Syllabus: Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources
Recent Incident:
- 25 children died linked to contaminated cough syrup; paediatrician allegedly received ₹2.54 commission per bottle.
- Deaths occurred despite Union Health Ministry banning certain cough syrup formulations for children under four years in April 2025.
Constitutional and Legal Framework Regarding Childrens
- Constitutional Guarantee: Article 39(f) guarantees children’s protection as Directive Principle of State Policy.
- Demographic Significance: Children (under 18 years) constitute 39% of India’s population requiring special protection.
- Existing Laws: Approximately 13 laws and policies protect children from National Policy for Children 1974 to India Newborn Action Plan 2014.
- Focus Gap: Laws heavily concentrate on child labour and sexual exploitation; pharmacovigilance in paediatric drugs needs more oversight.
Paediatric Medicine Challenges
- Therapeutic Orphans: Dr. Harry Shirkey’s term highlighting children aren’t small adults; pharmacodynamic responses vastly different.
- Clinical Trial Gap: Drug trials conducted on adults, rarely on children due to ethical reasons; creates alarming dosage guideline deficiency.
- Extrapolation Risk: Children’s dosages extrapolated from adult guidelines causing overdosage danger and serious consequences.
- Special Development Need: Children-specific drug development strategies cornerstone of public health care requirements.
- Essential Medicine
- WHO Initiative: Essential Medicine List for children (EMLc) ensures priority health-care needs availability and affordability.
- While adult Essential Medicine Lists periodically revised, children’s list not addressed regularly requiring immediate attention.
- Affordability Crisis: Health-care financial burdens push impoverished families into deeper poverty; affordable paediatric pharmaceuticals vital.
International Regulatory Framework
- European Union: Paediatric Use Marketing Authorisation regulates children’s pharmaceuticals with clear guidelines.
- United States: Best Pharmaceuticals for Children Act provides incentives for paediatric drug research.
- India: Operates on general guidelines without specific policy or legislation for children’s pharmaceuticals.
Safety Practices Required
- Caregiver Education: Constant education for caregivers and pharmacists mandatory for safe medicine administration.
- Label Reading: Mandatory label reading, correct dosage dispensing and side-effect monitoring especially for over-the-counter medication.
- OTC Regulation: Over-the-counter medication for cough, cold, fever requires stringent public health care regulation.
- Urban-Rural Variation: OTC medication use varies but more common in urban settings requiring targeted interventions.
- Public Health Care Outlets
- Zero Tolerance Policy: Must adopt against substitute or substandard medication in public health outlets.
- Clear Guidelines: Enforcement needed in dispensing pharmaceuticals to children ensuring quality and safety.
- Teenage Focus: Attention required preventing drug misuse among teenagers through awareness and monitoring.
- Global Responsibility
- WHO Warnings: Last three years saw multiple warnings on contaminated cough syrup from Indian manufacturers.
- International Deaths: Children died in Gambia, Uzbekistan, Indonesia, Cameroon from contaminated Indian syrups.
- Global South Pharmacy: India’s huge cough syrup exports carry responsibility ensuring absolute medicine safety.
- India-Specific Data Requirement
- Unique Genetics: Indian children’s genetics unique; health policy cannot rely solely on foreign data.
- Research Imperative: Paediatric medicine research must be based wholly on Indian data, not adult extrapolations.
- Off-Label Risks: Adult medicines modified for children considered off-label, unlicensed; contraindicated by formulation, age, indicators.
Way Forward
- Fiduciary Duty: Owe responsibility framing comprehensive health policy considering environmental factors like malnutrition exacerbating toxicity.
- Holistic Infrastructure: Urgently need robust monitoring system promoting safety protocol awareness for children’s medicines.
- Rights Violation: Using unproven medicines on children violates rights of voiceless population requiring immediate protective action.
Q- Critically examine the constitutional and legal provisions for protecting vulnerable populations in healthcare. Suggest measures to strengthen pharmacovigilance systems in India. (15 Marks, 250 words)