Content
- On GLP-1 drugs, match access with vigilance
- It’s time to bring fathers into fold of parental leave
On GLP-1 drugs, match access with vigilance
Source : Indian Express
Why in News ?
- Patent expiry of Semaglutide (March 20, 2026) enabling entry of ~50 generic brands, significantly reducing prices by 20–30% (industry estimates).
- Rising concern over misuse of GLP-1 drugs (Ozempic, Wegovy) amid increasing diabetes and obesity burden in India.
Relevance
- GS 2 (Governance):
- Drug regulation framework (Drugs & Cosmetics Act, CDSCO)
- Public health policy and regulatory enforcement
- Pharmacovigilance and ethical marketing
- GS 3 (Economy & Science & Tech):
- Pharmaceutical industry and generics market
- Healthcare affordability and NCD burden
- Biotech innovations in diabetes and obesity treatment
Practice Question
Q. “While GLP-1 drugs can revolutionise diabetes and obesity management, their misuse and regulatory gaps pose significant challenges.” Analyse in the Indian context. (250 words)
Static Background
- GLP-1 receptor agonists are drugs that enhance insulin secretion, delay gastric emptying, and reduce appetite, used in Type-2 Diabetes and obesity management.
- Examples: Semaglutide, Liraglutide; globally popular due to dual benefits—glycaemic control + weight reduction.
- Classified as Schedule H drugs (CDSCO) → require mandatory prescription, not for over-the-counter sale.
- India has ~101 million diabetics (ICMR 2023) and rising obesity prevalence (~24% adults overweight/obese, NFHS-5).As of 2024–2025, India faces a massive diabetes epidemic with an estimated 101 million people living with diabetes and another 136 million with pre-diabetes.(International Diabetes Federation)
Central Drugs Standard Control Organization (CDSCO)
- Definition: India’s national regulatory authority for drugs and medical devices, functioning under Central Drugs Standard Control Organization within the Ministry of Health and Family Welfare.
- Legal Basis: Operates under Drugs and Cosmetics Act, 1940 and Rules, 1945; complemented by Medical Devices Rules, 2017.
- Head: Led by the Drugs Controller General of India (DCGI)—central authority for approvals and regulatory decisions.
- Core Functions: Approval of new drugs, vaccines, clinical trials, regulation of imports, and setting standards for drugs across India.
- Division of Powers: Centre (CDSCO) – approvals, imports, clinical trials; States – manufacturing licenses, sale, and distribution (federal regulatory structure).
Public Health Significance
- Affordable generics can expand access to middle- and lower-income groups, improving health equity in chronic disease care.
- Provides multi-dimensional benefits: glycaemic control, weight loss (~10–15% body weight in trials), reduced cardiovascular risk.
- Can reduce long-term healthcare burden, lowering complications like heart disease, kidney failure, stroke.
- Aligns with shift toward preventive healthcare and NCD management (National Health Policy 2017).
Economic Dimensions
- Cost reduction (40–50%) improves affordability in a system where ~48% health expenditure is out-of-pocket (NHA estimates).
- Expansion of domestic pharma manufacturing strengthens India’s role as “pharmacy of the world”.
- Potential to reduce economic burden of NCDs, estimated to cost India ~5–10% GDP loss (WHO projections).Addressing this burden through targeted interventions offers significant potential to reduce this economic impact, with some projections indicating a 15% return on investment .
- However, uncontrolled use may increase irrational drug expenditure and strain public health systems.
Governance Dimensions
- CDSCO regulates GLP-1 drugs under Schedule H, requiring prescription-based access.
- Risk of over-the-counter culture undermining regulation and enabling misuse.
- Need for pharmacovigilance systems to track adverse effects and long-term outcomes.
- CDSCO advisory restricts misleading advertisements, preventing branding as “weight-loss shortcuts”.
Social & Ethical Dimensions
- Risk of cosmetic misuse among non-obese individuals due to rapid weight-loss appeal.
- May reinforce body image pressures and inequitable access, favouring urban affluent populations initially.
- Ethical concern over diversion of drugs from diabetic patients to lifestyle users.
