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Subject: Sectoral Regulatory Bodies

  • SC seeks clarity on FSSAI’s warning label norms

    Why in the News

    The Supreme Court has questioned the Food Safety and Standards Authority of India (FSSAI), the statutory food regulator, on how it proposes to determine whether a packaged food is “high” in sugar, salt or fat for the purpose of front of pack warning labels. The regulator had proposed such labels a month earlier, after the Court questioned its reluctance to introduce them. Its affidavit sets the thresholds by reference to the Dietary Guidelines for Indians, 2024 issued by the ICMR National Institute of Nutrition, without stating the triggering level itself. The Court described food safety as a cause of “national interest” and said it would pass a detailed order seeking further information from stakeholders. A warning label operates entirely through the number that switches it on, and that number is the one part of the proposal not yet on record.

    What is a front of pack warning label?

    1. Where it sits, and why that matters: It is a mark printed on the front of a package rather than inside the nutrition panel on the back, so a purchaser sees the risk before choosing to read anything.
    2. The form proposed: A red hexagonal warning would appear on the front of the pack.
    3. The trigger proposed: It would apply where a product is found to be high in two or more of the specified nutrients of concern, namely added fat, added sugar and salt.

    What did the Court ask that the affidavit does not answer?

    1. The threshold question: A two judge Bench asked how the regulator would fix the level beyond which a packaged food is classified as high in sugar, salt or fat.
    2. Whether any standard exists at all: The Bench asked directly whether guidelines had been laid down for making that determination.
    3. The answer on record: The Additional Solicitor General, appearing for the Centre and the regulator, said the regulator was adhering to the guidelines issued by the ICMR National Institute of Nutrition.
    4. A dietary guideline is not a labelling standard: Those guidelines advise individuals on what to eat. A labelling rule needs a numeric limit stated per unit of food, which a manufacturer can apply and an inspector can test.

    How did the case reach this point?

    1. The petition behind it: The proceeding is a public interest litigation filed by non profit organisations seeking warning labels that indicate high levels of salt, sugar and saturated fats.
    2. The regulator moved only under scrutiny: The proposal for prominent red warnings marked a regulatory pivot, and it arrived after judicial questioning rather than from the regulator’s own standard setting cycle.
    3. The Court’s stated ground: The Bench said it had undertaken its own study, asked the regulator to treat its directions seriously, and grounded its concern in the health of the population and of growing children in particular.

    Challenges to front of pack warning labels

    1. The threshold decides the policy, and it is the contested part: Industry attention concentrates on the cut off rather than on the label, because a lenient limit leaves most products unmarked. Eg. An earlier Indian proposal offered an Indian Nutrition Rating awarding stars, which public health bodies criticised for rewarding marginal reformulation instead of warning about risk.
      The Fix: Notify numeric limits per 100 g for solids and per 100 ml for liquids, separately for each nutrient, so the standard is testable rather than advisory.
    2. A two nutrient trigger lets single nutrient products pass: A food extremely high in one nutrient alone would carry no mark at all. Eg. A sugar sweetened beverage low in fat and salt escapes a label that requires two breaches.
      The Fix: Apply one warning mark for each nutrient breached, so the label scales with the risk rather than with the count of risks.
    3. Enforcement reaches only the packaged segment: Loose and unbranded food sold without a package falls outside any labelling rule. Eg. Fried snacks and sweets sold by weight carry no nutrition declaration whatsoever.
      The Fix: Pair the label with mandatory menu and point of sale declarations for chain food outlets, where the product is standardised and traceable.
    4. A label changes purchase only if it is understood: Nutrient information fails where the reader cannot convert a figure into a judgement. Eg. Chile adopted a black octagonal mark carrying the words “high in” in 2016 precisely because numeric panels were going unread.
      The Fix: Test the mark for comprehension among low literacy consumers before notification, and pair it with restrictions on marketing such products to children.

    Conclusion

    The regulator has conceded the principle and left the operative part open. A warning is a binary statement, so it cannot be issued out of advice about balanced diets, it needs a limit written per unit of food. What follows is that the useful output of this litigation is not a further affidavit accepting labels but a notified numeric standard, with a compliance date and a named enforcement authority behind it. Until that exists, the label is a design and not a rule.

    Matching Previous Year Question

    “[2016] With reference to pre-packaged items in India, it is mandatory to the manufacturer to put which of the following information on the main label, as per the Food Safety and Standards (Packaging and Labelling) Regulations, 2011? 1. List of ingredients including additives 2. Nutrition information 3. Recommendation, if any, made by the medical profession about the possibility of any allergic reactions 4. Vegetarian/non-vegetarian Select the correct answer using the code given below. (a) 1, 2 and 3 (b) 2, 3 and 4 (c) 1, 2 and 4 (d) 1 and 4 only ANSWER: (c)”

  • Why does India’s food safety system need a Clint Eastwood?

    Why does India’s food safety system need a Clint Eastwood?

    Why in the News

    India’s food safety regulation fails at disclosure and enforcement rather than at data collection. Between May and July a Maharashtra Food and Drug Administration drive led by a 2005 batch Indian Administrative Service officer inspected 3,137 restaurants, issued 764 improvement notices and shut 165 eateries.

    What is FoSCoS?

    1. The regulator’s integrated digital platform: The Food Safety Compliance System (FoSCoS) is the Food Safety and Standards Authority of India’s single platform for licensing, inspections, laboratory results and penalties, with the compliance chain digitised and connected.
    2. The designed sequence: A violation is found, a laboratory test is ordered, results are analysed, an audit is conducted, adjudication follows, a penalty issues and the establishment is closed.
    3. The record is held, never published: The platform accumulates violation data that never reaches the person choosing where to eat.

    Why does the enforcement chain stall?

    1. The design is a series of checkpoints: A violation sits in audit, then in adjudication, then in enforcement.
    2. No step carries a closing clock: Each checkpoint can hold a file indefinitely, so a violation is never formally disposed of.
    3. The system has more blockers than doers: The count of officers who can stop a file exceeds the count who can conclude one, so enforcement resumes only when a senior officer personally drives it.

    What did the Maharashtra drive actually demonstrate?

    1. A crackdown is not a system: The drive produced closures at a scale the routine machinery had not, using powers the routine machinery already held.
    2. A folk hero is evidence of failure: Celebrating an enforcement officer amounts to conceding that the enforcement design does not work without one.
    3. The output is not durable: An enforcement wave attached to one officer’s posting ends with that posting, and the platform returns to recording violations nobody acts on.

    What do the disclosure regimes elsewhere show?

    1. Singapore publishes the result where the customer stands: Inspections and rules resemble India’s. A failed inspection produces a rating displayed on the storefront and online.
    2. The pressure that works is commercial: The owner fears customers who see a failed grade and walk away, not the inspector or the fine. Revenue falls the same week and the problem is fixed at once.
    3. Denmark and Australia publish within days: Violations become public within days and the media carries them.
    4. Publication also disciplines the regulator: A lenient district looks bad against a neighbouring district’s published record, so an official cannot let files sit unseen.

    Why would publication work where inspection has not?

    1. The system is built for the wrong user: The compliance chain is designed for the convenience of the regulator, and the customer, who bears the risk, sees none of its output.
    2. Automatic publication is the specific proposal: Violation data should go public online within 48 hours, in food delivery apps and in restaurant windows, so a customer knows before ordering.
    3. A working regulator is invisible: Countries with published hygiene ratings generate no news coverage of their food safety enforcers, because enforcement there is routine rather than exceptional.

    Where else would published regulatory data change behaviour?

    1. Real estate: Buyers cannot tell whether a building was flagged for structural problems. Municipal violation history displayed in property listings would move demand away from flagged buildings and force developers to remedy them.
    2. Television channels: Official data exists on complaints against news channels for fake news, hate speech and bias, and never appears at the point where a viewer chooses a channel.
    3. Schools: Education departments inspect schools and record violations that parents never see while comparing institutions.
    4. Hospitals: Data on doctor complaints, disciplinary action and malpractice cases is held and withheld, so a patient chooses on reputation alone.

    Challenges to the food safety regulator’s enforcement design

    1. Testing capacity and procedure are the weak link: An enforcement order stands only if the sampling and laboratory chain behind it survives challenge. Eg. The 2015 national recall order on Maggi noodles was set aside by the Bombay High Court in August 2015, partly over how the samples had been tested.
      The Fix: Accredit a referral laboratory for every zone and publish its sample turnaround time against a fixed standard.
    2. Penalties are capped in absolute rupees: A ceiling fixed in the statute does not scale with the turnover of the business penalised. Eg. Section 52 of the Food Safety and Standards Act, 2006 caps the penalty for sub-standard food at Rs 5 lakh.
      The Fix: Link the penalty for a repeat violation to declared annual turnover rather than to a flat statutory ceiling.
    3. Most food businesses are registered rather than licensed: Small operators below a turnover threshold need only registration, which carries a lighter inspection and record obligation. Eg. Street food vendors and small eateries fall almost entirely into the registration category.
      The Fix: Extend a simplified published hygiene grade to registered outlets, so the lighter compliance route still produces a visible signal.
    4. The regulator sets standards and does not enforce them: Designated officers and food safety officers are appointed and paid by State commissioners, so the national platform records violations that no national authority can act on. Eg. An enforcement drive in one State changes nothing about a chain’s outlets in the next State.
      The Fix: Publish State-wise enforcement counts and pendency on the platform, so a State’s inaction is visible against its neighbours.

    Conclusion

    The instrument that would change behaviour is already built and already loaded, and it is pointed at the regulator instead of at the customer. Disclosure converts a compliance record into a commercial consequence, which is the one pressure a restaurant answers within the week. What is worth watching is whether any State food safety commissioner makes publication automatic and time-bound rather than discretionary, since the platform holding the data is national and the decision to open it is not.

    Laws and Rules Governing Food Safety Regulation

    1. Food Safety and Standards Act, 2006: Consolidated the earlier food laws into a single statute and created the Food Safety and Standards Authority of India as the standard-setting regulator.
    2. It repealed the Prevention of Food Adulteration Act, 1954, which had governed food adulteration for five decades.
    3. Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations, 2011: Split food businesses into registration and licensing categories by turnover and scale of operation.
    4. Food Safety and Standards (Labelling and Display) Regulations, 2020: Fixed the mandatory declarations and the display obligations for food service establishments.
    5. Consumer Protection Act, 2019: Created the Central Consumer Protection Authority, which acts against misleading advertisements and unsafe goods independently of the food regulator.

