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Subject: Governance

Important aspects of Society

  • [15th July 2024] The Hindu Op-ed: The problem with the Karnataka Gig Workers Bill

    [15th July 2024] The Hindu Op-ed: The problem with the Karnataka Gig Workers Bill

    PYQ Relevance:

    Mains: 

    Q) Examine the role of ‘Gig Economy’ in the process of empowerment of women in India. (UPSC IAS/2021)
    Q) Can the strategy of regional-resource-based manufacturing help in promoting employment in India?  (UPSC IAS/2019)

    Prelims:
    Consider the following statements: (UPSC IAS/2017)
    1. The Factories Act, 1881, was passed with a view to fix the wages of industrial workers and to allow the workers to form trade unions.
    2. N.M. Lokhande was a pioneer in organizing the labour movement in British India.Which of the statements give above is/are correct?
    (a) 1 only
    (b) 2 only
    (c) Both 1 and 2
    (d) Neither 1 nor 2

    Note4Students: 

    Prelims: Right to Employment; Social Welfare Policies of the Government;

    Mains:  Gig Workers and Economy; Minimum Wage Policies adopted in India;

    Mentor comment: Last time we discussed that Gig workers are independent contractors, freelancers, or often through online platforms, rather than being employed in traditional long-term employer-employee relationships. We also studied the key highlight of the Bill proposed for the welfare of gig workers. Gig workers are often excluded from social security and labor legislation due to their ambiguous employment status. In India, we lack a comprehensive code coverage for their security. In this aspect, we need to study the areas of scope where we can bring out significant change in governance and policy frameworks.

    Let’s learn!

    __

    Why in the news? 

    The Karnataka Platform-based Gig Workers (Social Security and Welfare) Bill, 2024 follows a similar model to the Rajasthan Platform-Based Gig Workers (Registration and Welfare) Act, 2023, which also established a welfare board for gig workers.

    • However, critics argue that this model does not address the employment relations of gig workers, which is a crucial aspect of their working conditions.

    The rise of Gig work and the work issues associated in India:

    As per the Economic Survey 2020–21, India has emerged as one of the world’s largest countries for flexible staffing, or gig workers.

    Gig Economy Growth:
    • Current Size: Approximately 7.7 million workers.
    • Future Projections: Expected to rise to 23.5 million by 2029-30.
    • Proportion of Livelihood: Comprising around 4% of overall livelihood in the country.

    Job Distribution:
    • Low Skilled Jobs: 31% (e.g., cab driving, food delivery).
    • Medium Skilled Jobs: 47% (e.g., plumbing, beauty services).
    • High Skilled Jobs: 22% (e.g., graphic design, tutoring)
    • The growing gig economy: The number of gig and platform workers in India is rising rapidly, projected to reach 23.5 million by 2030. Gig work is providing livelihoods amid an overall slowdown in employment generation.
    • Work Issues with Gig Employment:
      • Unresolved Issues: Lack of employment relations means no application of protective labor laws. Many gig workers have protested against issues like revenue sharing, working hours, and poor working conditions.
      • No Minimum Earnings: No guarantee of minimum earnings even when available for work.
      • No Regulation on Working Hours: Regular incidents of overwork and accidents. Gig workers demand fair treatment, improved working conditions, and access to social security.
      • Employment Relations: The existing labor laws are inadequate as they are based on traditional employer-employee relationships, which are absent or complicated in the gig economy. 
      • Aggregator companies consider gig workers as independent contractors, while workers see them as employers who control the terms of service.
    Case Study: U.K. Ruling:
    • The UK Supreme Court Ruled that Uber drivers need to be classified as workers who are entitled to minimum wage and paid leave.
    • This verdict helped in setting a precedent for gig economy workers, potentially leading to significant compensation and improved conditions, due to Uber’s control over their work.

