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  • In news: Operation Storm Makers II

    Central Idea

    • The Interpol operation Storm Makers II against fraud schemes fuelled by victims of human trafficking has unearthed further evidence that the trend is expanding beyond the Southeast Asian region.

    About Operation Storm Makers II

    • This operation was a special mission organized by Interpol Headquarters in Lyon, France.
    • The operation took place from October 16 to 20.
    • It involved law enforcement in 27 countries across Asia and other regions.

    The operation targeted human trafficking and cyber scams. It resulted in:

    1. Rescue of 149 human trafficking victims
    2. Hundreds of arrests
    3. More than 270,000 inspections and police checks

    Back2Basics: INTERPOL

    Details
    Full Name International Criminal Police Organization
    Member Countries Comprises 195 member countries
    Function Facilitates coordination among police forces globally; shares data on crimes and criminals
    Headquarters Located in Lyon, France
    Global Complex Has a Global Complex for Innovation in Singapore
    Satellite Offices Several regional offices in different parts of the world
    India’s Membership Joined in June 1956
    National Central Bureau (NCB) Each member country has an NCB; in India, it’s under the Ministry of Home Affairs (MHA)

    NCBs are the contact points for Interpol’s General Secretariat and other NCBs; run by police officials of the country
    Databases Manages 19 police databases with real-time access to information on crimes and criminals
    Investigative Support Provides forensic, analysis, and assistance in locating fugitives globally
    Red Notice (RN) Issued to alert police worldwide about fugitives wanted for prosecution or to serve a sentence; for provisional arrest pending extradition or similar legal action

  • PM Vishwakarma Scheme: Empowering Traditional Craftspeople

    vishwakarma

    Central Idea

    • The PM Vishwakarma Scheme, launched by the Centre on September 17, has received over 21 lakh applications in two and a half months, data from the Ministry of Skill Development and Entrepreneurship (MSDE) show.

    PM Vishwakarma Scheme

    • The PM Vishwakarma Scheme boasts an impressive allocation of Rs 13,000 crore, fully funded by the Central government.
    • It aims to benefit individuals predominantly from the OBC community engaged in traditional skills and crafts such as carpentry, gold-smithing, masonry, laundry services, and more.
    • The scheme derives its name from Vishwakarma, a revered figure in Hindu mythology known as the architect of the gods.
    • Vishwakarma was the divine carpenter and master craftsman responsible for crafting the gods’ weapons, building their cities and chariots.
    • He is considered the patron deity of workers, artisans, and artists.

    Eligibility for the Scheme

    • Supported Sectors: The PM Vishwakarma Scheme extends assistance to families associated with 18 diverse sectors, including carpentry, boat making, blacksmithing, goldsmithing, pottery, and more.
    • Registration: Vishwakarma workers can register for free through Common Services Centres using the biometric-based PM Vishwakarma portal.

    Features of the Scheme

    • Recognition: Workers will receive recognition through the PM Vishwakarma certificate and ID card.
    • Skill Upgradation: The scheme offers basic and advanced training to enhance skills.
    • Toolkit Incentive: Artisans receive a toolkit incentive of ₹15,000.
    • Credit Support: Collateral-free credit support is provided up to ₹1 lakh (first tranche) and ₹2 lakh (second tranche) at a concessional interest rate of 5%.
    • Digital Transactions: Incentives for digital transactions and marketing support are available.
    • Knowledge Enhancement: A toolkit booklet, available in 12 Indian languages with accompanying videos, helps workers stay updated on new technologies in their field.
    • Skill Training Stipend: Artisans can benefit from a stipend of Rs 500 for skill training and Rs 1,500 for purchasing modern tools.
    • Coverage: The scheme aims to cover five lakh families in the first year and 30 lakh families over five years.
    • Global Integration: It also seeks to integrate Vishwakarma into domestic and global value chains.

    Need for such scheme

    • Traditional craftsmen and skilled artisans, often taught these crafts by family elders, have encountered several hurdles.
    • These include a lack of professional training, access to modern tools, geographical remoteness from relevant markets, and limited capital for investment.

