A shift towards non-animal methods (NAMs) can significantly reduce the timelines and costs associated with drug development, said a multi-stakeholder report released on Thursday. The report said that the cost of drug development can go down by up to 90% if NAMs can be implemented responsibly.
“Traditionally, animal models have been central to preclinical testing. However, species-specific differences in physiology and genetics limit their ability to predict human outcomes. Only around 10% of drugs entering Phase I trials ultimately receive regulatory approval, leading to higher costs, longer timelines, and the loss of potentially beneficial therapies,” the report said.
Further, the report stated that countries like India, the US and the UK have now explicitly authorised the use of non-animal alternatives to test safety and efficacy of new drugs. Also, companies like Dr Reddy’s, Sun Pharma and Biocon have been actively pursuing NAMs to develop drugs while adhering to the regulatory norms.
Regulatory Green Light
While releasing the report, Satish Reddy, chairman of Dr. Reddy’s Laboratories said that emerging technologies now provide pathways that are not only more ethical but often more predictive of human responses. “Recent policy developments, including the FDA Modernisation Act 2.0 and it’s subsequent 3.0 updates as well as India’s New Drugs and Clinical Trials (Amendment) Rules, 2023, reaffirm regulatory openness to scientifically-validated alternatives to traditional animal studies,” he said.
Through a detailed assessment across generics, new chemical and biological entities (NCEs/NBEs), and cell and gene therapies, the report has identified specific areas where animal tests can be eliminated and replaced with science-driven, patient-specific technologies.
Generic Efficiency
For instance, in many cases, especially for developing generics, biologics and biosimilars, mandatory animal studies often provide minimal incremental scientific value. “Redundant animal testing in the development of generic drugs can often be waived because the active pharmaceutical ingredients (APIs) involved are already well-established in terms of safety, and the excipients used are generally recognised as safe,” it said.
Drugs Controller of India Rajeev Raghuvanshi said that the report puts India at the forefront of the global shift toward NAMs, which includes organ-on-chip systems, lab-grown human tissues and computer-based models involving AI/ML, that can reduce clinical attrition and accelerate development timelines. “If pursued with rigor and integrity, India can not only meet global standards but lead in developing and exporting human-relevant testing platforms and expertise,” Raghuvanshi said.
Inputs from various stakeholders – pharma companies, CDMOs, regulators and academicians – were taken to prepare the report, including Dr Reddy’s Laboratories, DBT BRiC –Institute for Stem Cell Science and Regenerative Medicine (inStem), and Animal Law & Policy Network.
