Lethal dose

The deaths of more than 20 children across several states in India with 14 being from Madhya Pradesh, linked to the contaminated cough syrup Coldrif, should be read not as an isolated horror but as a blunt indictment of India’s pharmaceutical oversight. Laboratory tests revealing 48.6% diethylene glycol (DEG) – an industrial solvent and antifreeze – in a medicine intended for children is a failure of every institution tasked with protecting public health. Within fifteen days of exposure, victims suffered kidney failure and died. Bans and arrests followed, but they do little to console the bereaved or to prevent the next catastrophe.This tragedy is part of a grim, recurring pattern. The owner of Sresan Pharmaceutical, the maker of Coldrif, has been arrested. However, criminal charges, while necessary, are an insufficient remedy for a systemic malaise. As per media reports, India’s record in recent years reads like a dossier of preventable calamities: a dozen children in Jammu (2019–20) died after ingesting toxic syrups; in 2023, contaminated Indian syrups were tied to the deaths of 70 children in The Gambia and 18 in Uzbekistan. These episodes are about a supply chain that endangers the most vulnerable.Medical professionals have long cautioned against casual use of cough syrups, and branches of the Indian Academy of Pediatrics have issued advisories against self-medication and unsupervised administration to children. Yet guidance without enforcement is hollow. Cough syrups enjoy a peculiar cultural immunity: perceived as harmless household remedies, they are widely used and often overprescribed. Many formulations are little more than sugar, flavoring and a mix of antihistamines, decongestants and expectorants-components whose benefits for routine viral coughs are marginal at best. Most coughs resolve spontaneously, but consumer demand and habitual prescribing have produced a lucrative market-valued at over $260 million in 2024 and projected to nearly triple by 2035. That commercial momentum, combined with lax oversight, is a lethal mix when quality controls fail.The structural causes are clearly due to a fragmented manufacturing sector with hundreds of small producers, inconsistent quality assurance, and a regulatory apparatus that is often reactive rather than preventive. Analysts point to the 2023 amendments to the Drugs and Cosmetics Act as weakening, not strengthening, deterrents-diluted penalties signal that the cost of cutting corners may be bearable to unscrupulous operators. When enforcement is inconsistent and consequences tepid, market incentives can easily override caution.What is required is systemic reform, not episodic outrage. Mandatory testing of raw materials and finished products must be codified, with joint accountability for state and central authorities and transparent public reporting. Manufacturing standards should be uniformly tightened and enforced; violations must attract punitive sanctions substantial enough to deter misconduct and mechanisms for adequate victim compensation. A court-monitored independent inquiry into recurring contamination incidents would help restore public trust and ensure lines of accountability across manufacturers, suppliers and regulators. Parallel measures—robust clinical guidance, stricter controls on pediatric formulations, and public education to curb unnecessary use-are also essential.Drug safety is not a bureaucratic formality but a moral obligation. When children die from medicines that should heal, the failure is collective involving – industry, regulators and policymakers. India must move from reactive gestures to decisive, structural reform so that medicine remains a safeguard of life, not a hidden threat.