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Biologics and Biopharma SHAKTI Strategy

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Source: TH

Context:

Union Budget 2026 promotes biologics under Biopharma SHAKTI strategy

  • Focus on domestic production of biologics and biosimilars
  • Shift toward non-animal testing models
  • Boost to biotechnology and pharmaceutical sector

What are Biologics?

Biologics are advanced medicines produced using living organisms.

  • Unlike traditional drugs:
    • Made through biological processes
    • Large and complex protein structures
  • Examples:
    • Monoclonal antibodies
    • Vaccines
    • Insulin
  • Used in:
    • Cancer
    • Diabetes
    • Autoimmune diseases

What are Biosimilars?

Biosimilars are near-identical versions of existing biologic drugs.

  • Features:
    • Similar safety and effectiveness
    • Lower cost than original biologics
  • Importance:
    • Improves affordability
    • Expands access to treatment

How are Biologics Produced?

Production involves multiple complex stages:

  • Host Cell Selection:
    • Bacteria, yeast, or mammalian cells
  • Genetic Engineering:
    • DNA inserted to produce desired protein
  • Large-scale Culture:
    • Cells grown in bioreactors
  • Purification:
    • Protein extracted and cleaned
  • Batch Testing:
    • Ensures safety and consistency
What is Immunogenicity?

Immunogenicity is the ability to trigger an immune response.

  • Risk:
    • Body may reject biologics
  • Solution:
    • Rigorous testing and monitoring
MCQs
Q.1) What are biologics?

[1] Chemical drugs
[2] Medicines from living organisms
[3] Herbal drugs
[4] Synthetic drugs

Q.2) What are biosimilars?

[1] New drugs
[2] Copies of biologics
[3] Vaccines
[4] Antibiotics

Q.3) What is the main aim of biologics?

[1] General treatment
[2] Targeted therapy
[3] Cheap drugs
[4] Fast production

Q.4) What is used in biologics production?

[1] Machines only
[2] Living cells
[3] Metals
[4] Chemicals only

Q.5) What is precision medicine?

[1] General treatment
[2] Targeted treatment
[3] Surgery
[4] Therapy

ANSWERS

1 → [2]
2 → [2]
3 → [2]
4 → [2]
5 → [2]

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  • Answer Key
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  • IRDAI
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