Context

• The deaths of twenty-five children in Madhya Pradesh due to contaminated cough syrup have cast a long shadow over India’s healthcare system.
• More than a tragedy, the incident is a mirror reflecting the deep cracks in the nation’s regulatory and ethical framework governing paediatric medicines.
• While public outrage has focused on the culpability of one doctor and the meagre ₹2.54 commission that allegedly cost young lives, the true issue lies far deeper, in India’s systemic neglect of child-specific pharmaceutical oversight.

Systemic Gaps in Regulation and Children as “Therapeutic Orphans”

• Systemic Gaps in Regulation
  • Despite the Union Health Ministry’s ban on certain cough syrups for children under four, the circulation of contaminated formulations exposes failures at multiple levels of governance.
  • The Central Drugs Standard Control Organisation (CDSCO) and state drug regulators share overlapping jurisdictions that often result in diluted accountability.
  • The tragedy underscores the urgent need to strengthen coordination, transparency, and enforcement within these institutions to prevent such incidents from recurring.
• Children as Therapeutic Orphans
  • Children have historically been treated as therapeutic orphans, a term coined by Dr.  Harry Shirkey to describe their marginalisation in pharmaceutical research.
  • Unlike adults, children’s bodies process drugs differently, yet clinical trials rarely include paediatric subjects due to ethical and logistical barriers.
  • Consequently, paediatric dosages are often extrapolated from adult data, leading to risks of overdose and toxicity.
  • The absence of dedicated paediatric drug development and testing makes tragedies like the recent one tragically predictable.

Legal and Policy Framework: Gaps and Opportunities

• India boasts a wide array of child-focused policies, from the National Policy for Children (1974) to the India Newborn Action Plan (2014), but these primarily focus on labour protection and sexual abuse, not pharmacological safety.
• In contrast, international frameworks such as the European Union’s Paediatric Use Marketing Authorisation (PUMA) and the United States’ Best Pharmaceuticals for Children Act (BPCA) provide clear guidelines and incentives for paediatric drug research.
• India, however, operates only on general guidelines, with no statutory framework to govern paediatric medicines. This regulatory vacuum leaves millions of Indian children exposed to untested, substandard, or mis prescribed drugs.

The Economics of Health and the Need for Essential Medicines

• Unsafe medicines exacerbate the economic vulnerabilities of poor families, who often rely on cheap over-the-counter (OTC) drugs due to inadequate healthcare access.
• The essential medicines concept, introduced by the World Health Organization (WHO), aims to ensure availability, affordability, and quality of critical drugs.
• However, India’s Essential Medicines List for Children (EMLc) remains outdated and inconsistently implemented.
• A systematic revision based on Indian epidemiological and genetic data is urgently needed to safeguard children’s right to health and prevent health-induced poverty among vulnerable families. 

The Way Forward: Towards a Holistic Framework

• A truly protective system must rest on three pillars: regulation, research, and awareness.
  • Regulation: Strict pharmacovigilance mechanisms and zero-tolerance policies against counterfeit or contaminated drugs are essential.
  • Research: Paediatric pharmacology must be grounded in India-specific data, recognizing that global findings cannot simply be transplanted into the Indian context.
  • Awareness: Continuous education for caregivers, pharmacists, and healthcare workers, along with clear labelling and dosage protocols, is crucial for safe medicine use.
• These measures together can build a robust and transparent paediatric drug safety infrastructure capable of protecting India’s children.

Conclusion

• The deaths of these 25 children are not isolated misfortunes but symptoms of a structural failure.
• As India aspires to be the pharmacy of the Global South, it bears an ethical and legal responsibility to ensure the safety of the medicines it manufactures, both for its own children and for those abroad.
• To neglect paediatric pharma-covigilance is to betray the constitutional promise of Article 39(f), the duty to secure for every child the opportunity to grow in health, safety, and dignity.
• The nation owes its children not just grief, but governance, not just sorrow, but systemic reform. Only then can India truly claim to protect the most vulnerable among its citizens.