The Government of India has recently introduced an amendment to the New Drugs and Clinical Trial Rules, 2023, raising a new wave in drug testing methodologies. This revolutionary step addresses ethical and scientific concerns related to animal usage in research. The amendment facilitates researchers to adopt innovative non-animal and human-relevant methods for testing new drugs, paving the way for more accurate, efficient, and ethically appropriate drug development processes.
The Current Drug-Development Landscape
Every drug’s journey from conception to marketability involves rigorous tests to evaluate its effectiveness and potential side effects. Conventionally, these tests have depended on animals, primarily rodents like mice or rats, and non-rodents such as canines and primates. Nonetheless, this approach has significant limitations; it fails to replicate the complex human reaction to drugs due to species mismatch and exhibits high failure rates in drug development. These challenges highlight the need for alternative testing methods that can adequately mirror human biology and responses.
Key Emerging Alternative Testing Methods
Researchers worldwide are exploring alternative testing methodologies to better simulate human biology and responses. Organoids are a promising solution; they are three-dimensional cellular structures that mimic specific organs of the body. Organs-on-chip are small devices lined with human cells that reproduce critical physiological aspects, providing a platform for more precise drug testing. Another novel approach is 3D bioprinting technology, which allows the creation of intricate human tissues and organs using patient-specific cells, permitting the development of personalized drug testing methods.
Global Regulatory Shift Towards Novel Methods
In recognizing the rise of emerging methodologies, several countries have revised their laws to accommodate these alternative testing techniques. The European Union passed a resolution in 2021 transitioning towards non-animal testing methods, while the U.S. introduced the FDA Modernization Act 2.0 in 2022. South Korea and Canada have also endorsed legislation promoting substitutes to animal testing. India, mirroring this global shift, amended the New Drugs and Clinical Trial Rules 2019 in March 2023, allowing for the assimilation of human-based testing methods into the drug development pipeline.
Regulatory Mechanism of Clinical Trials in India
India’s clinical trials are governed by the Drugs and Cosmetics Act, 1940; the Medical Council of India Act, 1956; the Central Council for Indian Medicine Act, 1970; and the Guidelines for Exchange of Biological Material (MOH order, 1997). To conduct a clinical trial in the country, researchers must obtain permission from the Drugs Controller General, India (DCGI); get approval from the Ethics Committee established under Drugs and Cosmetics Rules; and register on the ICMR-maintained website.
Challenges and Opportunities Rising from Regulatory Shift in India
Adopting emerging technologies like organoids and organs-on-chip requires multidisciplinary expertise spanning cell biology, materials science, electronics, and pharmacology. To bridge knowledge gaps, India needs to invest in multidisciplinary training and resource-building. The country also faces a resource challenge due to its dependence on imported reagents, cell-culture materials, and instruments. Overcoming this obstacle involves focusing on developing robust infrastructure in areas like cell culture, material science, and electronics. Furthermore, variability in laboratory protocols can lead to inconsistent data, underscoring the need for clear guidelines and quality criteria to ensure reliable results across different labs.
