Non-animal testing is key to next phase of pharma growth, Pg13

Key Highlights:

• Non-Animal Testing Models (NAMs) are crucial for India's pharmaceutical sector to transition towards original drug discovery, complex biologics, and stronger domestic innovation.
• Animal testing's limitations contribute to high attrition rates, increased costs, and delays in drug development, with only 10-14% of drug candidates reaching regulatory approval.
• NAMs, including organoids, organ-on-chip platforms, and AI-enabled approaches, offer improved predictive accuracy and shorter development timelines.
• India possesses significant scientific capabilities but lacks regulatory clarity and a unified national strategy for integrating NAMs into drug development.
• A national framework and clear regulatory guidance are essential for India to adopt NAMs at scale and remain competitive globally.

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Detailed Insights:

• The global drug development challenge stems from testing models that do not always accurately predict how medicines will behave in the human body.
• India's engagement with NAMs has evolved, driven by laboratory animal ethics and institutional oversight, leading to the adoption of various alternative platforms.
• Countries like the U.S., European Union, U.K., and Japan have already established national centers, funding, and validation programs for NAMs.
• Integrating NAMs into research and development pipelines can enable more reliable science and faster development cycles, positioning India as a hub for drug discovery.
• NAMs can enhance efficiency in quality testing for generics and biosimilars, with validated non-animal alternatives already available for pyrogen and endotoxin testing.
• The relevance of NAMs extends beyond pharmaceuticals to sectors like cosmetics and personal care, where they provide robust safety data.
• While India's regulatory system permits NAMs for proof-of-concept studies, target identification, drug screening, and toxicology, formal integration is lacking.
• The adoption of NAMs aims to progressively reduce dependence on laboratory animals, though animal studies still play an important role.

Key Concepts Involved:

• Non-Animal Testing Models (NAMs): In-vitro and in-silico methods using human biology-based systems to predict drug behavior and safety.
• Organoids: 3D cell cultures that mimic the structure and function of human organs for drug testing and disease modeling.
• Organ-on-chip: Microfluidic devices engineered to simulate human organ physiology and function for drug development and toxicity testing.
• Biosimilars: Biologic medical products that are highly similar to an already approved reference biologic drug.