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Subject: Science and Technology

  • The personalised vaccine that could cut skin cancer death risk

    The personalised vaccine that could cut skin cancer death risk

    Why in the News

    A new personalised cancer vaccine, intismeran, administered alongside the immunotherapy drug Keytruda, has been shown in Phase 3 results to reduce the risk of death from the recurrence and spread of skin cancer.

    How does intismeran work?

    1. Step one, read the tumour: The therapy begins by identifying the mutations, called neoantigens, in a sample of the patient’s own tumour.
    2. Step two, build the instruction set: A vaccine is then made of synthetically developed messenger RNA (mRNA), a single stranded molecule that carries genetic instructions from DNA in the cell nucleus and tells the cell which proteins to make. Each treatment consists of mRNA coding for 34 such neoantigens.
    3. Step three, administer and translate: Once administered, the body generates these proteins from the mRNA instructions.
    4. Step four, present to the immune system: The body then presents those proteins to the immune system, which is trained to recognise them as belonging to the cancer.

    Why must a cancer vaccine be personalised?

    1. Neoantigens exist only on cancer cells: Neoantigens are proteins found only on the cancerous cells, which the body’s immune system can be trained to recognise.
    2. They differ from patient to patient: These neoantigens vary from person to person, so they become an identifier for that individual’s cancer and cannot be mass produced as a single formulation.
    3. The principle is the same as any vaccine: A vaccine for an infectious disease contains the antigen from a pathogen, the proteins or lipids that train the immune system to recognise and fight it, and this therapy contains cancer neoantigens instead.
    4. The benefit is immunological memory: The cancer’s fingerprint enters the immune system’s memory, so if the cancer returns the body can recognise it immediately and mount a response, prolonging recurrence free survival.
    5. A decade of work behind one result: Work on this approach has run for around a decade, and this is the first clinical breakthrough.

    What did the Phase 3 study find?

    1. Death risk from recurrence fell: When the vaccine was given with Keytruda, the risk of death owing to recurrence of skin cancer went down by 49 per cent.
    2. Death risk from spread fell further: The risk of death owing to the cancer spreading went down by 59 per cent.
    3. The comparison arm matters: Both results are measured against treatment with Keytruda alone, not against no treatment.
    4. The comparison arm is already strong: Keytruda (pembrolizumab, a checkpoint inhibitor that blocks the PD-1 receptor cancer cells use to switch off the immune response against them) has over the years been shown to be much more effective in treating certain cancers than traditional chemotherapy, so the gain sits on top of an established benchmark.
    5. Side effects were mild: The most common side effects noted in the study were fatigue, injection site pain and chills.

    What does this mean for India?

    1. Reason one, the disease is rare here: Melanoma is one of the most common types of cancer in the caucasian population, and is not commonly seen among Indians.
    2. The share is a fraction of a per cent: Globocan, short for Global Cancer Observatory, an online platform that maintains cancer statistics, shows that melanoma accounts for only 0.26 per cent of all cancer cases in India and 0.17 per cent of deaths.
    3. Reason two, cost: Most patients in India are unable to afford Keytruda even with patient assistance programmes, and a combination therapy compounds a barrier that already exists for the immunotherapy alone.
    4. Access to immunotherapy is already narrow: A real world study from Tata Memorial Hospital showed that only 1.6 per cent of the patients who need such immunotherapy are able to access it.

    Challenges to personalised mRNA cancer vaccines

    1. Every dose is a separate manufacturing run: The vaccine must be sequenced, designed and produced per patient, so the process cannot be batched and the turnaround competes with tumour progression. Eg. Each treatment encodes 34 neoantigens specific to one person’s tumour. Fix. Build automated, closed-system manufacturing units co-located with cancer centres, on the model already used for cell therapy production.
    2. Cost scales with individualisation: A therapy that cannot be mass produced carries no volume discount, so the price gap over a standard drug widens rather than narrows with adoption. Eg. Even the standard companion immunotherapy reaches only 1.6 per cent of Indian patients who need it. Fix. Negotiate outcome linked pricing, where payment is tied to recurrence free survival achieved rather than to doses supplied.
    3. Cold chain requirements restrict reach: mRNA products require ultra-low temperature storage and transport, which most Indian district level oncology facilities do not have. Eg. Covid-19 mRNA vaccines were never widely deployed in India partly for this reason. Fix. Extend the cold chain built for the universal immunisation programme with ultra-low temperature capacity at regional cancer centres before such therapies are introduced.
    4. Tumours can escape the target: Cancer cells can lose the targeted antigen over time, which is the known failure mode of antigen directed immunotherapy. Eg. Relapse through antigen escape is documented in CAR-T cell therapy for blood cancers. Fix. Design vaccines against multiple conserved neoantigens and pair them with checkpoint inhibitors, so escape from one target does not end the response.
    5. Regulatory pathways assume a fixed product: Approval systems are built to assess an identical formulation across a trial population, while each dose here differs by design. Eg. India’s biotechnology approvals are already split across the Department of Biotechnology, the drug regulator and the environment ministry. Fix. Create a platform approval route that licenses the manufacturing process and the design algorithm rather than each individual product.
    6. The evidence is disease specific: The result is established for melanoma alone, and benefit in the cancers that dominate India’s burden is not demonstrated. Eg. Melanoma is 0.26 per cent of Indian cancer cases while breast, oral and cervical cancers account for the bulk. Fix. Prioritise Indian participation in trials of the same platform for oral, breast and cervical cancers, so approval evidence is generated on the local disease profile.

    Conclusion

    A personalised mRNA vaccine has for the first time produced a meaningful clinical benefit in cancer, cutting the risk of death from recurrence by 49 per cent and from spread by 59 per cent when added to an existing immunotherapy. The result validates the principle that a therapy can be built against each patient’s own tumour mutations rather than against a disease in general. For India the immediate impact is limited, because melanoma is rare here and the companion drug reaches under two per cent of the patients who need it. The question that remains open is whether the platform is extended to the cancers that actually dominate India’s disease burden.

    “[2022, GS3, 15 marks] What is the basic principle behind vaccine development? How do vaccines work? What approaches were adopted by the Indian vaccine manufacturers to produce COVID-19 vaccines?”

  • What India can learn from EU’s AI reset

    What India can learn from EU’s AI reset

    Why in the News

    The European Union’s Artificial Intelligence (AI) Omnibus entered into force on 27 July 2026 and changes parts of the European Union Artificial Intelligence Act, 2024 (EU AI Act). It extends some deadlines, simplifies some compliance requirements and gives regulators and companies more time to prepare for the high-risk AI rules.

    What is the EU AI Act’s risk-based framework?

    1. The organising principle: The Act sorts AI systems by the level of risk they pose and attaches obligations to each tier. The regulatory burden rises with the potential for harm rather than with the technology used.
    2. The prohibited tier: Some AI practices are prohibited outright under the Act. No compliance route is available for a practice in this category.
    3. The high-risk tier: High-risk systems face strict obligations before and during deployment. These are the obligations whose preparation deadlines the Omnibus has extended.
    4. General-purpose models: General-purpose AI models, meaning models trained broadly and adaptable to many downstream tasks rather than built for one application, came under a specific set of rules. They are governed separately from the risk tiers that apply to particular deployments.

    What does the AI Omnibus change, and why now?

    1. The instrument and its date: The AI Omnibus entered into force on 27 July 2026. It amends parts of the AI Act rather than replacing the framework.
    2. Deadlines extended: Some compliance deadlines under the Act have been pushed back. Regulators and companies have more time to prepare for the high-risk AI rules.
    3. Compliance simplified: Some compliance requirements have been simplified. The obligations themselves remain in place at their existing levels.
    4. The reason stated: Implementation of the original framework proved difficult in practice. The Omnibus is the EU’s response to that implementation experience rather than to a change in the risk assessment.
    5. How it is characterised: The change is an admission that AI is changing faster than laws can normally change. It demonstrates that even a carefully designed regulation must be capable of adjustment.

    What are the five lessons for India?

    1. Regulation must be capable of learning: Technology changes and risks change, so regulators must have the ability to review and adjust rules. Regulation should be treated as a continuing process rather than a single enactment.
    2. Regulation needs an escape valve: Rules work only where regulators and companies have the capacity to implement them. India should consider regulatory sandboxes and regular reviews of AI rules, and sunset mechanisms could make regulation more responsive.
    3. Compliance cost decides who can compete: Large technology companies can hire lawyers, engineers and auditors, and start-ups cannot always do so. Excessive compliance costs could unintentionally favour large companies and reduce competition.
    4. Simplification must not mean deregulation: Reducing paperwork is different from reducing safeguards. AI can create serious risks involving privacy, discrimination, manipulation and opaque decision-making, and simpler regulation must not mean weaker protection.
    5. Institutional maturity is the fifth lesson: The EU has shown that even a major regulatory framework can be revised after enactment. Regulatory maturity means recognising when rules are not working and changing them.

    Where does India’s AI governance currently stand?

    1. A different path so far: India has focused on responsible AI, innovation and sector-specific governance rather than creating a comprehensive AI law. Sectoral regulators apply existing mandates to AI within their own domains.
    2. Flexibility carries a cost: Flexibility can be useful and it should not become uncertainty. Businesses need clarity, citizens need protection and regulators need clear responsibilities.
    3. The proportionality principle India would need: The regulatory burden should depend on potential harm. The greater the risk to people and society, the stronger the safeguards should be.
    4. The assets India brings: India has a large digital population and experience with digital public infrastructure. It also has a growing technology sector and experience in deploying digital services at scale.
    5. The institutions available to build on: The IndiaAI Mission can play an important role in an adaptive Indian model of AI governance. Regulatory sandboxes, sectoral regulators, research institutions and industry bodies can carry the rest.

    Is regulation genuinely a trade-off against innovation?

    1. The framing the debate defaults to: The debate over AI is often presented as a choice between regulation and innovation. That framing treats every safeguard as a cost to be traded away.
    2. Why the framing is wrong: The choice is false because unregulated deployment carries its own costs in privacy, discrimination and opaque decision-making. The challenge is to design regulation that makes innovation safer and more trusted.
    3. What the EU revision actually demonstrates: The EU relaxed timelines and paperwork and did not relax the substantive safeguards. The revision therefore tests the trade-off framing and does not confirm it.
    4. The asymmetry the framing hides: Compliance cost falls hardest on the smallest firms, so heavy regulation reduces competition and light regulation reduces protection. India must create a framework that protects citizens while allowing experimentation, and be capable of changing as technology changes.