    Government Initiatives for Food Safety

    1. Eat Right India: The regulator’s national movement combining regulatory measures, industry self-compliance and consumer awareness on safe and healthy food.
    2. Food Safety Training and Certification (FoSTaC): Mandatory training and certification of food safety supervisors for licensed food businesses.
    3. Clean Street Food Hub and Eat Right Station certification: Audited hygiene certification for street food clusters and railway stations.
    4. BHOG, Blissful Hygienic Offering to God: Hygiene certification programme for places of worship that prepare and distribute prasad.

    [2018] Consider the following statements:

    1. The Food Safety and Standards Act, 2006 replaced the Prevention of Food Adulteration Act, 1954.

    2. The Food Safety and Standard Authority of India (FSSAI) is under the charge of Director General of Health Services in the Union Ministry of Health and Family Welfare.

    Which of the statements given above is/are correct?

    (a) 1 only

    (b) 2 only

    (c) Both 1 and 2

    (d) Neither 1 nor 2

  • Step up regulation

    Step up regulation

    Question (2024, GS2 – 15 Marks): “In a crucial domain like the public healthcare system, the Indian State should play a vital role to contain the adverse impact of marketisation of the system. Suggest some measures through which the State can enhance the reach of public healthcare at the grassroots level.”
    Linkage: The fact that non-government institutions account for 85–86% of AYUSH colleges is a stark example of the “marketisation” of healthcare education. The incentive of private players to “maximise student intake without matching increases in faculty and laboratory infrastructure” illustrates the precise “adverse impacts” of market-led growth that the state must step in to regulate.

    Mentor Comment

    Non-government institutions accounted for 86 per cent of Ayurveda colleges and 85 per cent of homoeopathy colleges in 2024, according to government data. Permitted seats rose by 43 per cent and total admission capacity by 25 per cent between 2021 and 2024. The Centre’s AYURGYAN allocation for AYUSH education, training, research, innovation and capacity building increased nearly sixfold over the same period, AYUSH being the group of systems covering Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy. Through that expansion the sector’s regulators have been denying permissions and grading colleges poorly. The tension is that private led growth carries an incentive to maximise student intake without matching increases in faculty and laboratory infrastructure, and the regulatory answer to it arrives one inspection at a time.

    How fast has AYUSH education expanded, and who is running it?

    1. The private sector runs the great majority of colleges: Non-government institutions accounted for 86 per cent of Ayurveda and 85 per cent of homoeopathy colleges in 2024.
    2. Seats grew faster than institutions: Permitted seats rose by 43 per cent and total admission capacity by 25 per cent between 2021 and 2024.
    3. Public funding rose alongside private capacity: The AYURGYAN allocation increased nearly sixfold over the same period.
    4. The private sector is leading the build out: The expansion of AYUSH medical education infrastructure is being driven by non-government institutions rather than by State run colleges.

    Why do the quality questions differ from those in allopathic education?

    1. The allopathic concern is narrower: Debate there has been confined to whether institutions adequately prepare students for evidence-based practice.
    2. AYUSH raises two questions at once: The first is the quality of training delivered, and the second is what students are being trained to practise.
    3. The evidence base is itself in question: Tougher quality control does not settle the separate question of the evidence backing AYUSH medicinal systems.

    Do the quality problems predate the current expansion?

    1. A 2005 audit found widespread deficiencies: The Comptroller and Auditor General found insufficient hospital beds, outpatient services or staff to be widespread among homoeopathy colleges.
    2. Bed occupancy ranged from 1 per cent to 71 per cent: The same audit recorded that spread across the colleges it examined.
    3. Faculty shortfalls exceeded half the requirement: A 2020 article in the Journal of Ayurveda and Integrative Medicine reported that many institutions fell short by more than 50 per cent of the teaching staff required by the standards then in force.

    What are the regulators finding now?

    1. The Ayurveda regulator has denied 17 permissions: As of 21 August the National Commission for Indian System of Medicine (NCISM) had listed 17 Ayurveda colleges, all private, whose permissions it had denied.
    2. Several denials were for obstructing the process itself: The stated reason in several cases was non-compliance with the inspection process.
    3. The homoeopathy regulator graded 41 per cent of colleges lowest: The National Commission for Homoeopathy placed that share at the bottom grade, including nearly half of all private institutions.
    4. The recorded failures are specific and repeated: They include inadequate or disputed faculty strength, failures in inspection requirements and student intake numbers, and allegations of fictitious faculty.

    What incentive does private led expansion create?

    1. Intake is the revenue lever: Expansion led by private institutions is accompanied by an incentive to maximise student intake while holding faculty size and laboratory infrastructure at existing levels.
    2. A court has recorded the practice: The Karnataka High Court in Hillside Ayurveda Medical College (2023) acknowledged that educational institutions are often guilty of admitting excess students for financial gains.
    3. The regulatory response is retrospective: Permission withheld after an inspection corrects a college that has already been built and has already admitted students.
    4. Causation is not yet established: It is premature to infer that the rapid expansion has amplified these problems, and the persistent non-compliance is established on its own.

    Challenges to regulating AYUSH medical education

    1. Faculty can be produced on paper: A college can satisfy a faculty norm on inspection day by listing teachers who do not actually teach there. Eg. Aadhaar linked biometric attendance was introduced in allopathic medical colleges precisely because faculty were being shown only for inspections.
      The Fix: Extend biometric and payroll linked faculty verification to every AYUSH college and publish the verified roll monthly.
    2. Approval and assessment sit with the same body: A regulator that grants permission to a college also rates it, so a poor rating is a verdict on its own earlier approval. Eg. Allopathic regulation separated the two, creating a distinct Medical Assessment and Rating Board under the National Medical Commission.
      The Fix: Split permission and rating into separate boards with published criteria, on the model already used in allopathic regulation.
    3. Seats are cheaper to add than laboratories: Where fees are capped, a college raises revenue by raising intake rather than by improving what it teaches with. Eg. Private professional education in India has produced capitation fee litigation running from T.M.A. Pai Foundation (2002) onward.
      The Fix: Link seat sanction to an audited per student cost of teaching and clinical infrastructure rather than to floor space and declared faculty strength.
    4. Clinical exposure is measured by beds, not patients: An attached hospital can meet a bed norm without meeting an occupancy norm, so a student can qualify with very little clinical contact. Eg. Minimum standard requirements for AYUSH colleges specify bed numbers, which a college can satisfy with wards that stay largely empty.
      The Fix: Make verified average bed occupancy and outpatient footfall a condition of annual permission renewal.
    5. Efficacy sits outside the regulator’s remit: A regulator can enforce faculty and infrastructure norms without settling whether the therapy being taught works. Eg. Research on Ayurvedic medicine is largely funded and evaluated by the Central Council for Research in Ayurvedic Sciences, a body under the same ministry that promotes the system.
      The Fix: Route efficacy trials for AYUSH therapies through independently assessed, pre-registered protocols outside the promoting ministry.

    Conclusion

    AYUSH education can expand meaningfully only when capacity growth is matched by quality assurance. Stronger faculty verification, independent assessment, outcome based accreditation and evidence based research can ensure that expansion delivers credible, high quality healthcare education.

    Back2Basics: National Commission for Indian System of Medicine

    1. Governing Act: Established under the National Commission for Indian System of Medicine Act, 2020 as the statutory regulator for Indian systems of medicine.
    2. Predecessor: It replaced the Central Council of Indian Medicine, which had regulated the sector since 1970.
    3. Jurisdiction: It covers education and practice in Ayurveda, Unani, Siddha and Sowa-Rigpa.
    4. Structure: It works through autonomous boards handling education standards, assessment and rating of institutions, and ethics and registration of practitioners.

  • Why is FSSAI tightening the rules on food claims?

    Why in the News

    The Food Safety and Standards Authority of India (FSSAI) has issued more than 150 notices to food companies in recent months over misleading advertisements, false claims and labelling non compliance. Mondelez India has withdrawn certain health and nutrient comparison claims for Bournvita and removed the related advertisements from e-commerce platforms. The regulator has extended its scrutiny beyond the physical package to online marketplaces and food service establishments. A claim can be withdrawn on notice years after consumers have already acted on it, which is what makes the reach of this enforcement contested.

    What is a health claim, and what is a nutrient comparison claim?

    1. Health claim: A statement suggesting that a product helps deliver a particular health outcome. It can create expectations beyond what the product’s ingredient composition or the available evidence justifies.
    2. Nutrient comparison claim: A claim that positions a product’s nutrient content against another product or against a reference, such as a comparative calcium benefit.
    3. What the regulator governs: Food regulation is not limited to whether a product contains permitted ingredients. It also governs how a product’s nutritional qualities and benefits are communicated.

    Which claims and companies are under scrutiny?

    1. The companies served notices: The list includes Nestlé India, PepsiCo, Coca-Cola India, Abbott India, Red Bull India, Danone India, Mondelez India, Ferrero India and Kenvue.
    2. Bournvita: The product came under public scrutiny in 2023 over its sugar content and its claims about nutritional benefits. The present action does not establish that the product is unsafe, it questions whether particular claims are adequately supported.
    3. Amway India: The company removed “100%” from its “100% Pure Coconut Oil” packaging and promotional material. It also dropped the “Energy Drink” descriptor from its caffeinated XS products.
    4. Juza Foods: The Kerala based company agreed to withdraw claims of immunity, stronger bones and comparative calcium benefits from its baby food products.

    Why has the regulator targeted the word “100%”?

    1. The advisory: In May 2025 FSSAI advised food businesses to stop using “100%” on food labels, packaging and promotional material.
    2. The reasoning: The regulator held that such language conveys a false sense of absolute purity or superiority to consumers.
    3. Why absolute words matter: Words such as “pure”, “natural”, “healthy”, “immunity-boosting” and “100%” influence a purchase before the consumer examines the nutrition panel or the ingredient list.

    Why has enforcement moved to e-commerce?

    1. Notices beyond the shelf: Notices have gone to online marketplaces as well as to restaurants and other food businesses.
    2. Online pages carry different content: An online product page can carry claims, images and promotional language that differ from what appears on the physical package.
    3. How consumers now decide: A purchase is often made off an online banner or product description rather than off the label read in a shop.

    What does the crackdown still leave unaddressed?