  • Protecting Basic Structure from judicial arbitrariness

    1973: Kesavananda Bharati case - Frontline

    Central idea 

    The article reflects on the 50th anniversary of the Kesavananda Bharati case, emphasizing the enduring significance of the “Basic Structure Doctrine” in safeguarding constitutional pillars. It acknowledges debates surrounding its constitutional validity and introduces insights from jurist Dietrich Conrad, highlighting the need for checks and balances on institutional powers.

    Key Highlights:

    • 50th Anniversary of Kesavananda Bharati Case: Marks the establishment of the “Basic Structure Doctrine” by the Supreme Court of India in 1973, consistently upheld but occasionally questioned for its open-ended nature.
    • Dietrich Conrad’s Contribution: Acknowledges the influence of Dietrich Conrad, a German jurist, whose lecture on “Implied Limitation of the Amending Power” laid the foundation for the Basic Structure doctrine in India.
    • Arun Jaitley’s Critique: Former Finance Minister Arun Jaitley’s critique highlights concerns about the doctrine potentially undermining other constitutional mandates.

    Key Challenges:

    • Constitutional Validity Doubts: Doubts raised about the constitutional validity of the Basic Structure doctrine, questioning its open-ended nature and the exclusive powers it grants to the Supreme Court.
    • Potential Undermining of Other Mandates: Criticisms, exemplified by Arun Jaitley’s statement, argue that the doctrine, while upholding judicial independence, may diminish other vital constitutional structures.

    Key Terms and Phrases:

    • Basic Structure Doctrine: Judicial principle recognizing fundamental features of the Constitution, protecting them from amendments or legislative interventions.
    • Implied Limitation of Amending Power: Concept stressing the need for limitations on powers exercised by institutions, anticipating extreme cases of conflict.

    Key Quotes:

    • “The judgment has upheld the primacy of one basic structure — independence of judiciary — but diminished five other basic structures of the Constitution.” – Arun Jaitley
    • “Any amending body… cannot by its very structure change the fundamental pillars supporting its constitutional authority.” – Dietrich Conrad
    • “The basic structure of our Constitution, like a north star, guides and gives a certain direction to the interpreters and implementers of the Constitution when the path ahead is convoluted.” – Chief Justice D Y Chandrachud

    Key Examples and References:

    • Emergency Period: Recognition that the Basic Structure doctrine prevented potential recasting of the Constitution during the Emergency in 1975.
    • Constitutional Pillars: Arun Jaitley’s reference to the primacy of judicial independence but potential diminishment of parliamentary democracy, elected government, etc.

    Key Facts and Data:

    • Kesavananda Bharati Case: Celebrates the 50th anniversary of the case that established the Basic Structure Doctrine.
    • Legislative Interventions during Emergency: Historical context emphasizing the need for checks and balances on parliamentary powers.

    Critical Analysis:

    • Debate on Doctrine’s Validity: Ongoing debate about the constitutional validity of the Basic Structure doctrine, particularly its potential impact on other constitutional mandates.
    • Checks and Balances Necessity: Acknowledgment of the necessity for judicial checks and balances on parliamentary powers, especially in the context of historical abuses during the Emergency.

    Way Forward:

    • Deeper Understanding of Jurisprudential Foundations: Emphasizes the importance of a fuller appreciation of the jurisprudential foundations of legal doctrines, including the Basic Structure doctrine.
    • Reducing Judicial Arbitrariness: Proposes a thoughtful examination of how judicial arbitrariness in deciding the Basic Structure can be minimized, ensuring greater legitimacy and transparency.
    • Public Demand for Transparency: Addresses the contemporary need for transparency in the functioning of democratic institutions, aligning with a changing information age and public demands.

  • The hypocrisy of Western democracy

    Understanding the Israel-Palestine conflict - Frontline

    Central idea 

    The article explores the tragic situation in Palestine, emphasizing the West’s complicity in enabling Israel’s actions. It highlights the suppression of freedom of expression, media bias, and challenges in Europe, calling for an exposé of Western democracies’ hypocrisies and a truthful reckoning to address the root causes of Palestinian oppression.

    Key Highlights:

    • Tragic Toll: The passage reveals the staggering death toll of over 17,000 Gazans since October 7, underscoring the magnitude of the ongoing tragedy.
    • West’s Enabling Role: The West is implicated in enabling Israel’s actions through support, framing the conflict, and reducing Palestine to the actions of Hamas.

