Why in the News?

India’s growing burden of non-communicable diseases and its vast genetic diversity make precision biotherapeutics and targeted therapies a strategic medical priority.

About Precision Biotherapeutics:

• Concept: Precision biotherapeutics are targeted medical treatments – gene therapies, biologics, mRNA drugs, engineered antibodies – designed according to a patient’s genetic, molecular, or cellular profile.
• Scientific Basis: Integrates genomics, proteomics, cell engineering, computational biology, and AI to correct disease at its root rather than treating symptoms.
• Genetic Targeting: Uses genomic and proteomic profiling to identify mutations and dysfunctional biological pathways.
• Gene Editing: Employs CRISPR and related tools to repair faulty genes, including those causing haemoglobin disorders.
• Nucleic-Acid Therapies: Uses mRNA, siRNA, and DNA-based platforms that instruct cells to produce or suppress specific proteins.
• Biologics & Antibodies: Develops monoclonal antibodies and targeted biologics for cancer, autoimmune diseases, and metabolic disorders.
• AI Integration: AI systems accelerate drug discovery, target prediction, and personalised therapy development.

Why India needs precision Biotherapeutics?

• High Disease Burden: Non-communicable diseases cause ~65 percent of deaths; standard therapies ignore India’s biological diversity.
• Genetic Variation: Indian populations show wide genetic diversity, making foreign-developed drugs less effective in many groups.
• National Genome Projects: Initiatives such as GenomeIndia and IndiGen create datasets enabling population-specific therapies.
• Healthcare Shift: Enables movement from reactive treatment to predictive, preventive, and personalised care.

Where does India stand today?

• Policy Recognition: Identified as a major pillar in the BioE³ Policy of DBT and BIRAC.
• Research Strength: Organisations like IGIB, NIBMG, THSTI are mapping Indian genetic variations.
• Industry Growth: Rapid expansion in biosimilars, immunotherapies, precision oncology, gene therapy.
• Key Players: Biocon Biologics, Dr Reddy’s, Zydus LifeSciences, Immuneel Therapeutics, ImmunoACT, 4baseCare, Akrivia Biosciences, Bugworks, miBiome Therapeutics.
• Challenges: Nascent regulation limited advanced biomanufacturing, high therapy costs.

Global Progress and Benchmarks:

• Regulatory Leaders: US and EU have clear approval pathways for cell and gene therapies.
• Breakthroughs: Approvals like Zolgensma (SMA) and Casgevy (first CRISPR therapy).
• Asia’s Momentum: China hosts 800+ active trials; Japan and South Korea use fast-track frameworks for regenerative medicine.

Opportunities:

• Disease Impact: Precision therapies improve outcomes for genetic, metabolic, rare, and cancer conditions, reducing long-term costs.
• Market Potential: Global precision medicine market projected to exceed 22 billion USD by 2027.
• India’s Edge: Strong IT ecosystem, data science capacity, cost-efficient manufacturing, and large clinical trial base.

Risks:

• Genomic Privacy: Sensitive data risks misuse without strict laws and consent rules.
• Cost Barriers: High treatment costs may deepen health inequity.
• R&D Gaps: Low domestic R&D investment can create dependence on foreign technologies.

Way Forward:

• Regulation: Establish a dedicated CDSCO pathway for cell and gene therapies.
• Data Protection: Enact a biobanking and genomic data law ensuring privacy and research access.
• Affordability: Integrate precision therapies into public insurance and health schemes.
• Ethics & Governance: Create national standards on consent, fairness, and data use.
• Manufacturing: Expand domestic biologics and gene therapy infrastructure to reduce import reliance.

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