    1. Withdrawal comes late: A company can remove a claim after receiving a notice, and consumers may already have encountered that claim for years.
    2. Messaging survives across platforms: An advertisement can disappear from one platform and its messaging remain present elsewhere.
    3. Listings change faster than checks: Online listings change rapidly, which makes sustained monitoring necessary rather than one time correction.
    4. Compliance is episodic: The regulator’s task is to make compliance routine rather than a temporary response to regulatory scrutiny.

    Conclusion

    The shift being sought is from broad marketing language to claims that can be demonstrated. This matters as India confronts rising obesity and unhealthy diets, and FSSAI has linked its food safety messaging to that wider push for healthier eating. For a consumer, a health claim on a food packet remains a claim and not a guarantee.

    Matching Previous Year Question

    “[2015, GS2, 12 marks] For achieving the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous. Discuss in the light of the experiences in recent past.”

  • SEBI’s ITRI: Global test for India’s future-ready financial architecture

    SEBI’s ITRI: Global test for India’s future-ready financial architecture

    Why in the News

    The Securities and Exchange Board of India (SEBI) has introduced an IT Resilience Index (ITRI) to assess the technological robustness of Market Infrastructure Institutions (MIIs), meaning stock exchanges, depositories and clearing corporations. The index responds to growing global concern about outages and cyberattacks at systemically important financial market infrastructure. It follows comparable resilience frameworks already adopted by regulators in the United Kingdom, the European Union, the United States, Singapore, Hong Kong and Australia. The tension is between certifying resilience on paper through a scored index and ensuring MIIs make the operational investment the index is meant to incentivise.

    What does the ITRI assess?

    1. Nine weighted parameters: The index scores each market infrastructure institution across nine parameters covering system uptime, cyber-incident preparedness, disaster recovery capability and related technology governance measures.
    2. Comparative design: SEBI has drawn on resilience frameworks used by regulators in the United Kingdom, the European Union, the United States, Singapore, Hong Kong and Australia in constructing the index.

    Why has SEBI shifted from compliance-checking to a quantitative resilience score for MIIs?

    • Systemic-risk trigger: Rising technological dependence in capital markets means even minutes of disruption at an MII can affect millions of investors and billions of rupees in trades.
    • Regulatory foundation: SEBI’s 2015 circular first classified MIIs as systemically important, mandating a robust cybersecurity framework.
    • Boardroom shift: Retail participation through online platforms, algorithmic trading volumes, and faster settlement cycles have made technology reliability inseparable from market efficiency.
    • Global first: ITRI is among the first attempts by any regulator to design a resilience barometer as measurable as capital adequacy is for banks.

    How does ITRI’s weighting structure reflect SEBI’s risk-prioritisation approach?

    • Nine-parameter design: ITRI rests on nine parameters, each weighted by a systemic-risk hierarchy, with sub-parameters to be defined by the Industry Standards Forum of MIIs.
    • Highest-weighted parameters: Availability and security carry the highest weight, at 20% each, as the first line of defence for market functioning.
    • Recovery-focused weighting: Business Continuity and Reliability carries 10% weight, reflecting a regulatory shift from preventing failures to absorbing shocks and recovering quickly.
    • Growth-risk calibration: Scalability carries only 5% weight, reflecting SEBI’s view that rapid market growth does not yet pose an immediate stability risk.
    • Early Warning System: MIIs will build an Early Warning System to detect parameter deterioration before it causes performance issues or disruptions.

    What do global resilience frameworks show about the alternatives to a single numeric index?

    • United Kingdom — FCA/PRA: Operational resilience rules require institutions to identify important business services and demonstrate recovery capability from severe shocks, without a single numeric score.
    • European Union — DORA: The Digital Operational Resilience Act functions as a regulatory rulebook rather than a numerical scorecard.
    • United States: No single resilience index exists for exchanges; technology resilience is embedded into general regulatory oversight instead.
    • Singapore — Monetary Authority of Singapore: Technology risk guidelines are considered particularly relevant to India given comparably high digital financial penetration and large retail investor bases.
    • Hong Kong: Cyber resilience assessment frameworks use measurable maturity levels, making them the closest structural parallel to SEBI’s numeric approach.

    Can a single numeric score capture resilience across MIIs with different technology architectures?

    • Architecture heterogeneity: Stock exchanges, clearing corporations and depositories operate different technology architectures and functions, raising doubts about a common index applying uniformly.
    • Weight uncertainty: Questions remain on the statistical estimation of the assigned weights, finalised through Technical Advisory Committee discussions rather than validated outage data.
    • Provisional status: The current weights are a starting framework that SEBI may have to refine using actual outage data, cyber incidents and stress tests.
    • Pace mismatch: Technology risks evolve faster than regulatory frameworks, making the index vulnerable to obsolescence even as it is being implemented.
    • Investment burden: Building automated monitoring systems, continuous testing and redundant infrastructure requires substantial investment from MIIs.

    Back2Basics: Market Infrastructure Institutions (MIIs)

    1. MIIs are the entities that provide the trading, clearing and settlement backbone of the securities market: stock exchanges, depositories and clearing corporations.
    2. They are classified as systemically important, since their failure or compromise can disrupt trading and settlement across the entire market rather than a single participant.
    3. SEBI regulates MIIs under the SEBI (Stock Exchanges and Clearing Corporations) Regulations and the SEBI (Depositories and Participants) Regulations.

    Conclusion

    SEBI’s ITRI converts technology resilience from a compliance checklist into a quantitative, weighted score, a model most global regulators have not attempted. Whether this scoring approach works depends on unresolved questions: the statistical basis of the weights, the comparability of a single index across MIIs with different architectures, and whether a high score actually translates into faster recovery during an actual technology shock. Until validated against real incident data, ITRI remains a measurement framework rather than a proven resilience guarantee.

    “[2015, GS2, 12 marks] For achieving the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous. Discuss in the light of the experiences in recent past.”

  • Centre moves to simplify medical device regulations

    Why in the News

    The Ministry of Health and Family Welfare has proposed amendments to Rule 44 and Rule 63 of the Medical Devices Rules, 2017, adding the European Union to the list of jurisdictions whose regulatory approval India recognises for faster market entry. The Medical Devices Rules, 2017 currently grant an expedited licensing route in India to devices already approved by a short list of recognised foreign regulators, such as the US Food and Drug Administration. Adding the European Union’s regulatory approval to that recognised list extends the fast-track route to a much larger set of globally marketed devices.

    What do Rule 44 and Rule 63 currently govern?

    1. Rule 44, predicate device and approval-based licensing: Rule 44 of the Medical Devices Rules, 2017 sets out the conditions under which a device already approved in a recognised foreign jurisdiction can secure an Indian manufacturing or import licence through a faster review, rather than a full fresh evaluation.
    2. Rule 63, licensing timelines and reliance on foreign approval: Rule 63 governs the timelines and documentary requirements for import licences, with reliance on foreign regulatory approval used to compress India’s own review period for devices from recognised jurisdictions.
    3. Currently recognised jurisdictions are limited: The existing fast-track list includes major regulators such as the US Food and Drug Administration, but has not included the European Union’s regulatory framework, requiring EU-approved devices to go through India’s standard, longer review.

    Why add the European Union to the recognised list?

    1. The EU covers a large share of globally marketed devices: A significant share of medical devices sold worldwide first secure approval under the European Union’s regulatory framework, so recognising EU approval widens the pool of devices eligible for India’s fast-track route considerably.
    2. Reduces duplicate testing for already-approved devices: Recognising EU approval avoids re-running clinical and safety evaluations in India for a device that has already cleared a comparably rigorous regulatory process abroad.
    3. Intended to speed access to newer medical technology: A faster licensing route is expected to bring newer diagnostic and treatment devices to the Indian market sooner than the standard review timeline would allow.

    Conclusion

    The proposed amendments to Rule 44 and Rule 63 extend India’s fast-track medical device licensing route to European Union-approved devices, alongside the jurisdictions already recognised. The amendments are at the proposal stage, with the next step being their formal notification under the Medical Devices Rules, 2017.

    Back2Basics: Medical Devices Rules, 2017

    1. Notified under the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017 created a dedicated regulatory framework for medical devices, distinct from the drug-licensing framework they had earlier been regulated under.
    2. Classify devices by risk into four classes, A to D, with review stringency rising with the device’s risk class.
    3. Are administered by the Central Drugs Standard Control Organisation, the national regulator for drugs and medical devices.
    4. Recognise approval from specified foreign regulators to allow an expedited licensing route for devices already cleared in those jurisdictions.

    Matching Previous Year Question

    “[2015, GS2, 12 marks] For achieving the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous. Discuss in the light of the
    experiences in recent past.”

  • When the inspector leaves: Can food safety become a daily habit?

    Why in the News

    Food safety compliance in Maharashtra has risen sharply since inspection drives intensified in May, with more than 3,000 inspections producing 165 licence suspensions and 750 improvement notices between 25 May and 31 July. The Food and Drug Administration (FDA) drive follows the appointment of a new State Commissioner, and restaurant associations have been sending compliance reminders to members in response. The Food Safety and Standards Authority of India (FSSAI) separately revised its turnover based licensing categories with effect from 1 April this year. Compliance that improves when inspections intensify is not compliance embedded in daily operation, and the regulatory question is whether safe practice survives once the drive ends.

    What is the Food Safety and Standards Authority of India (FSSAI)?

    1. A statutory regulator under the health ministry: FSSAI is an autonomous body under the Ministry of Health and Family Welfare, established under the Food Safety and Standards Act, 2006 to protect and promote public health through food regulation.
    2. Its core powers: It frames standards for food products, regulates their manufacture, storage, sale and import, and grants licences to food businesses based on compliance with those standards.
    3. Enforcement is shared with the States: FSSAI sets standards centrally, and inspection, sampling and prosecution are carried out by State food safety commissioners and their food safety officers.

    What do the revised turnover based licensing slabs require?

    1. Registration for the smallest businesses: Food businesses with an annual turnover of up to Rs 1.5 crore must obtain FSSAI registration.
    2. State licence for the middle tier: Businesses with a turnover between Rs 1.5 crore and Rs 50 crore require a State FSSAI licence.
    3. Central licence at the top: Businesses with turnover above Rs 50 crore require a Central FSSAI licence.
    4. The slabs are a proxy for reach, not risk: The distinction matters because India’s food sector ranges from small local vendors and retailers to large restaurants, manufacturers, importers and exporters, and turnover is the only variable the tiering uses.
    5. The licensed base is already large: FSSAI has issued around 26,000 licences across Maharashtra, Gujarat, Goa and Madhya Pradesh, covering five-star restaurants as well as importers and exporters handling essential commodities through various ports.
    6. A licence establishes presence, not practice: A licence establishes that a business sits within the regulatory system. It does not establish that safe practices are being consistently followed.

