Editorial 1: India takes first step to remove animals from drug-testing
Introduction
- An amendment to the New Drugs and Clinical Trial Rules (2023), recently passed by the Government of India, aims at stopping the use of animals in research, especially in drug testing. 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.
Current drug-development pipeline
- Every drug in the market goes through a long journey of tests, each designed to check whether it can treat the disease for which it was created and whether it has any unintended harmful effects.
- For a long time, the first step of this process has been to test the 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.
- This ‘mismatch’ between the two species is reflected in the famously high failure-rate of the drug development process.
- Despite increasing investment in the pharmaceutical sector, most drugs that cleared the animal-testing stage fail at the stage of human clinical trials, which come towards the end of the pipeline.
Alternative testing modes
- In the last few decades, several technologies have been 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”.
- Another popular technology is the “organ-on-a-chip” which are AA-battery-sized chips lined with human cells connected to microchannels, 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.
- Researchers have also used additive manufacturing techniques for more than two decades.
- In 2003, researchers developed the first inkjet bioprinter by modifying a standard inkjet printer. Several innovations in the last decade now allow a 3D bioprinter to ‘print’ biological tissues using human cells and fluids as ‘bio-ink’.
- These systems promise to reshape drug-design and -development. Since they can be built using patient-specific cells, they can also be used to personalise drug-tests.
Developing the organ-on-a-chip system
- One problem is that developing an organ-on-a-chip system typically requires multidisciplinary knowledge.
- This means expertise in cell biology to recreate the cellular behaviour in the lab; materials science to find the right material to ensure that the chip does not interfere with biological processes; fluid dynamics to mimic blood flow inside the microchannels; electronics to integrate biosensors that can measure pH, oxygen etc.in the chip; engineering to design the chip; and pharmacology and toxicology to interpret action of the drugs in the chips.
- It’s a truly interdisciplinary endeavour and needs focused training and human-resource building, which is lacking in the country at present.
Way forward
- To manage the complexity of recreating human tissues and organs in the petri dish, researchers often minimise the number of components required to simulate the disease being investigated.
- It is important to bring out guidelines on the minimal quality criterion and standards for these systems.
- Also, the current guidelines on animal testing requirements must be re-evaluated and revised, considering newer developments in cell-based and gene-editing based therapeutics.
Editorial 2: Can SMRs help India achieve net zero?
Introduction
- The world’s quest to decarbonise itself is guided, among other things, by the UN Sustainable Development Goal 7: “to ensure access to affordable, reliable, sustainable and modern energy for all”.
Challenges of decarbonisation
- The transition from coal-fired power generation to clean energy poses major challenges, and there is a widespread consensus among policymakers in several countries that solar and wind energy alone will not suffice to provide affordable energy for everyone.
- According to the International Energy Agency, the demand for critical minerals like lithium, nickel, cobalt, and rare earth elements, required for clean-energy production technologies, is likely to increase by up to 3.5 times by 2030.
- This jump poses several global challenges, including the large capital investments to develop new mines and processing facilities.
- The environmental and social impacts of developing several new mines and plants in China, Indonesia, Africa, and South America within a short time span, coupled with the fact that the top three mineral-producing and mineral-processing nations control 50-100% of the current global extraction and processing capacities, pose geopolitical and other risks.
The issues with nuclear power
- Nuclear power plants (NPPs) generate 10% of the world’s electricity and help it avoid 180 billion cubic metres of natural gas demand and 1.5 billion tonnes of CO2 emissions every year.
- NPPs are efficient users of land and their grid integration costs are lower than those associated with variable renewable energy (VRE) sources because NPPs generate power 24×7 in all kinds of weather.
- Nuclear power also provides valuable co-benefits like high-skill jobs in technology, manufacturing, and operations.
- Conventional NPPs have generally suffered from time and cost overruns. As an alternative, several countries are developing small modular reactors (SMRs) — nuclear reactors with a maximum capacity of 300 MW — to complement conventional NPPs.
- SMRs can be installed in decommissioned thermal power plant sites by repurposing existing infrastructure, thus sparing the host country from having to acquire more land and/or displace people beyond the existing site boundary.
Advantages of SMRs
- SMRs are designed with a smaller core damage frequency and source term (a measure of radioactive contamination) compared to conventional NPPs.
- They also include enhanced seismic isolation for more safety.
- SMR designs are also simpler than those of conventional NPPs and include several passive safety features, resulting in a lower potential for the uncontrolled release of radioactive materials into the environment.
- The amount of spent nuclear fuel stored in an SMR project will also be lower than that in a conventional NPP.
- Studies have found that SMRs can be safely installed and operated at several brownfield sites that may not meet the more stringent zoning requirements for conventional NPPs.
- Accelerating the deployment of SMRs under international safeguards, by implementing a coal-to-nuclear transition at existing thermal power-plant sites, will take India closer to net-zero and improve energy security because uranium resources are not as concentrated as reserves of critical minerals.
- Since SMRs are mostly manufactured in a factory and assembled on site, the potential for time and cost overruns is also lower.
- Further, serial manufacture of SMRs can reduce costs by simplifying plant design to facilitate more efficient regulatory approvals and experiential learning with serial manufacturing.
Integration of SMRs with the national grid
- India’s Central Electricity Authority (CEA) projects that the generation capacity of coal-based thermal power plants (TPPs) in India must be increased while enhancing the generation capacity of VRE sources.
- The CEA also projects that TPPs will provide more than half of the electricity generated in India by 2031-2032 while VRE sources and NPPs will contribute 35% and 4.4%, respectively.
- Since India has committed to become net-zero by 2070, the country’s nuclear power output needs a quantum jump.
- Since the large investments required for NPP expansion can’t come from the government alone, attracting investments from the private sector (in PPP mode) is important to decarbonise India’s energy sector.
Way forward
- The Atomic Energy Act will need to be amended to allow the private sector to set up SMRs.
- To ensure safety, security, and safeguards, control of nuclear fuel and radioactive waste must continue to lie with the Government of India.
- The government will also have to enact a law to create an independent, empowered regulatory board with the expertise and capacity to oversee every stage of the nuclear power generation cycle.
- The security around SMRs must remain under government control, while the Nuclear Power Corporation can operate privately-owned SMRs during the hand-holding process.
- Finally, the Department of Atomic Energy must improve the public perception of nuclear power in India by better disseminating comprehensive environmental and public health data of the civilian reactors, which are operating under international safeguards, in India.
