Subject: Art & Culture – Monument Conservation; ASI; UNESCO; AMASR Act, 1958; Adopt a Heritage.

Why in News?

• India now has 44 UNESCO World Heritage Sites, with the recent addition of the Maratha Military Landscapes (inscribed July 2024)
• Archaeological Survey of India (ASI) safeguards 3,686 centrally protected monuments
• Expenditure on conservation of monuments for 2024-25: ₹374 crore

Constitutional and Legislative Framework

Constitutional Provisions

Article 49 (DPSP)

• State shall protect monuments, places, and objects of artistic or historic interest declared to be of national importance

Article 51A(f) (Fundamental Duty)

• Every citizen to value and preserve the rich heritage of India’s composite culture

Seventh Schedule – Division of Responsibilities

• Union List (Entry 67): Monuments and archaeological sites of national importance (Central jurisdiction)
• State List (Entry 12): Monuments not declared of national importance (State responsibility)

Key Legislation

• Ancient Monuments and Archaeological Sites and Remains (AMASR) Act, 1958 – empowers ASI to declare monuments as protected, regulate construction in surrounding areas, ensure conservation

Institutional Framework

Archaeological Survey of India (ASI)

• Established: 1861 (founder: Alexander Cunningham)
• Parent Ministry: Ministry of Culture
• Mandate: Archaeological research, protection of ancient monuments and sites of national importance
• Protected monuments: 3,686 centrally protected monuments
• Network: ~38 Circles (regional administrative units headed by Superintending Archaeologist)
• Functions: Structural and chemical conservation, exploration and excavation, epigraphy, site museums

National Mission on Monuments and Antiquities (NMMA)

• Established: 2007
• Implemented under: ASI
• Mandate: Build national database of built heritage and antiquities
• Documentation so far: 11,406 Built Heritage and Sites; 12.48 lakh antiquities

National Policy for Conservation (2014)

Key Principles

• Scientific preservation and management of monuments of national importance
• Maintain authenticity, integrity, and longevity of heritage structures
• Minimal intervention – use traditional materials and skills with modern techniques
• Conservation as a continuous process supported by documentation, research, capacity building, and community participation

Emerging Frameworks and Initiatives

Adopt a Heritage 2.0 (revamped 2023)

• Public-private partnership under Ministry of Tourism, Ministry of Culture, and ASI
• Entities designated as “Monument Mitras” develop and maintain visitor amenities
• Conservation and preservation remain ASI’s exclusive mandate
• Benefitted sites: Agra Fort, Qutub Minar, Ajanta Caves, Red Fort, Mehrauli Archaeological Park

Heritage-Linked Cultural Festivals

• Konark Dance Festival (Sun Temple, Odisha)
• Khajuraho Dance Festival (Khajuraho Group of Monuments, MP)
• Modhera Dance Festival (Gujarat)
• Natyanjali festivals (Chidambaram)

Museum Grant Scheme

• Supports establishment, modernization, and digitization of museums
• Emphasizes capacity building and technology-driven upgrades

Technology-Supported Conservation

Modern Tools Used

• LiDAR scanning – high-precision mapping of complex structures
• Photogrammetry – capturing detailed architectural features
• Drone-based surveys – aerial mapping, structural monitoring (collaboration with NISER)
• GIS-based mapping – analyse environmental pressures, track development around protected zones
• Artificial Intelligence (AI) – digitization, documentation, accessibility of cultural assets

Kedarnath Temple Restoration (Case Study)

• Post-2013 disaster, ASI undertook structural and chemical conservation
• IIT Chennai collaborated for scientific structural assessment using Multi-Channel Analysis of Spectral Waves (MASW)
• Example of integrating engineering expertise with traditional conservation practices

UNESCO World Heritage Sites in India

Total: 44 (as of 2024)

Breakdown

• Cultural: 36
• Natural: 7
• Mixed: 1

Recent Addition (July 2024)

• Maratha Military Landscapes – 44th UNESCO World Heritage Site

Notable Sites

• Cultural: Taj Mahal, Sanchi Stupa, Khajuraho, Hampi, Ellora, Ajanta, etc.
• Natural: Kaziranga, Manas, Keoladeo, Nanda Devi, Sundarbans, Western Ghats
• Mixed: Khangchendzonga National Park (Sikkim) – first mixed site from India

Intangible Cultural Heritage (UNESCO 2003 Convention)

Definition

• Living traditions and practices passed down through generations: performing arts, rituals, festivals, oral traditions, traditional knowledge

Examples from India

• Yoga, Vedic chanting, Buddhist chanting of Ladakh, Kumbh Mela, Durga Puja, Ramlila, Nowruz, etc.

