India should take the lead in promoting alternatives to animal testing in drug discovery and accelerate the adoption of non-animal methodologies (NAMs), said K. Satish Reddy, Chairman of Dr Reddy’s Laboratories.
Regulatory Readiness Key to Progress
Highlighting the evolution of drug discovery, Reddy said the industry is constantly adopting new methodologies and regulatory frameworks must keep pace. “Drug discovery is a journey with new methodologies emerging from time to time. The Indian regulatory framework should also be prepared for NAMs,” he said. He added that the Central Drugs Standard Control Organisation (CDSCO) has already begun aligning with these approaches and could further strengthen the ecosystem through improved infrastructure, staffing, and policy support.
Call for Dedicated Non-Animal Testing Infrastructure
Building on the report’s findings, Alokparna Sengupta, Managing Director, Humane World for Animals India, called for the creation of a central agency dedicated to validating and promoting non-animal methodologies.
The report recommends:
*Setting up a national non-animal methodology agency and validation centre
*Creating a comprehensive database of validated alternatives
*Forming a multi-stakeholder consortium for collaboration
*Establishing centres of excellence for training, skilling, and infrastructure
These measures, she said, would accelerate the transition toward more ethical and scientifically reliable testing systems.
Validated Alternatives to Replace Animal Testing
The study also urges faster replacement of traditional animal-based pyrogen testing. It recommends promoting validated alternatives such as:
*Monocyte Activation Test (MAT)
*Recombinant Factor C (rFC) assay
With proper training, standardisation, and reagent availability, these methods can significantly reduce reliance on animals while maintaining safety standards. “In this modern age, we have human cell-based and computational models that reflect human biology far more accurately,” Sengupta noted. “These technologies can reduce drug failures, save animal lives, and make drug development faster and more cost-effective.”
Industry Backing for NAM Adoption
Importantly, major Indian pharmaceutical companies are already moving in this direction. Deepak Sapra, CEO – API & Services, Dr Reddy’s Laboratories, said the company is actively integrating non-animal methodologies into its research processes. “We are working closely with other industry leaders such as Biocon, Cipla, and Sun Pharma to adopt NAMs,” Sapra said. He added that technologies like organoids, computational tools, and advanced cardiac and liver models are helping create more predictive, human-relevant testing systems. “Dr Reddy’s is actively integrating NAMs and will continue to push for wider adoption,” he said.
Cost, Time, and Accuracy Benefits
According to Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois and Chancellor of Chicago University, NAMs can significantly cut development costs and timelines. He pointed out that generics, biologicals, and biosimilars may not require animal testing at all, making NAM adoption both economically and scientifically advantageous. Traditionally, animal models have dominated preclinical research. However, species-specific physiological and genetic differences often limit their ability to predict human outcomes accurately. As a result, only about 10% of drugs entering Phase I clinical trials eventually receive regulatory approval, leading to higher costs, delays, and lost therapeutic opportunities.
Gradual Transition Still Necessary
While experts advocate rapid adoption of alternatives, they acknowledged that animal testing cannot yet be fully eliminated, especially for certain chemical drugs and novel molecules. Therefore, stakeholders must continue exploring balanced approaches that combine scientific advancement with safety requirements.
A Roadmap for Ethical and Efficient Drug Development
Overall, the report positions India at a critical juncture. By investing in non-animal drug testing technologies, strengthening regulations, and building collaborative platforms, the country can reduce costs, improve accuracy, and promote ethical research practices. As reported by thehindubusinessline.com, if implemented effectively, India could not only modernise its drug development ecosystem but also lead the global shift toward humane and human-relevant testing solutions.