    The issue with the Code and Social Security assigned to Gigworkers in India:

    • Prevailing unclear Law:
      • In the Code on Social Security 2020, the Gig workers are included as informal self-employed. Even in other codes, there is no mention of ‘gig workers’ on Wages, Industrial Relations, and Occupational Safety.
      • Now at present, the issue is that the recent legislations introduced in Rajasthan and Karnataka do not define employment relations, using the term “aggregator” instead of employer.
    • Limitations of the Welfare Board Model
      • The welfare board model adopted by Rajasthan and Karnataka provides some benefits but does not replace institutional social security like provident fund, gratuity, or maternity benefits available to regular workers.
      • Historically, welfare boards have been poorly implemented, as seen with the Construction Workers Welfare Act of 1996 and the Unorganized Workers Social Security Act, where funds were inadequately used.
    • Lack of minimum wage and working hour protections
      • The Karnataka Bill discusses income security regarding payment deductions (through cess) but does not guarantee minimum income, wage entitlements, or revenue sharing between aggregators and gig workers.
      • The bill only requires weekly payments without specifying a minimum amount.

    Conclusion: The Karnataka Bill, like the Code on Social Security, 2020 and the Rajasthan Act 2023, fails to address employment relationships in the gig economy. This oversight confuses employment relations and absolves employers of legal obligations, making it difficult to fully protect workers’ rights

  • Release of SDG India Index 2023-24- NITI Aayog     

    Why in the news?

    Overall SDG score for the country is 71 for 2023-24, significant improvement from 66 in 2020-21 and 57 in 2018 (Baseline report).

    About SDG India Index:

    • The SDG India Index is a comprehensive tool developed by NITI Aayog to measure the progress of India and its states/UTs towards achieving the Sustainable Development Goals (SDGs).
    • The index tracks the progress on 113 indicators aligned with the National Indicator Framework of the Ministry of Statistics and Programme Implementation (MoSPI).

    Key highlights and results from the fourth edition of the SDG India Index:     

    • Top Performers: Uttarakhand and Kerala secured the top spots with a score of 79 out of 100, showcasing strong performance across Sustainable Development Goals (SDGs) such as poverty eradication, health, education, and environmental sustainability.
    • National Improvement: India’s overall SDG score improved from 66 points in 2020-21 to 71 points in 2023-24, indicating significant progress in achieving the SDGs nationwide. This improvement reflects efforts in poverty reduction, economic growth, and environmental conservation.
    • State-wise Variations: Bihar ranked lowest with 57 points, indicating areas needing more attention and development. States like Punjab, Manipur, West Bengal, and Assam showed notable improvements, with Punjab leading the pack with an increase of 8 points to reach 76 points.
    • Goal-specific Insights: Goals such as “No Poverty,” “Decent Work and Economic Growth,” and “Life on Land” saw the highest increases in scores, reflecting advancements in income equality, employment opportunities, and biodiversity conservation efforts.
    • Challenges and Focus Areas: Gender Equality received the lowest score at 49 points, highlighting persistent challenges in achieving parity in workforce participation, education access, and political representation. Addressing issues related to hunger and nutrition remains a priority, with the “Zero Hunger” goal scoring 52 points, emphasizing the need for nutritious food access and combating malnutrition.

    How did States and UT performed?    

    • Score Ranges: States’ scores range from 57 to 79, while UTs score between 65 and 77. This indicates an improvement compared to the 2020-21 scores, where the range was 52 to 75 for States and 62 to 79 for UTs.
    • Front Runner Category: There has been a significant increase in the number of States and UTs achieving Front Runner status. In the latest edition, 32 States/UTs scored between 65 and 99, up from 22 in the previous edition. Notably, 10 new States and UTs entered the Front Runner category, including Arunachal Pradesh, Assam, Chhattisgarh, Madhya Pradesh, Manipur, Odisha, Rajasthan, Uttar Pradesh, West Bengal, and Dadra and Nagar Haveli and Daman and Diu.
    • Score Improvements: Across all States and UTs, there has been improvement in composite scores ranging from 1 to 8 points since the 2020-21 edition. Leading in score improvements are Assam, Manipur, Punjab, West Bengal, and Jammu and Kashmir, each showing an increase of 8 points.
    • Methodology: The methodology involves compiling raw data for indicators, setting 2030 targets, normalizing data to a 0-100 score, and calculating Goal scores as means of relevant indicators. The composite score represents an average of all Goal scores, excluding Goal 14 focused solely on coastal States.

    Way forward: 

    • Targeted Interventions for Lagging States: Implement customized, data-driven interventions in States with lower scores, such as Bihar, to address specific challenges in poverty, health, and education.
    • Enhance Focus on Gender Equality and Nutrition: Strengthen policies and programs aimed at improving gender equality and combating malnutrition, particularly by increasing female workforce participation and ensuring access to nutritious food.
  • What is the draft Digital Competition Bill?  