Safeguarding in India

• UNESCO Convention for the Safeguarding of Intangible Cultural Heritage (2003)
• Supported by constitutional provisions (Article 29) and national schemes

Source/Reference:

https://www.pib.gov.in/PressReleasePage.aspx?PRID=2253199&reg=3&lang=1

Subject: Geography – Water Governance; Brahmaputra Board; ILR; RBM Scheme.

Why in News?

• RBM Scheme to continue from 2026-27 to 2030-31 with a budget of ₹2,183 crore (fully funded by government)
• Previous phase (2021-26): ₹1,276 crore
• Focus on Brahmaputra, Barak, Teesta, and Indus basins

What is RBM Scheme?

• Central Sector Scheme under Ministry of Jal Shakti
• Aims: Integrated planning, investigation, and development of water resources at river basin level (surface + groundwater)

3 Implementing Agencies

• Brahmaputra Board – Master Plan, flood control, anti-erosion (e.g., Majuli Island protection)
• Central Water Commission (CWC) – Surveys, Detailed Project Reports (DPRs)
• NWDA – Interlinking of Rivers (ILR) studies

Priority Areas

• North Eastern Region basins
• Indus Basin (J&K / Ladakh)
• States with capacity gaps: J&K, Sikkim, Mizoram, Manipur, Nagaland

Key Achievements (2021-26)

Modern Tools Used

• GIS, Remote sensing, LiDAR, Drone-based surveys, Hydrological modelling

Static (Geography / Economy Syllabus)

• River Basins of India: 12 major river basins (Ganga, Brahmaputra, Indus, Godavari, Krishna, etc.)
• Brahmaputra Board: Established 1980 under Brahmaputra Board Act, 1980
• CWC: Established 1945; headquartered in New Delhi
• NWDA: Established 1982 under Ministry of Jal Shakti
• Interlinking of Rivers (ILR): National Perspective Plan (1980) – 30 links (14 Himalayan, 16 Peninsular)

Dynamic (Current Affairs – 2026)

• RBM Scheme continuation (2026-31): ₹2,183 crore budget (increase from ₹1,276 crore in previous phase)
• Majuli Island protection: Anti-erosion works under Brahmaputra Board
• Cross-border water management: Indus (Pakistan), Brahmaputra (China), Teesta (Bangladesh)
• Springshed management: Community-based intervention in hilly North Eastern states

Source/Reference:

https://www.pib.gov.in/PressReleasePage.aspx?PRID=2252895&reg=3&lang=1

Subject: Economy – Tourism; NITI Aayog; Government Initiative; Cultural Heritage; Sustainable Development.

Why in News?

• NITI Aayog launched an anthology titled “Divya Bharat: A Window to the Soul of India” on April 17, 2026

What is Divya Bharat?

Nature

• A comprehensive anthology (collection of writings) presenting India’s tourism offerings
• Conceived as a year-round companion for travellers

Key Features

• Presents destinations through a unique seasonal lens – aligning with the rhythm of months
• Covers all States and Union Territories
• Includes: iconic landmarks, heritage sites, cultural traditions, festivals, cuisines, and lesser-known destinations

Philosophy

• Goes beyond conventional sightseeing
• Encourages experiential journeys – deeper engagement with local communities, traditions, and ways of life
• Promotes balanced tourism – travel across seasons and regions (not just peak seasons)

Objectives

• Inspire citizens and global travellers to explore India’s diverse tourism landscape
• Promote domestic awareness and global appeal of India’s tourism sector
• Support local economies and preserve cultural heritage
• Foster greater community participation in tourism
• Promote longer tourist stays (domestic and religious tourism)

