Systemic Lapses, Lost Lives

The deaths of 19 children in Madhya Pradesh’s Chhindwara district after consuming a contaminated cough syrup are not just a public health failure — they are a moral indictment of India’s pharmaceutical oversight. These were not deaths by illness or accident; they were deaths by neglect, greed, and the slow corrosion of regulatory vigilance that should have protected our most vulnerable citizens. The tragedy centres on Coldrif syrup, manufactured by Sresan Pharmaceutical Pvt. Ltd., a Tamil Nadu-based firm now under investigation for producing a batch containing diethylene glycol (DEG) — a toxic industrial solvent known to cause acute kidney failure. Laboratory analysis found DEG levels far exceeding permissible limits. Several state governments across India — including Madhya Pradesh, Tamil Nadu, Rajasthan and Uttar Pradesh — acted after test reports found contamination in the cough syrup. But banning a drug after children have died is no triumph of governance. It is an admission of failure — a failure to enforce the Drugs and Cosmetics Act, to test high-risk formulations, and to ensure that the profit motive does not override human life.

A Recurring Nightmare

India has seen this horror before. In 1998, 33 children died in Gurgaon after consuming DEG-tainted cough syrup. In 2020, a similar tragedy struck Jammu. Indian-made cough syrups have also been linked to 70 child deaths in The Gambia and 18 in Uzbekistan — all traced to DEG and ethylene glycol contamination.

Each time, the response has been the same: outrage, suspensions, and promises of “strict action.” Yet the systemic rot persists. Why does this keep happening in a country hailed as the “pharmacy of the world” and ranked third globally in pharmaceutical manufacturing by volume? The answer lies in the fractured, under-resourced, and politicised structure of India’s drug regulatory system. While the Central Drugs Standard Control Organisation (CDSCO) frames rules, enforcement lies with state drug authorities. In practice, this means uneven implementation, weak coordination, and a lack of accountability. Laboratories in several states lack modern testing equipment, and drug inspectors are overburdened, often overseeing thousands of licensees.

Profit Over Principle

Pharmaceutical companies, especially small and medium firms, operate under fierce competition and wafer-thin margins. In such an environment, quality control becomes the first casualty. Substandard raw materials are sourced, often from unverified suppliers, and corners are cut in testing and certification. In the Chhindwara case, Sresan Pharmaceutical allegedly procured glycerin — a key syrup ingredient — from an unlicensed trader. Similar negligence has surfaced in earlier DEG cases, where industrial-grade glycerin, cheaper but deadly, was used instead of its pharmaceutical-grade counterpart. Corporate ethics, it seems, has been outsourced to convenience. When business decisions directly endanger children, such lapses amount to criminal negligence, not mere error.

The State’s Share of Blame

Madhya Pradesh’s Food and Drug Administration (FDA), like many state regulators, has struggled with manpower shortages and weak surveillance. The fact that Coldrif syrup was freely available across retail outlets shows that routine sample testing either did not occur or failed to detect toxicity.

The government’s reaction — suspending a few officials, transferring the FDA Controller, and arresting a doctor — addresses only the symptoms, not the disease. An FIR has been registered against the Coldrif syrup manufacturer, the government paediatrician who prescribed the syrup, and others under sections 105 and 276 of the Bharatiya Nyaya Sanhita (BNS) and section 27A of the Drugs and Cosmetics Act, 1940. A drug licence has also been terminated in Parasia of Chhindwara. Accountability in India’s health disasters often stops at the lowest rung, while senior regulators and corporate executives escape unscathed. Chief Minister Mohan Yadav visited grieving families in the affected areas and assured them of justice and government support, terming the tragedy “heart-wrenching and unacceptable.” “No guilty person will be spared,” he said. Yet unless “guilty” includes those who allowed systemic decay to persist, such assurances will remain hollow.

The Need for a Unified National Regulator

India urgently requires a single, autonomous national drug regulatory authority, free from political interference. The model should unify powers to license, test, recall, and prosecute across states. Currently, state agencies act in silos, often failing to report substandard drugs to the CDSCO. The absence of a centralised public database of drug recalls leaves consumers uninformed and unsafe. Digital batch tracking, mandatory source verification, and a transparent national database could have averted this tragedy. Yet such reforms have languished in bureaucratic files for years.

A Question of Conscience

Beyond regulation lies a deeper moral failure: we have normalised preventable deaths. Condolences, compensation, and committee reports follow each DEG episode. Then, as attention fades, the machinery of neglect resumes.

Afreen Khan, a mother who lost her five-year-old son in Chhindwara, told the Chief Minister: “We couldn’t save our child, but if others survive, our hearts will find some peace.” Her words lay bare our collective guilt.

Never Again — And This Time, Mean It

If India wants to retain its reputation as a global pharmaceutical leader, it must prove that safety and ethics are non-negotiable. The Centre should launch a nationwide audit of all paediatric syrups and certify each batch as DEG-free. Drug regulation must move from punitive to preventive enforcement. State labs must be equipped for real-time testing, and violators should face immediate licence cancellation. Above all, India’s leaders must find the will to act before another headline reads: “Children die after taking cough syrup.”

Views expressed are personal. The writer is a senior journalist, panellist on news channels, and an academician in the field of journalism