Why in News?
- A detailed expert analysis by Shambhavi Naik (Takshashila Institution) was published, highlighting India’s progress, challenges, and opportunities in precision biotherapeutics.
- Comes amid rapid global advances in gene editing, CAR-T therapy, mRNA therapeutics, and India’s push towards genomics-driven healthcare under DBT’s biotechnology priorities.
Relevance:
GS 3 – Science & Technology
- Gene editing (CRISPR), mRNA therapeutics, cell therapy, biologics.
- India’s biotech sector: regulatory vacuum, ATMP challenges.
- GenomeIndia, IndiGen, precision oncology.
GS 2 – Health
- NCD burden in India, health innovation priorities.
- Access, affordability, public health ethics.
What Are Precision Biotherapeutics?
- Definition: Medical interventions tailored to a patient’s unique genetic, molecular, proteomic, or cellular profile.
- Aim: Correct the root cause of disease rather than managing symptoms.
Core Technologies
- Genomic & proteomic analysis
- Identifies mutations, protein dysfunctions; basis of personalised therapies.
- Gene editing therapies
- CRISPR-based correction of defective genes (e.g., blood disorders).
- mRNA / nucleic acid therapeutics
- Program cells to produce needed proteins or silence harmful ones.
- Monoclonal antibodies & biologics
- Target specific disease proteins (cancer, autoimmune, viral diseases).
- AI-driven drug discovery
- Predicts molecular interactions, accelerates drug design.
Why India Needs Precision Biotherapeutics
- 65% of deaths in India caused by NCDs (cancer, diabetes, cardiovascular diseases).
- High genetic diversity → foreign-developed drugs may not suit Indian populations.
- Enables predictive, preventive, personalised healthcare.
- Uses large Indian genomic resources:
- IndiGen, GenomeIndia, disease-mapping studies.
- Addresses India-specific disease burdens and drug response variations.
Where India Stands: Current Status
Government & Research Initiatives
- DBT lists precision biotherapeutics as 1 of 6 national biotech priorities.
- Leading institutions:
- Institute of Genomics & Integrative Biology (IGIB)
- National Institute of Biomedical Genomics (NIBMG)
- Translational Health Science and Technology Institute (THSTI)
- Focus: genetic diversity mapping, disease susceptibility profiling.
Private Sector Efforts
- Biocon Biologics, Dr Reddy’s: biosimilars, monoclonal antibodies.
- Immuneel Therapeutics: immuno-oncology.
- Bugworks Research: novel antibiotics.
- Akrivia Biosciences: precision cancer diagnostics.
- miBiome Therapeutics: patient-centric healthcare.
- 4baseCare: AI-driven precision oncology.
- ImmunoACT: first Indian company to bring CAR-T therapy to India.
Challenges for India
Regulatory
- No clear regulatory framework for gene editing, cell therapy, mRNA therapeutics.
- Guidelines restrict therapeutic use but do not define scope of therapy.
- Lack of harmonised ethics guidelines across institutions.
Manufacturing & Infrastructure
- Limited biologics and advanced therapy (ATMP) manufacturing capacity.
- Heavy dependence on imports for raw materials and equipment.
Cost & Access
- Precision therapies are extremely expensive → accessible only to affluent urban patients.
- Insurance coverage gaps and weak public-sector capacity.
Data Governance Risks
- Genetic data privacy concerns.
- Lack of comprehensive protections (DPDP Act insufficient for genomic data).
- Risk of misuse: discrimination, insurance profiling, surveillance.
India’s Opportunities
- Global precision medicine market projected to cross $22 billion by 2027.
- India’s advantages:
- Skilled scientific workforce.
- Strong IT + data analytics ecosystem.
- Low-cost biotech manufacturing potential.
- Can emerge as global hub for affordable precision therapeutics.
- Export potential: biosimilars, AI-driven diagnostics, cell therapy services.
- Opportunity to build a regulatory model balancing innovation, ethics, and affordability.
