BioPharma SHAKTI & Non-Animal Models (NAMs)

Why in News?

• Union Budget 2026 announced and recently Government proposed BioPharma SHAKTI to boost biologics and biosimilars in India.
• Shift from animal testing → human-relevant non-animal methodologies (NAMs) is gaining importance globally.

UPSC Relevance

GS-II: Health sector policies, Regulatory institutions

GS –III: Biotechnology, Science & Tech in healthcare

GS-IV: Ethics of animal testing

What are Drugs? The Two Categories

Types of Biologics

What are Biologics and Biosimilars and their difference?

• Biologics:
  • Complex, large-molecule drugs produced using living cells (bacteria, yeast, or mammalian cells).
  • Examples: Monoclonal antibodies (mAbs), vaccines, insulin, CAR-T cell therapies, growth factors.
  • Unlike traditional small-molecule chemical drugs (e.g., paracetamol), biologics are highly specific, target particular receptors/proteins, and are sensitive to manufacturing processes.
  • Used for chronic/non-communicable diseases (NCDs): Cancer, rheumatoid arthritis, diabetes, autoimmune disorders, Alzheimer’s.
  • Global market growing rapidly due to rising NCD burden.
• Biosimilars:
  • Highly similar (not identical) versions of approved biologics, produced after the original patent expires. They are “generic” equivalents but require rigorous similarity testing (not simple chemical copying).
  • Cheaper alternatives that improve access and affordability.
• Why important for India? India is the “pharmacy of the world” (strong in generics), but weak in high-value biologics/biosimilars. Domestic production reduces import dependence and positions India as a global hub.

Problem with Traditional Drug Testing

Animal Testing (Traditional Method)

• Drugs tested on animals (mice, monkeys) before human trials
• Issue: Animals ≠ Humans biologically

Real Case Example: Northwick Park Tragedy

• In 2006, drug theralizumab caused:
  • Severe immune reaction
  • Organ failure in humans
• However, the same drug had shown no harmful effects in animal testing, especially in monkeys.
• This incident demonstrated that animal models may fail to capture human-specific immune responses.

Why This Problem is Severe for Biologics

• Biologcs interact with specific human receptors
• These receptors may:
  • Not exist in animals
  • Function differently

Solution: Non-Animal Methodologies (NAMs)

What are NAMs?

• Non-animal methodologies (NAMs) are advanced scientific techniques that use human cells, tissues, or computational models instead of animals. These methods aim to replicate human biological conditions more accurately.

Types of NAMs

1. Organoids

• Organoids are miniature, lab-grown versions of human organs created from stem cells. They replicate key structural and functional features of real organs, allowing precise testing of drug effects.
• Example: mini brain, liver

2. Organ-on-a-chip

• An Organ-on-a-Chip (OOC) is a multi-channel microfluidic cell culture device —essentially credit-card sized chips with living human cells — designed to Mimic blood flow, tissue interaction and simulate the key activities, mechanics, and physiological responses of a living human organ or organ system in a controlled, in-vitro environment. These thumb-drive-sized devices contain hollow channels lined with living human cells and tissues, providing a more accurate model of human biology than traditional two-dimensional cell cultures or animal testing
• Use: Lung-on-chip, gut-on-chip, heart-on-chip to test drug absorption, toxicity, and immune responses.

Practical Example

• A breast cancer-on-chip model was developed to test CAR T-cell therapy, which is a cutting-edge biologic treatment. The model recreated the tumour environment, including blood vessels and immune interactions.
• NAMs (breast cancer-on-chip) allow researchers to model this challenge without animals.
• This allowed scientists to study how immune cells attack cancer cells, helping assess both effectiveness and safety without relying on animal testing.

3. 3D Bioprinting

• 3D bioprinting involves printing human tissues using living cells, which can mimic real organ structures.
• This allows researchers to test drugs in environments that closely resemble the human body.