    Key Challenges:

    • Freedom of Expression Suppression: Western societies, despite professing democracy, are suppressing freedom of expression, particularly in universities, where pro-Palestine advocates face public exposure.
    • Media Bias: The media, a significant influencer, is criticized for its overwhelming bias towards Israel, neglecting the historical roots and international illegality of Israeli occupation.

    Key Terms and Phrases:

    • Zionism and Apartheid: These terms highlight ideological aspects and the discriminatory nature of certain Israeli policies.
    • Genocidal Intent and Settler Colonialism: These phrases emphasize the severity of actions and the historical context of Israeli actions in Palestinian territories.

    Key Quotes:

    • “The West has shockingly enabled this [tragedy] in various ways,” pointing to the culpability of Western nations.
    • “The media has been key in framing the Palestine-Israel conflict for 75 years,” exposing the media’s role in shaping public perception.

    Key Examples and References:

    • University Actions: Instances of Harvard and Columbia exposing details of pro-Palestine students highlight the suppression faced by advocates.
    • European Countries’ Stance: The passage cites bans on pro-Palestinian protests in countries like the U.K., France, Germany, and Italy as concrete examples of European support for Israel.

    Key Facts and Data:

    • Death Toll: Over 17,000 Gazans killed since October 7, quantifying the scale of the tragedy.
    • Harvard’s Philanthropy Dependency: Highlighting that 45% of Harvard’s revenue in 2022 came from philanthropy underscores the potential influence of donors.

    Critical Analysis:

    • Suppression of Free Speech: The critical analysis underscores the severe impact of suppressing freedom of expression on informed dialogue.
    • Media’s Role: Emphasizing media bias prompts reflection on the potential manipulation of public opinion.

    Way Forward:

    • Expose Hypocrisies: Advocates for change should actively expose the hypocrisies of Western democracy, challenging the status quo.
    • Acknowledge Complicity: A call to acknowledge Western complicity in Palestinian oppression encourages introspection and accountability.
    • Listen to Dissenting Voices: Encouraging the acknowledgment of dissenting voices, including Jewish dissenters, fosters a more inclusive dialogue.
    • Truthful Reckoning: Highlighting the need for a truthful reckoning emphasizes the importance of understanding historical roots and actions for a sustainable resolution.

  • Expulsion of MP from Lok Sabha

    MP expulsion mahua moitra

    Central Idea: Expulsion of Mahua Moitra

    • A Member of Parliament from West Bengal was expelled from the Lok Sabha over allegations of a cash-for-query scandal.
    • Her expulsion highlights the importance of maintaining strict ethical standards and parliamentary etiquette in legislative proceedings.

    Parliamentary Etiquette and Rules

    • Expected Conduct of MPs: MPs must adhere to rules of parliamentary etiquette, such as not interrupting speeches, maintaining silence, and avoiding obstruction during debates.
    • Updated Rules for Modern Protests: In 1989, rules were updated to include prohibitions against shouting slogans, displaying placards, tearing documents, and using electronic devices for protest in the House.
    • Rajya Sabha’s Similar Rules: The Rajya Sabha, like the Lok Sabha, has similar rules to ensure smooth conduct of proceedings.

    Power of Suspension in Parliament

    • Presiding Officer’s Authority: The presiding officer of each House can direct an MP to withdraw from the chamber for disorderly conduct, resulting in absence for the day.
    • Naming and Suspension Process: MPs obstructing House business can be “named” by the presiding officer, leading to a possible suspension motion by the Parliamentary Affairs Minister.
    • Duration of Suspension: Suspensions can last until the end of the session.

    Legal Recourse: Approaching the Supreme Court

    • Option for Judicial Review: The expelled MP has the option to challenge the expulsion in the Supreme Court, as explained by former Lok Sabha Secretary General P D T Achary.
    • Constitutional Provisions: Article 122 of the Constitution provides immunity to parliamentary proceedings from judicial scrutiny based on procedural irregularity.
    • Scope for Judicial Review: Despite this immunity, the Supreme Court in the 2007 Raja Ram Pal case clarified that judicial review is possible in cases of substantive or gross illegality.

