Industry seeks establishment of central agency for non-animal testing methods

As India’s pharmaceutical industry moves towards becoming a $500 billion global powerhouse by 2047, as part of the country’s Viksit Bharat vision, a new multi-stakeholder report highlights the growing role of non-animal, science driven testing methods in strengthening drug development, improving translational science, and accelerating innovation.

The report titled “Landscape Analysis on Alternatives to Animal Testing for Drug Development in India”, was jointly developed by Humane World for Animals India, DBT-InSTEM,  Animal Law and Policy Network and Dr. Reddy’s Laboratories Limited.

Key sector-specific findings from the report highlight significant opportunities across categories:

• Establish an industry-led consortium to advocate for adoption of the 3Rs—Replace, Reduce and Refine, raise awareness of global best practices, and enable structured engagement with regulators
• Create a central agency for Non-Animal Methods (NAMs) to support validation, standardisation, and integration of NAMs into regulatory review and submissions
• Accelerate replacement of animal-based pyrogen testing by promoting validated alternatives such as the Monocyte Activation Test (MAT) and recombinant Factor C (rFC) assay, supported by training, standardisation, and improved reagent availability
• Invest in indigenous infrastructure, including local biobanks, reagents, culture media, software platforms, and testing tools, to reduce costs and logistical barriers
• Establish hub-and-spoke Centres of Excellence (CoEs) to support NAMs research, infrastructure development, and workforce training across the country
• Strengthen capacity building and awareness, through workshops, training programmes, and multi-stakeholder engagement to build confidence in NAMs
• Enhance regulatory engagement and policy alignment, including strengthening 3R-related language in the New Drugs and Clinical Trials (NDCT) Rules, updating guidance on NAM adoption, and enabling routine inclusion of validated NAMs in regulatory submissions