Removing Animals from Drug-Testing Process

• 14 Aug 2023

For Prelims: Organoids, Organs-on-Chip, 3D Bioprinting, New Drugs and Clinical Trial Rules 2019, Drugs and Cosmetics Act, 1940, Drugs Controller General, India.

For Mains: Key Emerging Alternative Testing Methods,Regulatory Mechanism of Clinical Trials in India.

Source: TH

Why in News?

The Government of India has recently introduced an amendment to the New Drugs and Clinical Trial Rules, 2023. The amendment addresses the ethical and scientific concerns surrounding the use of animals in research, particularly in drug testing.

• This step authorizes researchers to utilize innovative non-animal and human-relevant methods for testing new drugs, ushering in an era of more accurate, efficient, and ethically aligned drug development processes.

What is the Current Drug-Development Landscape?

• The journey of every drug from conception to market involves a series of rigorous tests to assess its efficacy and potential side effects. Traditionally, this process has involved testing candidate molecules on animals, typically rodents like mice or rats, as well as non-rodents such as canines and primates. However, this approach has significant limitations:
  • Species Mismatch: Humans exhibit intricate biological variations due to factors such as age, genetics, diet, and pre-existing diseases.
    • Animal models, even non-rodents, cannot fully replicate the complex human response to drugs.
  • High Failure Rates: The considerable divergence between animal and human responses contributes to the high failure rate of drug development.
    • Despite advancements in the pharmaceutical sector, most drugs that pass animal testing fail during human clinical trials.
• Recognizing these limitations, researchers globally have been exploring alternative testing methods that better replicate human biology and responses.

What are the Key Emerging Alternative Testing Methods?

• Organoids: Organoids are three-dimensional cellular structures that emulate specific organs of the body.
  • These miniature organs, developed from human cells or stem cells, provide a more accurate representation of human physiology, enabling researchers to study drug interactions in a human context.
• Organs-on-Chip: Organs-on-chip are small devices lined with human cells, mimicking the blood flow and cellular interactions within the body.
  • These chips replicate key physiological aspects and allow researchers to analyze tissue-tissue interactions and chemical signals, providing a platform for more accurate drug testing.
• 3D Bioprinting: 3D bioprinting technology enables the creation of complex human tissues and organs using patient-specific cells.
  • This advancement allows for the development of personalized drug testing approaches, catering to individual variations in biology.

What are the Global Regulatory Shift to Accommodate Emerging Methods?

• The European Union passed a resolution in 2021 to transition towards non-animal testing methods.
• The U.S. introduced the FDA Modernization Act 2.0 in 2022, allowing the use of human-relevant systems for drug testing.
• South Korea and Canada also introduced legislation to promote alternatives to animal testing.
• In March 2023, India joined this global shift by amending the New Drugs and Clinical Trial Rules 2019, enabling the incorporation of human-based testing methods into the drug development pipeline.

What is the Regulatory Mechanism of Clinical Trials in India?

• The major legislations that govern clinical trials in India are: Drugs and Cosmetics Act, 1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970, Guidelines for Exchange of Biological Material (MOH order, 1997).
• Prerequisites of conducting a clinical trial in India are:
  • Permission from the Drugs Controller General, India (DCGI)
  • Approval from the Ethics Committee established under Drugs and Cosmetics Rules.
  • Mandatory registration on the ICMR maintained website

What are the Challenges and Opportunities Related to Regulatory Shift for India?

• Multidisciplinary Expertise: Developing and implementing technologies like organoids and organs-on-chip demand diverse expertise, ranging from cell biology and materials science to electronics and pharmacology.
  • India must invest in multidisciplinary training and resource-building to bridge existing knowledge gaps.
• Resource Localization: The current reliance on imported reagents, cell-culture materials, and instruments poses a resource challenge.
  • To establish a self-sufficient ecosystem, India should focus on developing a robust infrastructure in areas like cell culture, material science, and electronics.
• Standardization and Guidelines: Variability in laboratory protocols can lead to inconsistent data.
  • Clear guidelines and quality criteria are essential to ensure reliable and comparable results across different labs.
  • Regulatory bodies must adapt to the advancements in cell-based and gene-editing-based therapeutics.