The recurring controversies around child deaths linked to cough syrups reveal gaps in India's pharmaceutical regulatory architecture. Critically examine.

Since 2022, the WHO has issued repeated global alerts on paediatric oral liquids contaminated with diethylene glycol (DEG), with over 300 deaths reported across several countries [5]; in October 2025 India's own regulator reported DEG in three syrups, including Coldrif [3]. The recurrence points to structural, not merely episodic, weaknesses.

Gaps the episodes expose

• Fragmented Centre–State authority: the Drugs and Cosmetics Act, 1940 vests approval and standards with CDSCO but manufacturing licensing with state drug controllers [2], producing uneven enforcement across small manufacturing units.
• Capacity and scrutiny deficits: the Parliamentary Standing Committee on Health examined CDSCO's functioning and flagged severe understaffing and drug approvals granted without adequate scrutiny of trial evidence [4].
• Irrational and untested paediatric formulations: the Chlorpheniramine Maleate + Phenylephrine Hydrochloride FDC was marketed for infants for years before restriction, despite safer alternatives [1].
• Reactive post-market surveillance: quality testing of raw materials and excipients is inconsistent in smaller units, so contamination surfaces only after fatalities rather than at release [3].
• Weak last-mile control: over-the-counter sale and self-medication for children dilute whatever prescription safeguards exist.

Corrective capacity — the other side

• Section 26A empowers the Centre to restrict or prohibit any drug posing risk or lacking therapeutic justification [2] — a genuinely strong statutory lever, used earlier against hundreds of irrational FDCs.
• Acting on expert-committee advice, the Ministry notified S.O. 4595(E) dated 18 August 2026, extending an April 2025 restriction to all formulations of this FDC for children below four years, with a mandatory warning on label, insert and promotional literature [1].
• India's prompt reporting of contaminated batches to the WHO shows a functioning, if belated, detection-and-recall chain [3].

India's regulatory architecture is legally well-armed but administratively under-powered — the law can ban, yet cannot reliably prevent. The way forward lies in shifting from episodic prohibition to prevention: uniform risk-based licensing, strengthened state drug-testing laboratories, mandatory batch testing of excipients, and stricter paediatric labelling. Such preventive regulation would give real content to the right to health under Article 21.