    The Raja Ram Pal Case (2007)

    • Case Background: Raja Ram Pal, a BSP leader, was among 12 MPs expelled in the 2005 cash-for-query scam.
    • Supreme Court’s Stance: The Court upheld the expulsion but noted that proceedings tainted by substantial illegality are open to judicial scrutiny.
    • Judicial Review of Parliamentary Actions: The Court affirmed its role in scrutinizing legislative actions that infringe on fundamental rights.

    Article 105 of the Constitution

    • Powers and Privileges of Parliament: Article 105 deals with the powers, privileges, and immunities of Parliament and its Members.
    • Judicial Scrutiny of Privilege Enforcement: The Court recognized that the enforcement of privilege by the legislature can be subject to judicial review, within certain constitutional limits.

    Grounds for Challenging Expulsion

    • Examining Privilege and Procedure: The court can scrutinize whether the privilege cited for expulsion existed and if proper procedures were followed.
    • Functioning of Committees: The roles of the Privileges Committee and Ethics Committee are distinct, focusing on investigating misconduct and ensuring dignity in the House.
    • Investigative Procedures: Proper investigative procedures, including the right to depose and cross-examine, are essential for fairness and truth-finding.

    Determining Offense and Punishment

    • Article 20 of the Constitution: This article stipulates that punishment requires an existing law defining the act as an offense.
    • Case-Specific Issues: In the case of the expelled MP, issues like sharing Parliament login-passwords and accepting money for questions are examined for rule violations.
    • Breach of Privilege and Inquiry: Accepting money for asking questions in Parliament is a breach of privilege warranting inquiry by the Privileges Committee.

    Conclusion

    • Ongoing Debate and Implications: The case continues to spark debate on the limits of parliamentary privilege, the role of the judiciary, and the ethical standards expected of elected representatives.
    • Balancing Authority and Rights: The expulsion case underscores the delicate balance between parliamentary authority and the rights of its members.
    • Importance of Judicial Oversight: The potential for judicial review emphasizes the importance of legal oversight in maintaining democratic principles and fairness in legislative processes.

  • Advisory issued against drug ‘Meftal’

    Central Idea

    • Pharma standard body Indian Pharmacopoeia Commission (IPC) has issued a drug safety alert for commonly used painkiller mefenamic acid, popularly sold under the brand name Meftal.

    What is Meftal used for?

    • Meftal 500, a non-steroidal anti-inflammatory drug (NSAID) is usually prescribed in treatment for conditions like menstrual pain, headache, muscle, joint, or dental pain.
    • It has been advised to take the table with food.
    • The most common side effects of the medicine include mild vomiting, stomach pain, nausea, headache, and dizziness.

    What does the alert against Meftal say?

    • IPC stated that a preliminary analysis of adverse drug reactions from the Pharmacovigilance Programme of India (PvPI) database revealed drug reactions with eosinophilia and systemic symptoms (DRESS) syndrome.
    • DRESS, also known as drug induced hypersensitivity syndrome, is an adverse drug reaction that can even be life threatening.
    • It may cause damage to several organs, especially to the kidneys, heart, lungs, and pancreas.
    • The mortality rate is high and is about 10 per cent.

    Back2Basics: Indian Pharmacopoeia Commission (IPC)

    Details
    Establishment 1956,

    An autonomous body under the Ministry of Health and Family Welfare
    Primary Objective To promote public health by setting and updating standards for drug quality in India.
    Key Publication Indian Pharmacopoeia (IP), a legally recognized book of drug standards.
    Role in Drug Regulation Standards set in the IP are enforceable by law, crucial for India’s drug regulatory framework.
    International Recognition Collaborates with WHO and aligns with global drug standards.
    Pharmacovigilance Program Involved in monitoring and analyzing adverse drug reactions through the PvPI.
    Quality Control & Training Engages in drug quality control and provides training to regulatory bodies and the pharmaceutical industry.
    Publication Updates Periodically updates the IP to include new drugs and revise existing standards.
    Collaboration Works with the pharmaceutical industry, academia, and regulatory bodies.
    Global Harmonization Aims to harmonize the IP with international pharmacopoeias like the USP and BP.

