Also called New Approach Methodologies (NAMs), they are innovative testing methods and strategies used to assess the safety, efficacy, and quality of drugs.

• To achieve India’s $500 billion pharma target by 2047, NAMs can be key to transitioning from a generics-based industry to a global hub for drug discovery and innovation.

Types of NAMs

Biological Models (In Vitro & Ex Vivo):

• Organ-on-Chip: 3D chips created from human cells mimicking human organs. E.g. lung-on-a-chip
• Organoids: Miniature, lab-grown human organs (e.g., liver, intestine) created from stem cells that mimic real organ functions. E.g. pivotal in proving that Zika virus causes microcephaly
• Human blood cell-based assays: E.g. replacing the rabbit pyrogen test (to detect fever-causing contaminants)

Computational (In Silico Models)

• AI and Computer Modelling: Predict drug toxicity, efficacy and interactions. 
  • E.g. Using recordings of human heart activity to test for arrhythmias, screening out dangerous compounds earlier. 

Significance of NAMs

• Reduced Attrition Rates: Traditional animal testing poorly predicts human responses, with only 10–14% of Phase I drug candidates ultimately approved.
• Biological Precision: E.g., brain organoids linked the Zika virus to microcephaly, a discovery not possible in animal models due to brain differences.
• Reduced Time and Cost: Recent report suggests NAMs can cut drug development timelines by more than half and reduce costs by ~70-90% in India.
• Global Competitiveness: As regulators in the U.S., EU, and Japan establish national centers for NAMs, India’s early adoption ensures it remains competitive.
  • Under India’s New Drugs and Clinical Trials (Amendment) Rules, 2023, authorized use of human-relevant, non-animal testing methods for evaluating drug safety and efficacy.