Rule amendment . Drug trials may soon be done on human tissues, cells developed in labs; change in rules in offing

Pre-clinical trials of new drugs could soon be done on human tissues and cells developed in laboratories and not just on animals as the Union Health Ministry is working on bringing in amendments to the New Drugs and Clinical Trials Rules, 2019.

A recent draft notification to amend the rules stated that alternative technology platforms such as human organ on chips, micro-physiological systems and other in vitro or cell-based assays can be used prior to and in conjunction with animal testing to establish the safety and efficacy of new drugs before human clinical trials.

Pre-clinical tests are important for establishing the safety and efficacy of investigational drugs.

Landmark bill

In September, the US Congress approved a landmark FDA Modernization Bill that allows a pharmaceutical drug developer to use alternative methods -- including cell-based assays, organ on chips, micro-physiological systems and other human biology-based test methods -- for establishing the safety and effectiveness of new or investigational drugs in the laboratory, along with animal testing, ahead of human clinical trials.

Once the amendments to the New Drugs and Clinical Trials Rules, 2019, are approved and notified by the Union Health Ministry, India will become the second country in the world after the US to adopt and promote such innovative and cutting-edge technologies that promise significant reduction in time as well as costs in bringing novel drugs and effective therapies while reducing cruelty on animals, official sources said.

Improving success rate

"Human bio-specimens such as blood, tissues and urine made available during planned surgeries through the informed consenting process are being used to develop in the laboratory organ systems, organoids and organ on chips that mimic actual human organs for pre-clinical testing of drugs before human clinical trials," an official source explained.

These alternative technologies have shown the potential to improve the success rate of preclinical and clinical discoveries by 70 per cent to 80 per cent compared to drugs developed using animal models alone which continue to show a failure rate as high as 80 to 90 per cent. 

This reduces the risk posed to humans through exposure to ineffective and toxic drugs tested on animal systems alone that fail to replicate human systems. It also enables the discovery of new drugs in a time-bound and cost-effective manner which is likely to boost new drug discovery and clinical innovation in the country, the source explained.

Moreover, since there are genetic differences in different human races and ethnicities this technology will also be useful in testing the effectiveness of drugs in a given population when they have been tested previously on another population, ethnicity and geography.

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