    Challenges to a risk-based AI law in India

    1. Risk tiers age faster than statutes: A fixed list of prohibited and high-risk uses is overtaken by capabilities that did not exist when the list was drawn. Eg. General-purpose models required a separate rule set in the EU Act after the original risk-tier design was settled. Fix. Place the risk classification in delegated rules subject to a mandatory periodic review rather than in the parent statute.
    2. Regulatory capacity is the binding constraint: Enforcement requires auditors and technical staff who can inspect model behaviour, and those skills are scarce in the public sector. Eg. Implementation difficulty is the stated reason the EU extended its own high-risk deadlines. Fix. Build a shared technical audit facility under the IndiaAI Safety Institute that sectoral regulators can draw on.
    3. Algorithmic bias reproduces existing exclusion: Models trained on historical data encode the patterns of that data, including patterns of discrimination. Eg. An automated recruitment system built at Amazon was found to downgrade applications from women. Fix. Mandate pre-deployment bias testing and published audit results for any system used in employment, credit or welfare decisions.
    4. The accountability gap in automated decisions: It is often unclear who is answerable for an AI-driven decision, the developer, the deployer or the administrator. Eg. A welfare eligibility system can deny a benefit without producing a reason the applicant can contest. Fix. Impose a statutory right to an explanation and to human review for any automated decision affecting a legal right or entitlement.
    5. Compute and data concentration: AI capability is concentrated in a few advanced economies, which leaves other countries as consumers rather than creators of the technology. Eg. India’s response has been a national compute grid of over 38,000 graphics processing units under the IndiaAI Mission. Fix. Treat compute, datasets and models as shared developmental resources with subsidised access for start-ups and researchers.

    Conclusion

    The EU has demonstrated that a comprehensive AI framework can be enacted and then revised when implementation shows it is not working, and the AI Omnibus of 27 July 2026 is that revision. Its lesson for India is not that regulation should be lighter but that it should be capable of learning, proportionate to harm, affordable for small firms and explicitly separate from deregulation. India has no comprehensive AI law and has the digital public infrastructure, the sectoral regulators and the IndiaAI Mission to build an adaptive one. What remains unresolved is whether India converts its current flexibility into a stated framework with clear responsibilities, or leaves it as uncertainty that businesses and citizens both bear.

    Government Initiatives on Artificial Intelligence

    1. IndiaAI Mission, 2024: Approved with an outlay of ₹10,371 crore and implemented by IndiaAI under the Ministry of Electronics and Information Technology. Its stated vision is making AI in India and making AI work for India, delivered through seven pillars.
    2. IndiaAI Compute and AIKosh: The compute pillar operates a national AI compute grid with over 38,000 graphics processing units at up to 40 per cent lower cost for eligible users. AIKosh is the national dataset repository with over 3,000 datasets and 243 models across 20 sectors.
    3. IndiaAI Foundation Models and FutureSkills: The foundation models pillar supports indigenous multimodal models built by entities including Sarvam AI and Gnani AI. FutureSkills funds fellowships and AI labs with a focus on Tier-2 and Tier-3 cities.
    4. Safe and Trusted AI: This pillar covers bias mitigation, privacy, explainability and AI governance, and it established the IndiaAI Safety Institute as a national trust framework. NITI Aayog’s Responsible AI for All initiative runs alongside it on public discourse and ethical audits.
    5. Language and access platforms: Digital India Bhashini provides speech and translation tools across 22 Indian languages, and Project Vaani has assembled a 150,000 hour Indian speech dataset. India hosted the India AI Impact Summit 2026 at Bharat Mandapam, the first major global AI summit in the Global South.

    “[2026] Which of the following statements with regard to Large Language Models (LLMs) used in machine learning is/are correct?

    1. LLMs assign probabilities to the next possible words and then pick the one with the highest probability.

    2. LLMs process data through mathematical optimization to minimise prediction errors.

    3. LLMs produce unbiased outputs.

    (a) 1 only

    (b) 1 and 2 only

    (c) 2 and 3 only

    (d) 1, 2 and 3

  • What changes when AI moves from reading viral genomes to designing them?

    Why in the News

    Researchers at Stanford University and the Arc Institute used Artificial Intelligence (AI) to design complete genomes of bacteriophages, viruses that infect bacteria. Of 285 AI-generated designs physically synthesised and tested in the laboratory, 16 produced functioning phages, and some overcame bacterial resistance that had defeated the original virus. Humans have been synthesising viral genomes and deliberately modifying viruses for decades, so what is new is not the physical manufacture of a virus. AI has entered the design stage of biology, deciding what the genome should be rather than executing a design a human specified. The tension is that the same capability that could transform antimicrobial resistance research, vaccines and therapeutics could also accelerate harmful biological engineering.

    What is a genome language model?

    1. What it is: A genome language model is a machine learning system trained on genetic sequence data rather than on text, and the two used in this experiment were Evo 1 and Evo 2.
    2. How it works: The principle resembles a large language model, except that instead of learning patterns in words, it learns patterns in DNA.
    3. What it reads: It studies the genetic alphabet of A, C, G and T across vast numbers of genomes, and then generates new genetic sequences from the patterns it has learned.
    4. How it was specialised: For this experiment the models were further trained on thousands of bacteriophage genomes related to ΦX174, so the sequences they generated stayed within a known biological family.

    What did the Stanford-Arc experiment actually do?

    1. The design step was handed over: The scientists already knew the ΦX174 genome and already knew how to synthesise viral DNA and recover functioning phages. What changed was who, or what, proposed the genome.
    2. The output was constrained, not open-ended: AI did not invent a completely unrelated virus from nothing. It generated previously unseen ΦX174-like whole genomes within a known biological framework.
    3. The build step was conventional: Scientists selected some of these sequences, physically manufactured the DNA and introduced it into E. coli. Where the genetic instructions were biologically coherent, the bacterial machinery produced new phage particles.
    4. The yield: Of the 285 designs tested, 16 succeeded in producing functioning phages.
    5. Some designs beat the natural virus: Combinations of AI-designed phages overcame resistance in E. coli strains against which the original ΦX174 failed.
    6. The most significant result was combinatorial: An AI-designed phage successfully combined a viral protein with other genetic changes in a way conventional engineering had struggled to achieve, which suggests the system can identify multiple genetic changes that work together across an entire genome.

    How did biology get from reading genomes to writing them?

    1. Phages are old and abundant: Bacteriophages, literally “bacteria eaters”, have been known for more than a century and are among the most abundant biological entities in nature.
    2. Reading came first: In 1977, one particularly small phage, ΦX174, became the first complete DNA genome to be sequenced.
    3. Writing came next: By the early 2000s, scientists had shown that viral genetic material could be synthesised from known sequence information and used to recover functioning viruses.
    4. Deliberate modification followed: The controversial influenza gain-of-function experiments of 2011-12 showed that genetic changes could modify important properties such as transmission in experimental animals.
    5. The unresolved dilemma: That research highlighted a dilemma that remains open, since the same science that can improve pandemic preparedness may also create biosafety and biosecurity risks.
    6. Design is the fourth step: The progression runs from reading viral genomes, to writing them, to modifying them, and now to AI helping decide what should be written.

    What does this open up in medicine?

    1. Phage therapy is the nearest application: Antibiotic resistance is steadily eroding conventional treatment options, and bacteriophages offer another way of killing bacteria.
    2. Specificity is the limitation: A phage effective against one bacterial strain may fail against another, and bacteria can also develop resistance to phages.
    3. The search model has limits: Researchers have traditionally searched nature and phage libraries for suitable candidates, or modified existing viruses, which caps the available options at what already exists.
    4. The question changes: Generative biology moves medicine from asking whether the needed phage can be found to asking whether it can be designed.
    5. The applications extend well beyond phages: AI can assist the design of vaccine antigens, antibodies, therapeutic proteins and the viral vectors used to deliver genetic treatments, and may eventually help optimise oncolytic viruses that selectively attack cancer cells.
    6. The real shift is broader than viruses: The larger revolution is AI becoming capable of designing biological function, rather than AI making viruses.

    Is the simplicity of the target a safeguard, or is the risk the acceleration?

    1. The reassuring reading: ΦX174 is an exceptionally simple bacteriophage, while dangerous human viruses are vastly more complicated.
    2. Human pathogens are harder targets: They must negotiate receptor binding, host range, tissue tropism, replication, immune escape and transmission, each of which is a separate design problem.
    3. Complexity is not a defence: Human scientists already understand much about these determinants, and decades of virology, reverse genetics and gain-of-function research have linked many genetic changes to viral behaviour.
    4. AI does not need to rediscover virology: Its power lies in integrating what humanity already knows, examining vastly more combinations than humans can explore manually, and accelerating the path from hypothesis to experimental design.
    5. The concern is capability amplification: The relevant question is not whether an untrained individual can ask today’s chatbot to generate a pandemic virus. It is whether increasingly capable AI could make a knowledgeable and well-equipped laboratory substantially more effective at designing biological systems.
    6. A low success rate is a temporary comfort: The yield reported above is low, but digital systems can generate enormous numbers of candidates, so a low success rate is reassuring only while the number of attempts remains small.

    How must biosecurity change?

    1. Current screening looks for resemblance: Traditional DNA-synthesis screening often asks whether an ordered sequence resembles a known pathogen or toxin.
    2. Resemblance fails against generated sequences: A previously unseen sequence generated inside a known family may not resemble anything on a watchlist while still doing the same thing.
    3. Screening must move to function: In the age of generative biology, screening must also consider what a sequence might actually do, not simply whether it looks dangerous.
    4. Over-restriction has its own cost: Claude Fable 5 was initially deployed with strong safeguards around biology, chemistry and cybersecurity, and legitimate scientific work could sometimes trigger a fallback to a less capable model.
    5. The correction points to graduated access: Those safeguards have since been refined to reduce false-positive biology fallbacks while more sensitive capabilities remain restricted, which points toward graduated, auditable access under institutional and security controls.
    6. Model refusal is not a strategy: Biosecurity cannot rest entirely on what an AI model agrees or refuses to answer, so safeguards are needed throughout the chain: AI systems, DNA-synthesis providers, laboratories and institutional biosafety oversight.

    Why does this matter for India?

    1. Frontier AI becomes scientific infrastructure: If frontier AI becomes central to drug discovery, genomics, vaccines, protein engineering and experimental design, access to advanced AI becomes part of national scientific infrastructure.
    2. Sufficiency and compulsion are different things: Smaller and specialised models will be sufficient for many tasks, but a country should choose a small model because it is sufficient, not be forced to use one because somebody else owns the frontier.
    3. Restricted access compounds over time: If researchers elsewhere receive trusted access to highly capable biomedical models while Indian scientists depend on restricted public versions, the disadvantage accumulates across drug discovery, vaccines and antimicrobial resistance.
    4. The investment exists but needs a scientific arm: India is already investing through the IndiaAI Mission and indigenous foundation-model programmes, and that ambition should extend to scientific and biomedical AI, secure compute and high-quality datasets.
    5. Trusted access needs a framework: Legitimate researchers need a defined route to stronger capabilities, which requires an institutional trusted-access framework rather than case by case negotiation with model providers.
    6. The two goals are not separable: AI sovereignty without biosecurity would be reckless, and biosecurity without AI sovereignty could leave the country scientifically dependent.