    Why in the news? 

    In February 2023, the Ministry of Corporate Affairs (MCA) established a Committee on Digital Competition Law (CDCL) to assess the necessity for distinct legislation concerning competition within digital markets.

    What is an ex-post framework?

    • An ex-post framework refers to a regulatory approach where authorities intervene and enforce regulations after potentially harmful activities or behaviors have already occurred.
    • In the context of competition law, it means that enforcement actions are taken against anti-competitive practices only after they have been observed or reported.

    How is an ex-post framework different from an ex-ante framework?

    Timing of Intervention:

    • Ex-post framework: Intervenes after anti-competitive conduct has occurred and its effects are observed. It relies on retrospective enforcement based on complaints or identified issues.
    • Ex-ante framework: Proactively sets rules and obligations before anti-competitive behavior happens, aiming to prevent market distortions and protect competition from potential harms.

    Nature of Regulation:

    • Ex-post framework: Reactive in nature, focusing on remedial measures and enforcement actions against established instances of anti-competitive behavior.
    • Ex-ante framework: Proactive in nature, establishing upfront rules and obligations to guide behavior and prevent market abuses by dominant players before they occur.

    Focus and Objectives:

    • Ex-post framework: Focuses on addressing past harms to competition, ensuring fair market practices, and correcting market distortions post-occurrence.
    • Ex-ante framework: Focuses on maintaining competitive markets, promoting innovation, and protecting consumer choice by setting clear rules and preventing anti-competitive behavior from developing in the first place.

    Why does the draft Bill encourage an ex-ante competition regulation?

    • Proactive Prevention: Digital markets exhibit characteristics such as rapid growth, network effects, and economies of scale that can lead to quick and irreversible market dominance. An ex-ante framework allows regulatory authorities to preemptively set rules and obligations to prevent anti-competitive practices before they occur, thereby maintaining market competition and ensuring consumer choice.
    • Timely Intervention: The existing ex-post framework under the Competition Act, 2002 is considered inadequate for digital markets, where traditional enforcement mechanisms may be too slow to effectively address evolving market dynamics and prevent potential harms to competition. An ex-ante approach enables timely intervention and regulatory oversight to curb monopolistic tendencies and promote a level playing field for all market participants.

    What framework does the European Union follow?

    • The European Union follows an ex-ante competition framework under the Digital Markets Act (DMA). It regulates large digital platforms identified as gatekeepers, imposing specific obligations to ensure fair competition.
    • Objectives: To promote competition, innovation, and consumer choice in digital markets by proactively addressing potential market distortions caused by dominant players.

    What are systemically significant digital enterprises (SSDEs)?

    • SSDEs are digital enterprises identified as dominant in specific digital market segments under the draft Digital Competition Bill.Identified through quantitative tests based on financial strength and user reach in India, or qualitatively based on significant influence and market impact.
    • SSDEs are required to operate transparently, refrain from anti-competitive practices like self-preferencing and data misuse, and ensure fair access to their platforms for other businesses.

    Conclusion: Ensure that the criteria used to designate SSDEs are well-defined and balanced. Conduct periodic reviews to adjust these criteria based on market dynamics and technological advancements to accurately capture entities with significant market power without overly burdening smaller players.

    Mains PYQ: 

    Q Examine the impact of liberalization on companies owned by Indians. Are they competing with the MNCs satisfactorily? Discuss. (UPSC IAS/2013)

  • What are the new provisions for Police Officers?  

    Why in the News? 

    The Bureau of Police Research and Development (BPRD) has issued Standard Operating Procedures (SOPs) to assist police officers in implementing these new provisions in the criminal laws.      

    With the new criminal laws coming into effect, how have the basic duties of police officers changed?

    • Registration of FIRs: The officer in charge cannot refuse to register an FIR due to jurisdiction issues. They must register a zero FIR and transfer it to the respective station. Non-registration can attract penal action.
    • Electronic Filing of FIRs: Information for FIRs can be given electronically, which must be signed within three days.
    • Mandatory Videography: Videography is now required during searches, crime scene documentation, and property possession processes. This is to ensure transparency and integrity in investigations.
    • Display of Arrest Information: Information about arrested individuals must be displayed prominently in police stations, ensuring transparency and accountability.