- Raises question of medicalisation of lifestyle issues vs holistic health approaches.
Health Concerns
- Side effects: nausea, pancreatitis risk, gastrointestinal complications (clinical trial evidence).
- Global BMI thresholds may not suit Indians, who develop metabolic risks at lower BMI (~23 vs 25 WHO Asian standards).South Asians, including Indians, develop metabolic risks such as Type 2 diabetes, hypertension, and cardiovascular disease at lower BMI levels.
- Lack of long-term Indian population data on safety and efficacy.
- Requires context-specific clinical guidelines tailored to Indian metabolic profiles.
Data & Evidence
- Diabetes burden: ~101 million cases (ICMR–INDIAB Study 2023).
- Pre-diabetes: ~136 million individuals (ICMR 2023).
- Overweight/obesity: ~24% adults (NFHS-5, 2019–21).Roughly 24% of women and 23% of men aged 15–49 classified as overweight or obese
- Out-of-pocket expenditure: ~48% of total health spending (National Health Accounts 2021–22).
- Weight loss efficacy: 10–15% reduction (global clinical trials, NEJM studies on Semaglutide).
Challenges
- Regulatory gaps due to proliferation of multiple generic brands (~50 expected).
- Weak pharmacovigilance infrastructure for monitoring adverse drug reactions.
- OTC misuse undermining Schedule H compliance.
- Lack of India-specific clinical guidelines and BMI thresholds.
- Risk of inequitable access and diversion from medically eligible patients.
Way Forward
- Strengthen prescription enforcement and digital tracking (e-prescriptions, Ayushman Bharat Digital Mission).
- Develop India-specific clinical guidelines for GLP-1 use considering lower BMI risk thresholds.
- Expand pharmacovigilance systems (PvPI under CDSCO) for real-time monitoring of adverse effects.
- Regulate advertising and marketing practices to prevent misuse as lifestyle drugs.
- Integrate with NCD programmes (NPCDCS) combining medication with lifestyle interventions.
Prelims Pointers
- GLP-1 receptor agonists: used in Type-2 diabetes and obesity management.
- Semaglutide: key drug whose patent expiry enables generics.
- Schedule H drugs: require prescription; cannot be sold OTC legally.
- CDSCO: India’s national drug regulatory authority.
It’s time to bring fathers into fold of parental leave
Why in News?
- Supreme Court judgment dated 17 March 2026 struck down restriction on maternity leave for adoptive mothers under Code on Social Security, 2020. The court ruled that adoptive mothers are entitled to 12 weeks of paid leave, regardless of the child’s age, calling the previous restriction unconstitutional and discriminatory.
- Court further urged Centre on 18 March 2026 to frame a law on paternity leave as social security measure.
- Debate intensified after judicial remarks on menstrual leave and women’s employment trade-offs (March 2026 hearings).
Relevance
- GS 1 (Indian Society):
- Gender roles, family structure, and unpaid care work
- Changing social norms and shared parenting
- GS 2 (Polity & Governance):
- Fundamental Rights (Articles 14, 15, 21)
- Labour laws (Code on Social Security, 2020)
- Judicial activism in social policy
Practice Question
Q. “Gender-neutral parental leave is essential for achieving substantive equality in the workplace.” Examine in light of recent judicial developments in India. (250 words)
Static Background
- Maternity Benefit Act, 1961 (Amended 2017) provides 26 weeks paid leave for biological mothers in formal sector.
- Code on Social Security, 2020 (Section 60(4)) earlier restricted adoptive mothers’ leave to children below 3 months (now invalidated).
- As of March 2026, paternity leave for male central government employees in India remains limited to 15 days of paid leave under the Central Civil Services (Leave) Rules, 1972.
- There is no universal, statutory legal mandate in India that enforces similar paternity leave entitlements in the private sector.
- India’s labour market marked by low female LFPR (~35.3%, PLFS Feb 2026) and high informal workforce (~80%).
Key Judicial Observations
- 17 March 2026 verdict: Court held denial of leave for adoptive mothers of older children “irrational/unconstitutional”, ensuring equal maternity rights.
