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Archives: News

  • Economic Indicators and Various Reports On It- GDP, FD, EODB, WIR etc

    A Study of Budgets of 2024-25 (Fiscal Reforms by States) Report released by RBI

    Why in the News?

    • According to the RBI report on state finances, India’s fiscal deficit has increased from 2.8% of GDP in FY22 to a projected 3.2% in FY24, signaling that fiscal consolidation is being side-lined in favor of increasing expenditure.
      • Capital expenditure (capex) has risen from 2.2% of GDP in FY23 to a budgeted 3.2% in FY24, indicating increased investment in assets for future growth.

    Fiscal position of the States as per the Report

    • Fiscal Deficit:
      • The Gross Fiscal Deficit (GFD) of states is projected to rise from 2.7% of GDP in FY2022-23 to 2.9% of GDP in FY2023-24.
      • This rise indicates that fiscal consolidation has been put on hold, with states continuing to spend more than their revenues.
      • Many states have budgeted for fiscal deficits above the 3% of GSDP mark, including Andhra Pradesh, Himachal Pradesh, Madhya Pradesh, and West Bengal, among others.
    • Revenue Expenditure:
      • Revenue Expenditure is expected to increase to 14.6% of GDP in FY2025, up from 13.5% in FY2024, indicating a rise in the current expenditure of states.
    • Capital Expenditure (Capex):
      • States have ramped up their capital expenditure (spending on creating assets), which has increased from 2.2% of GDP in FY2023 to 3.2% of GDP in FY2024.
      • This increase is in line with the government’s focus on infrastructure and long-term growth.
    • State Revenue:
      • State revenues are projected to increase from 13.3% of GDP in FY2024 to 14.3% in FY2025, driven by improved tax collections.
      • There has been a marked improvement in own tax revenue buoyancy compared to the pre-Covid period.
    • Debt-to-GDP Ratio:
      • The debt-to-GDP ratio for states has increased slightly to 28.8% in FY2024, from 28.5% in FY2023.
      • States with high fiscal deficits tend to have debt-to-GDP ratios above the national average, which suggests they have been sustaining deficits for a longer time.
    • Borrowing Trends:
      • States have shifted significantly towards market borrowings.
      • The share of market borrowings in financing the fiscal deficit has increased from 17% in 2005-06 to 79% in FY2024-25.
    • Recommendations:
      • The report suggests prudent management of subsidies, rationalization of centrally sponsored schemes, debt consolidation, and the adoption of climate and outcome budgeting to improve state fiscal health.

    PYQ:

    [2018] Consider the following statements:

    1. The Fiscal Responsibility and Budget Management (FRBM) Review Committee Report has recommended a debt to GDP ratio of 60% for the general (combined) government by 2023, comprising 40% for the Central Government and 20% for the State Governments.
    2. The Central Government has domestic liabilities of 21% of GDP as compared to that of 49% of GDP of the State Governments.
    3. As per the Constitution of India, it is mandatory for a State to take the Central Government’s consent for raising any loan if the former owes any outstanding liabilities to the latter.

    Which of the statements given above is/are correct?

    (a) 1 only
    (b) 2 and 3 only
    (c) 1 and 3 only
    (d) 1, 2 and 3

  • NITI Aayog’s Assessment

    Niti Aayog moots policy measures to develop workers’ accommodation around factories

    Why in the News?

    NITI Aayog has proposed a set of policy interventions to enable the creation of mega workers’ accommodations near factories under its initiative called S.A.F.E (Site Adjacent Factory Employee) Accommodation-Worker Housing for Manufacturing Growth.