    What are some of the changed provisions concerning arrests of elderly and infirm people?

      • Permission from an officer not below the rank of DySP is required to arrest individuals above 60 years or those who are infirm for offenses punishable by less than three years.
      • Handcuffing is restricted and can only be used if there is a possibility of the person escaping custody or causing harm. This aligns with the Supreme Court guidelines.
    • What about preserving electronic evidence?
      • The new laws emphasize maintaining the sequence of custody for electronic devices to ensure the integrity of evidence.
      • The investigating officer must inform the informant or victim about the progress of the investigation within 90 days.

    How can electronic evidence be stored?

    • Use of eSakshya App: A cloud-based mobile app, eSakshya, allows police to capture photos and videos, ensuring they are geo-tagged and time-stamped.
    • Integration with ICJS: The data captured via eSakshya is part of the Inter-operable Criminal Justice System (ICJS), making it accessible to the judiciary, prosecution, and forensic experts.
    • Training and Equipment: Investigating officers must be provided with electronic devices and proper training to handle and preserve electronic evidence effectively.

    Challenges and Implementation Issues: 

    • Implementation and Training: The transition to new protocols, such as mandatory videography and electronic filing of FIRs, requires extensive training for police officers. 
      • Ensuring that all officers are proficient with the new technology and understand the updated procedures can be a significant logistical and financial challenge.  
    • Infrastructure and Connectivity: Effective implementation of electronic evidence preservation and zero FIR registration demands robust digital infrastructure and reliable internet connectivity, especially in remote or rural areas. 
      • Many police stations may lack the necessary resources or face frequent connectivity issues, potentially hindering the timely and accurate processing of electronic evidence and FIRs.  

    Way forward:

    • Need Enhanced Training Programs: Implement comprehensive training programs for police officers nationwide to familiarize them with the new criminal laws and technological advancements.
    • Need Improved Digital Infrastructure: Invest in upgrading digital infrastructure and ensuring reliable internet connectivity across all police stations, especially in rural and remote areas.

    Mains PYQ: 

    Q The jurisdiction of the Central Bureau of Investigation (CBI) regarding lodging an FIR and conducting probe within a particular State is being questioned by various States. However, the power of the States to withhold consent to the CBI is not absolute. Explain with special reference to the federal character of India. (UPSC IAS/2021)

     

  • Food Colorants and Chemical Additives Under Crackdown in Karnataka

    Why in the News?

    Karnataka’s Food Safety Department ordered action after 40 kebab samples showed unsafe artificial colours, extending the crackdown to Panipuri, Cotton candy, and Gobi Manchurian.

    Artificial Colours in the Controversy 

    • Some artificial colours under scrutiny include:
    1. Sunset Yellow (Yellow 6, E110): Approved in the US but requires a warning label in the EU.
    2. Carmoisine (Red No. 10, E122): A deep red dye often used in food.
    3. Rhodamine B: A banned textile dye sometimes illegally used in food.
    • Different countries have varying regulations for these dyes. For example, tartrazine (E102 in the EU, Yellow 5 in the US) is permitted but only in limited quantities. 

     

    Legal Action against FBOs

    • To take legal action, the department collects a survey sample from an FBO and, if found unsafe, collects four more legal samples for further testing at the Central Food Technological Research Institute (CFTRI).
    • If CFTRI deems the samples unfit for consumption, the FBO is booked under the Food Safety Act and tried at a court of Judicial Magistrate of First Class (JMFC). Penalties can include a fine of up to Rs 10 lakh and imprisonment for 7 years.

    Role of FSSAI in Food Safety and Colorants Regulation

    • The Food Safety and Standards Authority of India (FSSAI) plays a crucial role in regulating and ensuring food safety across the country under the Food Safety & Standards Act, 2006. 