Significance (Static Link)

Tourism as Economic Driver

• Contributes to GDP, employment, and foreign exchange
• Supports MSMEs (hotels, transport, handicrafts, guides)

Divya Bharat’s Role

• A structured and accessible view of India’s tourism landscape
• Resource for travellers, policymakers, and stakeholders
• Builds on ongoing efforts to promote tourism as a pillar of inclusive growth, cultural pride, and sustainable development

Static-Dynamic Linkage

Static (Economy / Art & Culture Syllabus)

• NITI Aayog: Established 2015 (replaced Planning Commission)
• Ministry of Tourism: Nodal ministry for tourism policy (Incredible India campaign)
• IITTM: Established 1983; campuses in Gwalior, Bhubaneswar, Nellore, Noida
• Tourism as driver: Contributes ~9% to GDP (pre-COVID) and ~8% to employment

Dynamic (Current Affairs – 2026)

• Divya Bharat launch (April 17, 2026) – NITI Aayog’s first tourism anthology
• Seasonal lens approach – promoting off-season and lesser-known destinations
• Centre-State collaboration – unified platform for tourism promotion
• Sustainable tourism – balancing economic growth with cultural preservation

Source/Reference:

https://www.pib.gov.in/PressReleasePage.aspx?PRID=2253135&reg=3&lang=1

Subject: Polity – Labour Laws; Economy – Labour Codes 2026; Social Justice – Worker Welfare.

Why in News?

• Earlier this week, rare scenes unfolded in Noida, a satellite city of India’s capital Delhi, as thousands of factory workers blocked roads, demanding higher wages and better working conditions.
• The four Labour Codes came into full effect from 21 November 2025, rationalising 29 central labour laws into a single cohesive framework 
• The reform has been acknowledged as the most significant overhaul of employment regulation since independence 

Overview of the Four Labour Codes

1. Code on Wages, 2019

• Repeals: 4 laws including Payment of Wages Act, 1936; Minimum Wages Act, 1948; Payment of Bonus Act, 1965; Equal Remuneration Act, 1976 
• Key changes:
  • Wage definition: “Wages” must constitute at least 50% of total remuneration (basic + DA + retaining allowance). Excluded components like HRA and bonus cannot exceed 50% 
  • Universal coverage: Payment of wages provisions now apply to all employees (no wage ceiling) 
  • Equal pay: Transgender persons included in gender discrimination protections 
  • National floor wage: Central Government to fix a floor wage; state minimum wages cannot be lower than this 

2. Code on Social Security, 2020

• Repeals: 9 laws including EPF Act, ESI Act, Maternity Benefit Act, Payment of Gratuity Act, etc. 
• Key changes:
  • Gig and platform workers formally recognised for first time; aggregators to contribute 1-2% of annual turnover (capped at 5% of payments) 
  • Fixed-term employees (FTE) entitled to equal benefits as permanent workers; gratuity eligibility after one year (reduced from five years) 
  • Universal Account Number (UAN) linked to Aadhaar for portable social security benefits 
  • ESIC coverage for establishments with 10+ employees (mandatory); voluntary for smaller units; even one employee in hazardous processes covered 

3. Industrial Relations Code, 2020

• Repeals: 3 laws including Trade Unions Act, 1926; Industrial Employment (Standing Orders) Act, 1946; Industrial Disputes Act, 1947 
• Key changes:
  • Terminology shift: “Workman” replaced with “worker” and “employee” – broader coverage including supervisory staff 
  • Stricter strike norms: Employees must give 14 days’ notice before strike; notice of lock-down by employer also required 
  • Layoff threshold: Prior government approval now required for establishments with 300+ workers (increased from 100) 
  • Negotiating unions: Statutory framework for recognition of negotiating unions or councils 
  • Grievance redressal committee: Mandatory for establishments with 20+ workers 
  • Workers’ Re-skilling Fund: Employers to contribute when retrenching workers 