    About the S.A.F.E. (Site Adjacent Factory Employee) Initiative

    Overview
    • S.A.F.E. initiative by NITI Aayog aims to provide affordable dormitory-style housing for workers near industrial areas, especially migrant laborers, including women.
      • The housing will include essential amenities like water, electricity, and sanitation, improving workers’ living conditions and enhancing productivity.
    Key Features
    • Location: Housing will be near industrial hubs to minimize commute time.
    • Basic Amenities: Includes water, electricity, and sanitation.
    • Ownership: Non-transferable accommodations, strictly for worker use, ensuring worker welfare.
    Significance
    • Worker Welfare: Improves living standards and promotes gender inclusivity.
    • Productivity: Reduces commute time, enhancing productivity and reducing attrition.
    • Economic Growth: Attracts global investors and supports India’s manufacturing growth target of 25% GDP by 2047.
    Key Recommendations
    • Tax & GST Benefits: Reclassification for tax exemptions to make the initiative financially viable.
    • Zoning Laws: Amendments for mixed-use developments to integrate worker housing.
    • Viability Gap Funding (VGF): 30%-40% of project cost for financial support.
    • Environmental Clearances: Streamlining for faster approvals.
    • Financial Support: Public-private partnerships for development and management.
  • Foreign Policy Watch: India-Sri Lanka

    [20th December 2024] The Hindu Op-ed: Reality check on Sri Lanka’s Tamil question

    PYQ Relevance:

    Q) ‘India is an age-old friend of Sri Lanka.’ Discuss India’s role in the recent crisis in Sri Lanka in the light of the preceding statement. (UPSC CSE 2022)

    Mentor’s Comment: UPSC Mains have focused on ‘India is an age-old friend of Sri Lanka (in 2022), and how domestic factors influence foreign policy between India and Srilanka’ (in 2013).

    Sri Lankan President Anura Kumara Dissanayake’s recent visit to India drew significant attention, marking his first foreign trip since taking office. The visit highlighted the shift in Sri Lanka’s political landscape, with the National People’s Power’s surprising electoral success. India’s priorities have also evolved, focusing on countering China’s influence in the region.

    Today’s editorial highlights the importance of Sri Lanka for India. This content can be used to substantiate the challenges and significance due to Srilanka for India in UPSC IAS mains paper GS2.

    _

    Let’s learn!

    Why in the News?

    The joint statement released by New Delhi and Colombo during the Sri Lankan President’s visit to India shows what is currently important to both countries.

    What is the joint statement released by New Delhi and Colombo during the Sri Lankan President’s visit?

    • Bilateral Cooperation: The statement emphasizes the deep-rooted cultural ties and geographical proximity that underpin the India-Sri Lanka partnership. 
      • Both leaders reaffirmed their commitment to enhancing cooperation in areas such as parliamentary exchanges, development cooperation, debt restructuring, energy cooperation, trade and investment, and strategic defense engagement.
    • Economic Support and Stability: President Anura Kumara Dissanayake expressed gratitude for India’s support during Sri Lanka’s economic crisis, highlighting India’s provision of nearly USD 4 billion in aid. 
      • The leaders agreed on an investment-based approach to assist Sri Lanka’s economic recovery and growth, while also addressing shared security interests in the Indian Ocean Region

     

    What is 13th Amandment?

    • The 13th Amendment to the Constitution of Sri Lanka, passed in 1987, was introduced as part of the Indo-Sri Lanka Accord signed between Indian Prime Minister Rajiv Gandhi and Sri Lankan President J.R. Jayewardene. 
    • Its primary aim was to provide a framework for the devolution of power to provincial councils, thereby addressing the demands for greater autonomy from the Tamil minority, particularly in the Northern and Eastern provinces.

    What is the current status of the 13th Amendment’s implementation in Srilanka?

    • Stagnation in Implementation: The 13th Amendment, which was designed to provide power devolution to provincial councils in Sri Lanka, has seen little progress in its implementation. 
      • The recent joint statement from India and Sri Lanka did not address the amendment or the political solutions for Tamil aspirations, highlighting a lack of commitment from the current government led by President Anura Kumara Dissanayake.
    • Political Hesitance: The Dissanayake administration has avoided explicitly referencing the 13th Amendment due to its association with “Indian imposition,” which is viewed negatively by the Sinhala-Buddhist majority. Instead, the government’s focus has shifted towards broader promises of provincial council elections and constitutional reforms without a clear plan for implementing the amendment.

    How do historical grievances impact contemporary Tamil-Sinhala relations?

