A new report calls to develop, adopt non-animal lab testing tech to pivot India as R&D hub

Global regulators are already loosening the mandate for animal data.

• India urged to end animal testing for drugs, switch to human-relevant tech
• Report suggests industry consortium to boost Non-Animal Methods (NAMs) adoption.
• NAMs may reduce biosimilar costs by 90% and accelerate drug development.

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A coalition of scientific and industry leaders is pushing to phase out animal testing in favour of advanced human‑relevant technologies, through streamlining of R&D, reducing failures and strengthening the country’s ambitions to become a global innovation hub.

In a study released on Thursday called Landscape Analysis on Alternatives to Animal Testing for Drug Development in India, offered a roadmap for adopting Non-Animal Methods (NAMs), including organ-on-chip systems and AI-based toxicity models.

The study was a joint effort by Humane World for Animals India, DBT-InSTEM, the Animal Law and Policy Network, and drugmaker Dr. Reddy’s Laboratories.

The 10 percent success rate problem

For decades, animals have served as the default for drug testing, but the biological divide between species is proving costly. Currently, only about 10 percent of drugs that enter human trials receive approval.

“Human cell‑based and computational methods reflect human biology more accurately, reducing the risk of drug failures,” said Alokparna Sengupta, Managing Director of Humane World for Animals India.

The inefficiency of the current model translates to massive financial losses and delayed treatments. By recreating human biology in labs or through computer simulations (in silico), NAMs aim to fix these reliability gaps.

The economic edge

The shift isn't just ethical; it's a massive cost-saving play. For biosimilars—which currently cost between $100 million and $150 million to develop for US market, the savings could be transformative. NAMs could slash biosimilar development costs steeply.

"The use of NAMs could bring cost savings as high as 75 percent to 90 percent in biosimilars, and save a significant amount of time," said Sarfaraz Khan Niazi, Professor at the University of Illinois, Chicago. Niazi says for cancer biologics animal studies can be eliminated, saving years of development time.

“Human‑relevant models can dramatically improve the predictability and efficiency of preclinical research,” noted Dr. Arvind Ramanathan of DBT-InSTEM.

Rewriting the Regulatory Playbook

Global regulators are already loosening the mandate for animal data. The U.S. FDA Modernisation Act 2.0 now allows non-animal data for approvals, and India’s 2023 New Drugs and Clinical Trials Amendment followed suit.

To capitalise on this, the report proposes an industry-led consortium. This group would advocate for the 3Rs: Replace, Reduce, and Refine animal testing. Align India with international regulatory benchmarks and work with the CDSCO to make NAM-based dossiers a routine part of drug filing.

Despite the momentum, India faces "significant gaps," including a shortage of high-quality human cell lines and fragmented infrastructure. To bridge this, the report recommends establishing a National NAMs Agency, developing Made-in-India supply chains for labware and culture media to keep costs low and launching large-scale workforce training for pharma scientists.

“Non-animal methods present an opportunity to strengthen early R&D, lower development costs and accelerate timelines,” said Deepak Sapra, CEO–API & Services at Dr. Reddy’s Laboratories.

As India pursues its $500-billion "Viksit Bharat" pharma vision by 2047, the stakes are high. Already providing 60 percent of the world’s vaccines, the report says country now has a "narrow window" to pivot from being a generic supplier to a front-line innovator.