    Challenges to AI-designed genomes

    1. Sequence screening cannot see intent: Order screening matches against known pathogen sequences, so a generated sequence within a benign-looking family passes even where its function is hazardous. Eg. Screening protocols built around named agents on an export control list match those names, so a functionally equivalent sequence outside the list is not flagged. Fix. Require DNA-synthesis providers to run function prediction alongside sequence matching, with a reporting duty on flagged orders.
    2. Automated laboratories compress the safety window: Combining generative design with robotic experimentation shortens the interval in which oversight can intervene. Eg. Future systems may compress months or years of literature review, modelling and experimental planning into much shorter cycles. Fix. Mandate institutional biosafety committee sign-off at the design stage rather than only before physical synthesis.
    3. Volume defeats low success rates: A weak per-attempt success rate becomes a strong aggregate capability once attempts are cheap and unlimited. Eg. The design pool in this experiment was generated computationally, so the number of candidates was bounded by compute rather than by laboratory effort. Fix. Impose volume-based reporting thresholds on synthesis orders from a single requester within a stated period.
    4. Model safeguards obstruct legitimate research: Blunt refusal policies block the research they were meant to protect, which pushes scientists toward unsupervised alternatives. Eg. Legitimate scientific queries triggered fallback to a less capable model under initial biology safeguards. Fix. Operate tiered credentials, where verified institutional researchers receive higher-capability access under audit logging.
    5. Governance is nationally fragmented: Biosecurity rules stop at borders while synthesis orders and model access do not. Eg. The 2011-12 gain-of-function controversy produced divergent national moratoria rather than a common standard. Fix. Negotiate a common minimum synthesis-screening standard through the Biological Weapons Convention review process.
    6. India lacks a biosecurity institution for generative biology: Existing oversight bodies were designed for genetically modified organisms and field trials, not for computational design of pathogens. Eg. The Genetic Engineering Appraisal Committee and the Review Committee on Genetic Manipulation are structured around organism release rather than sequence design. Fix. Create a statutory biosecurity review function covering generative design, synthesis orders and model access, reporting jointly to the Department of Biotechnology and the Ministry of Electronics and Information Technology.

    Conclusion

    The experiment does not show that AI can casually manufacture dangerous human viruses. It shows something more precise: computers are beginning to move from analysing biological information towards proposing biological designs that scientists can physically build, a capability that serves therapeutic research and harmful engineering alike. The answer is neither prohibition nor unrestricted access, but controlled acceleration, with safeguards rising as capability and risk rise. The unresolved question is no longer whether AI should be allowed to understand biology, but how to govern it once understanding biology becomes the ability to design it.

    Back2Basics: IndiaAI Mission

    1. What it is: The IndiaAI Mission is the national artificial intelligence programme approved in 2024 with an outlay of ₹10,371 crore, implemented by IndiaAI under the Ministry of Electronics and Information Technology.
    2. Its stated vision: “Making AI in India and Making AI Work for India”, built around seven pillars covering compute, applications, datasets, foundation models, skills, startup financing and safe and trusted AI.
    3. Compute pillar: It operates a national AI compute grid with over 38,000 graphics processing units, offering up to 40 per cent lower compute costs to eligible users.
    4. Safety arm: The IndiaAI Safety Institute is its national trust framework, covering bias mitigation, privacy, explainability and AI governance.

    Matching Previous Year Question

    “[2026] Which of the following statements with regard to genetic medicine is/are correct? 1. Genetic medicines correct/compensate for the faulty genes responsible for disease. 2. Engineered viruses and lipid nanoparticles are used as carriers of the genetic medicine. 3. Genetic medicines alter the entire DNA sequence. (a) 1 only (b) 2 and 3 only (c) 1 and 2 only (d) 1, 2 and 3 ANSWER: C”

  • Global space norms find a firm footing in India’s new re-entry rules

    Global space norms find a firm footing in India’s new re-entry rules

    Why in the News

    The Indian National Space Promotion and Authorisation Centre (IN-SPACe) has released India’s first guidelines on planned re-entry, requiring any Indian entity undertaking such a re-entry to obtain its authorisation, whether the re-entry occurs within or outside Indian territory.

    What is a planned re-entry?

    1. The defining test is intent and survivability: Objects designed to survive re-entry, or intentionally controlled towards a particular landing or impact area, require separate authorisation. This is what makes a re-entry planned.
    2. What falls outside the definition: Objects expected to burn up, melt or fragment sufficiently during natural orbital decay do not count as a planned re-entry.
    3. Why the distinction carries regulatory weight: The category separates a return that must be assessed and cleared in advance from one that requires no clearance, so the definition determines the reach of the entire framework.

    Why has re-entry become a governance problem now?

    1. The historical baseline was negligible: For many decades there were few rocket launches and few new satellites in orbit each year, so there were also few re-entries.
    2. The consequences used to be trivial: Most of those re-entries simply burned up in the atmosphere with little consequence.
    3. The orbital population has changed: Low-earth orbit, the band of orbits closest to the earth where most satellites operate, now hosts several thousand satellites, with private companies planning for many more.
    4. Deliberate de-orbiting has become routine: Satellite operators are also deliberately bringing satellites down at the end of their operational lives as part of post-mission disposal, in great numbers.
    5. The physical risks are specific: A spacecraft returning to the earth has to negotiate many risks, including deviating from its planned path and breaking up into smaller pieces.
    6. The risks cross jurisdictions: A returning object may affect airspace and maritime zones, and may potentially crash in the territory or jurisdiction of another state, which makes re-entry a governance problem as well as a physics problem.

    What are the three important elements of the guidelines?

    1. Accountability: Any Indian entity undertaking a planned re-entry, whether within or outside Indian territory, now requires IN-SPACe authorisation.
    2. Foreign operators must route through an Indian entity: Non-Indian entities seeking to undertake planned re-entry over Indian territory must route the activity through an Indian-incorporated entity, such as a subsidiary, joint venture or partnership.
    3. The Indian entity carries the compliance duty: That Indian entity is responsible for complying with Indian laws, regulations and national security requirements.
    4. Why the accountability gap exists: Commercialisation separates ownership from consequence, since the spacecraft may belong to a private company and the effects of its return lie across maritime zones and jurisdictions. India has responded by attaching regulatory responsibility to a re-entering entity before the risk materialises.
    5. Risk must be acceptable: The expected casualty risk must remain below 1 in 10,000, supported by survivability and ground-casualty assessments.
    6. Failure scenarios must be modelled and shared: Operators have to analyse and share failure scenarios, fragmentation patterns, ballistic coefficients, de-orbit plans, flight-path angles and danger zones.
    7. Surviving and hazardous components must be identified: They must identify components likely to survive re-entry, and hazardous systems such as batteries and pressure vessels.
    8. A number makes sustainability measurable: By requiring quantitative studies and attaching a figure to the acceptable risk threshold, the guidelines make sustainability measurable and therefore trackable.
    9. Permissions: IN-SPACe will re-verify the latest re-entry parameters approximately three months before the proposed operation.
    10. A post-launch decision needs six months’ notice: If a planned re-entry is decided upon after launch, the operator must apply at least six months in advance.
    11. Airspace and maritime warnings at 45 days: Operators must obtain an IN-SPACe advisory note to issue warnings to airborne and marine vessels in the re-entry area at least 45 days before the re-entry begins.
    12. A foreign jurisdiction requires that state’s clearance: If a re-entry site falls within the territorial control of a non-Indian state, including its exclusive economic zone, the applicant must submit the relevant clearance or authorisation from that state.
    13. The checkpoints are intervention windows: These checkpoints give the regulator fixed windows and mechanisms to intervene when re-entry parameters change after the mission has launched, or when the risk pattern changes.

    What international framework do the guidelines translate?

    1. The development period: For nearly two decades the international community has developed principles for sustainable space activities.
    2. The two leading instruments: They are the Inter-Agency Space Debris Coordination Committee’s Space Debris Mitigation Guidelines, and the Guidelines for the Long-term Sustainability of Outer Space Activities of the United Nations Committee for the Peaceful Uses of Outer Space.
    3. The treaty foundation: Article IX of the Outer Space Treaty 1967 provides an important foundation for environmental responsibility in the conduct of space activities.
    4. The working definition of sustainability: The UN Guidelines define sustainability as maintaining space activities while preserving the outer space environment for future generations.
    5. The structural weakness of that architecture: Most of the contemporary sustainability architecture works on guidelines and other similar forms of soft law, which operators are not obligated to follow.
    6. How the national regulator closes it: The IN-SPACe guidelines solve this problem for India by tying an operator’s fragmentation analysis and insurance policies to the national regulator, which converts a voluntary standard into a condition of permission.

    How do the guidelines handle liability?

    1. The treaty position on liability: The Space Liability Convention 1972 places absolute liability on a launching state for damage caused by its space object on the surface of the earth, or to aircraft in flight.
    2. The state carries the claim, not the operator: Absolute liability means the launching state answers for the damage regardless of fault, so a private failure becomes a sovereign liability by default.
    3. The guidelines invert that internally: Operators must undertake planned re-entries at their own risk, and they remain liable for third-party damage and claims.
    4. Indemnity to the government: Operators indemnify the Government of India and its agencies for liability incurred under India’s international commitments.
    5. Insurance as the backing: Operators must satisfy the applicable third-party insurance requirements, so the indemnity is funded rather than merely promised.

    Challenges to the IN-SPACe planned re-entry guidelines

    1. The regulator has no statutory backing: IN-SPACe functions as the sector’s regulator without legislative authority, so its guidelines rest on executive policy rather than on an Act. Eg. India has no dedicated space activities legislation, and the Indian Space Policy 2023 is a policy document. Fix. Enact a space activities law placing authorisation, liability and penalties on a statutory footing.
    2. The regulator sits inside the body it regulates: IN-SPACe authorises activities of private companies and government entities including ISRO, and it operates under the Department of Space. Eg. The same department is both the policy custodian and the parent of the entity it must clear. Fix. Place IN-SPACe under an independent appointments and reporting structure, with appeals lying outside the Department of Space.
    3. No appellate route for a refused authorisation: An operator refused authorisation, or held to a risk finding it disputes, has no defined appeal forum. Eg. The guidelines fix a casualty risk threshold without naming any forum before which an operator may contest a risk finding. Fix. Constitute a space disputes appellate tribunal with technical members, on the model used for telecom and electricity regulation.
    4. Verification capacity lags the requirement: A casualty risk below 1 in 10,000 must be independently verifiable, and that requires tracking and modelling capability the regulator does not itself hold. Eg. Debris tracking rests on ISRO’s Project NETRA, which is oriented to collision avoidance rather than to re-entry survivability audit. Fix. Build an independent re-entry analysis cell with access to radar and optical tracking data, empanelling accredited third-party assessors.
    5. Insurance capacity is untested at Indian scale: Third-party space insurance is a thin market, and a small operator may be unable to price cover for a low-probability, high-consequence event. Eg. Indian space startups have grown from a handful to around 200, most of them without balance sheets that carry catastrophic risk. Fix. Create a graded liability cap with a government-backed pool above it, on the model used for civil nuclear liability.

