A PIL has been filed in the Supreme Court over the deaths of 14 children in Madhya Pradesh and Maharashtra linked to contaminated cough syrup. The plea seeks a CBI probe, nationwide recall, and judicial inquiry into drug safety failures.
New Delhi: A public interest litigation (PIL) has been filed in the Supreme Court of India seeking urgent action after the death of several children due to alleged consumption of poisonous cough syrup in Madhya Pradesh and Maharashtra.
The petition highlights a serious case of regulatory failure in India’s drug safety system and demands immediate judicial intervention.
According to reports, at least 14 children have died since early September, with most of the cases being reported from Nagpur in Maharashtra and Chhindwara in Madhya Pradesh.
The PIL has been filed by advocate Vishal Tiwari, who pointed out that laboratory tests conducted by the Madhya Pradesh government confirmed the presence of Diethylene Glycol (DEG) in the syrup.
DEG is a highly toxic industrial solvent that is strictly prohibited for use in medicines. The syrup in question is ‘Coldrif Cough Syrup,’ manufactured by Tamil Nadu-based company Sresan Pharma Pvt. Ltd.
The first cases were reported in Chhindwara, Madhya Pradesh, in the beginning of September. Within a few days, similar reports started coming in from Nagpur, Maharashtra, and the death toll of children rose sharply.
Despite the findings of toxic substances, there was no immediate nationwide ban or recall of the product. The plea filed before the Supreme Court has strongly criticized the inaction of the authorities and said:
“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 petition also reminded the court of similar global tragedies where Indian-manufactured cough syrups were linked to child deaths abroad. It specifically referred to incidents in Gambia and Uzbekistan where DEG contamination in syrups was connected to the death of over 90 children.
The plea described the current case as an example of systematic failure, stating:
“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.”
Seeking strict judicial directions, the PIL has asked the Supreme Court to set up a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge.
This body would conduct a detailed investigation into the entire process of drug manufacturing, regulation, testing and distribution of the contaminated syrups, and would also recommend long-term reforms in drug safety laws and procedures.
Another key demand in the PIL is a CBI investigation into the deaths of children across states. The petition requests that this investigation be supervised by a former Supreme Court judge to ensure independence and credibility.
It also asks the Supreme Court to transfer all pending FIRs related to these deaths from different states to the CBI so that the probe remains uniform and not scattered across jurisdictions.
In addition, the PIL calls for the immediate recall, seizure, and prohibition of all batches of Coldrif Cough Syrup and other related medicines made by Sresan Pharma Pvt. Ltd., until their safety is confirmed by NABL-accredited laboratories.
The petition emphasizes that only after thorough toxicological testing and clearance by independent labs should these drugs be allowed back into circulation.
The case has also caught the attention of the National Human Rights Commission (NHRC). On Monday, the NHRC issued notices to the Principal Secretaries of the Health Departments of Madhya Pradesh and Rajasthan after receiving a complaint about major lapses in drug safety and regulatory checks.
The human rights body has also directed the Drugs Controller General of India (DCGI), the CDSCO, and the Union Ministry of Health and Family Welfare to carry out a wide-ranging investigation into the supply chain of these alleged spurious medicines.
The NHRC further ordered all state drug testing laboratories in the affected states to immediately collect samples and test them.
In a strongly worded directive, the NHRC said:
“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.”
This PIL, together with the NHRC’s intervention, brings the focus back on India’s recurring problem of contaminated and spurious medicines, which not only damage public health but also tarnish India’s reputation globally.
The plea has been filed by Advocate Vishal Tiwari.
The Supreme Court is now expected to consider whether urgent judicial measures are needed to prevent further loss of lives and to enforce accountability on regulators and manufacturers.
Case Title:
Vishal Tiwari v. Union of India
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