4. Occupational Safety, Health and Working Conditions Code, 2020

• Repeals: 13 laws including Factories Act, 1948; Mines Act, 1952; Contract Labour Act, 1970; Inter-State Migrant Workmen Act, 1979; Building and Other Construction Workers Act, 1996, etc. 
• Key changes:
  • Women allowed in all establishments including night shifts, underground mining, and hazardous jobs – subject to consent and safety measures 
  • Annual health check-up mandatory for all workers 
  • Appointment letter mandatory for every worker (formalising employment) 
  • Inter-state migrant workers: Definition expanded to include self-migrated workers; entitled to annual travel allowance and portable benefits 
  • Mandatory safety audits, registers, and training programs across sectors 

Static-Dynamic Linkage

Static (Polity / Economy Syllabus)

• Labour as Concurrent Subject: Entry 24 of Concurrent List (List III) – both Centre and States can legislate
• Article 43 (DPSP): Living wage, decent standard of life for workers
• Article 43A: Workers’ participation in management
• Article 19(1)(c): Right to form trade unions (subject to reasonable restrictions)
• Article 23: Prohibition of forced labour

Legislations Repealed (29 total)

• Code on Wages: 4 laws (Payment of Wages Act, 1936; Minimum Wages Act, 1948; Payment of Bonus Act, 1965; Equal Remuneration Act, 1976)
• Social Security Code: 9 laws (EPF Act, ESI Act, Maternity Benefit Act, Gratuity Act, etc.)
• Industrial Relations Code: 3 laws (Trade Unions Act, 1926; Industrial Employment Act, 1946; Industrial Disputes Act, 1947)
• OSH Code: 13 laws (Factories Act, 1948; Mines Act, 1952; Contract Labour Act, 1970; Migrant Workmen Act, 1979; Building Workers Act, 1996; etc.)

Dynamic (Current Affairs – 2026)

• Codes effective from 21 November 2025 – unified labour law framework
• IR Code Amendment (Feb 2026) – clarifies repeal of three old Acts 
• State rules finalisation ongoing – 2 states yet to publish draft rules 
• Delhi, AP, Puducherry, Gujarat – recent state-level amendments (March 2026) 
• ESG implications: OSH Code compliance now part of investor scrutiny 

Source/Reference:

https://www.bbc.com/news/articles/ce8444gex65o

Subject: Economy – GDP Rankings; IMF Report; Base Year Revision; Rupee Depreciation.

Why in News?

• According to the IMF’s World Economic Outlook (April 2026), India is no longer the fourth largest economy in the world
• India has slipped to sixth position behind Japan and the UK

GDP Rankings (2026)

• USA: $32.38 trillion (1st)
• China: $20.85 trillion (2nd)
• Germany: 3rd
• Japan: $4.38 trillion (4th)
• UK: $4.27 trillion (5th)
• India: $4.15 trillion (6th – down from 4th in 2025)

Why Did India Slip? (Two Key Reasons)

1. GDP Base Revision (February 2026)

• India updated its GDP estimates with a new base year
• Previous series was overestimating India’s GDP
• In rupee terms, GDP for 2025-26 rolled back from ₹357 lakh crore to ₹345 lakh crore
• For 2025, India’s dollar GDP fell from $4.1 trillion (old) to $3.9 trillion (new)

2. Rupee Depreciation

• Rupee lost significant value against the US dollar over the past year
• Dollar itself lost value against British pound and Japanese yen
• This gap expansion works against India when IMF calculates GDP in dollar terms

Future Projections (IMF)

• 2027: India will retake fourth position
• 2031: India expected to overtake third-placed Germany
• Previous expectation (overtaking Germany by 2029) now pushed to 2031

Static-Dynamic Linkage

Static (Economy Syllabus)

• Nominal GDP vs PPP GDP: India is 3rd largest in PPP terms (after China and USA)
• Base Year: Currently 2011-12 (under revision)
• GDP calculation: Expenditure method, income method, production method
• Exchange rate impact: Depreciation reduces dollar-denominated GDP

Dynamic (Current Affairs – April 2026)

• India slips to 6th – from 4th in 2025
• IMF April 2026 WEO – revised rankings
• Base year revision – GDP rolled back from ₹357 to ₹345 lakh crore
• Projected recovery – 4th in 2027; overtake Germany in 2031

Source/Reference:

https://epaper.indianexpress.com/4141845/Delhi/April-18-2026#clip/79657643/57ea7e99-75e5-4a17-ad27-c5d4c9f68e15/1226.6666666666665:570.4423480083858

Subject: Geography – El Niño; Economy – Monsoon Impact; Agriculture; Inflation; RBI Policy.