  • Why Parliament passed the Advocates Amendment Bill?

    Central Idea

    • The primary aim of the recent legislative changes is to eliminate ‘touts’ from the legal system and streamline legal practice in India.
    • The Legal Practitioners Act, 1879, a colonial-era law, and the Advocates Act, 1961, have been central to the regulation of legal practitioners in India.
    • The Bill repeals the 1879 Act and amends the 1961 Act to reduce redundant laws and repeal obsolete ones.

    The Legal Practitioners Act, 1879

    • Inception and Scope: Enacted in 1880, it aimed to consolidate the law relating to legal practitioners in certain Indian provinces.
    • Definition of Legal Practitioner: The Act defined legal practitioners as advocates, vakils, or attorneys of any High Court.
    • Introduction of ‘Tout’: A significant aspect was the definition of ‘tout’, referring to individuals who procure clients for legal practitioners for remuneration.

    The Advocates Act, 1961

    • Consolidation of Legal Practice Laws: This Act was enacted to unify and amend laws relating to legal practitioners and establish Bar Councils and an All-India Bar.
    • Pre-1961 Legal Framework: Previously, legal practitioners were governed by multiple acts, including the 1879 Act.
    • Law Commission and All-India Bar Committee Recommendations: Post-independence, reforms were suggested by the Law Commission and the All-India Bar Committee, leading to the 1961 Act.

    The Advocates Amendment Bill, 2023

    • New Provisions: The Bill introduces a new section (Section 45A) in the 1961 Act, focusing on illegal practice and the regulation of touts.
    • Punishment for Illegal Practice: It prescribes imprisonment for persons illegally practicing in courts and other authorities.
    • Regulation of Touts: The Bill empowers High Courts and district judges to frame and publish lists of touts, ensuring due process before inclusion.
    • Penalties for Touts: It includes provisions for punishing individuals acting as touts with imprisonment, fines, or both.

    Rationale and Implications

    • Streamlining Legal Enactments: The Bill aims to reduce superfluous laws and repeal those that have become obsolete.
    • Government’s Policy on Obsolete Laws: In line with the government’s policy to repeal outdated pre-independence Acts, the Bill seeks to modernize legal practice regulations.
    • Consultation with Bar Council of India: The amendments were made in consultation with the Bar Council of India, reflecting a collaborative approach to legal reform.

    Conclusion

    • Addressing Legal System Complexities: The Bill addresses long-standing issues in the legal system, particularly the exploitation of legal complexities by touts.
    • Balancing Tradition and Modern Needs: By repealing outdated laws and amending existing ones, the Bill balances the need to respect legal traditions with the demands of contemporary legal practice.
    • Future Outlook: These changes are expected to enhance the integrity and efficiency of legal practice in India, contributing to a more transparent and accessible legal system.

  • Essential Services Maintenance Act (ESMA) and Its Implications

    Central Idea

    • The Odisha Government invoked its Essential Services (Maintenance) Act (ESMA) prohibiting strikes by paramedical staff, including nurses, pharmacists and technicians to ensure that medical services are not disrupted.

    About Essential Services Maintenance Act (ESMA)

    • Description: The Essential Services Maintenance Act (ESMA) is a significant piece of legislation enacted by the Parliament in 1968.
    • Constitutional Placement: It falls under list no. 33 in the 7th schedule under the concurrent list of the Indian Constitution.
    • Purpose: ESMA is primarily used by states to manage strikes by employees, especially in essential services.
    • Essential Services: The Act empowers the government to designate any economic activity or service as ‘essential’, where disruption would impact the normal life of people.

    Provisions and Powers under ESMA

    • Police Authority: The Act grants police the authority to arrest protestors without a warrant if they violate the provisions of ESMA.
    • State-Specific Provisions: Each Indian state has its unique version and provisions of the ESMA.

    Right to Strike in Context

    • Worker’s Basic Right: Striking is a fundamental means for workers to legitimately promote and defend their economic and social interests.
    • Legal Status: While the right to protest is a fundamental right under Article 19 of the Indian Constitution, the right to strike is a legal right with certain restrictions.
    • Industrial Dispute Act 1947: This act outlines the legal framework and restrictions for strikes, especially in public sectors and essential services.
    • Restrictions in Specific Sectors: Strikes are particularly restricted for public sector employees, banking, oil, metropolitan transport, and education sectors under state jurisdiction.