    What do the Maharashtra inspection figures show?

    1. Statewide drive since May: More than 3,000 inspections were conducted across Maharashtra between 25 May and 31 July, which is the whole period since the drive began.
    2. Statewide outcomes: Those inspections resulted in 165 licence suspensions and 750 improvement notices, so the great majority of adverse findings were correctable rather than disqualifying.
    3. Pune leads on complaints: Pune recorded the highest number of complaints among the State’s divisions, which is what directed the drive’s field effort towards that division.
    4. Pune division activity: Between 25 May and 19 August the Pune division alone saw 691 inspections, with 53 licences suspended and 408 improvement notices issued.
    5. The regional baseline: Inspections in the western region identified around 2,300 improvement notices last year, and those findings arose even among larger and licensed businesses.
    6. The trigger was administrative: Inspection drives intensified after a new Maharashtra FDA Commissioner took charge in May, which ties the enforcement level to a posting rather than to a system.

    Why does compliance rise with inspection intensity and fall without it?

    1. The checklist does not verify itself: A refrigerator may have to be maintained at a prescribed temperature, an employee may have to follow a hygiene protocol and an outlet may have to maintain a register. The existence of a checklist does not guarantee that any of it happens when an inspector is absent.
    2. Enforcement is treated as preventive health by the regulator: The State FDA Commissioner has framed food safety as part of the non-communicable disease burden, on the position that a significant portion of that burden comes from what is consumed.
    3. Established operators run their own parallel systems: A 90-year-old Pune restaurant carries out pest control twice a month, checks refrigerator temperatures, cooking oil registers and staff training, and maintains hand-wash stations, exhaust systems and insect-proof doors and windows.
    4. Industry associations act as a second layer: The Pune Restaurants and Catering Association has been circulating compliance reminders and double-checking member compliance with both FDA and FSSAI requirements.
    5. The industry asks for proportionality, not leniency: The association has urged a “rational” approach in which minor compliance issues attract time to correct rather than public shaming, with the distinction drawn between a correctable deficiency and a violation that poses a public health risk.
    6. The stated goal is sustained compliance: The association’s own position is that the real challenge is sustained compliance without making the system dependent on periodic crackdowns.

    Why is training not producing behaviour change?

    1. Certification is not a precondition to a licence: Food safety training and certification, known as FoSTaC, is not currently mandatory before a food licence is issued, so an operator can be licensed before being trained.
    2. Awareness of the requirement is itself missing: Many food operators lack awareness of food safety laws and do not know that FoSTaC exists.
    3. Training risks becoming a document: Businesses must actually understand and implement what they have been taught, or the certificate becomes another compliance document rather than a mechanism for changing behaviour.
    4. The regulator’s own diagnosis agrees: The FSSAI regional director for the western region identifies lack of awareness and education as the major cause of non-compliance.
    5. Outreach has been substantial: Over the past three to four years FSSAI has trained street vendors, students and other groups to detect adulteration, with around 10,000 street food vendors trained in Mumbai and over 60 officer-led training programmes on street hygiene.
    6. Visible practice has shifted at the margin: Vendors are reported using headgear, steel chopping boards and smarter waste disposal methods, alongside farmer-connect programmes linking food businesses and farmers.

    Should enforcement be a numbers game or risk-based?

    1. Visibility works, delay undoes it: A former FSSAI Chief Executive Officer holds that visible and credible action of the kind seen in Maharashtra can change behaviour, and that long delays between violation detection and final accountability weaken deterrence.
    2. Violations are not equal in risk: Not all violations pose the same health risk, so regulatory effort should be prioritised rather than spread evenly across the licensed base.
    3. Prioritisation should follow hazard, not visibility: Effort should target foods, establishments and supply chains with the highest risk, including microbial and chemical hazards that are not always visible during an inspection.
    4. The remedy set is procedural: Faster case adjudication, credible evidence, proportionate penalties and transparency about outcomes are what convert detection into deterrence.
    5. Transparency must cover acquittals too: Outcomes should be published including where allegations do not hold, so publicity is not itself the penalty.

    What do international results show about restaurant focused food safety?

    1. Restaurants are a concentrated transmission point: Food is prepared in large quantities and served to many people, so an outlet level failure reaches a population rather than a household.
    2. Los Angeles County, United States, graded hygiene publicly: A publicly displayed restaurant hygiene grading system was introduced in 1998, and foodborne-disease hospitalisations were compared against trends elsewhere in California.
    3. The measured effect was large and durable: After adjustment for baseline temporal and geographic trends, the grading programme was associated with a 13.1 per cent reduction in foodborne-disease hospitalisations in the first year, sustained over two years.
    4. Training and systems show similar gains: A 2022 systematic review and meta-analysis of food safety interventions in catering establishments found a 28.6 per cent reduction in microbial contamination, from interventions involving food-handler training and food safety systems.
    5. The pathogen list is specific: Restaurant level food safety has been effective against norovirus, Salmonella Typhi which causes typhoid fever, Shiga toxin-producing E. coli which affects the kidney, Shigella which infects the intestinal lining, hepatitis A which affects the liver, and Listeria monocytogenes and Campylobacter which trigger gut infection.

    What does the detection and laboratory gap add?

    1. Elaborate rules, weak implementation: India’s food safety regulations are elaborate, and implementation is weakened by poor enforcement, manpower shortages, inspection capacity limits, delayed test results and lack of coordination among agencies.
    2. A violation must be provable, not merely observed: The capacity to detect and establish a violation is a separate constraint from the capacity to inspect, and it sits with accredited testing laboratories.
    3. Delay destroys the deterrent: A regulator can inspect a food business, and if laboratory results are delayed or enforcement action takes too long, the deterrent effect is weakened.
    4. Manpower limits targeting: If inspection teams do not have the manpower to identify the highest-risk businesses and supply chains, the existence of detailed rules matters little.
    5. The requirement is a shift in approach: The recommendation is to move from a reactive, routine approach to a risk-based system focused on high-risk foods, supply chains and repeat violators, supported by robust laboratory infrastructure, advanced analytical capacity and speedy access to test results.

    What lies beyond kitchen hygiene?

    1. The definition of food safety is wider than the kitchen: Food safety is not merely about clean kitchens, pest control or properly stored ingredients. It also concerns what consumers are told about food and how products are marketed.
    2. Deceptive practice is a safety question: The convenor of Nutrition Advocacy in Public Interest (NAPi), a network of public health professionals working on nutrition policy, holds that food safety means protection from deceptive practices by food manufacturers.
    3. The data gap on ultra-processed foods: Immediate action is needed to assess risks and generate data about consumption of ultra-processed foods in India.
    4. Two consumer protections remain pending: Front-of-Pack Labelling (FOPL) and tighter restrictions on marketing of ultra-processed and high-fat, sugar and salt (HFSS) foods have not been notified.
    5. Regulatory gaps defeat the compliance drive: Major regulatory gaps of this kind will defeat the purpose of normalising clean dining, because the risk migrates from preparation to composition.
    6. The product mix keeps moving: Complexity is increasing as the food industry expands into nutraceuticals and functional foods, which sit between food and medicine in the standards framework.

    Challenges to the Food Safety and Standards Authority of India

    1. No statutory definition of high-fat, salt and sugar foods: FSSAI has not precisely defined the HFSS category, so restrictions cannot be enforced against a class of products that has no legal boundary. Eg. The Indian Nutrition Rating star scheme has been under consultation without notification. Fix. Notify threshold values for salt, sugar and fat per 100 grams first, and attach the labelling scheme to those thresholds.
    2. Laboratory capacity limits prosecution: A limited number of notified food laboratories causes delays in sample analysis, and a delayed report weakens the case at trial. Eg. Sample results in adulteration cases routinely arrive after the statutory reporting window. Fix. Accredit private laboratories under the National Accreditation Board for Testing and Calibration Laboratories to a published turnaround standard and pay them per sample.
    3. Approval delays for new formulations: Lengthy approval of proprietary food formulations delays market entry and pushes products into the unregulated segment. Eg. Nutraceutical and functional food products face repeated re-submission. Fix. Introduce a deemed approval on lapse of a notified timeline, with post-market surveillance replacing pre-market delay.
    4. Weak enforcement allows recurring adulteration: Poor field monitoring lets known adulteration patterns persist across cycles. Eg. Cases of synthetic milk and spurious honey recur across States. Fix. Publish a State-wise repeat violator register so a business cannot re-register under a fresh licence after suspension.
    5. Industry resistance to disclosure: Packaged food makers resist front-of-pack labelling on the expectation that it reduces sales, and consultation stretches indefinitely. Eg. Debate continues between star ratings and clearer warning labels of the Nutri-Score type. Fix. Fix a statutory deadline for notification, with the warning label design applying by default if no consensus design is notified by that date.
    6. Marketing to children is unregulated: Endorsements associate unhealthy products with aspiration at an age when food preference is formed. Eg. Celebrity endorsement of high sugar beverages remains permitted. Fix. Prohibit celebrity and cartoon endorsement of products crossing the HFSS thresholds once those thresholds are notified.

    Conclusion

    Maharashtra’s inspection drive has produced a measurable rise in compliance, and the drive itself is tied to a change of Commissioner rather than to a permanent system. The current status is that FSSAI’s revised turnover based licensing slabs are in force from 1 April this year, with Front-of-Pack Labelling and restrictions on HFSS marketing still pending notification. The next milestone is whether FoSTaC certification is made a precondition to licensing and whether enforcement is reorganised around risk rather than inspection count. The evidence from graded hygiene systems elsewhere shows that a design change in how compliance is displayed and adjudicated moves outcomes more than the number of inspections does.

    Matching Previous Year Question

    “[2015, GS2, 12 marks] For achieving the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous. Discuss in the light of the experiences in recent past.”

  • Due diligence: curbs on surrogate advertising must avoid regulatory overreach

    Why in the News

    The Maharashtra Food and Drug Administration (FDA) Commissioner has begun summoning celebrity endorsers of a pan masala brand, treating the endorsement as a surrogate promotion of tobacco. The action moves enforcement from the manufacturer to the person who supplies the brand recall, and it tests whether the state can discharge the burden of proof that the courts have already placed on it.