Key Advantage

These models:

• Replicate human physiology better
• Improve accuracy of drug testing

Benefits of NAMs

1. Better Predictability

• More accurate than animal models
• Reduces clinical trial failures

2. Cost Reduction

• Drug development cost reduced by 10–26%

3. Faster Development

• Time for drug optimisation reduced (~19%)

4. Ethical Advantage

• Reduces animal suffering
• Aligns with global ethical standards

5. Personalised medicine

• Patient-derived organoids allow testing of drug efficacy on individual’s own cells

6. Disease modelling

• Can recreate rare diseases and complex tumour microenvironments not possible in standard animals

What is BioPharma SHAKTI?

• Government initiative (Budget 2026)
• Outlay: ₹10,000 crore

Objectives:

• Boost biologics manufacturing
• Promote biosimilars
• Strengthen R&D ecosystem

Importance for India

1. Healthcare

• Cheaper biologics → better access
• Affordable biosimilars can significantly improve access to advanced treatments for diseases like cancer and diabetes.

2. Economic Growth

• Biologics represent a high-value segment of the pharmaceutical industry, offering opportunities for exports and employment generation.

3. Global Competitiveness

• India can become:
  • Biologics hub
  • Alternative to Western pharma

What are the Challenges?

• Limited Industry Adoption
  • Although many academic institutions in India are working on NAMs, their translation into industry applications remains weak.

• Infrastructure Constraints
  • Developing and scaling NAM technologies require advanced infrastructure and sustained funding, which are currently limited.

• Regulatory Uncertainty
  • The Central Drugs Standard Control Organisation is still evolving guidelines for integrating NAMs, leading to uncertainty for companies.

• Patent Evergreening
  • Pharmaceutical companies often extend patents through minor modifications, delaying the entry of affordable biosimilars.

• Investment Gaps
  • Investors in India are often unfamiliar with the biologics sector, leading to limited funding for startups and innovation.

Global Trends

• Countries like UK moving to:
  • Phase out animal testing
• India:
  • New Drugs and Clinical Trials (Amendment) Rules, 2023 support NAMs

But still lagging in implementation

Key Concepts

Critical Analysis

Positives

• Scientific advancement
• Ethical improvement
• Economic opportunity

Concerns

• Regulatory readiness low
• High cost of technology
• Slow industry adoption

Way Forward

• Strengthen:
  • Industry-academia collaboration
• Provide:
  • Regulatory clarity for NAMs
• Invest in:
  • Infrastructure & startups
• Prevent:
  • Patent evergreening
• Promote:
  • Standardisation of NAMs

Conclusion

BioPharma SHAKTI’s ₹10,000 crore is a necessary but not sufficient condition for India’s biologics transformation. The real multiplier will come from building enabling systems — validated NAM protocols, expedited regulation, sustained funding, and a mature biologics entrepreneurship ecosystem — that allow many companies to innovate simultaneously, positioning India as the global hub for human-relevant drug testing.

Practice MCQs

With reference to biologics, consider the following statements:

1. Biologics are drugs produced from living organisms and are structurally complex.
2. Biosimilars are exact chemical copies of biologics similar to generic drugs.
3. Biologics are commonly used in treating chronic diseases like cancer and diabetes.

Which of the statements given above is/are correct?

(a) 1 and 3 only
(b) 1 only
(c) 2 and 3 only
(d) 1, 2 and 3

 Answer: (a)

Consider the following statements regarding Non-Animal Methodologies (NAMs):

1. NAMs are based on human cells and tissues to replicate biological processes.
2. Organ-on-a-chip technology can simulate functions like blood flow and tissue interaction.
3. NAMs have completely replaced animal testing globally.

Which of the statements given above is/are correct?

(a) 1 and 2 only
(b) 2 and 3 only
(c) 1 only
(d) 1, 2 and 3

Answer: (a)

Which of the following best explains the limitation of animal testing in biologics?

(a) Animals cannot be used in laboratory conditions
(b) Biologics interact with human-specific receptors that may differ in animals
(c) Animal testing is more expensive than human trials
(d) Animals do not respond to any drugs

 Answer: (b)

With reference to BioPharma SHAKTI, consider the following statements:

1. It was announced in the Union Budget 2026.
2. It aims to promote biologics and biosimilars manufacturing in India.
3. It focuses only on vaccine production.

Which of the statements given above is/are correct?

(a) 1 only
(b) 2 only
(c) 1 and 2 only
(d) 1, 2 and 3

 Answer: (c)