    International Labor Organization (ILO) and the Right to Strike

    • ILO’s Stance: The ILO’s Committee on Freedom of Association has established principles regarding the right to strike.
    • Essential Services Definition: Essential services are those whose interruption could endanger the life, safety, or health of part or all of the population.
    • Examples of Essential Services: The committee identifies sectors like hospitals, electricity, water supply, telephone services, and air traffic control as essential services.
    • Restriction on Strikes: Employees in these essential services are generally not permitted to strike.

    Problems and Criticisms of ESMA

    • Irresponsible Use: The Act has been criticized for its sometimes irresponsible and unwise implementation.
    • Suppression of Democratic Rights: ESMA is seen as monopolizing power and suppressing the democratic rights of stakeholders, particularly the right to protest or strike.
    • Government’s Overpowering Role: Critics argue that ESMA dangerously skews the balance in industrial relations towards the government in the public sector.

    Conclusion

    • Debate on ESMA’s Role: The Essential Services Maintenance Act remains a contentious topic, balancing the need for uninterrupted essential services with the rights of workers to strike.
    • Need for Responsible Implementation: Responsible and democratic application of ESMA is crucial to maintain this balance.
    • Ongoing Discussions: The Act continues to spark debate about the extent of government power and the protection of workers’ rights in essential sectors.

  • Bridge this deficit between India and Sri Lanka

    India raises Sri Lankan Tamil issue in UN - Civilsdaily

    Central idea 

    The central idea revolves around Sri Lanka’s renewed proposal for land connectivity with India, emphasizing economic integration. Despite historical challenges, the persisting vision, including a proposed bridge and power grid, highlights the potential for mutually beneficial ties.

    Key Highlights:

    • Sri Lanka’s President Ranil Wickremesinghe proposed land connectivity with India for regional economic integration.
    • The idea dates back to 2003, with a proposed bridge between Rameswaram (India) and Talaimanar (Sri Lanka).
    • Despite opposition, the concept persisted, finding mention in a joint statement between Wickremesinghe and PM Modi in 2023.
    • Land connectivity aims to utilize ports in Colombo and Trincomalee for supply needs in southwest and southeast India.

    Key Challenges:

    • Opposition from groups representing Sinhalese-Buddhists has historically hindered progress.
    • The power grid project, initiated in 1970, has faced delays, with no electricity transmitted despite a memorandum of understanding.
    • Slow progress in implementing the India-Sri Lanka Free Trade Agreement, signed in 1998.
    • Tardiness in bilateral economic ties, despite India being the largest source of imports for Sri Lanka.

    Key Terms:

    • Land Connectivity: Proposal for physical linkage between India and Sri Lanka for economic integration.
    • Free Trade Agreement: Trade deal signed in 1998 between India and Sri Lanka.
    • Power Grid: Project aiming to connect the electricity networks of India and Sri Lanka.

    Key Phrases:

    • “Feasibility study for connectivity will be conducted at an early date” (Joint statement, 2023).
    • “Utilize Colombo port to meet the supply needs of southwest India and Trincomalee port for southeast India” (Budget address, 2023).

    Key Quotes:

    • “We expect to utilize Colombo port to meet the supply needs of southwest India and Trincomalee port to meet the supply needs of southeast India” (Wickremesinghe, Budget address, 2023).

    Key Statements:

    • “The relationship in infrastructure development should be deeper” (Author’s viewpoint).
    • “The progress of the transmission network project does not reflect well on the two countries” (Author’s observation).

    Key Examples and References:

    • Nitin Gadkari’s announcement of the Asian Development Bank’s willingness to fund the bridge project in 2015.
    • India’s successful energy collaboration with Bangladesh, highlighting the contrast with Sri Lanka.

    Key Facts and Data:

    • India-Sri Lanka bilateral trade in 2021: $5.45 billion.
    • Bangladesh-India bilateral trade in 2021: $18.14 billion.

