Why in News ?
- Union Budget 2026–27 announced a ₹10,000 crore Biopharma SHAKTI programme to scale biologics and biosimilars, strengthen CDSCO regulation, and expand NIPER network, signalling strategic push toward biopharma self-reliance.
Relevance
GS-2 (Polity & Governance)
- Government policies & interventions in health sector
- Regulatory bodies (CDSCO) and reforms
- Public health & access to medicines
- Centre–State coordination in health governance
GS-3 (Economy, S&T, Internal Security)
- Biotechnology & pharma innovation
- Industrial policy (PLI, Make in India)
- R&D ecosystem and knowledge economy
- Biosecurity and dual-use technology risks
Biopharma – Basics
What is Biopharma
- Biopharmaceuticals are medicines derived from living organisms like cells or microbes, including vaccines, monoclonal antibodies, gene therapies, unlike small-molecule chemical drugs synthesized through conventional pharmaceutical chemistry.
Biologics vs Biosimilars
- Biologics are original complex biological medicines; biosimilars are highly similar follow-on versions with no clinically meaningful differences, offering cost-effective alternatives after reference product patent expiry.
Budget 2026–27 Biopharma SHAKTI – Key Features
Financial Allocation
- ₹10,000 crore outlay over multiple years targets R&D, manufacturing clusters, clinical ecosystems, regulatory strengthening, aiming to position India as a global biologics manufacturing hub.
Regulatory Strengthening
- Focus on upgrading Central Drugs Standard Control Organisation to global regulatory standards, enhancing scientific review capacity, predictable approvals, pharmacovigilance, and harmonisation with WHO/ICH norms.
Institutional Capacity
- Proposal to establish three new NIPERs and expand clinical trial infrastructure, creating skilled workforce pipelines for bioprocess engineering, regulatory science, translational research, and innovation-driven pharmaceutical growth.
Rationale Behind the Push
Health Transition
- Rising non-communicable diseases like cancer, diabetes, autoimmune disorders increase demand for advanced biologics, which offer targeted therapies and improved outcomes compared to conventional small-molecule drugs.
Economic Opportunity
- Global biologics market valued above US$400 billion and growing faster than traditional pharma; capturing biosimilar share can boost exports, high-value manufacturing, skilled employment, and technology upgrading.
Strategic Autonomy
- COVID-19 highlighted supply-chain vulnerabilities; domestic biologics capacity strengthens health security, vaccine sovereignty, critical drug resilience, aligning with Atmanirbhar Bharat and Make in India objectives.
Constitutional / Legal Dimension
- Aligns with Article 47 duty to improve public health, while regulatory strengthening under Drugs and Cosmetics Act, 1940 framework must ensure safety, efficacy, and ethical clinical practices.
Governance / Administrative Dimension
- Requires coordination between DBT, ICMR, CDSCO, state regulators, streamlined single-window approvals, and stronger bioethics oversight committees to maintain credibility in clinical research ecosystems.
Economic Dimension
- Biopharma shift supports move from volume-driven generics to value-driven innovation, enhancing gross value addition, export competitiveness, and integration into global pharmaceutical value chains.
Social / Ethical Dimension
- Biosimilars can reduce therapy costs by 20–40% globally, improving affordability; however, ethical concerns around clinical trials, informed consent, and data integrity require strict oversight.
Environmental / Tech / Security Dimension
- Biomanufacturing demands high bio-safety, waste management, cold-chain logistics, and digital bioprocess control systems; dual-use biotechnology risks necessitate strong biosecurity frameworks.
Data & Evidence
- India supplies ~20% of global generic medicines by volume but small biologics share; biologics contribute disproportionately to global pharma revenues, showing clear upgrading potential.
- India hosts 3,000+ pharma companies and 10,000+ manufacturing units, providing strong base for biologics scaling if supported by advanced biologics infrastructure and regulatory credibility.
Challenges / Gaps
- High capital intensity and long gestation periods deter private investment without risk-sharing or incentives, limiting domestic innovation beyond contract manufacturing and licensed biosimilar production.
- Regulatory unpredictability and limited reviewer capacity in biologics evaluation can delay approvals, affecting investor confidence and global acceptance of Indian biologics.
- Skilled workforce gaps in bioprocessing, regulatory science, and translational research constrain movement toward innovation-led biologics ecosystems.
- Fragmented industry–academia linkages reduce commercialization of research outputs, weakening innovation pipeline despite strong basic science institutions.
Way Forward
- Expand PLI-like incentives for biologics, encourage public–private partnerships, and create shared biomanufacturing facilities to reduce entry barriers for domestic firms.
- Strengthen regulatory science ecosystem through international collaborations, joint reviews, and continuous training to build globally trusted approval systems.
- Promote innovation clusters linking NIPERs, IITs, startups, and hospitals for translational research and faster lab-to-market pathways.
- Ensure ethical clinical trial frameworks, patient registries, and real-world evidence systems to build credibility and safety assurance.
Data & Facts
- India is the largest vaccine supplier globally, providing ~60% of global vaccine demand (UNICEF/WHO procurement).
- India accounts for ~20% of global generic drug exports by volume but <5% share in global biologics market, showing value-upgradation potential.
- Biologics constitute ~30–35% of global pharma market value but much smaller share in volume → high-value segment.
- USFDA-approved pharma plants: India has the highest number outside the USA (600+ facilities).
- R&D spending in Indian pharma ≈ 7–8% of revenue, lower than global innovators (15–20%), showing innovation gap.
- India’s bioeconomy crossed $80–90 billion and targets $300 billion by 2030 (DBT vision).
