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Opinion Deaths in MP due to spurious cough syrups point to grave regulatory deficits

India’s pharmaceutical industry has positioned itself as the ‘pharmacy of the world’. Its regulatory mechanisms fail to do justice to this billing.

Deaths in MP due to spurious cough syrups point to grave regulatory deficitsThe MP deaths are another warning for the industry and regulators — they have much to do to rebuild public trust.

By: Editorial

October 7, 2025 07:29 AM IST First published on: Oct 7, 2025 at 07:29 AM IST

The deaths of at least 14 children in Madhya Pradesh’s Chhindwara district and in Rajasthan, between August and the first week of October, after consuming a contaminated cough syrup, mark yet another preventable tragedy in India’s troubled pharmaceutical landscape. The Coldrif syrup, later found to contain 48.6 per cent diethylene glycol (DEG) — a toxic industrial solvent — was prescribed to children suffering from common cold and cough. The WHO pegs its globally acceptable standard at 0.10 per cent. Madhya Pradesh has since banned the syrup and arrested a doctor, but this is not an isolated incident. From Cameroon in 2023 to the 2022 Gambia and Uzbekistan incidents that killed nearly 150 children due to similar contamination, to earlier deaths in J&K in 2020, the pattern speaks of systemic regulatory collapse.

In the post-Covid years, India’s pharmaceutical industry has positioned itself as the “pharmacy of the world” — it supplies 40 per cent of generics used in the US and more than 90 per cent of medicines in several African nations. Its regulatory mechanisms, however, fail to do justice to this billing — the deficits are particularly glaring when it comes to monitoring small-scale units that constitute a major part of the sector. Data from India’s Central Drugs Standard Control Organisation show that 36 per cent of inspected drug-manufacturing units were shut down for serious violations in 2023-24 alone. The deaths in MP indicate that several others may have fallen outside the radar. Pharma units are required to maintain a database on manufacturing practices and inspection results to alert regulators and doctors about the history of a brand. However, state regulators often lack resources and autonomy, and drug inspectors are regularly tasked with administrative work. Scrutiny of drugs for safety and efficacy — even monitoring for known adulterants such as DEG — has suffered as a result. In MP, officials admitted to being in the dark for weeks — even as more children fell sick — highlighting the absence of timely pharmacovigilance.

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As was evident in the Gambia and Uzbekistan scandals, outrage is rarely followed by accountability. Even after global condemnation, Indian firms implicated in the offences have faced minimal legal consequences. The MP deaths are another warning for the industry and regulators — they have much to do to rebuild public trust.

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