Animals are commonly used for scientific experiments to test the safety and efficacy of new drugs, vaccines, pesticides etc. Animal research has helped advance science, but it also raises ethical, social, and environmental concerns. Some of the main issues with animal research are:

• Animal suffering: Many animals experience pain, distress & mutilation during experiments, and may be killed afterwards, often inhumanely. Animal welfare laws and regulations vary widely across countries and regions and may not adequately protect animals.
• Human relevance: Animals are biologically different from humans in significant ways, such as anatomy, physiology, genetics, metabolism, and immune system. This limits the efficacy & validity of animal data to human health outcomes.
• Cost and efficiency: Animal research is often expensive, time-consuming, and resource intensive. It also generates a large amount of waste and greenhouse gas emissions. Animal research may also delay or hinder the development of more innovative and effective methods that do not rely on animals.

Advantages of non-animal models: Human relevance | Ethical acceptability |Cost, efficiency and speed

Examples of non-animal models: In vitro methods | Organ-on-a-chip methods | Body-on-chip methods |Computational methods |Stem cell methods |Clinical methods

Methods available to change the ecosystem

• Lobbying and advocacy: advocate for laws and regulations that promote the development and adoption of non-animal methods.
• Education and awareness: Educate and raise awareness among policymakers, researchers, regulators, consumers, and the public about the ethical, scientific, and economic benefits of non-animal methods.
• Collaboration and partnership: Animal advocacy groups and Pharma Industry can collaborate and partner with each and with other stakeholders to develop, validate and promote non-animal methods.

Positive Tailwinds

Collaboration with the pharma industry is feasible as their commercial interests also are aligned to promoting non-animal methods, since taking the animals out of drug testing will likely reduce the time and cost of drug development.

Besides the above, regulators across the world are modifying regulations to allow use of non-animal models. The recently passed FDA Modernisation Act includes provisions that encourage the development and use of alternative testing methods, including the use of in-vitro and computer-based models. Similarly, the EU Revised Guidelines on animal testing include recommendations for reducing and replacing animal testing in drug development. The guidelines require pharmaceutical companies to use non-animal testing methods whenever possible, and to provide scientific justification for any animal testing that is conducted. In India, the Ministry of Health recently amended the Clinical Trial rules to allow non-animal methods.

Challenges

However, the road to change is a very long one, with multiple challenges – regulators are extremely wary of change; new technologies take time to scale up and become available at affordable price points for the industry to adopt, amongst others.

Our Interventions

Building a coalition of industry players to support the agenda to accelerate the transition – Dr Reddy’s is on board and a few large pharma players are being approached. BMGF has been contacted to become a stakeholder as they support this agenda in the US.

Advocacy with the government through the pharma industry to change the regulations. Representations have been made to include NAM in the PRIP scheme.

Supporting CPHMS (Centre for Predictive human modelling systems), a think-tank under the aegis of CSIR by raising funds to help them raise awareness amongst the scientific community.