    Ingredients legally banned in India by the FSSAI and various states initiatives:

    Parameters Details
    Ingredients Banned in India
    • Rhodamine B: A textile dye sometimes illegally used as a food colorant.
    • Potassium Bromate: A flour treatment agent linked to cancer.
    • Oxytocin: A hormone used unethically in the dairy industry to increase milk production.
    • Calcium Carbide: Used for ripening fruits, which is hazardous to health.
    • Formalin: Used in fish preservation, which is carcinogenic.
    • Brominated Vegetable Oil (BVO): Used in soft drinks, which is linked to various health issues.
    State Initiatives for Food Safety
    • Karnataka: Crackdown on use of unsafe food colorants in kebabs, pani puri, cotton candy, and gobi manchurian.
    • Maharashtra: Rigorous checks on milk adulteration and stringent actions against offenders.
    • Kerala: Implementation of ‘Safe Food’ campaign focusing on reducing pesticide use in vegetables.
    • Tamil Nadu: Regular inspections of street food vendors and training programs on food safety.
    • Delhi: Special drives to monitor and control the use of banned substances in sweets during festive seasons.

    State Food Safety Index (SFSI) by FSSAI sheds light on the performance of Indian states in ensuring food safety.

     


    PYQ:

    [2021] Elaborate the policy taken by the Government of India to meet the challenges of the food processing sector.

    [2018] Consider the following statements: 

    1. The Food Safety and Standards Act, 2006 replaced the Prevention of Food Adulteration Act, 1954.
    2. The Food Safety and Standards Authority of India (FSSAI) is under the charge of Director General of Health Services in the Union Ministry of Health and Family Welfare.

    Which of the statements given above is/are correct?

    (a) 1 only
    (b) 2 only
    (c) Both 1 and 2
    (d) Neither 1 nor 2

     

  • [pib] SEHER Program to Empower Women Entrepreneurs

    Why in the News?

    The Women Entrepreneurship Platform (WEP) and TransUnion CIBIL have launched SEHER, a pioneering credit education program aimed at empowering women entrepreneurs in India.

    About Women Entrepreneurship Platform (WEP)

    • WEP, incubated at NITI Aayog in 2018; aims to create an enabling ecosystem for women entrepreneurs in India through a public-private partnership.
    • WEP’s Financing Women Collaborative (FWC) initiative accelerates access to finance for women entrepreneurs, addressing key barriers such as information asymmetry.

    About SEHER Program

    • SEHER aims to provide comprehensive financial literacy content and essential business skills to women entrepreneurs.
    • It will facilitate their access to financial tools crucial for business growth and employment creation.
    • The program includes personalized resources on financial literacy, emphasizing the importance of building a strong credit history and CIBIL score.

    Need for such a program

    • India has 63 million MSMEs, with 20.5% being women-owned, employing 27 million people.
    • Accelerating women’s entrepreneurship could create over 30 million new women-owned enterprises and 150 to 170 million jobs.
    PYQ:

    [2019] “Empowering women is the key to control population growth”. Discuss. 

     

  • Issues with ‘mandir’ tag for Ayushman Health and Wellness Centres

    Why in the News?

    Following Mizoram and Nagaland, Meghalaya has also refused to rename its health and wellness centres as Ayushman Arogya Mandirs as per the Centre’s directive.

    Context: Demographic composition of NE and its implications on policy decisions 

    • Christian Majority: About 75% of Meghalaya’s population practices Christianity, similar to the demographics of Mizoram (90%) and Nagaland (90%).
    • State Asserts Autonomy: Meghalaya’s Health Minister emphasized that health being a State subject grants them the right to decide independently of the Centre’s advisory.

    About Ayushman Bharat Health and Wellness Centres (AB-HWCs)

    • AB-HWCs were launched to move away from selective health care to a more comprehensive range of services spanning preventive, promotive, curative, rehabilitative and palliative care for all ages.
    • There are 1.6 lakh such centres across India under this initiative.
    • The National Health Policy of 2017 envisioned these centres as the foundation of India’s health system.
    • The Union Health Ministry renamed AB-HWCs as Ayushman Arogya Mandirs (AAM) with the tagline ‘Arogyam Parmam Dhanam’.
    • States and Union Territories were urged to complete the rebranding by the end of 2023.

