supply Resilience Remain the Foundation

Complex therapies require stronger process control, cold chains, data integrity and specialised testing. The revised Schedule M is therefore positioned as a foundation for higher-value manufacturing, alongside quality-by-design, risk-based inspections, product traceability and support for smaller manufacturers upgrading facilities.

Supply resilience also requires reducing vulnerabilities in APIs, intermediates and key starting materials. Rather than seeking domestic production of every input, the report recommends prioritising them by clinical importance and supply concentration.


Research Must Cross the Laboratory-to-Patient Gap

India has a substantial research base, but too few discoveries progress through validation, licensing, financing, clinical trials and manufacturing.

The roadmap proposes stronger technology-transfer offices, milestone-based development funding, shared testing infrastructure, trial-ready hospital networks and specialist skills in areas such as bioprocessing, genomics and regulatory science.

Progress would be measured not only through publications, but through technologies licensed, Indian-origin assets entering development, follow-on investment and patient outcomes.

Existing capacity includes the National Biopharma Mission’s 36-site GCP-compliant trial network, 21 disease registries covering around 90,000 patients and more than 100 clinical trials. The challenge is connecting these assets with product development, manufacturing and regulatory approval.


AI Requires Trusted Data and Regulatory Validation

The report sees AI supporting drug discovery, clinical trials, manufacturing, regulatory submissions and pharmacovigilance, but only when built on:

Reliable data | Validated models | Integrated workflows | Human and regulatory oversight | Measurable outcomes

India’s digital-health infrastructure, including ABHA and Ayushman Bharat Digital Mission registries, could support longitudinal research and real-world evidence.

But pharmaceutical AI also requires consent, privacy, cybersecurity, data quality, model validation and human accountability, particularly where outputs affect research, manufacturing quality or regulatory decisions.


Patient Access Becomes a Measure of Innovation

Advanced therapies have limited public value if patients cannot afford or access them. The roadmap therefore links innovation with affordable product design, diagnostics, treatment capacity, health-technology assessment, public financing and insurance, as well as new approaches for rare diseases and high-cost therapies.

Sector performance would consequently extend beyond exports and market size to time to diagnosis and treatment, affordability, coverage, real-world effectiveness and patient outcomes.


A National Scorecard Would Broaden Accountability

The report proposes a National Pharma Innovation Council, shared testing facilities, regulatory sandboxes for advanced therapies and AI, and a national talent strategy.

An annual scorecard would track:

Quality and trust | Supply resilience | Indian-origin innovation | Clinical research | Validated AI | Specialist talent | Patient access | Health outcomes | Sustainability

Each indicator would have a baseline, 2030 milestone, 2047 objective and institutional custodian, converting long-term ambition into measurable responsibilities.


Policy Relevance

India already has many of the required components—manufacturing standards, research incentives, biotechnology incubators, clinical-trial networks and digital-health infrastructure. The larger challenge is connecting systems that currently operate separately.

  • Build end-to-end innovation pathways: Track selected Indian-origin therapies from publicly supported research through licensing, trials, approval, manufacturing and patient access to identify where promising projects are being lost.

  • Measure outcomes rather than institutional activity: Distinguish facilities from quality performance, patents from assets entering trials, AI pilots from validated improvements, and product launches from effective patient access.

  • Make coordination operational: A National Pharma Innovation Council would be useful if it assigns clear responsibility across research, financing, regulation, manufacturing and reimbursement, rather than adding another layer of oversight.


Relevant Question for Policy Stakeholders: Which institution should be accountable for carrying promising Indian pharmaceutical discoveries across the full path from publicly funded research to clinical validation, commercial production and affordable patient access?


Follow the Full Report Here: CII: Vision 2047—India, Building the Innovation Powerhouse of Tomorrow

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