    “[2026] Consider the following statements about involvement of private entities in India’s space programme:

    1. IN-SPACe is an autonomous agency formed to facilitate participation of private entities.

    2. Agnikul Cosmos launched the world’s first flight using 3D-printed rocket engine.

    3. Skyroot Aerospace has developed liquid fuel for GSLV.

    (a) 1 only

    (b) 2 and 3 only

    (c) 1 and 2 only

    (d) 1, 2 and 3

  • How will Gaganyaan’s thermal shield protect the crew?

    Why in the News

    The Gaganyaan crew module will hit the atmosphere at 7,500 to 8,000 metres per second on return, with its exterior reaching 1,800 degrees Celsius while the structure must stay below 150 degrees Celsius. The shield chosen to hold that gap is a sacrificial ablative layer 30 to 35 millimetres thick, a choice driven by the mission’s single use design and India’s own re entry heritage rather than by peak performance.

    What is a thermal protection system?

    1. What it does: A thermal protection system is the outer layer that keeps a re entering vehicle’s structure and interior within survivable temperature while its exterior is exposed to the heat of atmospheric entry.
    2. Why it is needed: Almost all of the crew module’s kinetic energy is dissipated into the atmosphere as heat energy, and the small portion directed back towards the module is still intense enough to melt it.
    3. What it protects: It maintains the module’s structural integrity and keeps the interior within the temperature limit the structure and the crew can tolerate.
    4. How it is classified: Systems are grouped by how they remove heat, into ablative, radiative and heat sink types.

    What is heat flux?

    1. Definition: Heat flux is the rate at which heat energy passes through a unit area of a surface, measured in watts per square metre.
    2. Why it varies on a capsule: It is highest at the point of the vehicle that meets the airflow first, which is why the nose cap carries the most demanding shield material.

    What is a boundary layer?

    1. Definition: The boundary layer is the thin region of gas immediately next to a moving vehicle’s surface, where the flow is slowed by contact with that surface.
    2. Why it matters in ablation: Gases escaping from the decomposing shield thicken and cool this layer, which blocks intense heat from being transferred into the module.

    Why is atmospheric re entry harder than ascent for a crewed mission?

    1. Ascent is controlled and gradual: A rocket accelerates slowly through the atmosphere on the way up specifically to keep the mechanical loads on the vehicle to a minimum.
    2. Re entry cannot be aborted: Once the descent begins there is no provision to abort the mission, so every system must work through to splashdown.
    3. The crew cannot intervene: There is only a limited role for the crew to intervene and correct any system non conformance during descent.
    4. The event is too fast for human correction: Atmospheric descent is incredibly fast and the deceleration forces change constantly, and human response times are simply too high to manually correct a sudden system abnormality.
    5. What follows from this: All systems must therefore be made robust enough to withstand the scorching conditions of re entry on their own, since design margin substitutes for intervention.

    What thermal conditions must the Gaganyaan crew module survive?

    1. Entry velocity: The crew module will hit the atmosphere at a speed of 7,500 to 8,000 metres per second on return from its orbit around the earth.
    2. Energy dissipation: More than 99 per cent of that kinetic energy will be dissipated into the atmosphere as heat energy.
    3. Exterior temperature: The exterior of the module will encounter temperatures as high as 1,800 degrees Celsius in some regions.
    4. Shield thickness: The thermal protection system is just 30 to 35 millimetres thick.
    5. Interior limit: That layer must keep the module’s temperature safely below 150 degrees Celsius while performing the task of maintaining structural integrity.

    How do ablative, radiative and heat sink systems each remove heat?

    1. Ablative: A single use system that removes heat energy by sacrificing its own layers through chemical and physical processes, absorbing extreme quantities of thermal energy and chemically decomposing into a protective layer of solid char and outgassing vapours.
    2. The decomposition physically carries heat away from the module as the material burns off, and the escaping gases create a cooler boundary layer that blocks heat transfer into the module.
    3. Carbon phenolic and silica phenolic are examples of ablative materials.
    4. Radiative: A system that absorbs the extreme heat of re entry and then releases it back into space as electromagnetic radiation, primarily in the infrared spectrum and also as visible light when it is extremely hot.
    5. It remains intact and withstands the heat without melting or degrading, which makes it suited to reusable re entry vehicles.
    6. Heat sink: A system that absorbs heat energy and raises its own temperature without melting or changing phase in any other way.
    7. Copper and aluminium are examples of heat sink materials.

    Why has the Indian Space Research Organisation chosen an ablative shield for the crew module?

    1. It matches the mission’s design philosophy: The Gaganyaan crew module is a single use vehicle, and an ablative system is a single use system, so the shield’s life and the module’s life are the same.
    2. It is proven and robust: The Indian Space Research Organisation (ISRO) has selected it as a proven and highly robust solution rather than the highest performing one available.
    3. It tolerates fluctuating heat loads: Ablative heat shields can easily handle fluctuating heat loads to protect the structure underneath, which matters when the descent profile varies.
    4. Radiative systems are less forgiving: Any design error in a radiative system can quickly cause dangerous overheating, so its margin for error is narrower.
    5. It avoids a maintenance burden: An ablative system withstands an extreme thermal load without requiring complex or delicate surface maintenance between flights.
    6. It avoids the reusable system’s cost structure: By avoiding the expensive manufacturing, specialised inspection and complex installation processes associated with a reusable radiative system, ISRO has taken the safer and more cost effective option.

    Does choosing a single use shield trade away reusability for safety?

    1. What is given up: A sacrificial shield is consumed on every flight, so a new heat shield must be manufactured and installed for each mission rather than inspected and reflown.
    2. The recurring cost consequence: Per flight cost stays flat across a programme instead of falling with flight rate, which is the opposite of the economics a high cadence programme needs.
    3. Why the trade is correct for this mission: Reusability only pays back over a high flight rate, and a first generation crewed programme flying occasional missions never reaches that rate.
    4. Where the trade stops working: A sustained crew rotation programme to an orbital station changes the flight rate, at which point the reusable radiative option becomes the economically relevant one.
    5. The safety side of the trade: The ablative system’s tolerance of fluctuating heat loads and its independence from surface inspection are precisely the properties a programme flying its first crew needs most.

    What does India’s own re entry heritage contribute to the Gaganyaan shield?

    1. The first re entry mission: The Space Capsule Recovery Experiment, India’s maiden re entry mission, used a carbon phenolic ablative to protect the module’s nose cap, where heat flux was the highest.
    2. The crew module demonstration: The Launch Vehicle Mark-3 (LVM3) flew the Crew Module Atmospheric Re-entry Experiment (CARE) in 2014. That flight successfully demonstrated crew module re entry using an ablative thermal protection system.
    3. What that established: The 2014 mission established the foundational technology that is now being used in the Gaganyaan programme, so the shield is an inheritance rather than a new development.
    4. Why heritage reduces risk: Material characterisation, manufacturing process and flight data already exist for the ablative route, which removes the qualification uncertainty a new material class would carry.
    5. The programme position: The Gaganyaan crew module is built on this ablative heritage and on the lessons learned from both earlier missions.

    What does the SpaceX Crew Dragon comparison show about ablative shield design choices?

    1. United States, the Crew Dragon shield: The Crew Dragon capsule of SpaceX uses an ablative material named phenolic impregnated carbon ablator, or PICA, a lightweight carbon fibre matrix filled with a phenolic resin.
    2. The shared design logic: A crewed capsule operator with a very different cost structure has arrived at the same ablative class of solution, which indicates the choice follows from the capsule form rather than from budget constraint.
    3. The design feature that differs: PICA’s lightweight carbon fibre matrix trades density for mass saving, while carbon phenolic of the kind flown on India’s first re entry mission is denser and carries higher heat flux at the nose.
    4. The limit of this comparison: This is the single foreign system named in the evidence here, so it establishes that ablative shielding is the standard choice for crewed capsules, not a ranked comparison of national capsule programmes.

    Challenges to the Gaganyaan thermal protection system

    1. Ground testing cannot reproduce full re entry: No ground facility reproduces the combined velocity, heat flux and duration of an orbital re entry, so qualification relies on partial simulation and analysis. Eg. Arc jet plasma facilities test coupons at representative heat flux but not at the full 7,500 to 8,000 metres per second entry velocity.
    2. Bond line integrity over a curved surface: A 30 to 35 millimetre layer must adhere uniformly over the module’s full curvature, and a bond defect creates a local hot path into the structure. Eg. Shuttle era thermal protection failures originated in localised damage to the protective layer rather than in the material’s bulk performance.
    3. Predicting the recession rate: Ablative design depends on predicting how much material burns off, and an over prediction adds dead mass while an under prediction risks burn through. Eg. Nose cap regions carry the highest heat flux and therefore the largest uncertainty in recession estimates.
    4. Mass penalty on the launch vehicle: A sacrificial shield sized with margin is heavy, and every kilogram of shield reduces the payload the human rated launcher can carry. Eg. The human rated LVM3 has to lift the crew module, service module and shield together to a 400 kilometre orbit.
    5. Manufacturing repeatability: Each mission needs a newly manufactured shield, so process variation between production batches becomes a flight safety variable rather than a quality issue. Eg. Carbon phenolic layup is a manual intensive process where resin content and fibre orientation must be reproduced identically each time.
    6. Recovery environment after splashdown: A charred shield must survive water impact and sea recovery without compromising the crew compartment. Eg. India’s first re entry mission was recovered from the Bay of Bengal, which is the recovery zone the crewed programme also plans to use.
    7. Single point criticality: With no abort provision once descent begins and limited crew intervention, the shield has no backup system to fall back on. Eg. Human response times are too high to correct a sudden thermal abnormality during a descent where deceleration forces change constantly.

    Conclusion

    The Gaganyaan crew module’s protection against a 1,800 degrees Celsius re entry rests on a 30 to 35 millimetre ablative layer that sacrifices itself to carry heat away and hold the structure below 150 degrees Celsius. The choice of an ablative over a radiative system follows from the module’s single use design, its tolerance of fluctuating heat loads and the technology base established by India’s first re entry mission and the 2014 crew module demonstration. The programme’s current status is that the shield is qualified on this heritage, with the first uncrewed test flight launching shortly.