    Back2Basics: Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (PM-JAY)

    Details
    Details
    • World’s largest fully government-funded health insurance scheme.
    • Launched in 2018.
    • Provides Rs 5 lakh per family for secondary and tertiary care.
    Health Benefit Package
    • Covers the cost of surgery, medical and daycare treatments, medications, and diagnostics.
    • 3 days of pre-hospitalisation and 15 days of post-hospitalisation, including diagnostic care and expenses on medicines.
    • No restriction on family size, age or gender.
    • All pre-existing conditions are covered from day one.
    Beneficiaries
    • An entitlement-based scheme targeting beneficiaries identified by the latest Socio-Economic Caste Census (SECC) data.
    • Flexibility for States/UTs to use non-SECC data with a similar socio-economic profile to identify remaining SECC families.
    Financing
    • Jointly funded scheme: 60:40 between Centre and legislature for all States and UTs.
    • 90:10 for North-Eastern States, J&K, Himachal Pradesh, and Uttarakhand.
    • 100% central funding for Union Territories without legislature.
    Nucleus Agency
    • The National Health Authority (NHA) is an autonomous body under the Societies Registration Act, 1860, responsible for the effective implementation of PM-JAY.
    • State Health Agency (SHA) is the apex body of the State Government responsible for implementing AB-PMJAY in the State.

     

    PYQ:

    [2022] With reference to Ayushman Bharat Digital Mission, consider the following statements:

    1. Private and public hospitals must adopt it.
    2. As it aims to achieve universal health coverage, every citizen of India should be part of it ultimately.
    3. It has seamless portability across the country.

    Which of the statements given above is/are correct?

    (a) 1 and 2 only

    (b) 3 only

    (c) 1 and 3 only

    (d) 1, 2 and 3

  • [4th July 2024] The Hindu Op-ed: Trials, medical ethics and the orbit of power

    [4th July 2024] The Hindu Op-ed: Trials, medical ethics and the orbit of power

    PYQ Relevance:
    Mains: 

    Q) If an amendment bill to the Whistleblowers Protection Act 2011 tabled in the Parliament is passed, there may be no one left to protect. Critically Evaluate. (UPSC CSE 2015) 

    Q) With consideration towards the strategy of inclusive growth, the new Companies Bill, 2013 has indirectly made CSR a mandatory obligation. Discuss the challenges expected in its implementation in earnest. Also, discuss other provisions in the Bill and their implications. (UPSC CSE 2013) 

    Note4Students: 

    Prelims:  Whistleblowers Protection Act 2011,

    Mains:  Ethical issues in the Medical sector,

    Mentor comment: On January 10, 2021, Rashida Bee, Nawab Khan, Rachna Dhingra, and Nausheen Khan alleged ethical violations in Bharat Biotech’s Covaxin trial at People’s Hospital, Bhopal. They cited informed consent breaches, enrollment of vulnerable groups, non-reporting of adverse events, and inadequate participant monitoring. They demanded intervention to halt the study and independent investigation. The outcome of their letter remains undisclosed.

    Let’s learn!

    __

    Why in the news? 

    In India, the primary safeguards intended to prevent medical ethics abuse are ineffective.

    What are the Primary safeguards?

    • Primary safeguards are fundamental measures or systems put in place to prevent unethical practices and ensure ethical standards are maintained.
    • These safeguards are designed to protect individuals and maintain integrity within processes, such as clinical trials.
    • They typically include regulatory frameworks, oversight committees, informed consent procedures, transparency requirements, and accountability mechanisms.

    Ethical Abuse 

    • Allegations of Ethical Violations in Covaxin Trial: Irregularities and ethical violations were alleged in the Covaxin clinical trial conducted by People’s Hospital in Bhopal, Madhya Pradesh. Violations included lack of informed consent, enrollment of vulnerable populations, non-reporting of adverse events, and inadequate monitoring and follow-up.
    • Regulatory Approval and Ethical Guidelines before the completion of Phase III study: The Indian drug regulator, Central Drugs Standard Control Organisation (CDSCO), approved Covaxin for “Restricted Use under Clinical Trial Mode” before the completion of its Phase III study.This approval process was not defined in India’s Drug Regulatory Framework, creating ambiguity and potential ethical lapses.
    • Lacking in the effectiveness of Ethics Committees: Ethics committees at trial sites are meant to oversee and ensure ethical conduct in clinical trials. There were issues with the effectiveness of these committees, with allegations of gross violations of ethics guidelines.
    • Whistle-blowers show the various incidents of ethical violations: Whistle-blowers play a crucial role in exposing ethical violations in medical experimentation.  Carl Elliott’s book, “The Occasional Human Sacrifice,” details various incidents of ethical violations in medical trials, highlighting the courage required to speak out.