Why in News?

• India’s weather office has forecast a below-average monsoon in 2026, with an El Niño expected to develop and weigh on rainfall in the latter half of the June-September season
• In past El Niño years, India has seen below-average rainfall, at times triggering severe droughts, crop damage, and export curbs

What is El Niño?

Definition

• El Niño is the warming of the central and eastern Pacific Ocean (sea surface temperatures rise above normal)
• Alters atmospheric circulation and weakens monsoon winds over the Indian subcontinent

How it Affects Indian Monsoon

• Strongly linked to weaker monsoons (reduced rainfall)
• However, India has still seen average or above-average rains in at least 5 of 17 El Niño events over past seven decades
• But in the last six El Niño years, India has received below-average rains

Historical Example (2009)

• Even a weak El Niño led to sharp drop in rainfall to 78.2% of long-period average – lowest in 37 years
• Weather models suggest 2026 El Niño could be strong

Why is Monsoon Important for India?

Rainfall Contribution

• Delivers nearly 70% of India’s annual rainfall

Agricultural Significance

• Agriculture accounts for about 18% of India’s $4 trillion economy
• Employs nearly half of India’s 1.5 billion people

Impact of Below-Normal Rainfall

• Smaller harvests of: rice, cotton, soybeans
• Lower soil moisture affects winter crops (wheat, rapeseed)
• May prompt export restrictions (as in 2023 El Niño year)
• May force India to increase imports of edible oils (palm oil, soyoil)
• Reduces hydropower output (accounts for about 6% of power mix)

Impact on Inflation and Central Bank Policy

Food Inflation Link

• Food accounts for nearly one-third of India’s consumer price index (CPI)
• RBI monitors food inflation closely when setting monetary policy

Recent Context (2024-2025)

• Rainfall was above average over past two years
• Helped ease food prices and broader inflation
• Gave RBI room to cut lending rates

2026 Risks

• Below-normal rainfall + rising commodity costs (due to Iran conflict) = higher overall inflation
• Could force RBI to raise interest rates
• Slower economic momentum + higher inflation = further hit to foreign investment
• Additional pressure on rupee (already among worst-performing Asian currencies in 2026)

Static-Dynamic Linkage

Static (Geography / Economy Syllabus)

• El Niño & La Niña: Part of ENSO cycle; affects global weather patterns
• Indian Monsoon: June-September; southwest monsoon; 70% of annual rainfall
• Rainfall classification: Normal (96-104% LPA); Below-normal (90-96%); Deficient (<90%)
• RBI’s inflation targeting: 4% target with 2-6% tolerance band

Dynamic (Current Affairs – 2026)

• Below-average monsoon forecast – El Niño expected to develop in latter half of season
• Iran conflict – rising commodity costs compounding inflation risks
• Rupee depreciation – among worst-performing Asian currencies in 2026
• Export curbs possible – rice, wheat, sugar (as seen in 2023)

Source/Reference:

https://www.reuters.com/business/environment/how-el-nino-driven-weaker-monsoon-rains-could-impact-india-2026-04-16/

UPSC Mains Subject: GS Paper II – Polity & Governance (Parliament, Federalism, Constitutional Amendments)
Sub-topic: Delimitation; Women’s Reservation; Centre-State Relations; Article 368

Introduction

The Constitution (131st Amendment) Bill, 2026 failed to secure the two-thirds majority under Article 368, leading to its defeat and the shelving of the Delimitation Bill. 

This outcome highlights the constitutional safeguard against pushing major structural changes without broad consensus. The government’s approach—linking women’s reservation to delimitation based on the 2011 Census—raised federal concerns and overlooked key recommendations on Centre–State relations.