    What is surrogate advertising?

    1. Definition: Surrogate advertising is the promotion of a banned product through a legally saleable substitute that carries the same brand name, packaging and visual identity.
    2. How it operates: A tobacco or liquor manufacturer registers an extension product such as elaichi, soda or music CDs, then advertises that extension so the parent brand stays visible where direct advertising is prohibited.
    3. The legal test: An advertisement becomes surrogate when the substitute product has no market identity independent of its association with the prohibited product.
    4. The case at hand: The FDA holds that the pan masala brand endorsed by three leading film actors has no identity independent of tobacco, so endorsing it amounts to endorsing tobacco.

    What is endorser liability?

    1. Meaning: Endorser liability is the statutory responsibility placed on a celebrity or influencer for a false or misleading claim made in an advertisement they lend their name to.
    2. Source of the duty: The Consumer Protection Act, 2019 created this liability along with monetary penalties, which removes ignorance of the manufacturer’s intent as a defence.

    Why has enforcement shifted from the manufacturer to the endorser?

    1. The asymmetry named: The person carrying the persuasive power bears almost none of the health or economic cost of the product being consumed.
    2. Where the cost lands: The consumer absorbs that cost, and an underfunded public health system absorbs the treatment burden that follows.
    3. Why the manufacturer route stalls: Brand extension is legal on its face, so acting only against the manufacturer leaves the advertisement itself untouched.
    4. Why the endorser route bites: Requiring endorsers to explain their decision making applies the endorser liability principle at the enforcement stage rather than only after a complaint.
    5. The wider field: The same asymmetry runs through advertisements making unsubstantiated health claims such as “boosts immunity”, and through educational and financial products.

    What must the state prove before it can call an advertisement surrogate?

    1. The governing ruling: The Delhi High Court in DGHS vs Som Pan Product Pvt. Ltd. (2024) held that the state carries the responsibility of proving a case of surrogate advertising.
    2. Brand registration is not proof: The mere registration of an extension brand does not by itself establish that the advertisement is surrogate.
    3. Legality is not a shield either: The existence of a technically legal product does not automatically permit the particular advertisement built around it.
    4. What follows for the FDA: Suspicion must be converted into inquiries under the Cigarettes and Other Tobacco Products Act (COTPA), 2003 and its Rules and under the Food Safety and Standards Act, 2006 that survive judicial scrutiny.

    Why does the existing regulatory regime struggle with such advertisements?

    1. Fragmentation: Regulation is scattered across a series of Acts and Rules with no single authority owning the surrogate advertising question end to end.
    2. Forum shopping: Advertisers use the multiplicity of legal and administrative instruments to draw the judiciary into the dispute and stall enforcement.
    3. Definitional gap: No statute defines the threshold at which an extension product’s independent market identity becomes real rather than nominal.
    4. Health stakes: India carries the world’s largest burden of oral cancer, which is what makes treatment of these advertisements as unfair trade practices a consumer health question rather than a marketing dispute.

    Does tougher enforcement strengthen the rule or invite regulatory overreach?

    1. The case for acting: Penalties or prohibitions in this case would materially narrow the space that surrogate advertising currently exploits.
    2. The case for restraint: An action that fails the evidentiary standard set in 2024 becomes a precedent that advertisers cite in every later proceeding.
    3. The self defeating outcome: Enforcement seen as arbitrary strengthens the very practice it was meant to end, by converting a public health question into a dispute about administrative excess.
    4. The distinction that matters: Targeting the marketing chain is legitimate, targeting individuals without completing the statutory inquiry is not.

    Challenges to regulating surrogate advertising

    1. Proving the negative: The state must establish that a lawfully sold product has no independent market, which requires sales and distribution evidence that regulators rarely collect. e.g. brand extensions in elaichi and mouth freshener categories report genuine retail sales, which manufacturers cite as proof of independent identity.
    2. Split jurisdiction: Tobacco control sits with the health administration, food safety with the FDA and unfair trade practices with consumer authorities, so no single body carries the case through. e.g. the present action begins with a state FDA whose primary statute is the Food Safety and Standards Act, 2006, not COTPA.
    3. Digital advertising escapes the frame: Influencer posts and platform advertisements are transient and geo targeted, so they leave little evidence for a later inquiry. e.g. short video endorsements of betting and fantasy gaming platforms circulate widely without the disclosure labels print and television carry.
    4. Weak deterrence in practice: Penalties are small relative to advertising budgets and are contested for years. e.g. tobacco control prosecutions under COTPA are typically compounded at low fines rather than pursued to conviction.
    5. Sponsorship and event routes: Prohibited categories reach audiences through sports and cultural sponsorship where the brand appears without any product claim. e.g. surrogate liquor branding through music, soda and sporting event sponsorship has continued despite the advertising prohibition.
    6. Enforcement capacity: State drug and food administrations are staffed for sampling and licensing work, not for evidentiary media investigations. e.g. food safety officer vacancies in several States leave routine sampling targets unmet, before any advertising inquiry is added.

    Conclusion

    The action against celebrity endorsers is a defensible extension of endorser liability into the enforcement stage, and it addresses a real asymmetry between who persuades and who pays the health cost. Its survival depends entirely on whether the inquiry under COTPA, 2003 and the Food Safety and Standards Act, 2006 meets the evidentiary standard the Delhi High Court fixed in 2024. A well grounded order would narrow the space for surrogate advertising across tobacco, health claims, education and finance. An unsupported one would leave the practice stronger than it found it.

    Advertising Regulation in India

    1. What it covers: Advertising regulation governs the content, placement and truthfulness of commercial communication, and reaches the advertiser, the agency, the publisher and the endorser.
    2. Mixed model: India uses statutory control for specific product categories alongside self regulation by the Advertising Standards Council of India (ASCI), a voluntary industry body whose code is not itself law.
    3. Statutory anchor since 2019: The Central Consumer Protection Authority (CCPA), constituted under the Consumer Protection Act, 2019, can order the discontinuation of a misleading advertisement and impose penalties on the advertiser and the endorser.
    4. Prohibited categories: Direct advertising of tobacco products is banned, and liquor advertising is restricted, which is precisely what creates the incentive for brand extension.
    5. Scale: India is among the world’s largest advertising markets by volume of impressions, with digital and influencer marketing now the fastest growing segment and the least documented.

    Laws and Rules Governing Advertising and Surrogate Promotion

    1. Cigarettes and Other Tobacco Products Act (COTPA), 2003: Prohibits direct and indirect advertisement, promotion and sponsorship of tobacco products and regulates sale to and around minors.
    2. Section 5: Bars advertisement of cigarettes and other tobacco products, including indirect advertisement, which is the provision surrogate advertising is tested against.
    3. Consumer Protection Act, 2019: Defines misleading advertisement, creates the CCPA, and imposes liability and penalties on manufacturers and endorsers.
    4. Endorser penalty: Provides monetary penalty on an endorser for a false or misleading advertisement, with a prohibition on further endorsements for a stated period on repetition.
    5. Food Safety and Standards Act, 2006: Regulates food product claims and advertising, and prohibits misleading claims about the nature, quality or health effect of a food.
    6. Cable Television Networks (Regulation) Act, 1995: Bars advertisement of prohibited products on cable television through the Advertisement Code framed under it.
    7. Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954: Prohibits advertisements claiming cure for listed diseases and conditions.
    8. Central Consumer Protection Authority (Prevention of Misleading Advertisements and Endorsements) Guidelines, 2022: Set conditions for a non misleading advertisement, regulate bait and surrogate advertisements, and fix due diligence duties for endorsers.
    9. Endorsement Know hows for digital advertising, 2023: Require celebrities, influencers and virtual influencers to disclose a material connection with the advertiser in a clear and prominent manner.

    Government Initiatives in Advertising and Consumer Protection

    1. National Tobacco Control Programme (NTCP): Implemented by the Ministry of Health and Family Welfare to enforce COTPA, run awareness campaigns and support cessation, targeted at tobacco users and youth.
    2. National Tobacco Quitline and mCessation: Provide telephone and mobile based cessation support to tobacco users seeking to quit.
    3. Jago Grahak Jago: Consumer awareness campaign of the Department of Consumer Affairs, aimed at informing consumers about misleading advertisements and grievance routes.
    4. National Consumer Helpline and the INGRAM portal: Give consumers a single point to lodge complaints against misleading advertisements and unfair trade practices.
    5. Eat Right India: Food Safety and Standards Authority of India (FSSAI) campaign to curb misleading food claims and promote safe and healthy food, aimed at consumers and food businesses.

    Key Facts about Tobacco Control and Advertising Regulation

    1. World No Tobacco Day is observed on 31 May each year.
    2. India has the world’s largest burden of oral cancer, which is the health basis for the strict treatment of tobacco surrogate advertising.
    3. India is a party to the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), the first international public health treaty, which India ratified in 2004.
    4. Pictorial health warnings must cover 85 percent of the principal display area on both sides of a tobacco product package in India, among the largest such requirements globally.
    5. The Advertising Standards Council of India (ASCI) was set up in 1985 as a voluntary self regulatory body and its code has no statutory force of its own.

    Challenges in Advertising and Consumer Protection Regulation

    1. Self regulation without teeth: ASCI rulings bind only members and carry no penalty, so a non member advertiser faces no consequence. e.g. several offshore betting and crypto platforms advertising into India are outside ASCI’s membership entirely.
    2. Influencer economy outpaces disclosure rules: Paid endorsements are presented as personal opinion, and disclosure labels are omitted or hidden. e.g. financial influencers recommending securities without registration led the Securities and Exchange Board of India to restrict regulated entities from associating with unregistered advice givers.
    3. Dark patterns in digital interfaces: Design choices such as false urgency and forced action steer consumers without any express claim to test. e.g. the Department of Consumer Affairs notified guidelines in 2023 listing thirteen specified dark patterns on e commerce platforms.
    4. Regulatory capacity gap: The CCPA and State food and drug administrations have small investigation teams against a very large advertising volume. e.g. misleading claims in the coaching and edtech sector produced a separate CCPA advisory only after repeated complaints.
    5. Cross border advertising: Advertisements served from outside India for products banned within India are hard to reach through domestic statutes. e.g. offshore betting platforms advertise through surrogate news and sports content channels aimed at Indian audiences.
    6. Health claims without evidence: Immunity, weight loss and fortification claims sit between food law and drug law and are contested at the margin. e.g. claims on health supplements and nutraceuticals repeatedly draw FSSAI action for lacking substantiation.