    Innovative therapies and ethics

    • Balancing Risk and Benefit: Developing life-saving medicines involves a delicate balance between the potential risks to patients and the projected benefits of the therapeutic candidate. This process requires specialised knowledge and experience to make informed decisions, which is often lacking, leading to ethical challenges.
    • Lack of Expertise in Clinical Development: India has a strong generic drug manufacturing industry but lacks deep expertise in developing innovative therapies. The management of clinical development is often overseen by medical doctors who may not have specialized knowledge in drug development, leading to ethical violations and inadequate oversight.
    • Ethical Violations in Pandemic Response: During the COVID-19 pandemic, there were examples of medical ethics being compromised, such as unrealistic projections of case numbers and the creation of terms like “emergency use authorization in clinical trial mode” to justify premature decisions. These actions highlight the need for better guardrails and ethical standards in managing the development and approval of new therapies.

    Indian Patients and Clinical Studies

    • Violation of Informed Consent: There is a historic and repeated violation of informed consent in India, with poor and uneducated patients being enrolled in clinical studies without being fully informed of potential harm. Ensuring informed consent falls under the responsibility of institutional ethics committees, whose effectiveness is often questionable.
    • Ineffectiveness of Institutional Ethics Committees: Despite existing on paper and in regulations, the functioning and effectiveness of institutional ethics committees in India are patchy. A study by Gayatri Saberwal et al. (2022) identified numerous issues, such as clinical trials without ethics committees and trials with more sites than functional ethics committees.
    • Abuse of Regulations by the Industry: A significant abuser of these regulations is a section of the industry promoted by the Ministry of AYUSH, which conducts poorly designed and executed clinical studies with zero oversight. These studies often aim to provide a veneer of scientific validity to various concoctions without proper ethical standards.
    • Comparison with Western Systems: Even well-designed and well-run systems in the West face challenges in maintaining checks and balances on accountability. India’s systems are far from achieving the same level of function and effectiveness, highlighting a significant gap in ethical standards and accountability in clinical studies.

    Way forward: 

    • Enhancing Training and Oversight: Provide specialized training for members of institutional ethics committees to ensure they have the necessary knowledge and skills to oversee clinical trials effectively. Regular audits and monitoring should be conducted to assess the performance and adherence to ethical guidelines.
    • Independent Audits: Conduct independent audits of clinical trial sites and ethics committees to ensure compliance with ethical standards and regulatory requirements. Establish clear consequences for non-compliance to deter unethical practices.
    • Clear Guidelines and Definitions: Define clear regulatory pathways and guidelines for clinical trials, including terms like “Restricted Use under Clinical Trial Mode.” This will reduce ambiguity and ensure consistent application of ethical standards.
  • On Tamil Nadu’s financial distress   

    Why in the news?

    At a June 22 meeting for Union Budget 2024-25, Tamil Nadu’s Finance Minister Thangam Thennarasu requested ₹63,246 crore for Chennai Metro Rail Phase-2, ₹3,000 crore for disaster restoration, and increased unit costs for centrally sponsored schemes.

    How are the funds for phase two of the Chennai Metro Rail distributed?

    • Funding Agencies and International Support: Chennai Metro Rail Phase-2 is financed by multiple international agencies, including the Japan International Cooperation Agency (JICA), Asian Development Bank (ADB), Asian Infrastructure Investment Bank (AIIB), and New Development Bank (NDB).
    • State Government Contributions: Up to March 31, 2024, the Tamil Nadu government sanctioned ₹5,400 crore as share capital for the Chennai Metro Rail Limited (CMRL) and ₹12,013.89 crore as subordinate debt, bearing the entire expenditure due to delays in approval from the Union Cabinet Committee on Economic Affairs (CCEA).

    Is the Centre stalling the funds for the metro project?

    Approval Status:

    • Public Investment Board: The Chennai Metro Rail Project’s Phase-2 was approved by the Public Investment Board (PIB) as a Central sector project under the equity sharing model in August 2021.
    • Union Cabinet Committee on Economic Affairs: The project has been awaiting approval from the Union Cabinet Committee on Economic Affairs (CCEA) since then.