Main Body

The Constitutional Amendment Dimension: Article 368

The Two-Thirds Safeguard:

• Article 368 requires special majority: majority of total membership + two-thirds of members present and voting
• For amendments affecting federal provisions, ratification by half the States is also required (Article 368(2))
• The 131st Amendment fell at the first hurdle itself

Basic Structure Dimension:

• The Supreme Court in Kesavananda Bharati (1973) held that federalism is part of the basic structure
• S.R. Bommai (1994) reaffirmed that any amendment violating federal principles can be struck down
• A delimitation that disproportionately reduces representation of certain States could potentially violate this principle

Centre-State Relations: The Federal Fault Line

Constitutional Framework of Delimitation:

• Article 81: Lok Sabha seats allocated to States based on population
• 42nd Amendment (1976) and 84th Amendment (2002) froze delimitation until first Census after 2026
• Rationale: Incentivise population stabilisation without penalising successful States

The North-South Asymmetry:

• Southern States (Tamil Nadu, Kerala, Karnataka, Andhra, Telangana) stabilised population growth decades ago
• Northern States (UP, Bihar, MP, Rajasthan) continue to have higher fertility rates
• A strict population-based delimitation would reduce southern seats and increase northern seats

The Bill’s Language:

• Mandated delimitation based on latest Census (2011)
• Would have reduced share of southern, eastern, and northeastern States
• Contradicted the spirit of the 84th Amendment (2002)

Related Committees and Their Recommendations

Sarkaria Commission (1983-1988):

• Recommended that delimitation should not penalise States that controlled population growth
• Emphasised federal balance requires protection of smaller and economically advanced States

Punchhi Commission (2007-2010):

• Reaffirmed federalism as basic feature of the Constitution
• Recommended extensive consultation with States before any delimitation exercise
• Suggested demographic performance should be rewarded, not penalised

84th Amendment (2002):

• Froze delimitation until first Census after 2026
• Explicitly linked to “progress of family planning programmes in different parts of the country”
• The 131st Amendment sought to negate this rationale without fresh assessment

Way Forward

Constitutionally Mandated Route:

• Complete the 2026-27 Census (currently underway)
• Refer delimitation to a Joint Parliamentary Committee for genuine consensus
• Follow the precedent of the 84th Amendment (2002) which was passed after extensive consultation

Women’s Reservation:

• The 106th Amendment (2023) already provides for it
• Implementation requires delimitation, but delimitation need not be controversial
• Consensus can be built through proper process

Federal Principle:

• Balance democratic equality (“one vote, one value”) with federal fairness
• The Demographic Performance (DemPer) principle could be a way forward
• The Finance Commission already uses multiple criteria beyond population

Conclusion

The defeat of the Constitution (131st Amendment) Bill, 2026 is not a legislative failure but a constitutional safeguard in action. The two-thirds requirement under Article 368 prevented a rushed approach to delimitation based on the 2011 Census, without consensus or regard for federal concerns. 

The way forward lies in completing the Census, building parliamentary consensus, and following constitutional processes.

UPSC Mains Practice Question

1. Does the two-thirds requirement under Article 368 function as a substantive safeguard of federalism? Discuss in light of the defeat of the Constitution (131st Amendment) Bill, 2026, and its implications for Centre–State relations. (250 words, 15 marks)

https://www.thehindu.com/opinion/editorial/deservedly-dead-the-hindu-editorial-on-the-defeat-of-the-constitution-131st-amendment-bill-2026/article70875239.ece

UPSC Mains Subject: GS Paper II – Social Justice (Health) | GS Paper III – Science & Technology | GS Paper IV – Ethics
Sub-topic: Pharmaceutical Patents; Drug Pricing; Access to Medicines; Biosimilars; Innovation

Introduction

Immunotherapy drugs like Keytruda have transformed cancer care, but an International Consortium of Investigative Journalists probe reveals stark inequities—₹1.5 lakh per vial, unsafe vial diversion, and patent thickets delaying affordable options. 

India must fast-track biosimilars, tighten regulation, and shift from manufacturer to innovator to ensure access.

