India’s 2026 Union Budget has announced Biopharma SHAKTI, a ₹10,000 crore strategy to strengthen domestic production of biologics and biosimilars. The move comes amid growing evidence that animal testing often fails to predict the safety and efficacy of complex biologic drugs. This has revived attention on non-animal methodologies, or NAMs, such as organoids, organ-on-chip systems and 3D bioprinting, which use human cells and better reflect human biology.
Why Biologics Need New Testing Models
Biologics are large and complex medicines made using living cells. They include monoclonal antibodies, vaccines and insulin. Their targets are often human-specific receptors, which may be absent or behave differently in animals. This limits the value of animal studies for biologics. Cases such as the theralizumab trial in London and semorinemab’s failure in Alzheimer’s trials show this gap between animal models and human outcomes.
Rise of Non-Animal Methodologies
NAMs are increasingly used to reduce animal experimentation and improve predictive accuracy. They are being promoted globally, including through the U.K.’s roadmap to phase out animal experiments. In India, the New Drugs and Clinical Trials (Amendment) Rules, 2023 support NAMs in novel drug development. Recent research has shown their value in modelling complex diseases, including cancer, where organ-on-chip systems can assess whether immune cells can enter tumours and attack cancer cells.
Industrial and Regulatory Significance
NAMs may also reduce costs and shorten development timelines. Studies have estimated that organ-on-chip technologies can cut drug development costs by 10-26% and reduce lead optimisation time by 19%. However, industry adoption remains limited due to weak standardisation, insufficient documentation and lack of commercial readiness. Experts argue that Biopharma SHAKTI should build enabling systems, not just single products, to support wider innovation in biologics and biosimilars.
Biosimilars, Patents and Policy Gaps
Biosimilars are reverse-engineered versions of biologics introduced after patent expiry. Their development faces regulatory and market hurdles, including patent evergreening and slow approval processes. India’s biosimilar guidelines are still in draft form, and confidence in independently validated NAMs is evolving. Faster regulatory clarity, stronger funding and better infrastructure could make biologics manufacturing more predictive, cost-efficient and globally competitive.
Last Modified: April 29, 2026