    State Government Actions:

    • Foundation Stone: Despite the pending approval, the foundation stone for the phase was laid by Union Home Minister Amit Shah in November 2020 when the AIADMK was in power.
    • Ongoing Expenditure: The Tamil Nadu government continues to fund the project independently, stressing its finances and urging the Centre to sanction the project under the 50:50 equity sharing model as was done for Phase 1.

    What about funds released by the Centre for restoration work after natural disasters in the State?

    • Initial Request by Tamil Nadu: Tamil Nadu submitted detailed memoranda to the Union government, seeking approximately ₹37,906 crore for restoration works following two natural disaster spells in 2023.
    • Initial Central Release: The Union government initially released a sum of ₹276 crore for immediate restoration efforts.
    • Additional Approvals: The Union Ministry of Home Affairs (MHA) later approved additional assistance of ₹285.54 crore and ₹397.13 crore for the two disaster spells.
    • Disbursed Amounts: From these approvals, a total of ₹115.49 crore and ₹160.61 crore were disbursed under the National Disaster Response Fund (NDRF).
    • State Disaster Response Fund (SDRF): The Union government’s order also mentioned ₹406.57 crore as the 50% available in the State Disaster Response Fund (SDRF) account of Tamil Nadu as of April 1, 2023.

    Way forward: 

    • Metro Rail Project: The Union government should prioritize and expedite the approval process for significant infrastructure projects like the Chennai Metro Rail Phase-2. This can be achieved by setting stricter timelines for the Union Cabinet Committee on Economic Affairs (CCEA) to finalize decisions.
    • Natural Disaster Restoration: The Centre should reassess the current disaster relief funding mechanism to ensure timely and adequate financial support for states hit by natural disasters.

    Mains PYQ:

    Q Discuss the recent measures initiated in disaster management by the Government of India departing from the earlier reactive approach. (UPSC IAS/2020)

  • Will the Agnipath scheme be revamped? | Explained 

    Why in the news?

    Following the 2024 election results, NDA allies Janata Dal (United) and Lok Janshakti Party (Ram Vilas) raised concerns about the Agnipath scheme and called for discussions on the matter.

    What is the Agnipath scheme?

    • The Agnipath scheme recruits soldiers, sailors, and airmen into the Indian armed forces for a four-year term, replacing the previous system of permanent recruitment. After completing their four-year tenure, up to 25% of Agniveers can be selected for permanent positions within the armed forces.
    • Agniveers can obtain educational certificates and skill certifications during their service. They receive a lump sum amount upon completing their tenure but are not eligible for a pension.

    Issues Associated with the Scheme

    • Personnel Shortage: There is a significant shortage of personnel in the ‘below officer’s rank’ cadres, exacerbated by the recruitment freeze during the COVID-19 pandemic. The Army retires around 60,000 soldiers annually but only recruits 40,000, leading to a growing shortfall.
    • Low Conversion Rate: The 25% conversion rate from Agniveers to regular soldiers is considered insufficient to address the personnel shortage.
    • Compressed Training: The four-year tenure necessitates a shorter training period, which may impact the quality of training.
    • Political and Social Opposition: The scheme has faced political opposition and led to violent protests in some parts of the country. Critics argue for a clause-by-clause review or complete scrapping of the scheme.

    Present Scenario

    As the Agnipath scheme marks two years since its implementation, the Department of Military Affairs (DMA) in the Defence Ministry is reviewing the scheme based on feedback from the armed forces.

    • Feedback Compilation: The Navy and Air Force have compiled their feedback, while the Army is still in the process.
    • Recommendations: Suggestions include increasing the intake numbers, raising the permanent recruitment rate from 25% to at least 50%, and extending the age limit for technical recruits from 21 to 23 years.
    • Review Process: The DMA will compile all recommendations and submit them to the Defence Ministry for potential adjustments to the scheme.

    Way forward:

    • Enhance Educational and Skill Development Opportunities: Partner with educational institutions to provide Agniveers with advanced degrees and certifications that are recognized nationwide. Offer vocational training and skill development programs that are aligned with industry standards, improving post-service employability.
    • Increase Permanent Induction Rate: Raise the conversion rate of Agniveers to permanent positions from 25% to at least 50% to address the personnel shortage effectively.