A Public Interest Litigation (PIL) petition has been filed before the Supreme Court seeking an independent, court-monitored probe into the deaths of multiple children, which were reportedly caused by contaminated cough syrup [Vishal Tiwari v. Union of India].
The plea also calls for a complete overhaul of India’s drug safety and recall mechanisms.
The petition was filed after at least 14 children, all under the age of five, reportedly died in Madhya Pradesh recently after consuming Coldrif Cough Syrup manufactured by Tamil Nadu–based Sresan Pharma Pvt. Ltd.
Laboratory reports by the State Forensic Science Laboratory in Bhopal confirmed the presence of Diethylene Glycol (DEG) - a toxic industrial chemical used in antifreeze and banned for pharmaceutical use.
According to the petition, the tragedy first came to light in Chhindwara district, where several children developed acute renal failure after consuming the syrup. The death toll climbed rapidly, with suspected cases also emerging in Maharashtra and Rajasthan.
Despite confirmed contamination, the plea states that no immediate nationwide recall was issued by the Union Ministry of Health and Family Welfare or the Central Drugs Standard Control Organisation (CDSCO).
The petitioner argues that such inaction represents a catastrophic regulatory failure, drawing parallels to the 2022 incidents in Gambia and Uzbekistan, where Indian-made syrups were linked to the deaths of over 90 children abroad.
The World Health Organization (WHO) had, at the time, issued global alerts warning India about the risk of DEG and Ethylene Glycol (EG) contamination, and called for systemic reform.
The petition further submits that these warnings went unheeded, as India still lacks any uniform pre-release testing or a national drug recall policy.
"The State Government of Madhya Pradesh, upon receiving confirmation (that the cough syrup was toxic) issued an immediate ban on the product and ordered recall of all stocks within the State. However, no nationwide recall was initiated by the Union Ministry of Health & Family Welfare or the Central Drugs Standard Control Organisation (CDSCO), thereby allowing continued sale of the toxic drug in other States," the plea recounted.
It notes that even though several States, including Tamil Nadu, Kerala and Maharashtra, eventually suspended local sales of the contaminated cough syrup, the lack of a centralized recall mechanism allowed contaminated batches of the drug to remain in circulation for weeks.
It adds that government agencies issued contradictory statements, creating public confusion and delaying medical response.
The petition goes on to highlight that hundreds of small-scale drug manufacturers operate without adequate testing infrastructure or traceability of raw materials. Most of such manufacturers procure unverified chemical excipients (the syrup’s base ingredients), which may contain industrial-grade glycols, the petitioner has submitted.
The plea further says that such systemic negligence violates Articles 21 and 47 of the Constitution, which obligate the State to protect the right to life and public health.
The petitioner, therefore, seeks multiple directions from the Supreme Court, including the constitution of a judicially monitored National Expert Committee headed by a retired Supreme Court judge to conduct an inquiry into the manufacture, regulation, testing and distribution of contaminated cough syrups and recommend drug safety reforms.
It also seeks the immediate recall and seizure of all Coldrif Cough Syrup batches, suspension of Sresan Pharma’s manufacturing licence, and a Central Bureau of Investigation (CBI) probe under judicial supervision into all related deaths across States.
Further, the PIL demands a nationwide testing mandate for all syrup-based formulations for DEG and EG contamination and the establishment of a Central Digital Drug Recall and Pharmacovigilance Portal to track substandard or contaminated medicines in real time.
The petitioner has also urged the Court to direct the Union government to frame a National Drug Recall Policy and Toxicological Safety Protocol, mandating pre-release DEG/EG testing, particularly for paediatric syrups, to prevent recurring tragedies.
The plea has been filed by Advocate Vishal Tiwari.