Cough Syrup Deaths: PIL In Supreme Court Seeks CBI Probe, Review Of Drug Controls & Seizure Of Contaminated Medicines

Following the recent spate of child deaths in Madhya Pradesh and Rajasthan caused by the consumption of toxic cough syrups, a Public Interest Litigation (PIL) has been filed in the Supreme Court seeking an independent, court-monitored probe into the incident and a nationwide review of drug safety mechanisms.

The petition, filed by advocate Vishal Tiwari, calls for the constitution of a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge to conduct a comprehensive inquiry into the manufacture, testing, and distribution of contaminated cough syrups containing Diethylene Glycol (DEG) and Ethylene Glycol (EG), the same toxic compounds that have previously caused fatalities.

The PIL comes amid alarming reports from Shivpuri in Madhya Pradesh and Barmer in Rajasthan, where several children reportedly died after consuming Coldrif Cough Syrup, a formulation manufactured by M/s Sresan Pharma Pvt. Ltd., a Tamil Nadu-based pharmaceutical company. Preliminary investigations by local authorities and drug control departments have pointed to suspected contamination in the syrup, reigniting concerns over recurring lapses in India's drug quality control and export monitoring systems.

Advocate Tiwari's petition urges the Supreme Court to direct the Centre to set up a National Judicial Commission or Expert Committee to investigate the regulatory failures that allowed the circulation of substandard cough syrups, and to suggest robust measures to prevent such tragedies. The proposed body, he suggests, should be chaired by a retired Supreme Court judge and include experts in pharmacology, toxicology, and drug regulation.

The PIL also seeks a direction to transfer all pending FIRs and investigations related to the child deaths due to poisonous cough syrups in various states to the Central Bureau of Investigation (CBI), under the supervision of a former Supreme Court judge, to ensure an impartial, coordinated probe. It argues that multiple state-level inquiries have resulted in fragmented accountability, allowing recurring instances of toxic formulations to reach consumers.

The PIL also seeks to direct authorities to “immediately recall, seize, and prohibit the sale and distribution” of all batches of Coldrif Cough Syrup and any other products manufactured by Sresan Pharma Pvt. Ltd. or its related companies. The petitioner has sought that these products be subjected to toxicological testing and verification by NABL-accredited laboratories before any further sale or export is permitted.

The plea further calls for the mandatory pre-distribution quality testing of all cough syrups, both for domestic consumption and export, and the establishment of a uniform safety audit mechanism across states. It also seeks directions to the Central Drugs Standard Control Organisation (CDSCO) to strengthen its inspection and approval protocols, ensuring real-time batch-level monitoring of medicinal formulations containing solvents like DEG and EG.