    Human Spaceflight Programme of India

    1. What it is: Gaganyaan is India’s human spaceflight programme, aimed at demonstrating the capability to launch a crew to low earth orbit and return them safely to Indian waters.
    2. Mission profile: The mission is designed to carry a crew of up to three to an orbit of about 400 kilometres for a mission duration of up to three days, followed by splashdown recovery.
    3. The launch vehicle: The launcher is a human rated version of the LVM3, designated the Human rated Launch Vehicle Mark-3 (HLVM3), modified with additional redundancy and a crew escape system.
    4. The orbital module: The crew module and the service module together form the orbital module, with the crew module being the pressurised habitable segment that returns.
    5. Institutional base: The Human Space Flight Centre was established at Bengaluru in 2019 to lead the programme, with the Vikram Sarabhai Space Centre responsible for launch vehicle and re entry systems.
    6. The longer roadmap: India’s stated goals extend to the Bharatiya Antariksh Station by 2035 and a crewed lunar landing by 2040.

    Laws and Treaties Governing Space Activities

    1. Outer Space Treaty, 1967: Makes States internationally responsible for national space activities, whether carried on by governmental or non governmental entities, and bars national appropriation of outer space.
    2. Rescue Agreement, 1968: Obliges States to assist astronauts in distress and to return them and any recovered space objects to the launching authority.
    3. Liability Convention, 1972: Makes a launching State absolutely liable for damage caused by its space object on the surface of the earth or to aircraft in flight.
    4. Registration Convention, 1975: Requires launching States to maintain a national registry of space objects and to furnish details to the United Nations.
    5. Moon Agreement, 1979: Declares the Moon and its resources the common heritage of mankind, and India has signed but not ratified it.
    6. Indian Space Policy, 2023: Defines the roles of ISRO, the Indian National Space Promotion and Authorisation Centre, NewSpace India Limited and non governmental entities in the Indian space ecosystem.
    7. Space Activities Bill, 2017: A draft domestic law to license and regulate private space activity in India, which was circulated for comment and never enacted.
    8. Satellite Communications Policy and spectrum rules: Govern authorisation of satellite services, with spectrum assignment handled under the Telecommunications Act, 2023.

    “[2025] Consider the following space missions:

    I. Axiom-4

    II. SpaDeX

    III. Gaganyaan

    How many of the space missions given above encourage and support microgravity research?

    (a) Only one

    (b) Only two

    (c) All the three

    (d) None

  • China lands a rocket first stage for the first time with Zhuque-3

    Why in the News

    China has recovered the first stage of a rocket on land for the first time, using the reusable rocket Zhuque-3, which was launched on Wednesday morning. It is the country’s second rocket stage recovery overall, after a sea platform recovery in July, and the first to use deployable landing legs. State media described the result as a major breakthrough in the country’s reusable rocket technology.

    What is a reusable rocket?

    1. About: A reusable rocket is a launch vehicle whose stages are recovered intact after flight and flown again, instead of being discarded once the payload is delivered.
    2. Why it lowers cost: The first stage carries most of the engines and structure, so recovering it avoids rebuilding the most expensive part of the vehicle for every launch.
    3. How recovery works: The stage separates after boost, reorients, uses engine burns to slow its descent and lands vertically on a pad or on a sea platform.
    4. What landing legs add: Deployable landing legs stabilise the stage at touchdown on ground, which is why their first use is treated as a distinct technical milestone.

    What did the Zhuque-3 flight achieve?

    1. Launch and recovery: Zhuque-3 was launched on Wednesday morning and its first stage was recovered afterward.
    2. First on land: This marks China’s first successful recovery of a rocket first stage on land.
    3. Second overall: It is the second time the country has recovered a rocket stage, following a successful recovery on a sea platform in July.
    4. New hardware: The recovery marked China’s first use of deployable landing legs.
    5. Official assessment: The state news agency deemed the result a major breakthrough in the country’s reusable rocket technology.

    How does this compare with earlier recoveries?

    1. China’s July recovery: On 10 July, the first stage of a Long March-10B rocket separated from the second stage after lift off and returned to a platform at sea.
    2. The difference land makes: A sea platform recovery avoids overflight of populated areas, while a land recovery removes the need for a recovery vessel and shortens the turnaround.
    3. United States, SpaceX: SpaceX has been recovering rockets since 2015 and has driven down launch costs by reusing hardware that would otherwise be discarded after carrying satellites and other payloads toward space.
    4. United States, Blue Origin: Blue Origin has likewise been recovering boosters since 2015, establishing vertical landing as a repeatable rather than experimental technique.
    5. What the comparison shows: China is closing a capability gap that has stood for a decade, and the operator here is a private launch company rather than the state programme.

    Why does reusability decide launch economics?

    1. Cost per launch: Reuse spreads the cost of building a stage across several flights, which is the single largest lever on the price of access to orbit.
    2. Launch cadence: Recovery shortens the interval between flights, which matters for deploying large satellite constellations.
    3. The payload penalty: Propellant reserved for the landing burn and the mass of legs and grid fins reduce the payload the same vehicle can carry.
    4. The break even condition: Reuse pays only when the same stage flies many times, so refurbishment cost and inspection time determine whether the saving is real.
    5. Strategic consequence: Cheaper and more frequent launch capacity translates directly into faster deployment of communication, navigation and remote sensing assets.

    Conclusion

    Zhuque-3’s flight gives China its first land recovery of a rocket first stage and its second stage recovery in six weeks, after the Long March-10B sea platform recovery of 10 July. The flight also carried the country’s first use of deployable landing legs, which is the hardware element that makes routine ground landings possible. The state news agency has called it a major breakthrough in reusable rocket technology. The next measure of the achievement is whether the recovered stage is refurbished and reflown, since recovery without reflight does not deliver the cost saving that reusability exists to produce.

    “[2016] What is ‘Greased Lightning-10 (GL-10)’, recently in the news?

    (a) Electric plane tested by NASA

    (b) Solar-powered two-seater aircraft designed by Japan

    (c) Space observatory launched by China

    (d) Reusable rocket designed by ISRO

  • Teen ChatGPT: Safety Moves to Age Verification

    Why in the News

    OpenAI is rolling out a separate version of ChatGPT for teenagers, with tighter restrictions on conversations about self harm, suicide, eating disorders and sexual content. The move follows cases in which teenagers who died by suicide had interacted extensively with chatbots beforehand, and it arrives while a United States Federal Trade Commission (FTC) inquiry into seven AI companies is under way. The safeguard depends on estimating a user’s age and on parents choosing to switch controls on, which are the two weakest links in the chain.

    What is ChatGPT for Teens?

    1. About: It is a more restricted version of ChatGPT into which OpenAI places users it identifies as being under 18.
    2. Content limits: The teen version avoids romantic or sexual conversations and places stronger limits around self harm related content.
    3. Anti anthropomorphism rule: The chatbot is discouraged from presenting itself as conscious or as emotionally attached to the user.
    4. Parental layer: Parents can link their accounts, set usage restrictions and receive alerts in certain situations.

    How does OpenAI decide who is a teenager?

    1. Signal based estimation: OpenAI uses a combination of signals to estimate whether a user could be under 18.
    2. The three signals named: How an account is used, the subjects discussed in it, and how long the account has existed.
    3. Override of stated age: ChatGPT can automatically place an account under the teen safeguards even if a different age was entered at signing up.
    4. The admitted limit: Age detection systems are not foolproof, and several parental controls depend on families opting in.
    5. What that makes the product: The teen version is an attempt to reduce some of the risks emerging around AI companionship rather than a complete fix for them.

    Why do AI chatbots pose a different risk from social media?

    1. Designed agreeability: AI chatbots are programmed to be agreeable companions that validate users’ feelings, which is not how conventional social media platforms operate.
    2. The harm pathway: Unchecked validation can intensify suicidal behaviour and self mutilation among vulnerable children confiding their deepest fears.
    3. Neurological vulnerability: Children’s developing brains make them particularly vulnerable to AI systems that create dopamine responses.
    4. The combination that matters: The technology is highly responsive, anthropomorphic and adept at mimicking empathy, and for adolescents still developing judgement and a sense of self, that combination proves pernicious.
    5. Everyday embedding: For a generation of digital natives, AI is already a sounding board for curiosity and a companion shaping how they learn, communicate and seek reassurance.

    What do the litigation and the studies show?

    1. The Adam Raine suit: The parents of 16 year old Adam Raine sued OpenAI last year, alleging that ChatGPT had validated his suicidal thoughts and discussed methods of self harm before his death in April 2025.
    2. OpenAI’s own admission: The company acknowledged that some of its safety protections could become less reliable over the course of long conversations.
    3. The Character.AI settlement: Character.AI and Google agreed this year to settle a lawsuit filed by the mother of a 14 year old who died by suicide in 2024 after extensively interacting with a Character.AI chatbot, with the mother alleging he had developed an intense emotional attachment to the bot.
    4. The 2025 United States study: It found that ChatGPT provided dangerous responses to teens discussing self harm, substance abuse and eating disorders, including drafting suicide letters.
    5. A second study: It found chatbots suggesting violence, self harm and substance use every five minutes during testing.

    What are regulators elsewhere doing?

    1. United States, Federal Trade Commission: The FTC, the country’s consumer protection and competition regulator, has opened an investigation into seven AI companies, including OpenAI, over the effects of their products on children.
    2. United States, the Meta trial: Meta is facing a trial on the ground that it deliberately designed Facebook and Instagram to exploit young users’ vulnerabilities and to make its platforms addictive.
    3. China: It has moved to restrict AI systems that encourage emotional dependence, targeting the companionship design itself rather than the content output.
    4. India: It relies on a patchwork of laws, regulations and platform led interventions rather than a dedicated instrument for AI and minors.
    5. What the set demonstrates: Two jurisdictions are acting through litigation and inquiry after the harm, one is acting on product design in advance, and India has neither route settled.

    Why is a safer chatbot not the same as a safe one?

    1. Age prediction is an estimate: The safeguard applies only once the system correctly guesses that the user is a minor, and children can misrepresent their age.
    2. Enforcement dependent restrictions: Content restrictions are only as effective as their enforcement, which is not independently observable from outside the company.
    3. Track record on earlier controls: OpenAI introduced parental controls last year, and critics quickly demonstrated that these could be easily bypassed.
    4. Reactive sequencing: The protections arrived only after sustained public and legal pressure, which is a reminder that children’s online safety cannot be left to Big Tech alone.
    5. The tension that remains: A company that profits from engagement is being asked to design against the very property, unconditional validation, that generates the engagement.

