Respect the health rights of India’s children, Pg8

Key Highlights:

• 25 children died due to contaminated cough syrup, raising concerns about paediatric medicine regulation in India.
• The Union Health Ministry had banned certain cough syrup formulations for children under four in April 2025 due to contamination risks.
• India has approximately 13 laws and policies to protect children, but pharmacovigilance in paediatric drugs requires more oversight.
• The World Health Organization (WHO) has issued warnings about contaminated cough syrups, including those made in India.

Detailed Insights:

• The incident highlights the need to strengthen the regulatory framework for paediatric medicines and ensure the protection guaranteed to children under Article 39(f) of the Constitution.
• Existing laws focus on child labor and sexual exploitation, but pharmacovigilance in paediatric drugs requires more attention and infrastructure development.
• Children's pharmacodynamic responses differ from adults, making it dangerous to extrapolate drug dosages from adult guidelines.
• The essential medicine concept and the WHO's Essential Medicines List for Children (EMLc) are crucial for ensuring availability and affordability of life-saving medicines.
• India needs to generate its own data on paediatric medicines due to unique genetics and environmental factors, rather than relying on data from other countries or extrapolating from adult data.
• Constant education for caregivers and pharmacists, mandatory label reading, correct dosage dispensing, and side-effect monitoring are essential for safe distribution of children's pharmaceuticals.

Key Concepts Involved:

• Pharmacovigilance: The practice of monitoring the effects of medical drugs after they have been licensed for use, in order to identify and evaluate previously unreported adverse reactions.
• Essential Medicines: Medicines that satisfy the priority health-care needs of the population, intended to be available in all health-care systems, and are of assured quality and affordability.
• Article 39(f): A Directive Principle of State Policy in the Indian Constitution that directs the State to ensure that children are given opportunities and facilities to develop in a healthy manner.