    Back2Basics: Food Safety and Standards Authority of India (FSSAI)

    1. Governing Act: Established under the Food Safety and Standards Act, 2006.
    2. Year established: Constituted in 2008, with the Act’s substantive provisions brought into force from 2011.
    3. Parent ministry: Functions under the Ministry of Health and Family Welfare.
    4. Mandate: Lays down science based standards for articles of food and regulates their manufacture, storage, distribution, sale, import and advertising.
    5. Composition: Headed by a Chairperson of the rank of Secretary to the Government of India, with a Chief Executive Officer and members drawn from States, industry, consumer groups and food technology.
    6. Enforcement structure: Implemented on the ground by State Food Safety Commissioners, Designated Officers and Food Safety Officers, which is why a State FDA leads the present action.

    Way Forward

    1. Complete the statutory inquiry: Convert the summons into a documented proceeding under COTPA, 2003 and the Food Safety and Standards Act, 2006 that records evidence of the extension product’s dependent market identity.
    2. Define independent market identity: Notify an objective test combining sales volume, distribution reach and advertising spend of the extension product relative to the parent brand.
    3. Single window coordination: Create a joint mechanism between the CCPA, the health administration and State food and drug administrations so one authority carries a surrogate advertising case to conclusion.
    4. Raise the penalty to advertising spend: Link penalties to the advertising outlay of the campaign so the fine is not absorbed as a cost of business.
    5. Mandatory pre certification for prohibited categories: Require prior vetting of advertisements for brand names shared with tobacco and liquor products before release.
    6. Extend disclosure enforcement to digital: Audit influencer endorsements for the material connection disclosure and publish enforcement outcomes so the rule becomes visible.
    7. Consumer side remedy: Publicise the CCPA and National Consumer Helpline routes so complaints against misleading endorsements do not depend on regulator initiative alone.

    “[2014, GS2, 12.5 marks] The setting up of a Rail Tariff Authority to regulate fares will subject the cash strapped Indian Railways to demand subsidy for obligation to operate non-profitable routes and services. Taking into account the experience in the power sector, discuss if the proposed reform is expected to benefit the consumers, the Indian Railways or the private container operators.”

  • National Medical Commission proposes a single national licence to practise medicine

    Why in the News

    The National Medical Commission has notified draft regulations under which a doctor registered with any one State Medical Council would be able to practise anywhere in India without fresh registration, using a unique identification number in the National Medical Register. The right to practise is being nationalised while the power to discipline stays with the State where the alleged misconduct occurred.

    What do the draft Registration of Medical Practitioners and Licence to Practice Medicine (Amendment) Regulations, 2026 propose?

    1. The core change: A medical practitioner once registered with a State Medical Council would be eligible to practise across India without obtaining fresh registration or a licence in another State.
    2. The identifier: The practitioner would be allotted a Unique Identification (UID) number in the National Medical Register (NMR), which becomes the single reference for the right to practise.
    3. What it amends: The draft amends the 2023 regulations governing registration and licensing of doctors, and routes the process through a unified registration portal of the Commission's Ethics and Medical Registration Board.
    4. Stage and consultation: The draft was notified by the Commission on 11 August 2026, and objections and suggestions have been invited for 30 days from the date of notification.

    What is the National Medical Register (NMR)?

    1. Function: The National Medical Register is the central repository of registration details of all medical practitioners in India, maintained by the National Medical Commission alongside the State Medical Registers kept by each State Medical Council. Under the draft it would also hold disciplinary records and the active or inactive status of every licence.

    Who is the Ethics and Medical Registration Board?

    1. Role: The Ethics and Medical Registration Board is one of the four autonomous boards of the National Medical Commission, responsible for maintaining the National Medical Register and regulating professional conduct and ethics. Under the draft it would allot the unique identification number and operate the unified registration portal.

    How would the unique identification number work?

    1. Composition of the number: The unique identification number assigned in the register would incorporate the State or Union Territory code and the practitioner's State Medical Register number.
    2. Sequence of grant: The State Medical Council first grants registration, and the Ethics and Medical Registration Board then allots the unique identification number.
    3. Effect of allotment: Once the number is allotted, the doctor would not require fresh registration or a separate licence to practise in another State or Union Territory.
    4. Register synchronisation: The draft proposes automatic electronic synchronisation between the national and State registers, so a change made in one register is reflected in the other.

    What changes for State Medical Councils?

    1. Entry point unchanged: State Medical Councils would continue to scrutinise applications and to grant registration and licence for doctors to practise.
    2. Dual reflection of approval: The approval would be reflected in both the State Medical Register and the National Medical Register.
    3. Central oversight added: The Ethics and Medical Registration Board and the Commission would have powers to seek records and monitor State Medical Councils.
    4. The stated purpose of oversight: The monitoring power is intended to promote uniformity and transparency in regulation across States.

    How is disciplinary jurisdiction handled under the draft?

    1. Territorial principle retained: Disciplinary jurisdiction stays primarily with the State Council in whose territorial jurisdiction the alleged professional misconduct, unethical conduct or medical negligence occurred.
    2. Powers of that Council: It has the power to inquire into and decide the matter, and to record the outcome against the practitioner's credentials in the online register.
    3. Cross council cases: Where disciplinary action is recommended by a State Council other than the doctor's primary registering council, the action would be reflected in the National Medical Register.
    4. Automatic flow back: That action would then be automatically updated in the State register of the council of primary registration.
    5. What the register would carry: The National Medical Register would hold disciplinary proceedings including suspension, removal and restoration of registration, and details of disciplinary action taken.

    What happens to licence validity and renewal?

    1. Validity retained: The proposal retains the five year validity of a licence to practise.
    2. Renewal window: If a doctor does not apply for renewal within three months of expiry, the registration will be marked inactive.
    3. Consequence of inactive status: A practitioner whose registration is marked inactive is not entitled to practise medicine.
    4. Visibility of status: The National Medical Register would carry whether a doctor's licence is active or inactive, so the status is nationally visible.

    Does a national licence without a national disciplinary forum close the accountability gap?

    1. Portability of practice is immediate: A single number confers the right to practise in every State and Union Territory from the moment it is allotted.
    2. Portability of accountability is derived: Discipline still runs through whichever State Council has territorial jurisdiction over the place of the alleged misconduct, and reaches the rest of the country only through register synchronisation.
    3. The gap is procedural, not conceptual: If synchronisation lags or a State Council does not record an outcome, a suspended practitioner remains visible as active elsewhere.
    4. Uniformity of standards is not guaranteed: Different State Councils apply the professional conduct regulations with differing rigour, and a national licence carries the outcome of the least rigorous forum as readily as the most rigorous.
    5. The Commission's answer is oversight, not adjudication: The draft responds with powers to seek records and monitor State Councils rather than with a central disciplinary forum.

    Challenges to the proposed national licence framework

    1. Synchronisation dependence: The entire accountability design rests on electronic updates between the national and State registers working without delay. e.g. a suspension recorded by one State Council but not reflected in the National Medical Register would leave a barred doctor practising elsewhere.
    2. Uneven State Council capacity: State Medical Councils differ widely in staffing, digitisation and case disposal, and the weakest becomes the entry point for the whole country. e.g. State Councils with long pending complaint backlogs would still be the first scrutiny layer for national practice rights.
    3. Forum shopping in registration: Applicants may seek primary registration with the council perceived to have the lightest scrutiny, since the licence is then valid everywhere. e.g. the unique identification number carrying the State code makes the choice of registering State visible but does not restrict it.
    4. Renewal lapse risk: A three month renewal window creates a cliff on which an administrative omission ends the right to practise. e.g. a practitioner on long clinical assignment abroad missing the window and finding registration marked inactive.
    5. Data accuracy in the register: A national register carries forward whatever errors and duplicates the State registers already contain. e.g. duplicate entries across State registers have long complicated counts of registered allopathic practitioners in India.
    6. No stated appellate route in the draft: The draft records the State Council's power to inquire and decide without setting out a national appellate forum against an adverse finding. e.g. a doctor disciplined by a State Council other than the primary registering council faces consequences nationally through the register.
    7. Interface with the criminal and consumer forums: Professional discipline runs alongside criminal prosecution and consumer litigation, and the register reflects only the first. e.g. a practitioner facing a medical negligence complaint under the Consumer Protection Act, 2019 with no corresponding entry in the register.

    Conclusion

    The draft Registration of Medical Practitioners and Licence to Practice Medicine (Amendment) Regulations, 2026 stand notified by the National Medical Commission on 11 August 2026, with objections and suggestions invited for 30 days from the date of notification, which is the next milestone in the process. The proposal creates portable practice rights through a unique identification number while leaving discipline with the State Council of the place of misconduct. The accountability question turns on whether automatic synchronisation between the National Medical Register and the State registers actually works in practice. A national licence with a fragmented disciplinary record would widen mobility faster than it widens accountability.

    Medical Regulation in India

    1. The apex regulator: The National Medical Commission (NMC) regulates medical education and medical practice in India, having replaced the Medical Council of India in 2020.
    2. Four autonomous boards: The Under Graduate Medical Education Board, the Post Graduate Medical Education Board, the Medical Assessment and Rating Board, and the Ethics and Medical Registration Board.
    3. Two tier registration: Registration is granted by State Medical Councils and recorded in State Medical Registers, with the National Medical Register maintained centrally.
    4. Common entrance and exit: Admission to undergraduate and postgraduate medical courses runs through the National Eligibility cum Entrance Test, and the National Exit Test is provided for as a common final year and licentiate examination.
    5. Scale of the system: India has expanded medical college and undergraduate seat capacity substantially over the past decade, with the government citing a doctor to population ratio better than the World Health Organization norm of one per thousand when practitioners of all recognised systems are counted.
    6. Plural systems of medicine: Allopathic practice is regulated by the National Medical Commission. Ayurveda, Yoga, Unani and Siddha are regulated by the National Commission for Indian System of Medicine, and homoeopathy by the National Commission for Homoeopathy.

