Last updated : August 07, 2026 3:41 pm
The Central Insecticides Board and Registration Committee (CIB&RC) formally recognises the use of valid non-animal methods for assessing chemical pesticides and biopesticides
As the world's fourth-largest agrochemical producer and third-largest exporter, India has established itself as a global powerhouse. Maintaining that leadership will require regulatory frameworks that can efficiently evaluate products for their effects on human health and the environment using the best available science. Such frameworks will be increasingly important for facilitating market access, enabling scientific advancement, and strengthening India's competitiveness in a rapidly evolving global marketplace.
Chemical safety assessment is undergoing its most significant transformation in decades. At the heart of this shift are New Approach Methodologies (NAMs) or non-animal methods, a suite of modern scientific approaches that includes human cell- and tissue-based methods, computational models, in chemico assays, and integrated testing strategies—that generate toxicity information without the use of animals.
Today's regulatory challenges demand smarter science. A complete toxicity package supporting pesticide registration may involve tens of thousands of animals, while the number and complexity of chemicals to be assessed continue to grow. Coupled with the recognised limitations of animal tests in predicting human health outcomes, this has accelerated the development of tools that are more predictive, mechanistic, efficient, and relevant to human biology.
The Science Is Ready. Is the System?
The question is no longer whether non-animal methods work—it is how quickly they can become part of routine regulatory decision-making. Internationally valid non-animal methods have been incorporated into OECD test guidelines, while regulatory authorities such as the US Environmental Protection Agency, European Food Safety Authority, Health Canada, and the UK's Health and Safety Executive are publishing roadmaps and guidance to bring these approaches into mainstream regulatory practice.
India has already laid important groundwork. Through its 2017 and 2023 guidelines, the Central Insecticides Board and Registration Committee (CIB&RC) formally recognises the use of valid non-animal methods for assessing chemical pesticides and biopesticides. Yet, regulatory acceptance does not always translate into routine implementation. Uncertainty over when and how these methods can be used—or when additional tests can be waived—often leads companies to default to conventional testing to minimise the risk of perceived regulatory delays or rejection. At the same time, regulators have had limited opportunities to review submissions using the new approaches, which has limited their ability to build regulatory familiarity and confidence. The result is a classic implementation gap: valid methods exist, but their routine use remains limited.
These challenges are explored in our recent paper, published in Regulatory Toxicology and Pharmacology, which identifies practical opportunities to build a more scientifically modern risk assessment framework for pesticides.
Setting the Stage for Change
As new scientific tools emerge, regulatory frameworks must evolve to ensure that innovation translates into better regulatory decisions. Greater regulatory clarity is an important first step. Clearer language that actively encourages the use of non-animal methods, combined with a more flexible, science-based approach that waives new tests where existing evidence is sufficient, would provide greater certainty and encourage scientifically justified submissions. This means moving beyond a prescriptive testing paradigm towards a science-based framework that generates only the data needed to answer a specific regulatory question.
Improving access to regulatory information is equally important. A publicly accessible resource outlining accepted non-animal methods and opportunities for waiving studies, coupled with published case examples of successful regulatory submissions, would help demonstrate regulatory acceptance in practice and encourage wider adoption. Establishing a mechanism to periodically review and incorporate new methods, supported by ongoing training and scientific exchange, would further ensure that the regulatory framework remains dynamic, science-based, and aligned with international best practices.
Early scientific dialogue can further accelerate implementation. In jurisdictions such as the United States, Canada, Australia, and Japan, pre-submission consultations enable companies to discuss proposed non-animal approaches with regulators before investing time and resources in new studies. Similar mechanisms in India could reduce uncertainty, minimise the perceived risk of regulatory rejection, and encourage greater use of non-animal methods.
The Strategic Advantage
The value of non-animal approaches lies not only in reducing and replacing animal use but also in providing human-relevant, mechanistic evidence that can support better-informed decisions while improving efficiency, consistency, and international harmonisation.
For the industry, the transition represents a strategic investment. Many multinational companies already rely on these approaches for global regulatory submissions. Aligning India's regulatory framework with international best practices can strengthen regulatory preparedness, facilitate market access, and enhance competitiveness. Companies that build experience with valid non-animal methods will be better positioned to meet evolving regulatory expectations and generate data accepted across multiple jurisdictions.
India possesses many of the ingredients needed to lead this transition—scientific capability, growing infrastructure, and increasing industry interest. The opportunity now is to create a regulatory ecosystem that enables these advances to become routine practice. By doing so, India can strengthen pesticide safety assessment, foster innovation, and position itself as a global leader in modern regulatory science. India's next chapter in pesticide toxicity assessment will not be determined by the availability of better scientific tools but by the willingness to use them.
(Disclaimer: The views expressed in the articles are strictly those of the author and do not necessarily reflect the views of the Indian Chemical News.)