Why animal testing still drives drug approvals in India, and what it costs pharma?

Indian drugmakers are required to conduct animal toxicity studies in several categories where regulators in the US and Europe allow waivers or non-animal alternatives, an industry-backed report released on Thursday said.

The report, titled Landscape Analysis on Alternatives to Animal Testing for Drug Development in India, examined India’s non-clinical drug approval framework against regulatory practices followed in major global markets such as the US, the European Union, the UK and Japan, and identified areas where animal studies continue to be sought despite the availability of established human data or validated non-animal methods.

According to the analysis, the divergence is most visible in segments such as generic drugs, impurity qualification and certain quality tests, where animal toxicity studies often add limited incremental scientific value when the active pharmaceutical ingredient (API) already has a well-established safety record. In many such cases, overseas regulators rely on human bioequivalence data, published scientific literature or risk-based scientific justification instead of repeat animal testing.

In regulatory terms, toxicity studies are designed to assess whether a drug, formulation change or impurity could cause harm. The report noted that for generic medicines, where the molecule is already approved and widely used, robust human bioequivalence studies are often sufficient to establish safety and efficacy, reducing the need for repeat animal experiments.

The report said replacing animal-based toxicity studies with validated non-animal methods can sharply lower drug development costs by eliminating repetitive testing that adds time and expense without commensurate scientific value. In areas such as generics, biologics and biosimilars, where similarity can be demonstrated and safety is already well understood, these approaches can reduce overall development costs by as much as 70–90 per cent while also compressing timelines.

“Earlier, biosimilars were quoted at $100–150 million. I got a product approved for about $8 million end to end, with no animal testing,” said Sarfaraz K. Niazi, adjunct professor at the University of Illinois.

The findings gain significance as India’s pharmaceutical industry seeks to expand beyond its traditional strength in high-volume generics into complex drugs, biologics and emerging areas such as cell and gene therapies.

According to the Tufts Center for the Study of Drug Development, an independent academic research institution, developing a new drug from discovery to regulatory approval typically takes 10–15 years and can cost up to an estimated $2.6 billion, highlighting why companies and regulators globally are examining ways to improve efficiency in early-stage development.

“Science-driven, non-animal testing methods present a valuable opportunity for India’s pharmaceutical industry to strengthen early-stage research, improve scientific relevance, lower development costs, and accelerate drug development timelines,” said Deepak Sapra, Chief Executive Officer–API and Services at Dr. Reddy’s Laboratories, one of the firms involved in the study.

India amended its New Drugs and Clinical Trials Rules in 2023 to permit the use of non-animal, human-relevant testing approaches such as organoids, organ-on-chip systems and computational models. However, the report noted that the absence of detailed regulatory guidance on acceptance criteria and validation pathways has limited their routine use in formal drug approval submissions.

Globally, drug regulators are gradually moving away from default animal testing towards a risk-based approach. Policy changes in the US and Europe now allow drug developers, in certain cases, to rely on non-animal data or existing scientific knowledge, particularly where human safety data is already available, the report noted.

One area identified for near-term reform is pyrogen and endotoxin testing, which is carried out to assess whether injectable drugs or medical products could trigger fever-causing immune reactions. The report noted that animal-based tests are still commonly used for this purpose in India, even though non-animal alternatives are available internationally.

It recommended accelerating the adoption of validated alternatives such as the Monocyte Activation Test, which uses human immune cells to detect fever-inducing contaminants, and recombinant Factor C assays, which replace animal-derived reagents for endotoxin detection. These methods are already accepted in several international quality standards used by drug regulators, the report noted.

“For decades, there have been conversations around the use of animals and bringing in alternatives. The time has come now for these conversations to move to action,” said Alokparna Sengupta, Managing Director, Humane World for Animals India.

The report also called for clearer mechanisms to support validation, standardisation and regulatory engagement for non-animal methods, along with greater investment in domestic capabilities such as biobanks, reagents and trained personnel.

For Indian pharmaceutical companies, closer regulatory alignment could lead to faster approvals, lower duplication of studies and reduced development costs, improving integration into global drug development pipelines, the report said.