The Supreme Court on Friday dismissed a Public Interest Litigation (PIL) petition 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].
A Bench of Chief Justice of India BR Gavai and Justice K Vinod Chandran rejected the plea filed by advocate Vishal Tiwari.
"Daily deaths are rising. Not the first instance of such adulterated medicine. States are blaming each other. Probe by one agency is needed," Tiwari said, appearing in person.
Solicitor General Tushar Mehta opposed the petition. He said that Tiwari comes rushing to the Court after reading newspaper reports. He also said that the concerned States will take steps to alleviate the issues.
"Tamil Nadu, Madhya Pradesh etc will take steps. We cannot not trust the States. Of course they will take steps," SG Mehta said.
"There was no proper lab test or clinical trial done," Tiwari claimed.
"Whenever something happens even though all Institution in place, he (Tiwari) reads newspapers and come here," Mehta said.
The Court then proceeded to dismiss the petition.
The plea by Tiwari called 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 stated 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 petition said 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 petitioner submitted that these warnings went unheeded, as India still lacks any uniform pre-release testing or a national drug recall policy.
The petition noted 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.
The petition also highlighted 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 submitted.
The plea further said 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, sought 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 sought 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 petition said that there should be 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.