Context: The Department of Biotechnology (DBT) and BIRAC have placed Precision Biotherapeutics as a national priority under the BioE³ Policy (Bioeconomy for Emerging India Ecosystem). This signals India’s commitment to building capabilities in personalised, gene-based, targeted and molecular therapies — the future of advanced medicine.
What are Precision Biotherapeutics?
Precision biotherapeutics are personalised, molecular-profile-based medical interventions designed using genomics, proteomics, bioinformatics, gene editing, RNA technologies, engineered cells, biologics, and AI-driven drug design.
They represent a shift from the traditional, symptom-based approach to root-cause correction at the level of genes, cells, or molecular pathways.
Key Technology Pillars
- Genomic–Proteomic Profiling
Identifies patient-specific mutations, biomarkers, and disease signatures enabling personalised drug design. - Gene & Cell Editing Technologies
Includes CRISPR/Cas9, CAR-T therapy, siRNA, and AAV (Adeno-Associated Virus) vectors for targeted or curative interventions. - mRNA & Nucleic Acid Therapeutics
Synthetic RNA can act as programmable instructions to produce missing or corrective proteins within cells. - AI-Driven Drug Discovery
Uses machine learning for molecular docking, target prediction, toxicity screening, and accelerated drug development.
Significance of Precision Biotherapeutics for India
1. Targeted Cure Potential
Unlike general drugs, precision therapies directly treat root-cause mutations.
Example: CRISPR-based thalassemia therapy (Casgevy) approved by the US FDA and UK regulators in 2023.
2. Addressing India’s NCD Burden
Nearly 65% of deaths in India are due to non-communicable diseases. Standard medicine often fails for complex cancers, rare diseases, cardiometabolic disorders; precision medicine provides accurate, personalised solutions.
3. India-Specific Genomic Needs
India’s extreme genetic diversity means therapies developed abroad may not work optimally. Indigenous precision platforms are essential for “India-specific genotype therapies.”
4. Economic & Innovation Opportunity
The global precision biotherapeutics market is projected to exceed USD 22 billion by 2027, creating opportunities for biotech startups, IP creation, clinical trials, and high-value manufacturing.
Challenges in India
- High Therapy Cost
Global gene/cell therapies cost USD 0.5–2 million (e.g., Zolgensma: USD 2.1M), inaccessible to 99% of Indian households. - Regulatory Gaps
India still lacks a dedicated CDSCO approval pathway for gene, cell, RNA, and genome-edited products.
Japan’s PMDA regenerative fast-track is a model India could emulate. - Insufficient Manufacturing Capacity
India has a shortage of GMP-grade viral vector and biologics facilities.
China, in comparison, runs 800+ ongoing gene/cell therapy trials. - Skill Shortage
India has only a few trained clinical geneticists compared to 4,000+ medical geneticists in the US. - Ethical & Data Governance Concerns
India lacks a specific genomic data protection law for biobanks and large datasets like IndiGen and GenomeIndia.
Way Forward
- Dedicated Regulatory Pathway:
Establish a CDSCO Gene–Cell Therapy Division with accelerated approvals. - Biomanufacturing Expansion:
Create viral-vector & biologics GMP hubs under PLI-Biopharma. - Genomic Data Governance:
Enact a bio-banking and consent law, aligned with EU-GDPR norms. - Affordability & Insurance Models:
Pilot PM-JAY risk pooling for high-cost therapies. - Talent Pipeline:
Launch national fellowships in genomic medicine & AI-biotech; integrate DBT–IIT–AIIMS translational tracks.
