Non-Animal Methodologies: Benefits, Challenges & Role in India’s Biopharma Sector

The Union Budget 2026 launched Biopharma SHAKTI to boost biologics and biosimilars, amid limits of animal testing and a shift to non-animal methodologies (NAMs).

About Non-Animal Methodologies (NAMs)

• Non-Animal Methodologies (NAMs) are scientific approaches that replace, reduce, or refine the use of animals in research, testing, and drug development.
  • They rely on human-relevant systems such as cells, tissues, and computational models.

• It includes use of in vitro (cell-based), in silico (computer-based), and human-based approaches to better replicate human biology.
• They include organoids, organ-on-chip systems, and 3D bioprinting.
• Indian Policy Push: 
  • India is also promoting NAMs under the New Drugs and Clinical Trials (Amendment) Rules, 2023.
  • Biopharma SHAKTI (Union Budget 2026) supports biologics ecosystem

Need for Non-Animal Methodologies

• Ethical Concerns: There is a growing need for NAMs due to increasing ethical concerns regarding animal welfare and the moral implications of animal experimentation.
• Scientific Limitations of Animal Models: NAMs are required because animal models often fail to accurately predict human biological responses, leading to unreliable results in drug development and toxicity testing.
  • For Example: The 2006 Northwick Park Trial (Theralizumab) in London led to multiple organ failure in 6 volunteers, despite safe results in animal models.
    • Similarly, Semorinemab (2022) failed in 457 Alzheimer’s patients despite success in mouse models.
• Advancements in Technology: Rapid progress in fields such as artificial intelligence, biotechnology, and bioengineering has created opportunities to replace traditional animal testing with advanced NAMs.

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Benefits

• Ethical Basis: NAMs promote ethical research by adhering to the principles of replacement, reduction, and refinement (3Rs).
  • The European Union’s 2013 ban on animal testing for cosmetics significantly accelerated the adoption of NAMs.
• High-Throughput Capability: NAMs enable rapid and large-scale screening of chemicals and drugs.
  • For instance, automated in vitro platforms can test thousands of compounds per day, compared to limited testing capacity in animal-based methods.
• Efficiency (Time & Cost): NAMs reduce both the time and cost involved in testing.
  • In vitro toxicity testing can be completed within days or weeks, whereas animal studies may take several months.
• Mechanistic Understanding: NAMs provide detailed insights into molecular and cellular mechanisms of toxicity.
  • For Example: Toxicogenomics studies help identify gene expression changes caused by chemical exposure.

Challenges

• Technological and Infrastructure Constraints: The adoption of Non-Animal Methodologies (NAMs) in India is limited due to restricted access.
  • For Example: Only around 90 laboratories are currently engaged in such research involving NAMs.
• Regulatory Uncertainty: The adoption of NAMs in India is hindered by regulatory uncertainty, as the CDSCO guidelines for biosimilars are still in the draft stage
• Biological Limitations: Difficulty in replicating complex whole-body interactions such as immune and metabolic responses.
  • For Example: Organ-on-chip models may simulate a single organ (like liver) but fail to capture interactions between liver, immune system, and endocrine system.
• Skill Gap: Shortage of trained experts in interdisciplinary domains like bioinformatics and tissue engineering.
  • For instance, Limited availability of experts in computational biology and bioinformatics in developing countries.

Way Forward

• Strengthening Regulatory Clarity: India should expedite finalisation of biosimilar guidelines and formally integrate NAMs into approval pathways, as seen in the U.K.’s roadmap to phase out animal testing.
• Scaling Up Funding and Infrastructure: Targeted utilisation of the ₹10,000 crore Biopharma SHAKTI initiative can build shared platforms and testing facilities, enabling multiple firms to adopt NAMs rather than supporting isolated projects.
• Promoting Cost Efficiency and Industry Uptake: Evidence shows organ-on-chip technologies can reduce drug development costs by 10–26% and lead optimisation time by 19%, which should be leveraged to encourage pharmaceutical companies to shift toward NAMs.
• Enhancing Investment and Entrepreneurship: Increasing investor awareness and expanding support through agencies like DBT and ICMR can help scale start-ups and MSMEs in biologics and NAM-based technologies.

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