India is once again reeling from a preventable tragedy: the death of 25 children in Madhya Pradesh and Rajasthan due to contaminated cough syrup.
This grim pattern of recurring medical negligence and weak drug regulation can be traced as far back as 1986, when 14 patients died in Mumbai’s JJ Hospital after consuming glycerol contaminated with 18.5 per cent diethylene glycol (DEG). Then followed 11 child deaths in Bihar (1988), 33 in Gurgaon (1998), and 12 in Jammu & Kashmir (2020). Internationally, Indian cough syrups were linked to the death of over 60 children in Uzbekistan and nearly 70 in Gambia.
Investigations showed that cough syrups were manufactured with industrial-grade solvents, rather than pharmaceutical grade, leading to contamination with DEG, a toxic substance that causes fatal kidney failure. The Tamil Nadu Food and Drug Administration found many samples of cough syrups containing 48.6 per cent DEG — nearly 480 times the permissible limit of 0.1 per cent. Despite past inquiries and committee reports, poor enforcement sees unsafe drugs infiltrating the market.
The Hathi Committee (1974-75) had called for a ban on non-essential and irrational formulations, including paediatric cough syrups, due to the lack of proven benefit. The World Health Organization (WHO) and the Indian Academy of Paediatrics also advise against their use for children under four. Yet, these syrups remain widely available.
In 2023, the WHO issued alerts after Indian-made syrups were linked to deaths in Gambia. Data provided to Parliament show that 2.8 per cent of the drug samples tested in 2023-24 were substandard and 0.27 per cent were spurious or adulterated. A probe by the Central Drugs Standard Control Organisation (CDSCO) in 2024 showed that over 100 pharmaceutical units producing cough syrups for exports had failed quality testing. These figures expose the serious flaws in India’s drug regulatory system. Recommendations like those of the Mashelkar Committee — to appoint one drug inspector per 50 factories and one for every 200 retail outlets — remain unfulfilled. Enforcement remains deeply inadequate.
The responsibility for ensuring drug safety lies with pharmaceutical companies, the CDSCO, and State regulators. Yet irrational, over-the-counter cough syrups with questionable formulations are in the market. Medical associations concerned over the arrest of a doctor in MP serve to highlight broader accountability gaps.
Victims, primarily from marginalised communities, are left without justice because of delayed action, lack of a drug recall policy, and the absence of a compensation framework for drug-related injuries. India still lacks strong mechanisms to address adverse drug reactions and hold companies and officials accountable.
Trust in the regulatory system further eroded with the revelation that over 30 pharmaceutical firms bought electoral bonds worth over ₹900 crore — raising serious concerns on conflict of interest.
The way forward
India must act decisively. Irrational drug formulations should be banned, vacant regulatory posts filled, and the drug testing infrastructure strengthened. Modern quality management systems must be enforced by Indian regulators to restore credibility and protect lives. Recent advisories on rational prescribing are directionally good, but remain inadequate. Civil society groups have called for a ban on irrational cough syrups, accountability of officials, and a judicial commission to investigate the catastrophe.
This is more than a regulatory failure — it is a national shame. Both Central and State governments must accept collective responsibility. Like the 1937 US drug disaster that led to the formation of the USFDA, India must learn from its repeated tragedies and empower regulators to ensure that patient safety is above profits.
(The writer is National Convenor, Jan Swasthya Abhiyan India. Views are personal)
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Published on October 20, 2025
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