The ambitious task on hand is apparent from the weighty title of the report – ‘Landscape Analysis on Alternatives to Animal Testing for Drug Development in India.’ That the report has the foreword by Dr Rajeev Raghuvanshi, the Drugs Controller of India signals early on an alignment of intent. That the report also has the backing of multiple stakeholders, including academic researchers and pharmaceutical companies holds out hope for progress on what seems a rather long and arduous journey. The report is aimed at aligning various stakeholders on ways to leverage scientific advances in drug development with an eye on safety and efficacy with suitable regulatory science and skills. All of these while ensuring there are alternative approaches adopted to use of animal testing during drug development.
Present status of animal testing
Given that animal testing typically accounts for between 5 and 10 per cent of total drug development cost, Deepak Sapra, Chief Executive Officer- API and Services, Dr. Reddy’s, says, while a process that does away with animal testing helps reduce the cost to that extent, equally crucial is the time saved typically about a year. All in all, a faster, more efficient and better targeted with newer possibilities for outcomes that could also offer personalized solutions.
In this journey, he feels, the first step would be to establish an industry-led consortium to advocate for the adoption of non-animal testing methods for drug development on the principle of 3Rs – replacement, reduction and refinement. Along with this, raise awareness of global best practices and enable a structured engagement with regulators. Creating a central coordinating body for non-animal testing methods to facilitate validation, standardisation and regulatory dialogue.
Seeing a clear alignment, at least among some of the leading Indian pharma companies, he says, Dr Reddy’s in discussion with some of the other large companies, especially those like Sun Pharma, Biocon and Cipla, that have been participants in the framing of the report’s recommendations apart from the support of the Indian Pharmaceutical Alliance. In a year from now, he sees a yardstick to progress in the institutionalisation of the approach with greater regulatory acceptance and creation of infrastructure. On the institutional side, the hope is to see the creation certain formalised validation frameworks recognised by Indian regulators which would be crucial from an institutionalisation perspective. There are examples available globally on these like for instance, the NC3Rs (National Centre for Replacement, Refinement and Reduction of Animals in Research) in the UK apart from those in the US and other countries.
On regulatory acceptance, the hope is for a clear guidance from the regulator on where new alternatives can replace or reduce animal testing. Running in parallel but equally critical would be structures like a nationwide primary cell repository or a human tissue bio-bank that will enable not just adoption but also look at domestic manufacture of key non-animal platforms, reagents and organ chip devices, which will help in adoption and also create an industry by itself.
New horizons
A move in this direction along with the drug regulator already embarking upon this journey, especially in relation to biosimilars and adopting the guidelines, it does sound like a good start to Satish Reddy, chairman, Dr Reddy’s and one of the key forces behind this report. He says, “this journey will keep taking huge steps as India tries to lead this effort in terms of what can be done.”
Alokparna Sengupta, managing director, Humane World for Animals India, feels, “in this modern age, we have human cell-based and computational models that can reflect human biology far more accurately, reducing the risk of drug failures. These emerging technologies can save the lives of animals, revolutionize public health, and aid in quicker and cost-effective drug development.”
Professor Sarfaraz K Niazi, Adjunct Professor, University of Illinois, chancellor, Chicago University, USA, having seen the happenings more closely in biosimilars, does find doing away with animal studies and human efficacy trials reducing cost substantially while also speeding up the process.
The drug regulator Dr Raghuvanshi sums up the end goal of the report as one that would hopefully “catalyse the partnerships, investments, and regulatory clarity needed to make humane, predictive and efficient drug development the norm rather than the exception.”