    • Historical Conflict: Historical grievances from the civil war and ongoing issues related to Tamil rights significantly affect Tamil-Sinhala relations. The Tamil community continues to seek justice for wartime atrocities and greater political agency, while many in the Sinhala majority often view discussions about devolution and federalism with scepticism.
    • Political Dynamics: The recent electoral success of the National People’s Power (NPP) signifies a shift in Tamil political engagement, as Tamils have shown support for a party that traditionally opposed Indian intervention. 
      • However, this shift raises concerns about how effectively the NPP will address Tamil issues without alienating its base among Sinhala nationalists.

    What are the prospects for genuine reconciliation and autonomy for Tamils in Sri Lanka?

    • Need for Clarity: There is an urgent need for the NPP to clarify its position on Tamil rights and reconciliation. While the party’s manifesto promises provincial council elections and constitutional reforms, it lacks a concrete strategy for addressing historical grievances or ensuring autonomy for Tamils.
    • Challenges Ahead: Genuine reconciliation remains uncertain as long as past grievances are not adequately addressed. The Tamil polity must engage more directly with its constituents rather than relying on international actors. 
      • The NPP’s ability to foster inter-ethnic peace will depend on its willingness to confront historical failures and implement meaningful policies that reflect the aspirations of all communities in Sri Lanka.

    Way forward: 

    • Clear Political Vision: The NPP should outline a concrete plan for addressing Tamil rights, implementing the 13th Amendment, and ensuring provincial autonomy, while balancing the demands of both Tamil and Sinhala communities.
    • Inclusive Dialogue: Engage in direct, inclusive dialogue with all ethnic groups, focusing on national reconciliation and addressing past grievances, to foster a durable peace and meaningful political solution for all communities in Sri Lanka.
  • Should legislatures in India have fixed tenures?

    Why in the News?

    The 129th Constitution Amendment Bill, 2024, mandates fixed five-year Lok Sabha terms, aligning State Assembly elections, with mid-term polls serving only the remainder of the five-year tenure if dissolved.

    Do fixed legislative tenures promote better governance?

    • Potential for Improved Stability: Fixed tenures can provide a stable political environment, reducing frequent electoral disruptions that may hinder long-term governance plans.
    • Governance Challenges: However, Achary argues that while fixed terms might seem beneficial, they could lead to governance issues if political instability arises, as seen in states where mid-term elections are necessary due to governmental collapse.

    Note: 

    • Fixed Legislative Tenure refers to predetermined, non-variable terms for legislatures, ensuring elections occur at set intervals, and enhancing stability.
    • Mid-term polls are elections held before the scheduled end of a legislative term, usually triggered by government collapse or dissolution.

    How would fixed tenures impact the accountability of elected officials?

    • Increased Accountability: Frequent elections are believed to enhance political accountability since representatives must consistently engage with their electorate. Achary emphasises that regular electoral cycles compel politicians to remain responsive to public needs.
    • Mid-Term Elections as a Safety Valve: Allowing mid-term elections maintains accountability within the legislative framework, ensuring that elected officials remain answerable to their constituents even if they face political challenges during their term.

    What are some learnings from the Western world?

    • Lessons from the UK: The UK’s Fixed-term Parliaments Act of 2011 was meant to set fixed terms for its Parliament but caused problems like policy delays and constitutional issues.
      • It was eventually repealed. India’s plan is different because it allows mid-term elections, where new governments serve only the remaining term, not a full fixed term.
    • Lessons from Germany: The Constructive Vote of No Confidence in Germany mandates the selection of a new leader before the current one is removed, ensuring stability. However, this approach is not well-suited to India’s political system and has not gained significant support.

    What challenges might arise from implementing fixed tenures in the Indian political context?

    • Erosion of Federalism: Aligning State Assembly tenures with those of the Lok Sabha could weaken federalism by reducing the autonomy of state legislatures. This may result in premature dissolutions and disruptions in local governance.
    • Political Instability Risks: The bill’s provision for shorter tenures following mid-term elections could result in significant instability. If a government collapses mid-term, the resultant Lok Sabha might only serve for about a year, which is seen as undesirable by Madhavan.
    • Potential for Increased Political Maneuvering: There is doubt about whether fixed tenures can effectively deter practices like horse trading or efforts to destabilize governments. While the bill aims to address such issues, its success is uncertain.