    Challenges to AI Safeguards for Minors

    1. Unverifiable age estimation: The safeguard triggers on inference rather than on verified identity. e.g. OpenAI relying on account usage patterns, discussed subjects and account age to guess whether a user is under 18.
    2. Opt in dependence: Protections that require a parent to activate them reach only supervised households. e.g. the parental controls introduced last year that critics demonstrated could be easily bypassed.
    3. Safety degradation over long sessions: Guardrails hold in short exchanges and weaken in the extended conversations minors actually have. e.g. OpenAI’s acknowledgement that some protections become less reliable over the course of long conversations.
    4. Cross platform substitution: A restriction on one service pushes the user to a less restricted one. e.g. Character.AI, whose chatbot featured in the 2024 death that Google and the company settled this year.
    5. Absence of independent testing: Only external researchers have surfaced the failure modes, and they have no standing access. e.g. the 2025 United States study that found ChatGPT drafting suicide letters for teens.
    6. Divergent national rules: A globally distributed product faces incompatible obligations across markets. e.g. China restricting emotionally dependent AI systems while India relies on a patchwork of laws and platform led interventions.
    7. No liability standard for conversational harm: Existing intermediary law was written for hosted content, not for generated responses. e.g. the Adam Raine suit, which turns on whether a chatbot’s own outputs contributed to a death.

    Conclusion

    The property that makes chatbots compelling for adolescents, unconditional and empathetic sounding validation, is the same property that turned them dangerous in the Raine and Character.AI cases. ChatGPT for Teens restricts content, discourages the bot from claiming emotional attachment and adds parental linkage, which is a welcome and overdue intervention. It nonetheless rests on age estimation that is admittedly not foolproof and on controls that families must opt into, after the previous generation of parental controls was shown to be bypassable. What remains missing is independent testing, transparency and external scrutiny, alongside digital literacy for the parents the safeguards assume will be watching.

    Child Online Safety and Artificial Intelligence Governance in India

    1. About: Child online safety covers the protection of minors from harmful content, exploitative design, data exploitation and psychological harm arising from digital products.
    2. The distinctive AI risk: Generative systems produce responses rather than host content, so harm arises from the model’s own output and not from a third party post an intermediary can be asked to take down.
    3. Companionship design: Systems built to maximise engagement through empathy simulation create attachment, which is why regulation is beginning to target design features rather than only content categories.
    4. India’s scale: India has one of the world’s largest populations of internet users under 18, with smartphone access typically arriving before any formal digital literacy instruction.
    5. Regulatory posture: India has no dedicated artificial intelligence statute, and obligations flow from the Information Technology Act, 2000, data protection law and platform self regulation.
    6. Institutional anchor: The National Commission for Protection of Child Rights is the statutory body that issues advisories and takes cognisance of child rights violations, including online ones.

    Laws and Rules Governing Children’s Online Safety in India

    1. Information Technology Act, 2000: The parent statute for electronic records, intermediary liability and cyber offences.
    2. Section 79: Grants intermediaries conditional safe harbour subject to due diligence, which is the hook for content obligations.
    3. Section 67B: Penalises the publication and transmission of material depicting children in sexually explicit acts.
    4. Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021: Impose due diligence, grievance redress and expeditious removal obligations on intermediaries and significant social media intermediaries.
    5. Digital Personal Data Protection Act, 2023: Defines a child as a person below 18 and requires verifiable parental consent before processing a child’s personal data.
    6. Design prohibition: Bars tracking, behavioural monitoring and targeted advertising directed at children.
    7. Protection of Children from Sexual Offences Act, 2012: Criminalises sexual offences against children, including the use of children for pornographic purposes.
    8. Juvenile Justice (Care and Protection of Children) Act, 2015: Provides the care, protection and rehabilitation framework for children in need of care.
    9. Commissions for Protection of Child Rights Act, 2005: Establishes the National and State Commissions for Protection of Child Rights with powers of inquiry into violations.
    10. Bharatiya Nyaya Sanhita, 2023: Carries the general criminal provisions on abetment of suicide and obscenity that apply where a digital product is alleged to have contributed to harm.

    Government Initiatives for Child Online Safety

    1. IndiaAI Mission: The national programme for compute, datasets, applications and a safe and trusted artificial intelligence pillar covering risk assessment and governance tools.
    2. Cyber Crime Prevention against Women and Children scheme: Funds State capacity for handling online offences against women and children, including forensic and training support.
    3. National Cyber Crime Reporting Portal: Provides a dedicated reporting channel for child sexual abuse material and other online offences.
    4. Information Security Education and Awareness programme: Runs cyber safety awareness for students, teachers and parents through the Ministry of Electronics and Information Technology.
    5. Indian Computer Emergency Response Team advisories: Issues public advisories on online safety practices and coordinates incident response.
    6. National Commission for Protection of Child Rights advisories: Issues directions to platforms on age assurance, harmful content and child data practices.
    7. Cyber Swachhta Kendra: Operates as the botnet cleaning and malware analysis centre supporting safer end user devices.

    Key Facts about Children and the Digital Environment

    1. The Digital Personal Data Protection Act, 2023 sets the threshold for a child at below 18 years, which is higher than the 13 year threshold under the United States Children’s Online Privacy Protection Act, 1998.
    2. The National Commission for Protection of Child Rights is a statutory body constituted under the Commissions for Protection of Child Rights Act, 2005.
    3. Safer Internet Day is observed on the second Tuesday of February.
    4. The European Union Artificial Intelligence Act, 2024 is the first comprehensive statute to classify artificial intelligence systems by risk tier and to ban specified manipulative practices.
    5. The Convention on the Rights of the Child, 1989, to which India is a party, requires protection of children from all forms of exploitation prejudicial to their welfare.
    6. General Comment No. 25 (2021) of the United Nations Committee on the Rights of the Child extends child rights obligations explicitly to the digital environment.

    Challenges in Regulating Artificial Intelligence Use by Children

    1. Verifiable parental consent at scale: The law demands verification without prescribing a workable method that does not itself collect more child data. e.g. the Digital Personal Data Protection Act, 2023 requiring verifiable parental consent for every under 18 user.
    2. Mismatched age thresholds: A global product faces a different definition of a child in each market. e.g. India setting the threshold at 18 while the United States Children’s Online Privacy Protection Act, 1998 sets it at 13.
    3. Attributing harm to a model output: Causation is contested when the alleged harm is a conversation. e.g. the Adam Raine suit and the Character.AI settlement, both of which turn on whether chatbot responses contributed to a death.
    4. Cross border enforcement: Models hosted and trained abroad serve domestic minors with no local establishment to proceed against. e.g. Indian users accessing chatbots operated entirely from other jurisdictions.
    5. Absence of a dedicated statute: Regulation runs on instruments written for hosted content and for data, not for generated responses. e.g. India relying on the Information Technology Act, 2000 and platform led interventions.
    6. Parental digital literacy gap: Controls assume a supervising adult who understands the product. e.g. first generation smartphone households where the child is the more capable user.
    7. Design based harm outside content rules: Engagement optimisation and empathy simulation are not content categories that a takedown regime can reach. e.g. China moving to restrict AI systems that encourage emotional dependence, a design level rather than content level intervention.

    Way Forward

    1. Independent safety testing: Require third party red team testing of chatbot behaviour with adolescent personas, with results published rather than held by the developer.
    2. Statutory age assurance standards: Prescribe a privacy preserving age assurance method so protection does not depend on a company’s own inference or on a child’s self declaration.
    3. Default on, not opt in: Make the safest configuration the default for accounts assessed as belonging to minors, so protection does not depend on a parent activating it.
    4. Duty of care by design: Place an explicit obligation on developers to design against engagement maximisation and emotional dependence for minors, following the design level approach rather than a content list.
    5. Crisis routing obligations: Mandate that any self harm, suicide or eating disorder cue in a minor’s conversation trigger an immediate handoff to a human helpline, with logged compliance.
    6. Transparency reporting: Require periodic public reporting of safety failure rates, bypass incidents and the duration effect on guardrail reliability in long conversations.
    7. Digital literacy and sensitisation: Build chatbot specific awareness into school curricula and parent outreach, since the risk is a design property that neither group currently recognises.
    8. A dedicated Indian instrument: Move from the present patchwork to a clear framework for artificial intelligence products used by minors, backed by the National Commission for Protection of Child Rights and the data protection regulator.

    “[2025, GS2, 15 marks] The National Commission for Protection of Child Rights has to address the challenges faced by children in the digital era. Examine the existing policies and suggest measures the Commission can initiate to tackle the issue.”

  • To build AI for all, bring in more women

    Why in the News

    India ranks among the world’s leading artificial intelligence ready nations, powered by Digital Public Infrastructure and a large innovation ecosystem, while women fall from 43 percent of STEM graduates to 10 percent of senior AI leadership. Every artificial intelligence system begins with data and every dataset begins with people, so a pipeline that loses women at each stage produces systems that reproduce the inequality of the society they learn from.

    What is the AI pipeline?

    1. Definition: The AI pipeline is the full sequence from data collection through model training and deployment to the decisions the model produces.
    2. Not only technical: It is not merely a technological conduit of code, silicon and compute power. It is fundamentally a human pipeline.
    3. It starts early: The pipeline begins before the first line of code is written, at the point where data about people is collected or not collected.
    4. Where the consequences land: Its outputs shape decisions affecting millions, from loan sanction to clinical recommendation.
    5. The failure mode: When people are absent from that data, artificial intelligence inherits those gaps.

    What is Digital Public Infrastructure?

    1. Definition: Digital Public Infrastructure (DPI) is a set of shared, interoperable digital systems, such as digital identity, payments and data exchange layers, built as public utilities on which both government and private services run.
    2. Why it matters here: India’s artificial intelligence readiness is powered by DPI, which also determines whose transactions and records enter the datasets models are trained on.

    What is the India AI Mission?

    1. Definition: The India AI Mission is the national programme providing compute capacity, datasets, application development support, skilling and startup financing for artificial intelligence in India.
    2. Relevance here: It is the vehicle through which artificial intelligence in India can be steered onto the same inclusive path that DPI followed for public welfare.

    Where does the pipeline leak women?

    1. STEM foundation: Women account for 43 percent of India’s STEM graduates, one of the world’s largest pools of women STEM graduates.
    2. Tech workforce: Representation falls to 26 percent in the technology workforce.
    3. Advanced AI roles: Only 12 percent of professionals in advanced artificial intelligence roles are women.
    4. Senior AI leadership: Women hold just 10 percent of senior artificial intelligence leadership positions.
    5. What the sequence shows: At every stage the pipeline leaks talent, lived experience and innovation, so the loss compounds rather than occurring at one bottleneck.

    What causes the leakage?

