New Drugs and Clinical Trial Rules (2023) has been passed by the Government of India which aims to replace the use of animals in research, especially in drug testing.

Key-highlights of the Amendment:

• The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
• These rules mandate that any CRO conducting a clinical trial or bioavailability/bioequivalence study of new drugs or investigational drugs in human subjects must obtain registration from the Central Licensing Authority before conducting any such studies.

Clinical Trails module in India:

• Every drug goes through a long journey of tests, designated to check whether it can treat the disease for which it was created and its harmful effects.
• The first step of the process for drug testing involves candidate molecule in at least two animal species: a rodent (mouse or rat) and a non-rodent, such as canines and primates.
• However, humans are more complex creatures, and biological processes and their responses often vary from person to person as well, based on factors such as age, sex, pre-existing diseases, genetics, diet, etc. – and a lab-bred animal species reared in controlled conditions may not fully capture the human response to a drug.

Need for new regulations:

• Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials.
• The limitations of the conventional testing process, beginning with animals, have led an increasing number of researchers to focus on systems that do a better job of capturing the intricacies of human biology and predicting humans’ responses.

New Drugs and Clinical Trial Rules (2019):

• Objective: To change the regulatory landscape for the approval of new drugs and conduct of clinical trials in the country.
• Coverage: These rules will apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study and Ethics Committee.
• Application approval time: It has reduced the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country. In case of no communication from Drugs Controller General of India (DCGI), the application will be deemed to have been approved.
• Local clinical trial: The requirement of a local clinical trial may be waived for approval of a new drug if it is approved and marketed in any of the countries to be specified by the Drugs Controller General with the approval of the government.
• Safety in clinical trial: This will ensure patient safety, as they would be enlisted for trials with informed consent. The ethics committee will monitor the trials and decide on the amount of compensation in cases of adverse events.

Technologies suggested as alternatives:

To avoid animal use for clinical trials, technologies can be used effectively which includes;

• Technologies developed using human cells or stem cells: These include millimetre-sized three-dimensional cellular structures that mimic specific organs of the body, called “organoids” or “mini-organs”.
• ‘Organ-on-a-chip’ Technology: These are AA-battery-sized chips lined with human cells connected to micro channels, to mimic blood flow inside the body.
  • These systems capture several aspects of human physiology, including tissue-tissue interactions and physical and chemical signals inside the body.
• USING 3D Bioprinter: Bio printers are used to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
  • Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.

Possible Consequences:

The key challenges of clinical trials eased by technology are many.

• These include faster recruitment and better retention, improving the patient experience, improving patient data capture, access to non-traditional data sets, and remote patient monitoring.
• Additionally, trials can be decentralized, and a more patient-centric approach can be introduced.
• Moreover, the challenges trials face in the new normal brought about by COVID-19 can easily be met with breakthrough technologies.
• Patient Data Capturing: Mobile devices, smartphone-based apps, and wearable medical technology have significant potential for improving patient data capturing. Patient data is central to clinical trials as it informs research directions and final clinical outcomes.
• Remote Monitoring: Remote monitoring has become a particular focus of trials due to the COVID-19 pandemic and the need for social distancing to limit the spread of disease. Remote site access and monitoring tools are increasingly being employed by researchers.
• Barriers of Clinical trials: There are risks with these decentralized trials, however, including patient compliance and the level of the participant’s technological knowledge, but this type of clinical trial overcomes barriers such as logistics, transportation, and access to remote populations which otherwise interfere with the global expansion of trials.