    Way forward: 

    • Strengthen Federalism: Ensure state legislatures retain autonomy by allowing flexibility in election cycles and minimizing central influence on state governance.
    • Mitigate Political Instability: Introduce safeguards like stricter anti-defection laws and robust mechanisms to address mid-term government collapses while maintaining accountability.

    Mains PYQ:

    Q ‘Simultaneous election to the Lok Sabha and the State Assemblies will limit the amount of time and money spent in electioneering but it will reduce the government’s accountability to the people’ Discuss. (UPSC IAS/2017)

  • International Space Agencies – Missions and Discoveries

    Japan, India startups collaborate to tackle space debris

    Why in the News?

    space startups from Japan and India announced a joint agreement to explore the use of laser-equipped satellites for removing debris from orbit, addressing the growing issue of orbital congestion.

    What is Space Debris?

    • Space debris, often referred to as space junk, consists of non-functional spacecraft, spent rocket stages, and fragments from collisions or disintegration of satellites.
    • These objects orbit the Earth at high speeds, posing significant risks to operational satellites and manned missions.

    What are laser-equipped satellites for removing debris from orbit?

    • Laser-equipped satellites utilize focused laser beams to target and vaporize small parts of space debris, effectively stopping its rotation and making it easier for servicing spacecraft to rendezvous with and de-orbit defunct satellites. T
    • Companies like Japan’s Orbital Lasers and India’s InspeCity are collaborating to explore business opportunities for these laser systems.
    • They plan to demonstrate this technology in space, with potential deployment on satellites after meeting regulatory requirements in their respective countries, indicating a growing interest in international partnerships to tackle the issue of space debris.

    What are the concerns related to space debris?

    • Collision Risks: The increasing amount of space debris raises the likelihood of collisions with active satellites and spacecraft, which can lead to further debris generation in a cascading effect known as the Kessler Syndrome.
    • Operational Challenges: Space debris complicates satellite operations and can disrupt services such as telecommunications, weather forecasting, and global positioning systems.
    • Environmental Impact: The accumulation of debris in low Earth orbit (LEO) threatens the sustainability of space activities and could hinder future space exploration efforts.

    What are the initiatives to tackle space debris globally?

    • International Collaboration: Organizations like the United Nations have called for urgent action to track and manage space debris, emphasizing the need for global cooperation.
    • Technological Innovations: Companies like Orbital Lasers are exploring innovative solutions such as using laser-equipped satellites to de-orbit defunct satellites and mitigate debris by vaporizing parts of their surfaces.
    • Regulatory Frameworks: Various countries are developing regulations to ensure responsible satellite launches and operations, including guidelines for end-of-life satellite disposal to minimize future debris creation.

    What are the measures should be taken by Satellite? (Way forward)

    • Tracking and Monitoring: Satellites use onboard systems and ground-based tracking data to monitor the position of space debris and predict potential collision risks.
    • Avoidance Maneuvers: Satellites perform preemptive orbital adjustments or “collision avoidance manoeuvres” to shift their trajectory away from debris.
    • Shielding and Resilience: Some satellites are equipped with protective shielding to withstand minor debris impacts, minimizing potential damage in low-risk scenarios.

    Mains PYQ:

    Q What is India’s plan to have its own space station and how will it benefit our space programme? (UPSC IAS/2019)

  • International Space Agencies – Missions and Discoveries

    IRIS² Program

    Why in the News?

    The European Union has signed a contract for IRIS², a network of 290 satellites aimed at improving resilience, connectivity, and security.

    About IRIS²:

    Details
    • IRIS² stands for Infrastructure for Resilience, Interconnectivity, and Security by Satellite.
    • It consists of a 290-satellite constellation, including 264 satellites in Low Earth Orbit (LEO) and 18 in Medium Earth Orbit (MEO).
    • Collaboration between European Union and SpaceRISE.
    • First satellite launch planned for 2029.