Main Body

The Keytruda Case: Price, Shadow Economy, and Systemic Gaps

The Price Barrier:

• 100 mg vial: Rs 1.5 lakh; therapy over months/years costs tens of lakhs
• Places the drug beyond reach of most Indian patients

The Shadow Economy:

• Networks of hospital staff, pharmacists, middlemen divert used vials
• Refill with other substances; sell as genuine doses at discounted rates
• Desperate patients become easy targets

Systemic Gaps Exposed:

• Hospital waste disposal weak and poorly monitored
• Tracking systems for high-value drugs inadequate
• No real-time verification for patients to authenticate doses

How Big Pharma Games the Patent System

Primary Patent & Patent Thicket:

• Merck holds primary patent on pembrolizumab (Keytruda) till 2028
• Built a dense “patent thicket” around formulations, delivery mechanisms, incremental innovations
• Each additional patent adds years of exclusivity

Purpose of Patent Thickets:

• Delay entry of cheaper generic/biosimilar alternatives
• Create legal minefields; potential competitors must fight multiple patent challenges
• Deliberate corporate strategy, not incidental outcome

Evergreening & India’s Shield:

• Evergreening: extending patent life through minor modifications
• Section 3(d) of Indian Patents Act, 1970, prohibits patents on new forms of known substances unless significantly enhanced efficacy shown
• Novartis Glivec case (2013): Supreme Court rejected patent for beta-crystalline form, affirming Section 3(d) as safeguard

Biosimilars: The Cheaper Alternative and Regulatory Hurdles

What Are Biosimilars:

• Derived from living cells (unlike chemical generics)
• Demand advanced manufacturing capabilities
• Face stricter regulatory scrutiny due to complexity and immunogenicity risks
• Development time: 4-8 times longer than chemical generics

Indian Firms’ Progress:

• Working on Keytruda biosimilars; could reduce costs by up to 70%
• India has robust generics industry; biosimilars are next frontier

The Legal Hurdle:

• Courts have prioritised patient access when cheaper substitutes challenged
• But legal battles protracted (years); critically ill patients cannot wait

India’s CAR-T Therapy Success: A Model for Homegrown Innovation

What is CAR-T Therapy:

• Patient’s own T-cells extracted, genetically modified to attack cancer cells, reinfused
• Highly effective against certain blood cancers

India’s Achievement:

• First indigenous CAR-T (NexCAR19) developed by IIT Bombay and Tata Memorial Centre
• Cost: Rs 40 lakh vs. global price Rs 3-4 crore (one-tenth)

Why This Matters:

• Proves India can move from manufacturer of generics to innovator of cutting-edge therapies
• Demonstrates academia-industry collaboration works when properly funded
• Shows homegrown innovation can achieve 90% cost reduction

Way Forward: Short-Term and Long-Term

Short-Term (Immediate):

• Strengthen regulatory oversight of drug supply chain
• Fast-track biosimilar approvals without compromising safety
• Implement real-time tracking for high-value oncology drugs
• Strengthen hospital waste disposal protocols
• Criminal accountability for shadow economy operators

Medium-Term (2-5 Years):

• Scale CAR-T model through sustained R&D investment
• Strengthen academia-industry collaboration with clear IP-sharing frameworks
• Create financing mechanisms to absorb biotech risks
• Speedier regulatory pathways for biosimilars with safety guardrails

Long-Term (5-10 Years):

• India has world’s third-largest cancer burden (1.5+ million new cases annually)
• Cannot treat drug discovery as distant goal
• National mission on affordable cancer therapeutics needed; conversations must begin urgently

Conclusion

The ICIJ probe reveals a troubling nexus of exorbitant pricing, diverted drug vials, and patent strategies delaying affordable alternatives. While Section 3(d) curbs evergreening and Indian firms are developing cheaper biosimilars, regulatory delays remain a bottleneck. The CAR-T breakthrough shows India’s innovation potential. 

The priority is clear: fast-track biosimilars, scale indigenous innovation, and ensure timely patient access without being constrained by patent barriers.

UPSC Mains Practice Question

1. How do pharmaceutical patent practices like “patent thickets,” highlighted in the case of Keytruda, affect access to life-saving drugs? Examine how India can balance innovation incentives with affordable healthcare. (250 words, 15 marks)

https://indianexpress.com/article/opinion/editorials/search-for-cancer-cure-must-not-be-hostage-to-big-pharma-10640520/