    Critical Analysis:

    • Despite historical challenges, Sri Lanka should capitalize on recent positive developments.
    • The comparison with Bangladesh emphasizes the potential for mutually-beneficial economic relationships.
    • Acknowledges the need for sustained momentum in economic ties.

    Way Forward:

    • Overcome historical challenges and focus on mutually-beneficial economic relationships.
    • Prioritize the implementation of proposed projects, including land connectivity and the power grid.
    • Build on recent positive developments to enhance economic ties.
    • Address opposition through inclusive dialogue and communication.
    • Expedite the feasibility study for land connectivity and other collaborative projects.

  • India’s alarming ‘fixed dose combination’ problem

    Antimicrobial resistance is rising in India, says ICMR report | Mumbai News - Times of India

    Central idea 

    The study reveals a startling prevalence of unapproved and banned Fixed Dose Combinations (FDCs) of antibiotics in India, posing risks of antimicrobial resistance. The pharmaceutical industry’s exploitation of FDCs to evade regulations, coupled with regulatory inefficiencies, calls for urgent interventions to safeguard public health

    Key Highlights:

    • Alarming Prevalence: In 2020, 60.5% of antibiotics in India were unapproved FDCs, with an additional 9.9% banned, raising concerns about antimicrobial resistance.
    • Patient Compliance vs. Risks: FDCs, aimed at improving patient adherence, pose risks due to potential interactions between combined drugs, necessitating a stringent approval process.
    • Pharmaceutical Industry’s Strategy: Exploitation of FDCs allows the industry to evade drug price regulations, contributing to the proliferation of irrational combinations.

    Key Challenges:

    • Regulatory Framework Inefficiency: Continued sale of unapproved FDCs highlights regulatory inefficiency, allowing non-compliance despite existing legal provisions.
    • Reactive Regulatory Measures: Reliance on Section 26A orders reveals a reactive rather than proactive regulatory approach, indicating systemic challenges.

    Key Terms:

    • Fixed Dose Combination (FDC): Combinations of multiple drugs in a single dosage form, potentially affecting drug interactions and therapeutic efficacy.
    • Antimicrobial Resistance (AMR): The ability of microorganisms to resist the effects of medications, posing a global health threat.

    Key Phrases:

    • Pharmaceutical Industry’s Exploitation: The strategic use of FDCs to avoid regulatory scrutiny undermines the integrity of drug pricing and quality.
    • Ineffectiveness of Regulatory Measures: Despite legal provisions, the regulatory system relies on reactive prohibitions rather than proactive prevention.

    Key Quotes:

    • “Unapproved FDCs may contribute to the AMR problem in India.”
    • “The pharmaceutical industry gets to provide its own standards for government testing of FDCs.”

    Key Statements:

    • Extent of the Issue: The study underscores the alarming prevalence of unapproved and banned FDCs in India, emphasizing the urgent need for regulatory intervention.
    • Industry Motives: The article critically examines the pharmaceutical industry’s profit-driven motives, exposing the imbalance between pseudo-innovation for profit and genuine drug development.
    • Regulatory Challenges: Scrutiny of regulatory challenges and legal inconsistencies indicates a systemic failure in ensuring the safety and efficacy of pharmaceutical products.

    Key Examples and References:

    • Academic Study: Reference to the academic study published in the Journal of Pharmaceutical Policy and Practice (2023) highlighting the extent of unapproved FDCs.
    • Historical Context: Tracing the issue back to 1978 and subsequent regulatory amendments provides context to the ongoing challenges.

    Critical Analysis:

    • Industry Practices: The article critically examines the pharmaceutical industry’s motives, highlighting the imbalance between pseudo-innovation for profit and genuine drug development.
    • Regulatory Challenges: Scrutiny of regulatory challenges and legal inconsistencies indicates a systemic failure in ensuring the safety and efficacy of pharmaceutical products.

    Way Forward:

    • Urgent Regulatory Actions: Emphasizes the need for regulatory actions to address the menace of unapproved and banned FDCs, preventing potential contributions to antimicrobial resistance.
    • Proactive Regulatory Framework: Calls for a proactive regulatory framework that prioritizes public health over industry interests and plugs existing legal loopholes.