    Key Features of IRIS²:

    • Deployment of 264 satellites in LEO and 18 in MEO.
    • Provide secure, high-speed broadband connectivity, particularly in underserved regions.
    • Focus on Europe for secure satellite internet services.
    Project Funding and Implementation
    • 12-year concession for IRIS² is funded by the EU, ESA, and private firms like SES, Eutelsat, and Airbus.
    • Total cost: €10.6 billion (~$11 billion).
    Applications of IRIS²
    • Governmental Use: Border surveillance, crisis management, infrastructure security, and defense.
    • Civilian Use: Broadband access, smart energy, transportation, and remote healthcare.

     

    World’s Largest Earth Observation Programs: Take a look

    • Copernicus Program (EU): Launched in 2014, the Copernicus Program is a European Union initiative with satellites like Sentinel to monitor land, ocean, and atmosphere, enhancing environmental management and disaster response.
    • NASA Earth Observing System (EOS): Initiated in 1997, NASA’s EOS provides comprehensive Earth observation data from satellites like Terra and Aqua, focused on understanding Earth’s environment, climate change, and atmospheric composition.
    • Global Earth Observation System of Systems (GEOSS): Founded in 2005, GEOSS connects Earth observation systems globally to provide data on climate, water resources, biodiversity, and natural disasters, involving over 100 organizations.
    • Landsat Program (USA): Launched in 1972 by NASA and USGS, Landsat is the longest-running satellite program offering continuous Earth surface monitoring, focusing on land cover, land use, and environmental changes.

    Note: 

    In September, 2024, ISRO launched the Earth Observation Satellite EOS-08 under the SSLV-D3/EOS-08 mission from the Satish Dhawan Space Centre, Sriharikota, with the satellite operating in a circular Low Earth Orbit at an altitude of 475 km and a mission life of 1 year.

  • Parliament – Sessions, Procedures, Motions, Committees etc

    Joint Parliamentary Committee (JPC)

    Why in the News?

    • Law Minister is proposing that the Bills on “One Nation, One Election” be referred to a Joint Parliamentary Committee (JPC) for further examination.
      • The committee will have 21 members from the Lok Sabha and 10 members from the Rajya Sabha.

    About Joint Parliamentary Committee (JPC):

    What is a JPC?
    • JPC is a committee formed by both Houses of Parliament for scrutinizing a subject or Bill in detail.
    • It includes members from both Lok Sabha (Lower House) and Rajya Sabha (Upper House).
      • Members represent both ruling parties and opposition.
      • Number of members in a JPC can vary based on the task at hand and the members are decided by the Parliament.
    • The JPC is dissolved once its task is completed or its term ends.
    • A motion is passed in one House of Parliament, and the other House agrees to it.
    Structural Mandate
    • Mandate of a JPC is determined by the motion that forms it.
    • Scrutinizing documents related to the subject.
    • Summoning people for questioning.
    • Submitting a report and making recommendations to the government.
    • The proceedings and findings are confidential except in matters of public interest.
    • Speaker of the House resolves any disputes regarding evidence.
    Nature of JPC Recommendations
    • Recommendations are advisory and persuasive but not binding on the government.
    • The government can choose whether or not to follow the recommendations.
    • The government must submit an Action Taken Report to Parliament on the actions taken based on the JPC’s recommendations.
    Notable JPCs in the Past
      • Telecom Licenses and Spectrum Allocation (2011).
      • Stock Market Scam (1992) and related matters.
      • Irregularities in Securities and Banking Transactions.
      • Bofors Contract Inquiry (1987).
      • Constitutional and Legal Position Regarding the Office of Profit.
    • Waqf (Amendment) Bill (2024).

     

    PYQ:

    [2018] With reference to the Parliament of India, which of the following Parliamentary Committees scrutinizes and reports to the house whether the powers to make regulations, rules, sub-rules, by-laws, etc., conferred by the Constitution or delegated by the Parliament are being properly exercised by the Executive within the scope of such delegation?

    (a) Committee on Government Assurances

    (b) Committee on Subordinate Legislation

    (c) Rules Committee

    (d) Business Advisory Committee

  • Police Reforms – SC directives, NPC, other committees reports

    Criminal Tracking Network and Systems (CCTNS)

    Why in the News?

    All 17,130 police stations in India are now connected through the Crime and Criminal Tracking Network and Systems (CCTNS), a centralized online platform for filing FIRs, chargesheets, and investigation reports, accessible to law enforcement across the country.