    1. Access to the network itself: Only 57 percent of women have independent internet access, compared with 72 percent of men.
    2. Nutrition and education: Unequal nutrition and unequal education set the disparity before any career choice is made.
    3. Caregiving responsibilities: Unpaid care work removes women from the workforce at the point where advanced technical careers compound.
    4. Workplace discrimination: Discrimination at work blocks progression from entry level technical roles into advanced ones.
    5. Language barriers: Artificial intelligence education is dominated by English, which excludes those schooled in other languages.
    6. School infrastructure: A student cannot pursue robotics where her school lacks the necessary infrastructure, so the exclusion begins well before higher education.
    7. Influence, not only presence: A woman who becomes an artificial intelligence engineer often remains the only woman in the room, with limited influence in product design.

    What happens to systems built without women in the data?

    1. Credit assessment: A self help group member in rural Bihar applying for a micro-loan is scored by models relying mainly on historical male financial patterns, which may underestimate her creditworthiness.
    2. Maternal health tools: A community health worker in Gujarat depends on artificial intelligence enabled maternal health tools, and training data that fails to reflect local nutrition and health conditions produces inaccurate recommendations affecting maternal care.
    3. The general mechanism: Artificial intelligence automates existing inequalities when trained on incomplete or biased data.
    4. The learning relationship: Artificial intelligence learns from society, so an unequal society produces an artificial intelligence that reflects that inequality.
    5. Why datasets alone are insufficient: Correcting the output requires more than diverse datasets, because the decisions about what to collect and what to optimise are made by the people in the room.

    Does India’s AI readiness conceal an exclusion problem?

    1. The readiness claim: India ranks among the world’s leading artificial intelligence ready nations, powered by Digital Public Infrastructure and a thriving innovation ecosystem.
    2. The contradiction beneath it: India produces one of the world’s largest pools of women STEM graduates, and women steadily disappear as the artificial intelligence pipeline advances.
    3. Formal equality achieved early: When India adopted its Constitution in 1950, it granted women and men universal adult franchise simultaneously, ahead of the sequence followed in several western democracies.
    4. Substantive access lagging: That simultaneous political inclusion sits alongside a 15 percentage point gap in independent internet access between men and women today.
    5. What the measure of leadership should be: True artificial intelligence leadership cannot be measured only by models, investments or patents. It must be measured by whether artificial intelligence reflects India’s diversity of languages, cultures, socio-economic realities and lived experiences.

    What does the corrective path look like?

    1. The precedent of scale: India has already shown how technology can advance public welfare at scale, and the India AI Mission offers the opportunity to ensure artificial intelligence follows the same inclusive path.
    2. Existing women’s institutions: Across rural India, women’s self-help groups have built strong financial ecosystems through collective savings and entrepreneurship, which is usable financial data and an existing delivery network.
    3. Influence changes output: When women occupy positions of influence, the technology itself shifts.
    4. Four roles, not one: Women and marginalised communities must participate as researchers, engineers, entrepreneurs and policymakers, not only as subjects in the training data.
    5. The constitutional foundation: The commitment to simultaneous inclusion continues through Digital Public Infrastructure, which provides the base for building inclusive artificial intelligence.

    Challenges to building inclusive AI

    1. Unpaid care work truncates technical careers: Time available for advanced training and long project cycles is unequal, e.g. the Time Use Survey 2019 recorded women spending 299 minutes a day on unpaid domestic work against 97 minutes for men.
    2. Device and connectivity gap precedes the skills gap: Independent access, not shared household access, determines who generates data, e.g. the National Family Health Survey 2019 to 2021 found 33.3 percent of women had ever used the internet against 57.1 percent of men.
    3. Language exclusion in model and curriculum: English dominant material and models exclude most first generation learners, e.g. Bhashini and BharatGen were set up precisely because Indian language coverage in large models was thin.
    4. Data annotation labour has no design voice: The workers who label training data are outside the decisions the data shapes, e.g. annotation work is outsourced at low wages with no representation in product design.
    5. No bias audit obligation: Automated decision systems face no statutory fairness testing requirement, e.g. the Digital Personal Data Protection Act, 2023 governs consent and processing of personal data but imposes no algorithmic audit duty.
    6. Online safety drives women off the platforms that generate data: Harassment reduces sustained participation, e.g. National Crime Records Bureau data has recorded a rising count of cyber crimes against women.
    7. Absence of sex disaggregated public datasets: Models cannot be checked for differential performance where the data does not record the split, e.g. many administrative datasets used for training carry no reliable gender field.

    Conclusion

    The central point is that the artificial intelligence pipeline is a human pipeline, and the numbers show it losing women at every stage from 43 percent of STEM graduates to 10 percent of senior AI leadership. Diverse datasets alone will not correct outputs shaped by rooms in which women are absent, so participation must extend to research, engineering, entrepreneurship and policymaking. What remains unresolved is the access gap that precedes all of it, with only 57 percent of women holding independent internet access against 72 percent of men.

  • Gene Editing’s Bold Move: Permanently Shut Down PCSK9

    Why in the News

    VERVE-102, an experimental in vivo base editing therapy delivered as a single intravenous infusion, permanently switches off the PCSK9 gene inside liver cells and cut LDL cholesterol by about 62 percent in a phase 1 trial. Cholesterol control has until now been a lifelong compliance problem, and a one time genetic change replaces that problem with a permanent, irreversible one.

    How does VERVE-102 work?

    1. What it is: VERVE-102 is not a traditional drug. It is a form of in vivo gene editing, meaning the editing is done inside the patient’s body rather than on cells removed and returned.
    2. Step 1, delivery: Genetic instructions are delivered through a single intravenous infusion.
    3. Step 2, the edit: Those instructions make a one time targeted change to the DNA inside liver cells, altering a single base in the PCSK9 gene.
    4. Step 3, the effect: The edited liver cells permanently lose the ability to produce PCSK9.
    5. Step 4, the outcome: With PCSK9 production switched off, the liver clears more LDL cholesterol from the blood, and the effect persists without repeat dosing.
    6. The stated goal: A single infusion that permanently reduces the liver’s ability to produce PCSK9, so that a one and done cholesterol treatment could eventually replace conventional medicines.

    What is LDL cholesterol?

    1. Definition: LDL (low-density lipoprotein) is called bad cholesterol because high levels make it stick to artery walls and form hard fatty deposits called plaque.
    2. Why it matters: These deposits narrow the arteries and block blood flow, which raises the risk of heart attacks and strokes.

    What is PCSK9 and why is it the target?

    1. What it is: PCSK9 is a protein involved in regulating LDL cholesterol in the blood.
    2. The natural experiment: People who naturally carry certain loss-of-function changes in the PCSK9 gene have lower LDL cholesterol throughout their lives and a lower risk of coronary heart disease.
    3. The inference: Reducing PCSK9 activity is therefore a safe and effective route to lowering cardiovascular risk.
    4. Confirmed by drugs: PCSK9 monoclonal antibodies substantially reduce LDL cholesterol and cardiovascular events, confirming the target.
    5. The limitation VERVE-102 addresses: Traditional medicines temporarily block PCSK9 or reduce its production, so their effects require continued treatment.

    What did the phase 1 trial find?

    1. LDL reduction: LDL cholesterol fell by about 62 percent in the highest dose group after four weeks.
    2. PCSK9 reduction: PCSK9 levels in that group fell by about 88 percent.
    3. Absolute fall: LDL cholesterol decreased by approximately 78 mg/dL on average.
    4. Follow up length: Some participants were followed for at least one year, and the longest follow up reached 18 months.
    5. Durability so far: The reductions in PCSK9 and LDL cholesterol were relatively stable across that period.

    How much cardiovascular risk does that reduction translate into?

    1. The established ratio: For every 1 mmol/L reduction in LDL cholesterol, cardiovascular risk falls by 20 to 22 percent.
    2. Worked case: An LDL cholesterol of 4.0 mmol/L, approximately 155 mg/dL, falling to 1.6 mmol/L is a 60 percent reduction.
    3. Effect of that case: That fall halves the patient’s cardiovascular risk.
    4. What remains unproven: VERVE-102 has not yet been shown to prevent heart attacks or strokes directly.
    5. The supporting evidence: All cholesterol lowering trials so far have shown that lower cholesterol means fewer cardiovascular events, and drugs blocking the PCSK9 protein have been shown to reduce heart attacks.

    How does it compare with the treatments already in use?

    1. Statins: Usually the foundation of treatment. They are relatively inexpensive, widely available, and supported by extensive evidence showing reductions in cardiovascular events.
    2. Ezetimibe: A cholesterol absorption inhibitor, taken orally, that works by blocking cholesterol from being absorbed in the small intestine.
    3. PCSK9 antibody medicines: They produce powerful LDL reductions and have demonstrated cardiovascular benefits, but require repeated injections.
    4. Inclisiran: It reduces PCSK9 production and can lower LDL cholesterol by roughly 50 percent, with less frequent dosing that makes long term treatment easier. It does not permanently modify DNA.
    5. The distinguishing feature of VERVE-102: Every existing option acts temporarily and must be continued. VERVE-102 makes a permanent change to DNA.

    Does permanence justify the loss of reversibility?

    1. The compliance case: Repeat prescriptions and remembering daily doses are a standing burden, and a safe one time treatment would remove that burden entirely.
    2. The unknown: This is a permanent change and the long term consequences are not yet known, so treated patients will need close observation.
    3. The reassurance from biology: Naturally occurring loss-of-function mutations of the gene exist, and people carrying them have less heart disease and live longer, which is the basis for the trial.
    4. The evidence horizon problem: An 18 month period is very different from proving that an effect will last for decades, and that requires further research.
    5. The current standing of the therapy: It is a potential future option for selected high risk patients, not a replacement for statins, ezetimibe, PCSK9 inhibitors or inclisiran.
    6. Trial breadth: More diverse trials are needed to establish whether the effect holds across populations over decades.

    Who would be considered for it first?

    1. Familial hypercholesterolemia: An inherited condition producing very high LDL cholesterol from birth, whose patients have the most to gain from a permanent reduction.
    2. Very high cardiovascular risk patients: Those whose risk is not controlled by existing therapy would be the second group.
    3. The staging logic: Beginning with these groups allows observation for problems before any wider use.
    4. What it is not yet: It is not a population level cholesterol intervention and is not positioned as one.

