SC Rejects PIL Seeking Probe into Deaths of Children Linked to Toxic Cough Syrup

NEW DELHI:
The Supreme Court on Friday dismissed a public interest litigation (PIL) seeking a high-level probe into the deaths of children allegedly caused by the consumption of contaminated cough syrup in Madhya Pradesh and Maharashtra.

A Bench of Chief Justice of India (CJI) B.R. Gavai and Justice K. Vinod Chandran questioned advocate Vishal Tiwari, the petitioner in person, about how many PILs he has filed so far. After Tiwari responded “8-10 PILs”, the CJI Gavai-led Bench dismissed the petition.

During the hearing, Solicitor General Tushar Mehta, the second-highest law officer of the Centre, who was present in the courtroom but not representing any respondent authority, stated that state governments, including Tamil Nadu and Madhya Pradesh, were taking necessary steps.

“Tamil Nadu, Madhya Pradesh, etc., will take steps. We cannot ‘not’ trust the states. Of course, they will take steps,” Mehta said.

The PIL claimed that at least 14 children have died since early September, with most of the cases reported from Nagpur in Maharashtra and Chhindwara in Madhya Pradesh. The plea claimed that laboratory tests conducted by the Madhya Pradesh government confirmed the presence of Diethylene Glycol (DEG) — a toxic industrial solvent prohibited for pharmaceutical use — in ‘Coldrif Cough Syrup’ manufactured by Tamil Nadu’s Sresan Pharma Pvt. Ltd.

It added that initial cases were reported from Madhya Pradesh’s Chhindwara district in early September, and within days, the death toll mounted as similar cases emerged from Nagpur, Maharashtra.

“Despite the catastrophic findings, the Union Government and the Central Drugs Standard Control Organisation (CDSCO) allegedly failed to issue an immediate nationwide recall or ban, permitting the continued circulation of potentially poisonous medicines across States,” the plea stated.

It drew parallels with the Gambia and Uzbekistan incidents, where DEG-contaminated Indian syrups were linked to over 90 child deaths abroad. “This is not a tragedy of chance but of negligence, apathy, and regulatory failure — an institutional rot that allows counterfeit and adulterated drugs to enter the public market unchecked,” the PIL stated.

The plea had sought 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, regulation, testing and distribution of contaminated syrups and to recommend systemic drug-safety reforms. Further, it seeks a Central Bureau of Investigation (CBI) probe into the deaths of children across states, under the supervision of a former apex court judge.

The PIL also urged the top court to transfer all pending FIRs related to the deaths to the CBI to ensure a uniform and independent investigation. Another prayer was for immediate recall, seizure and prohibition of all batches of Coldrif Cough Syrup and other related formulations manufactured by Sresan Pharma Pvt. Ltd., until independent NABL-accredited laboratories issue toxicological clearance and verification of safety.

The National Human Rights Commission (NHRC) has already issued notices to the Principal Secretaries of the Health Departments of Madhya Pradesh and Rajasthan on a complaint alleging serious lapses in drug safety and regulatory mechanisms that led to the tragedy.

The apex human rights body has directed the Drugs Controller General of India (DCGI), Central Drugs Standard Control Organisation, Union Ministry of Health and Family Welfare, to initiate a comprehensive investigation into the supply chain of the alleged spurious drugs, apart from instructing all regional labs in the concerned states to collect and test samples.

“The authority is also directed to order all the Chief Drugs Controllers in the concerned states to process immediately the banning of the spurious drugs and submit reports,” the NHRC said.