|
In a bid to ensure proper product safety testing and maintain and respect animal and environmental welfare, specialty chemical manufacturers have urged the government to validate and implement New Approach Methodologies (NAMs) by aligning itself to global trends in developing alternatives to animal testing.
“With inclusion of India as a full-member for Mutual Acceptance of Data (MAD) in the OECD’s (Organization for Economic Cooperation and Development) Working Group on Good Laboratory Practices (GLPs), data generated from the nonclinical studies by the Indian GLP laboratories is acceptable in 37 OECD member countries and 7 nonmember MAD. There are opportunities for India to define its role in validating and implementing NAMs by aligning itself to global trends in developing alternatives to animal testing,” said Dr Fabian Grimm, head of toxicology and ecotoxicology, global product leadership, Clariant, a focused, sustainable, and innovative specialty chemical company.
He was speaking at a day-long industry workshop titled, ‘Navigating Headwinds in Regulatory Toxicology’ held by Clariant India in Mumbai recently.
Dr Grimm said “Today it is not chemical safety alone being a prerequisite for product compliance, marketability, customer satisfaction but it is safety and sustainability of our products. One of the major challenges is in creating a gradual shift towards animal-free test systems and approaches – collectively known as ‘New Approach Methods’ or NAMS.”
Echoing with him, Erika Kunz, head of global product stewardship said “A growing range of modern techniques can replace the use of animals and provide results that are more relevant to human patients. These include the use of human cells and tissues, and computer-based methods. Our work aimed to explore the societal benefits of accelerating the replacement of animals with these new research methods. We found that this approach would benefit animal welfare, public health and the economy.”
Kunz said “Global regulatory agencies are exploring alternative methods to replace laboratory animals in developing new drugs and products. In June 2021 the US Food and Drug Administration (FDA) came out with proposals for the New Alternative Methods Program focusing on replacing, reducing and refining the use of laboratory animals through the adoption of cutting-edge alternative methods. The aim is to produce findings that are more relevant to humans, streamline product development and reduce costs. The European Medicines Agency (EMA) is putting in place special support to developers to replace, reduce and refine animal use for the development, manufacturing and testing of human and veterinary medicines. The Agency is promoting these three principles — replace, reduce and refine; commonly referred to as 3Rs — through EMA’s Innovation Task Force (ITF).”
She said “Indian contract research organizations (CROs) and Clariant are jointly making efforts to adopt paradigm changes happening in the world of toxicology. Clariant has sustainability anchored to its corporate strategy. Chemicals go into several consumer applications, toxicological evaluation is therefore important, mainly for hazard identification, risk analysis, registrations and regulatory authorizations.”
Sadhana Kulkarni, head of product stewardship, Clariant India Ltd said “Today the chemical industry is facing increasing or stringent substance regulations worldwide. These regulations are mandatory and a global product launch becomes more and more time and cost consuming and must fulfill multiple regulations. As we know toxicity testing plays a pivotal role in identifying the potential adverse effects caused by chemicals. For instance, genotoxicity, carcinogenicity, immunotoxicity and reproductive and developmental toxicity in humans are generally observed after chronic chemical exposure.”
A workshop held by Clariant recently discussed initiatives in India towards orienting contract research organizations about the future of toxicology testing. The workshop also shed light on emerging methodologies in the world of toxicology and ecotoxicology, said Kulkarni.
Dr. Nitin Shetty of Bioneeds, a leading preclinical contract research organization who attended the workshop stressed the need for implementation of the three Rs (reduction, replacement and refinement) in regulatory toxicity and biosafety assessment.
Talking about new tools/strategies to implement new approach methods, Dr Shetty said “RNA sequencing reveals post exposure changes in the simultaneous expression of large numbers of genes. Text-mining tools using scientific-literature databases provide approaches for developing hypotheses on relationships between chemicals, genes and diseases.”
|