    Challenges to VERVE-102

    1. Irreversibility of a permanent edit: A therapy that cannot be stopped removes the physician’s ability to withdraw treatment, e.g. a statin prescription can be discontinued the day an adverse effect appears, while an edited liver cell population cannot be restored.
    2. Evidence horizon is short: Durability is established only to 18 months, e.g. statin cardiovascular outcome evidence rests on trials such as the Heart Protection Study that ran over five years in more than 20,000 participants.
    3. Delivery vector and off target risk: Gene therapy delivery carries historical safety precedent, e.g. the 1999 death of a participant in an adenoviral vector gene therapy trial in the United States halted the field for years.
    4. Cost and access: One time genetic therapies have been priced far beyond public health budgets, e.g. Casgevy, the first approved CRISPR based therapy, is priced at over two million dollars per patient in the United States.
    5. Population applicability: Early phase cohorts do not establish effect across differing lipid profiles, e.g. coronary artery disease in South Asians presents roughly a decade earlier and at lower body mass index than in western populations.
    6. Regulatory pathway for permanent somatic edits: Approval frameworks for irreversible somatic edits are still forming, e.g. India’s National Guidelines for Gene Therapy Product Development and Clinical Trials, 2019 permit somatic editing under review but bar germline editing outright.
    7. The competing benchmark is already cheap: A one time therapy must justify a large upfront price against an existing generic, e.g. statins cost a few rupees a day in India and are on the National List of Essential Medicines.

    Conclusion

    The central finding is that a permanent genetic switch off of PCSK9 through a single infusion produces LDL reductions larger than any daily medicine achieves, and that the reduction has held for 18 months. What remains unresolved is whether a permanent change is safe across a lifetime, and whether the LDL reduction converts into fewer heart attacks and strokes, neither of which the phase 1 data can answer. Until large outcome trials report, the therapy stands as an option for familial hypercholesterolemia and very high risk patients rather than a replacement for statins, ezetimibe, PCSK9 inhibitors or inclisiran.

    PYQ Relevance:

    Question (2021, GS3): “What are the research and developmental achievements in applied biotechnology? How will these achievements help to uplift the poorer sections of society?
    Linkage: Applied biotechnology is the primary field where gene editing techniques (like CRISPR) are developed to address challenges in health and agriculture, which can specifically benefit the underprivileged

  • Draft rules under the SHANTI Act could favour Russia’s Rosatom in India’s nuclear opening

    Why in the News

    Draft rules issued by the Department of Atomic Energy under the Sustainable Harnessing and Advancement of Nuclear Energy for Transforming India (SHANTI) Act require any foreign nuclear technology brought into India to be design certified by the regulator in its country of origin and already operational there or in another foreign country. Only two Small Modular Reactors are operational anywhere in the world, so a clause written as a safety filter narrows India’s field of eligible suppliers to the one country that already has an operating unit.

    Mentor’s Comment

    A proven technology test is the most defensible condition a regulator can write. It is also the condition that most reliably locks out every new entrant, because nothing can be operational before someone allows it to operate somewhere first.

    What is the SHANTI Act?

    1. Full name: The Sustainable Harnessing and Advancement of Nuclear Energy for Transforming India Act, referred to as the SHANTI Act.
    2. Function: It is the statute under which India’s expansion of nuclear power generation is being governed, including the terms on which foreign nuclear technology may be sourced for an Indian plant or reactor.
    3. Rule making authority: The Department of Atomic Energy (DAE) frames the subordinate rules under the Act, and has now issued them in draft.
    4. Operative clause in the draft rules: Foreign nuclear technology sourced for a nuclear power plant or reactor in India must mandatorily carry design certification or approval from the regulatory body in its country of origin, and must already be operational there or in another foreign country.

    What is a Small Modular Reactor?

    1. Definition: A Small Modular Reactor (SMR) is an advanced nuclear reactor with about one third the generating capacity of a conventional large power reactor, built from factory made modules rather than site fabricated components.
    2. Intended use: SMRs are aimed at supplying clean electricity to remote regions with limited grid infrastructure and to individual industrial enterprises.
    3. India’s interest: India is examining SMRs for localised applications such as energy hungry data centres, and for scaling up baseload capacity quickly.

    What do the draft rules actually require of a foreign supplier?

    1. Home regulator certification: The design must be certified or approved by the regulatory body of the technology’s country of origin.
    2. Prior operating record: The technology must already be operational in that country or in another foreign country.
    3. Cumulative condition: Both tests must be met together, so a design certified but not yet built fails the rule, and a demonstration unit without home regulator certification also fails it.
    4. Practical filter: The clause screens out first of a kind designs, which is the entire category most SMR developers currently sit in.

    What does the global SMR field look like?

    1. Russia, Akademik Lomonosov: A floating power unit with two modules of 35 MWe that began commercial operation in May 2020. It is a non self propelled power barge docked at Pevek harbour, supplying heat to the Arctic port town and electricity to the regional grid, and is the world’s northernmost nuclear power plant.
    2. China, HTR-PM: A demonstration project grid connected in December 2021 that started commercial operations in December 2023, the second of the two SMRs operational globally.
    3. United States, Holtec International: The New Jersey based developer’s SMR is still in the design certification phase and is yet to be cleared by its domestic regulator.
    4. United Kingdom, Rolls-Royce SMR: Also in the design certification phase, with no operating unit anywhere.
    5. United States, GE-Hitachi BWRX-300: A boiling water reactor derived SMR, likewise awaiting domestic regulatory clearance.
    6. What the set demonstrates: Only Russia and China clear the operational test today, and Russia is the only country in the world with expertise in floating nuclear power solutions.

    What is Russia already positioned to supply in India?

    1. Existing build: Russia is already constructing conventional nuclear projects in India and holds a lead in the nascent SMR field.
    2. Kudankulam: The Kudankulam Nuclear Power Project (KKNPP) in Tamil Nadu is India’s largest nuclear power station and the flagship project of Russian and Indian energy cooperation. Units 1 and 2 use Russia’s earlier VVER-1000 light water reactors, where water cools the reactor, and are connected to the national grid supplying south India.
    3. Serial construction pitch: A key negotiating point from the Russian side is serial construction of high capacity units of Russian design in India based on the new generation VVER-1200 reactor models, with technical specifications being proposed by Russia.
    4. SMR pitch: Rosatom State Corporation has made a strong pitch for deploying its SMRs for targeted applications in India, and construction of SMRs of Russian design in India is under discussion.
    5. Floating solutions: In April 2024, Rosatom presented its Indian partners with information on its floating nuclear power solutions.
    6. Bilateral track: Progress on Kudankulam and the SMR proposal was reviewed at a working meeting in Mumbai on 10 November between the Chairman of the Department of Atomic Energy and the Director General of Rosatom.

    Why does cost also point the same way?

    1. Indigenous benchmark: India’s indigenous pressurised heavy water reactors (PHWRs) cost about Rs 18 crore per MW-electric.
    2. Russian comparison: Russian reactors are estimated at about Rs 34 crore per MW-electric, which industry insiders describe as only marginally more expensive.
    3. Western comparison: Light water reactors offered by French and United States companies are significantly more expensive than India’s indigenous PHWRs.
    4. Where the cost sits: Fuel accounts for a relatively small share of the overall cost of nuclear generation, so the capital number dominates.
    5. Financing and time: High upfront capital cost remains the key challenge for new projects, and financing costs and the length of the construction period are critical determinants of the final cost of nuclear power.

    What are the other major changes in India’s nuclear framework?

    1. Change to an existing monopoly: The reform track opens nuclear power generation beyond the exclusive preserve of state owned entities, which the Atomic Energy Act, 1962 had reserved for the government.
    2. Change to an existing liability regime: The Civil Liability for Nuclear Damage Act, 2010, whose Section 17(b) gives the operator a right of recourse against the supplier, is part of the same reform track because that provision is the standing deterrent for foreign vendors.
    3. New institutional target: A Nuclear Energy Mission for Viksit Bharat carries an outlay of Rs 20,000 crore for research and development on Small Modular Reactors, with at least five indigenously designed SMRs targeted to be operational by 2033.
    4. New capacity goal: A national target of 100 GW of nuclear capacity by 2047 anchors the entire framework, against present installed capacity of under 9 GW.
    5. New subordinate rules: The draft rules now released are the first set of subordinate legislation under the SHANTI Act governing sourcing of foreign nuclear technology.

    Does a proven technology test buy safety at the cost of competition?

    1. The case for the clause: A design already certified and operating abroad carries demonstrated safety performance, which is the strongest assurance a regulator can demand before a first Indian deployment.
    2. The cost of the clause: Almost every SMR developer is in the design certification phase, so a rule keyed to operating status excludes the field rather than ranking it.
    3. Competition effect: With Holtec, Rolls-Royce SMR and the GE-Hitachi BWRX-300 all outside the gate, price discovery for Indian projects narrows to one supplier’s quotation.
    4. Reciprocity problem: India’s own first of a kind designs have no operating record either, so a mirror clause applied abroad would keep Indian reactors out of foreign markets.
    5. Strategic dependence: Serial construction of VVER-1200 units plus SMR supply from the same country deepens a single supplier relationship in a sector with sixty year asset lives.

    Challenges to the design certification and prior operation clause

    1. The eligible field collapses to two countries: Only Russia and China have an operating SMR, e.g. Akademik Lomonosov since May 2020 and HTR-PM since December 2023, so every other developer is excluded until its home regulator acts.
    2. First of a kind Indian designs get no reciprocal entry: An indigenous SMR has no operating unit anywhere, e.g. the Bharat Small Modular Reactor of about 200 MWe exists only on paper, so a comparable foreign rule would bar it abroad.
    3. Supplier liability still deters western vendors independently of this clause: Section 17(b) of the Civil Liability for Nuclear Damage Act, 2010 has kept projects frozen, e.g. the Jaitapur project with French supply has been under negotiation since 2010 without a single unit built.
    4. Construction period risk dominates project cost: Long build times inflate financing cost, e.g. Kudankulam Unit 1 was sanctioned in 1988 and reached criticality only in 2013.
    5. Fuel supply remains external for safeguarded reactors: Imported uranium underpins the light water fleet, e.g. India sources uranium from Kazakhstan, Uzbekistan, Russia and Canada under Nuclear Suppliers Group waiver arrangements.
    6. Local acceptance and land acquisition delay siting: Public opposition has stalled commissioning, e.g. protests at Kudankulam through 2011 and 2012 delayed the first unit by over a year.
    7. SMR economics depend on serial factory production: A handful of units cannot amortise a module factory, e.g. Pevek’s barge served a single Arctic town, which is not a template for grid scale Indian demand.

    Conclusion

    The rules under the SHANTI Act are at the stage of a draft released by the Department of Atomic Energy for public comment, and the operative clause requires foreign nuclear technology to be design certified in its country of origin and already operational there or abroad. The next milestone is the close of the comment window on 4 September 2026, after which the rules are to be finalised and notified. As drafted, the clause leaves Rosatom as effectively the only qualifying SMR supplier, with Holtec International, Rolls-Royce SMR and the GE-Hitachi BWRX-300 all still in design certification.