    Laws and Rules Governing Medical Practice in India

    1. National Medical Commission Act, 2019: Establishes the Commission and its four autonomous boards, provides for the National Medical Register, the National Eligibility cum Entrance Test and the National Exit Test, and repealed the Indian Medical Council Act, 1956.
    2. Statutory basis of the register: The Act requires a National Register of licensed practitioners to be maintained and made publicly available.
    3. Registration of Medical Practitioners and Licence to Practice Medicine Regulations, 2023: The regulations the present draft seeks to amend, governing registration and licensing procedure.
    4. National Medical Commission Registered Medical Practitioner (Professional Conduct) Regulations, 2023: Set out the ethical duties of doctors, including on prescribing by generic name, telemedicine and consent.
    5. Clinical Establishments (Registration and Regulation) Act, 2010: Provides for registration and minimum standards for clinical establishments in adopting States and Union Territories.
    6. Consumer Protection Act, 2019: Provides the forum for medical negligence claims as deficiency in service, separate from professional disciplinary proceedings.
    7. Drugs and Cosmetics Act, 1940: Regulates the manufacture, sale and prescription of drugs that registered practitioners are authorised to prescribe.
    8. Mental Healthcare Act, 2017: Governs the treatment and rights of persons with mental illness and the registration of mental health professionals and establishments.
    9. Transplantation of Human Organs and Tissues Act, 1994: Regulates removal, storage and transplantation of human organs, with obligations placed on registered practitioners.

    Government Initiatives in Medical Regulation and Health Human Resources

    1. National Medical Register portal: Launched by the Commission to create a verifiable public register of allopathic practitioners with unique identification numbers.
    2. Ayushman Bharat Digital Mission: Maintains the Healthcare Professionals Registry and the Health Facility Registry, linking verified practitioner identity to digital health records.
    3. Pradhan Mantri Swasthya Suraksha Yojana: Funds new All India Institutes of Medical Sciences and upgrades existing government medical colleges to expand tertiary care and teaching capacity.
    4. Centrally Sponsored Scheme for district hospital upgradation: Supports establishment of new medical colleges attached to existing district and referral hospitals in underserved districts.
    5. National Exit Test: Provided for under the National Medical Commission Act, 2019 as a single examination serving as the final year undergraduate examination, the licentiate examination and the postgraduate entrance test.
    6. Telemedicine Practice Guidelines, 2020: Permit registered practitioners to consult remotely within a defined professional and ethical framework.
    7. eSanjeevani: The national teleconsultation platform connecting patients to registered practitioners through health and wellness centres and directly from home.

    Key Facts about the National Medical Commission

    1. Year of operation: The Commission came into being in 2020 on the repeal of the Indian Medical Council Act, 1956 and the dissolution of the Medical Council of India.
    2. Composition: It is headed by a Chairperson and includes ex officio and part time members, with the presidents of the four autonomous boards as members.
    3. Medical Advisory Council: The Act creates a Medical Advisory Council as the primary platform through which States and Union Territories place their views before the Commission.
    4. Rating power: The Medical Assessment and Rating Board assesses and rates medical institutions and grants permission to establish new medical colleges.
    5. Fee regulation: The Commission frames guidelines for the determination of fees for a proportion of seats in private medical institutions and deemed universities.

    Challenges in Medical Regulation in India

    1. Maldistribution rather than absolute shortage: Doctors concentrate in metropolitan and urban districts while rural and tribal blocks remain unstaffed. e.g. persistent vacancies of specialists at Community Health Centres reported in successive Rural Health Statistics.
    2. Quackery and unqualified practice: Unregistered practitioners operate widely where regulated supply is thin, and a national register alone does not displace them. e.g. State Medical Councils issuing repeated public notices against unqualified practitioners in rural districts.
    3. Ethics enforcement capacity: Professional conduct proceedings are slow and outcomes are inconsistent across State Councils. e.g. complaints of professional misconduct pending for years before State Medical Councils.
    4. Cost of medical education: High private medical college fees shape both who enters the profession and where graduates practise. e.g. the Commission having to issue fee determination guidelines for a share of private and deemed university seats.
    5. Postgraduate seat bottleneck: Undergraduate seat expansion has outpaced postgraduate capacity, leaving a specialist training gap. e.g. the ratio of postgraduate to undergraduate seats remaining a standing constraint on specialist availability.
    6. Faculty shortage in new colleges: Rapid expansion of colleges has outrun the availability of qualified teaching faculty. e.g. assessment findings of faculty deficiencies at newly permitted medical colleges.
    7. Fragmented digital records: Practitioner data sits across State registers, the national register and separate health workforce databases with limited reconciliation. e.g. duplicate and outdated entries complicating any count of practising allopathic doctors.

    Back2Basics: National Medical Commission (NMC)

    1. Governing Act: Established under the National Medical Commission Act, 2019.
    2. Year established: Constituted in 2020, replacing the Medical Council of India which functioned under the Indian Medical Council Act, 1956.
    3. Parent ministry: Functions under the Union Ministry of Health and Family Welfare.
    4. Jurisdiction: Regulates medical education, medical institutions, medical research and medical professionals in the allopathic system across India.
    5. Composition: A Chairperson, ex officio members including the presidents of the four autonomous boards, part time members, and members representing States and Union Territories on a rotational basis.
    6. Autonomous boards: Under Graduate Medical Education Board, Post Graduate Medical Education Board, Medical Assessment and Rating Board, and Ethics and Medical Registration Board.
    7. Core mandate: To improve access to quality and affordable medical education, ensure availability of adequate and high quality medical professionals, and maintain a national register of licensed practitioners.
    8. Key instruments: The National Eligibility cum Entrance Test, the National Exit Test, the National Medical Register and the professional conduct regulations.

    Way Forward

    1. Guarantee synchronisation by design: Build the national and State registers on a single source of truth rather than on periodic updates, so that a suspension takes effect nationally the moment it is recorded.
    2. Set uniform disciplinary standards: Issue binding procedure and timeline norms for State Council inquiries, so that a national licence does not carry the outcome of the weakest forum.
    3. Create a national appellate tier: Provide an appeal from a State Council's disciplinary decision to the Ethics and Medical Registration Board, since the consequence of that decision is now national.
    4. Clean the register before nationalising it: Complete deduplication and verification of State registers before unique identification numbers become the basis of practice rights everywhere.
    5. Make the register publicly searchable: Allow patients and employers to verify a practitioner's licence status and disciplinary record by unique identification number, which is the only way a register changes behaviour.
    6. Provide a renewal grace mechanism: Allow reactivation on application with reasons where the three month window has lapsed for demonstrable cause, so that an administrative lapse does not end a career.
    7. Use the register for workforce planning: Link active licence data to district level workforce mapping so that maldistribution can be measured and addressed rather than estimated.

    Matching Previous Year Question

    “No direct PYQ traced in the provided files. Closest microtheme: Sectoral Regulatory Bodies.”

  • Editorial on the Air India AI 2379 reclassification argues crew testing over emphasises alcohol breathalysers relative to psychoactive substances under the Civil Aviation Requirements

    Why in the News

    The 4 August 2026 flight from Phuket to Delhi, carrying 137 passengers and eight crew, has been reclassified from an event of turbulence to a serious incident after technical faults and a significant altitude deviation injured more than 20 people on board. The post flight screening of the pilot in command for psychoactive substances has exposed a crew fitness regime built around alcohol breathalysers rather than drug testing.

    What are the Civil Aviation Requirements (CAR)?

    1. About: The Civil Aviation Requirements are the binding regulatory instructions issued by the Directorate General of Civil Aviation (DGCA) under the aircraft rules, organised into numbered Sections and Series that operators must comply with to hold and retain approvals.
    2. The relevant provision: Crew testing for psychoactive substances falls under CAR Section 5, Air Safety, Series F, Part V, which also applies to Air Traffic Controllers.
    3. Its testing design: The requirement leans towards random and post flight or post shift testing with graded disciplinary action for a confirmed positive result.

    What is a serious incident in civil aviation?

    1. About: A serious incident is an occurrence involving circumstances indicating that an accident nearly occurred, a category distinct from an accident by the absence of the resulting damage or injury threshold.
    2. Why the label matters: Reclassification from turbulence to a serious incident makes a formal independent investigation mandatory rather than leaving the occurrence to airline level reporting.

    What is the Aircraft Accident Investigation Bureau?

    1. About: The Aircraft Accident Investigation Bureau (AAIB) is the body under the Ministry of Civil Aviation that investigates aircraft accidents and serious incidents, kept institutionally separate from the DGCA so the regulator does not investigate outcomes of its own oversight.
    2. International participation: Investigations draw in the safety authority of the State of design and manufacture, which is why France’s Bureau d’Enquetes et d’Analyses (BEA) and technical representatives of the manufacturer have joined this probe.

    What are psychoactive substances in the aviation context?

    1. About: Psychoactive substances are drugs that act on the central nervous system and alter perception, mood or cognition, covering narcotics, sedatives, hypnotics, cannabis, stimulants and certain over the counter medications.
    2. Why they matter on the flight deck: They impair judgement, reaction time, coordination and decision making, which are the four skills a flight crew relies on during an abnormal event.

    What actually happened on the flight?

    1. Two parallel tracks: The occurrence now has a technical track and a crew fitness track, and the second has drawn the greater attention.
    2. The technical anomalies: The Airbus A320N briefly carried fault warnings across the hydraulic systems, elevator flight control faults, autopilot disconnection, emergency exit door indications and an engine anti ice warning.
    3. The consequence: Inflight technical issues and a significant deviation in aircraft altitude caused injuries to more than 20 passengers and crew.
    4. The manufacturer’s data: Airbus’s initial data is said to support the evidence of technical errors.
    5. The airline’s response: The operator has begun immediate and mandatory screening of its flight deck crew for any substances or unprescribed medications.

    Why does the current crew screening regime under detect impairment?

    1. The testing asymmetry: Pre flight and post flight breathalyser checks for alcohol are routine and near universal, while testing for psychoactive substances is comparatively sparse.
    2. Detection after the event, not before: The pilot in command’s result surfaced through post flight screening following an incident, which means the system caught the risk only after passengers were injured.
    3. Random testing as the primary tool: A regime built on random and post shift sampling cannot guarantee that an impaired crew member is stopped before a specific flight departs.
    4. Voluntary action filling a regulatory gap: Mandatory screening began because a single airline was prodded into it, not because the requirement applies uniformly across operators.
    5. Rising exposure: Expanding operations, crew citing stress related issues, and wider availability of substances for medicinal or recreational use together enlarge the risk the regime is not sized for.

    What does the regulator’s own evidence base already establish?