- Recognised that motherhood is linked to caregiving, not childbirth, expanding scope to adoptive and surrogate mothers.
- 18 March 2026 observation: recommended formal legal recognition of paternity leave, acknowledging fathers’ caregiving role.
- Emphasised rights-based approach over employer convenience, strengthening substantive gender equality framework.
Legal Dimensions
- Based on Article 14 (equality), Article 15(3) (protective discrimination), Article 21 (dignity & autonomy).
- Reinforces Directive Principles (Article 39, 42) promoting maternity relief and humane work conditions.
- Expands doctrine of reproductive autonomy beyond biological childbirth, consistent with progressive SC jurisprudence.
- Moves toward gender-neutral parental rights framework, not limited to women-centric benefits.
Administrative Dimensions
- Requires amendment of Code on Social Security, 2020 to remove unconstitutional age restriction.
- Necessitates national framework for paternity leave across public and private sectors.
- Calls for implementation mechanisms within labour codes and compliance monitoring systems.
- Needs integration with ICDS, POSHAN, maternal-child health schemes for holistic caregiving support.
Economic Dimensions
- Employer concerns: extended leave may increase cost of hiring women, especially in MSMEs. The burden of financing these leaves can lead to “short-sighted” decisions, creating a “men’s club” atmosphere and limiting women’s participation in the formal sector.
- However, gender-equal leave improves female workforce retention and productivity (OECD evidence).
- Reduces long-term costs of child health, attrition, and skill loss in labour market.
- Countries with parental leave show higher female LFPR and inclusive growth outcomes.
Social & Ethical Dimensions
- Addresses unequal burden of unpaid care work, historically borne by women.Globally, women spend 2.5 times more hours on unpaid care tasks than men, limiting their access to education, formal employment, and personal leisure.
- Encourages shared parenting, challenging patriarchal norms in household labour division.
- Promotes child welfare, emotional bonding, and equitable family structures.
- Raises ethical balance between labour market efficiency vs social justice in workplace policies.
- Statistics Sweden reports show a steadily narrowing gender gap in parental leave, with men’s share of benefit days rising from ~10% in 1999 to roughly 30-31% by 2018–2023, largely driven by “use-it-or-lose-it” earmarked months.
Challenges
- Employer bias may discourage hiring women due to perceived cost of extended leave benefits.This phenomenon, sometimes called the “motherhood penalty” or statistical discrimination.
- Lack of universal statutory paternity leave limits transformation of gender roles.
- Informal sector exclusion (~90%) reduces reach of legal protections.
- Persistent social norms may restrict actual uptake of paternity leave even if legislated.
Best Practices in Paternity Leave Globally
- Universal Provision + Legal Right
- ~35/38 OECD countries provide paid leave for fathers → indicates global norm formation in welfare states
- Ensures job protection + income security → core labour right.
- Adequate Duration (Beyond Tokenism)
- OECD average ≈ 2–3 weeks, but best performers go far beyond
- Spain: 16 weeks fully paid (global benchmark)
- Korea/Japan: up to 1 year (shared/earmarked)
- Wage Replacement (Income Security)
- Best systems offer 70–100% wage replacement (Nordic model)
- Prevents “leave avoidance” due to income loss.
- Father-Specific Quotas (“Use-it-or-lose-it”)
- Nordic countries (Norway, Sweden, Iceland) reserve non-transferable leave for fathers
- Increases uptake and promotes gender equality in care work
Way Forward
- Introduce gender-neutral parental leave framework with earmarked father quotas (“use-it-or-lose-it”).
- Provide state subsidies/incentives to employers to offset maternity/paternity costs.
- Extend benefits to informal workers via social insurance/DBT mechanisms.
- Promote behavioural change campaigns to normalise male caregiving roles.
- Align reforms with SDG 5 (Gender Equality) and ILO work-life balance standards.
Prelims Pointers
- 17 March 2026 SC Judgment: struck down 3-month age cap for adoptive mothers’ maternity leave.
- 18 March 2026 SC Observation: recommended law on paternity leave.
- Code on Social Security 2020 governs maternity provisions.
- Time Use Survey (MoSPI) measures unpaid care work.
