[Answered] Examine the necessity of a holistic framework to monitor medicine use for children. Justify the need to recognize and enforce the health rights of India’s children.

Introduction

According to UNICEF’s State of the World’s Children 2024 Report, nearly one in every five Indian children faces unsafe or irrational drug exposure—highlighting the urgent need for a robust paediatric pharmacovigilance framework.

The Context: A Crisis of Neglect in Child Health Governance

1. The recent tragedy of 25 child deaths due to contaminated cough syrup in Madhya Pradesh exposed deep structural weaknesses in India’s drug regulation ecosystem.
2. Despite the Union Health Ministry’s 2025 ban on certain paediatric syrups, lapses in enforcement and oversight underline a systemic failure to uphold children’s constitutionally guaranteed health rights (Article 39(f)).
3. Children constitute 39% of India’s population, yet the pharmacological frameworks governing medicine safety largely focus on adult physiology, leaving children—whom Dr. Harry Shirkey termed “therapeutic orphans”—vulnerable to inappropriate dosages and unsafe formulations.

Why a Holistic Monitoring Framework is Necessary

1. Unique Pharmacodynamics and Clinical Gaps: Children are not small adults. Their metabolism, organ maturity, and drug absorption differ drastically, but clinical trials are rarely conducted on them due to ethical constraints. Consequently, most paediatric prescriptions are “off-label” or extrapolated from adult guidelines, increasing risks of toxicity and overdose.
2. Regulatory Fragmentation: The Central Drugs Standard Control Organisation (CDSCO) oversees major manufacturers, while State Drug Controllers regulate local producers. Lack of inter-agency coordination, delayed recall systems, and poor quality audits often lead to regulatory capture and accountability voids.
3. International Models of Oversight:

• EU’s Paediatric Use Marketing Authorisation (PUMA) and the S. Best Pharmaceuticals for Children Act (BPCA) incentivise research and monitoring of paediatric formulations.
• In contrast, India lacks a Paediatric Medicines Act, relying instead on general guidelines under the Drugs and Cosmetics Act, 1940. These global frameworks demonstrate how child-specific regulation can align innovation with safety.

1. Essential Medicines for Children (EMLc): The WHO’s Essential Medicines List for Children (EMLc) offers a blueprint for ensuring equitable access to safe, affordable, and quality paediatric drugs. India’s National List of Essential Medicines (NLEM) updates adult drugs periodically but neglects paediatric formulations—an omission that perpetuates inequity.
2. Economic and Ethical Dimensions: Unsafe or ineffective medicines impose catastrophic health expenditures on poor families, pushing them deeper into poverty. From an ethical standpoint, failure to ensure drug safety violates the UN Convention on the Rights of the Child (UNCRC, 1989), ratified by India.
3. Data and Indigenous Research Deficit: India lacks nationwide pharmacovigilance data for children. Most paediatric drug efficacy data are imported from Western contexts, ignoring local genetic, nutritional, and environmental variations that influence drug toxicity and response.

The Way Forward: Towards a Child-Centric Health Governance Framework

1. Paediatric Drug Authority: Establish an autonomous National Paediatric Pharmacovigilance and Drug Safety Commission to coordinate between CDSCO, AIIMS, ICMR, and State agencies.
2. Mandatory Labelling and Dosage Guidelines: Enforce child-specific labelling and storage instructions for all over-the-counter (OTC) and prescription drugs.
3. Periodic EMLc Revision: Institutionalize biannual reviews of paediatric essential medicine lists aligned with WHO norms.
4. Awareness and Capacity Building: Integrate safe medicine practices into ASHA and Anganwadi training, and promote caregiver education through the National Health Mission (NHM).
5. Zero Tolerance for Substandard Medicines: Adopt Good Manufacturing Practice (GMP+) standards and real-time tracking of paediatric drug supply chains through blockchain-based monitoring.

Conclusion

As Amartya Sen’s Development as Freedom asserts, health is foundational to human capability. Safeguarding India’s children through a scientific, rights-based pharmacovigilance system is both a moral and developmental imperative.