    About Criminal Tracking Network and Systems (CCTNS):

    What is CCTNS?
    • A centralized online platform to file FIRs, charge-sheets, and investigation reports across 17,130 police stations.
    • Launched in 2009 with a ₹2,000 crore budget under the Ministry of Home Affairs.
    • Aimed at improving efficiency, transparency, and nationwide access to crime data.
    Key Features
    • Nationwide integration, with 100% connectivity across 28 states and 8 Union Territories.
    • Stores data on criminals, habitual offenders, missing persons, stolen vehicles, etc.
    • Generates analytical crime reports and detailed case statistics.
    • Integrated with the ICJS (Integrated Criminal Justice System) for coordination with courts, forensics, and other criminal justice pillars.
    Recent Modifications for New Criminal Laws
    • Incorporates the 2024 Bharatiya Nyaya Sanhita (erstwhile IPC), Bharatiya Sakshya Adhiniyam (Indian Evidence Act), and Bharatiya Nagarik Suraksha Sanhita (CrPC).
    • Introduces mandatory videography for crime scenes in serious cases, forensic investigations, and arrest transparency (including officer approval and informing relatives).
    • Updates include timely progress reports and digital reporting of daily diaries.
    Impact and Implementation
    • Facilitates efficient investigations by providing access to comprehensive crime data and analytical tools.
    • Improves police coordination across states and law enforcement agencies.
    • Enhanced citizen services with online tracking of complaints and case updates.
    • Supported by the National Crime Records Bureau (NCRB) and integrated with other public safety platforms for better coordination and resource management.

     

    PYQ:

    [2014] We are witnessing increasing instances of sexual violence against women in the country. Despite existing legal provisions against it, the number of such incidences is on the rise. Suggest some innovative measures to tackle this menace.

  • Foreign Policy Watch: India-China

    Places in News: Kailash Mansarovar

    Places in News: Kailash Mansarovar

    Why in the News?

    • India and China have agreed to resume the Kailash-Mansarovar Yatra.
      • The pilgrimage has been suspended since 2020 due to the COVID-19 pandemic and non-renewal of arrangements by China.

    India-China Talks on Border Management:

    • Disengagement and De-escalation: Agreed to continue implementing the October 2024 disengagement agreements for safe patrolling and grazing in certain areas.
    • Peace and Tranquility: Both sides agreed to maintain peace along the border and implement effective border management mechanisms.
    • Resolution of Boundary Dispute: Continued efforts toward a mutually acceptable solution to the boundary dispute.
    • Cross-Border Cooperation: Discussions included river cooperation, Nathula border trade, and other exchanges to strengthen bilateral relations.

    About Kailash Mansarovar:

    • Kailash Mansarovar is a sacred religious site located in the Tibetan Autonomous Region of China, near the borders of India, Nepal, and Tibet.
    • It consists of Mount Kailash, a peak considered to be the abode of Lord Shiva in Hinduism, and Mansarovar Lake, a high-altitude freshwater lake revered in Hinduism, Buddhism, Jainism, and Bon traditions.
    • Geographical Location:
      • Mount Kailash stands at an elevation of 6,638 meters (21,778 feet), making it one of the most difficult and revered peaks to approach.
      • The Mansarovar Lake is located at an altitude of 4,556 meters (14,950 feet) and spans approximately 88 square kilometers.
      • The region lies in the Tibetan Plateau.

    Religious Significance:

    1. Hinduism:
      • Mount Kailash is considered the abode of Lord Shiva and his consort Parvati. Pilgrims believe that a pilgrimage to Kailash is essential for liberation and salvation (Moksha).
      • Mansarovar Lake is believed to have been created by Lord Brahma. Bathing in its holy waters is believed to cleanse sins and grant spiritual merit.
    2. Buddhism:
      • The region is sacred as it is believed to be the home of Buddha Demchok, who represents supreme bliss.
      • The lake is also linked to the Jambhala, the god of wealth in Tibetan Buddhism.
    3. Jainism:
      • Jain tradition holds that Lord Rishabhanatha, the first Tirthankara, attained Nirvana at the peak of Mount Kailash.
    4. Bon Religion:
      • For practitioners of Bon, an ancient religion indigenous to Tibet, Kailash is regarded as the sacred center of the universe.