    1. The medical circular: DGCA Medical Circular No. 02 of 2021 on over the counter drugs and self medication flags impairment of pilot cognitive and psychomotor skills.
    2. The Indian precedents it draws on: The circular draws on the Mangaluru (2010) and Kozhikode (2020) fatal air accidents. The 2010 crash of an Air India Express flight at Mangaluru killed 158 people after a runway overrun on a tabletop runway, and the 2020 accident at Kozhikode killed 21 in a similar runway excursion.
    3. International documentation: Documented cases from Western jurisdictions show that even small levels of impairment affect crew judgement, reaction time, coordination and decision making.
    4. The implication: The evidence linking impairment to fatal outcomes already exists in the regulator’s own material, so the gap is enforcement design rather than knowledge.

    Challenges to crew fitness regulation in India

    1. Self reporting of medication and illness: Disclosure of prescribed and over the counter drug use depends on the crew member volunteering it, with a licence at stake. e.g. DGCA Medical Circular No. 02 of 2021 exists precisely because self medication goes undeclared.
    2. Punitive rather than rehabilitative framing: Graded disciplinary action deters disclosure of a substance or mental health problem instead of surfacing it. e.g. pilot bodies have repeatedly objected that a positive breathalyser result triggers suspension without a treatment pathway.
    3. Fatigue rules lagging operations: Flight duty time limitations are revised slowly while network expansion increases night operations. e.g. revised flight duty time limitation norms for night duty and weekly rest were phased in only after sustained pilot representations.
    4. Testing infrastructure at smaller stations: Drug testing requires sample collection, chain of custody and accredited laboratories that are absent outside metro airports. e.g. a post flight test at a small regional airport under the regional connectivity network has no on site collection facility.
    5. Thin regulatory staffing against a growing fleet: Oversight capacity has not scaled with aircraft and operator numbers. e.g. the International Civil Aviation Organization’s safety oversight audits have repeatedly flagged vacancies in the technical cadre of the Indian regulator.
    6. Air Traffic Controllers inside the same requirement, outside the same attention: The requirement covers controllers, and the screening debate stays confined to flight deck crew. e.g. controller fatigue and staffing shortfalls at busy terminal control areas rarely feature in post incident action.

    Conclusion

    The reclassification converts an event described as turbulence into a serious incident with a formal investigation into both airframe faults and crew fitness. The crew screening system detected a psychoactive substance result only after an incident had already injured more than 20 people, because the regime is built around alcohol breathalysers and random sampling. The next step is the Aircraft Accident Investigation Bureau’s findings with the French authority and the manufacturer, and the immediate question for the regulator is whether mandatory psychoactive substance screening becomes a uniform requirement across operators rather than one airline’s response. Safety here depended on the aircraft recovering, and that is an outcome, not a control.

    Civil Aviation Safety Regulation in India

    1. About: Civil aviation safety in India is regulated by the Directorate General of Civil Aviation under the Ministry of Civil Aviation, which certifies aircraft, licenses crew, approves operators and issues the Civil Aviation Requirements.
    2. Investigation function: Accidents and serious incidents are investigated by the Aircraft Accident Investigation Bureau, kept separate from the regulator, in line with the International Civil Aviation Organization’s Annex 13 principle that investigation is for prevention and not for apportioning blame.
    3. Economic regulation: The Airports Economic Regulatory Authority sets tariffs for major airports, and the Airports Authority of India provides air navigation services and manages airports.
    4. Scale: India is among the largest domestic aviation markets in the world, with fleet and passenger volumes growing faster than regulatory staffing.
    5. International anchor: India is a founding member of the International Civil Aviation Organization, and Indian standards derive from the Chicago Convention, 1944 and its Annexes.

    Laws and Rules Governing Civil Aviation Safety

    1. Bharatiya Vayuyan Adhiniyam, 2024: The principal aviation statute, which replaced the Aircraft Act, 1934 and governs the manufacture, possession, use, operation and sale of aircraft.
    2. Retains the power to make rules for licensing of personnel, airworthiness and investigation of accidents, and provides for statutory recognition of the regulator and the investigation bureau.
    3. Aircraft Act, 1934: The predecessor statute under which the existing rules and requirements were framed and which continues to supply their legal lineage.
    4. Aircraft Rules, 1937: Contain the operative rules on airworthiness, crew licensing, and prohibition on flying under the influence of alcohol or psychoactive substances.
    5. Rule 24 prohibits any person from acting as a crew member while under the influence of intoxicating liquor or drugs.
    6. Aircraft (Investigation of Accidents and Incidents) Rules, 2017: Provide the legal basis for the Aircraft Accident Investigation Bureau and define accident, incident and serious incident.
    7. Civil Aviation Requirements: Subordinate regulatory instructions of the DGCA, with Section 5, Series F, Part V governing psychoactive substance testing of crew and air traffic controllers.
    8. Airports Economic Regulatory Authority of India Act, 2008: Establishes the economic regulator for major airports.
    9. Anti Hijacking Act, 2016: Provides for the offence of hijacking and prescribes the death penalty where the offence results in death of a hostage or security personnel.
    10. Carriage by Air Act, 1972: Gives effect in India to the Warsaw and Montreal Conventions on carrier liability to passengers.

    Back2Basics: Directorate General of Civil Aviation (DGCA)

    1. Type: Attached office of the Ministry of Civil Aviation, functioning as India’s civil aviation regulator.
    2. Governing law: Operates under the Bharatiya Vayuyan Adhiniyam, 2024, which replaced the Aircraft Act, 1934, and the Aircraft Rules, 1937.
    3. Mandate: Regulation of air transport services, enforcement of civil air regulations, air safety and airworthiness standards.
    4. Functions: Registration of civil aircraft, certification of airworthiness, licensing of pilots, engineers and air traffic controllers, and grant of air operator certificates.
    5. Instruments: Issues Civil Aviation Requirements, Aeronautical Information Circulars and Medical Circulars.
    6. International role: Coordinates regulatory functions with the International Civil Aviation Organization, which was founded in 1944 under the Chicago Convention and is headquartered in Montreal.
    7. Related bodies: The Bureau of Civil Aviation Security handles aviation security, and the Aircraft Accident Investigation Bureau handles accident and serious incident investigation.

    Government Initiatives in Civil Aviation

    1. National Civil Aviation Policy, 2016: The first integrated civil aviation policy, covering regional connectivity, safety, maintenance and repair, and air cargo.
    2. UDAN (Ude Desh ka Aam Naagrik) Regional Connectivity Scheme: Connects unserved and underserved airports through capped fares and viability gap funding.
    3. Krishi UDAN: Supports air transport of perishable agricultural produce from hill, tribal and North Eastern regions.
    4. Digi Yatra: Facial recognition based contactless passenger processing at airports.
    5. eGCA: Digitisation of the regulator’s licensing, examination and approval processes to cut manual discretion.
    6. NABH Nirman: Initiative to expand airport capacity to handle a billion trips.
    7. Aviation Safety Programme and State Safety Programme: Framework of safety management systems, mandatory occurrence reporting and safety performance indicators for operators.
    8. Maintenance, Repair and Overhaul policy support: Tax and customs measures to develop domestic aircraft maintenance capacity.

    Key Facts about Civil Aviation Safety

    1. The Chicago Convention, 1944 created the International Civil Aviation Organization, headquartered in Montreal, and India is a founding member.
    2. Annex 13 of the Chicago Convention governs aircraft accident and incident investigation, and defines a serious incident.
    3. The Aircraft Accident Investigation Bureau was constituted in 2012 and functions under the Aircraft (Investigation of Accidents and Incidents) Rules, 2017.
    4. International Civil Aviation Day is observed on 7 December.
    5. The Mangaluru accident of 2010 killed 158 people and the Kozhikode accident of 2020 killed 21, both at tabletop runways.
    6. The Bharatiya Vayuyan Adhiniyam, 2024 replaced the Aircraft Act, 1934 as India’s principal aviation statute.
    7. CAR Section 5, Series F, Part V is the specific requirement governing psychoactive substance testing of crew and air traffic controllers.

    Challenges in India’s Civil Aviation Sector

    1. Regulator capacity against fleet growth: Technical posts remain vacant while aircraft numbers, operators and flights expand. e.g. International Civil Aviation Organization safety oversight audits have flagged shortfalls in trained flight operations inspectors.
    2. Airport and airspace congestion: Slot and runway capacity at metro airports lags demand, which compresses turnaround times and crew rest. e.g. Delhi and Mumbai airports operating near saturation during peak banks.
    3. Airline financial fragility: Thin margins push cost cutting into maintenance, training and rostering. e.g. the collapse of Jet Airways in 2019 and of Go First in 2023 left aircraft grounded and crew displaced.
    4. Skilled manpower shortage: Pilots, aircraft maintenance engineers and air traffic controllers are trained in numbers below the sector’s expansion rate. e.g. Indian carriers holding large order books have had to lease aircraft with foreign crew.
    5. Maintenance dependence on foreign facilities: A limited domestic maintenance base sends heavy checks abroad, raising cost and turnaround time. e.g. a large share of Indian airline heavy maintenance has historically been done in Sri Lanka, Singapore and West Asia.
    6. Bird strike and wildlife hazard at airports: Waste dumps and abattoirs near airport perimeters draw birds into approach paths. e.g. recurring bird strike reports at airports adjoining municipal landfill sites.
    7. Weather and terrain risk at critical airfields: Tabletop runways and monsoon operations narrow the safety margin. e.g. the Kozhikode runway excursion in heavy rain in 2020.

    Way Forward

    1. Make psychoactive substance screening mandatory and uniform: Extend routine pre flight and post flight screening for substances beyond alcohol across every operator rather than leaving it to voluntary action.
    2. Build a non punitive disclosure pathway: Create a confidential reporting and rehabilitation route for crew with a substance or mental health problem, with return to duty after medical clearance.
    3. Expand testing infrastructure: Provide accredited sample collection and chain of custody facilities at regional airports, not only at metro stations.
    4. Strengthen fatigue risk management: Enforce revised flight duty time limitations with audited rostering data instead of self declared compliance.
    5. Staff the regulator: Fill technical inspector vacancies and give the regulator recruitment autonomy so oversight scales with fleet growth.
    6. Extend the same rigour to Air Traffic Controllers: Apply the testing and fatigue standards uniformly to controllers, who are already covered by the same requirement.
    7. Publish investigation findings promptly: Release Aircraft Accident Investigation Bureau reports with safety recommendations and track their implementation publicly.

    PYQ:

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    [2015, GS2, 12 marks] For achieving the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous. Discuss in the light of the experiences in recent past.

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