    Route and Access:

    • India to Kailash Mansarovar: The pilgrimage is generally undertaken through the Lipulekh Pass, a high-altitude pass that connects Uttarakhand (India) with Tibet.
    • Pilgrims usually travel through Nepal, and the journey is conducted via Kailash Mansarovar Yatra (KMY) under the Ministry of External Affairs (MEA).
    • Travel to Mount Kailash and Mansarovar Lake is restricted, and permits are required from the Chinese government.
    • Pilgrims from India are primarily facilitated through the Kailash Mansarovar Yatra organized by the Government of India and other authorized agencies.

    PYQ:

    [2016] Border management is a complex task due to difficult terrain and hostile relations with some countries. Elucidate the challenges and strategies for effective border management.

  • Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

    Making affordable generics more reliable

    Why in the News?

    India’s decentralised drug regulation system dominated by State Drug Regulatory Authorities causes inconsistent quality standards. Strengthening oversight is essential to ensure generics are as affordable and effective as branded drugs.

    How Reliable Are Generic Medicines?

    • Bioequivalence to Innovators: Generic medicines are bioequivalent to brand-name drugs, meaning they have the same active ingredient and are intended to work the same way.
    • Affordability and Accessibility: Generics significantly lower healthcare costs, making treatment more accessible, especially for low-income populations.
    • Challenges in Quality: Despite their potential, the reliability of generics has been questioned due to variability in therapeutic outcomes, often caused by differences in excipients, manufacturing processes, and bioequivalence thresholds.

    What are the main quality concerns associated with it?

    • Efficacy and Bioavailability: Studies have shown that while generics are bioequivalent to branded drugs, they may not always achieve the same therapeutic levels.
      • For example, a study on itraconazole showed that only 29% of patients using generic versions achieved the right drug levels in their body within two weeks, compared to 73% of patients using the original branded drug.
    • Manufacturing Variability: The manufacturing processes for generics can differ significantly from those of branded drugs. Variations in excipients (binders, fillers) and production methods can lead to differences in tablet hardness, dissolution rates, and overall drug stability. This variability can result in inconsistent therapeutic outcomes.
    • Regulatory Oversight: India’s decentralized drug regulation system contributes to inconsistent quality standards across states.
      • The Central Drugs Standard Control Organisation (CDSCO) has limited authority over State Drug Regulatory Authorities (SDRAs), leading to regulatory arbitrage where manufacturers exploit weaker oversight. Moreover, the lack of stringent enforcement of stability testing further jeopardizes the quality of generics available in the market.

    What regulatory reforms are needed?  

    • Centralisation of Drug Regulation: A comprehensive overhaul of India’s drug regulation system is necessary. Centralising oversight under the CDSCO would help enforce consistent quality standards across all states and reduce the risk of substandard drugs entering the market.
    • Enhanced Stability Testing Protocols: Uniform stability testing protocols should be established to ensure that all generics maintain their quality under various climatic conditions. This would involve periodic reassessment of approved generics to uphold their efficacy over time.
    • Stricter Impurity Standards: Aligning India’s Pharmacopoeia with international standards regarding permissible impurity levels would improve the overall quality of generic medicines available in the market.

    How can patient and healthcare provider perceptions of generics be improved? (Way forward)

    To enhance patient and healthcare provider confidence in generic medicines, several strategies can be employed:

    • Public Awareness Campaigns: Educating patients about the efficacy and safety of generics compared to branded drugs can help dispel misconceptions that higher-priced medications are superior.
    • Incentives for Healthcare Providers: Offering incentives for prescribing generics can encourage healthcare professionals to recommend these cost-effective alternatives more frequently.
    • Strengthening Quality Assurance: Implementing stronger regulatory frameworks and ensuring compliance with quality standards can build trust among both patients and providers regarding the reliability of generics.

    Mains PYQ:

    Q Why is there so much activity in the field of biotechnology in our country? How has this activity benefitted the field of biopharma? (UPSC IAS/2018)

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