Supreme Court PIL Seeks Probe into Children’s Deaths from Toxic Cough Syrup

A Public Interest Litigation (PIL) has been filed before the Supreme Court seeking a court-monitored investigation into the deaths of several children allegedly caused by contaminated cough syrup. The petition, Vishal Tiwari v. Union of India, also calls for a complete reform of India’s drug safety system and a nationwide recall of all toxic cough syrups.

The PIL was filed after at least 14 children under the age of five reportedly died in Madhya Pradesh after consuming Coldrif Cough Syrup, manufactured by Tamil Nadu-based Sresan Pharma Pvt. Ltd.. Laboratory tests by the State Forensic Science Laboratory, Bhopal, confirmed that the syrup contained Diethylene Glycol (DEG) — a poisonous industrial chemical used in antifreeze, which is banned in medicines.

The incident first came to light in Chhindwara district, where several children suffered kidney failure after taking the syrup. As more cases were reported, the death toll rose, with similar cases suspected in Maharashtra and Rajasthan.

Despite clear evidence of contamination, the plea points out that the Union Ministry of Health and Family Welfare and the Central Drugs Standard Control Organisation (CDSCO) failed to issue an immediate nationwide recall. The petitioner described this as a serious failure of the regulatory system, drawing comparisons with the 2022 tragedies in Gambia and Uzbekistan, where Indian-made syrups were linked to the deaths of over 90 children.

The World Health Organization (WHO) had previously warned India about the risks of DEG and Ethylene Glycol (EG) contamination, urging stricter safety measures. However, according to the petition, the government ignored these warnings and has yet to implement a national recall policy or mandatory pre-release testing.

The petition notes that while the Madhya Pradesh government quickly banned the product and recalled it within the State, no similar action was taken at the national level. As a result, contaminated batches reportedly continued to be sold in other parts of the country. Although some States, including Tamil Nadu, Kerala and Maharashtra, later banned local sales, the lack of a central recall system delayed response and created public confusion.

The petitioner further highlighted that hundreds of small-scale pharmaceutical companies in India operate without proper testing facilities or reliable sourcing of raw materials. Many of them allegedly use unverified chemicals, which can contain harmful industrial-grade glycols.

The plea argues that such regulatory negligence violates Articles 21 and 47 of the Constitution, which protect the right to life and mandate the State to ensure public health.

The petitioner has requested the Supreme Court to:

• Set up a National Expert Committee headed by a retired Supreme Court judge to investigate the manufacturing, regulation, and distribution of contaminated syrups.
• Order the immediate recall and seizure of all Coldrif Cough Syrup batches.
• Suspend Sresan Pharma’s manufacturing licence.
• Direct the CBI to conduct a probe under the Court’s supervision into all related deaths.
• Introduce mandatory nationwide testing for all syrup-based medicines for DEG and EG contamination.
• Create a Central Digital Drug Recall and Pharmacovigilance Portal to track unsafe medicines in real time.

The PIL also calls for the Union government to frame a National Drug Recall Policy and a Toxicological Safety Protocol, which would make DEG and EG testing compulsory before any paediatric syrup is released to the market. The petition stresses that without such reforms, similar tragedies may continue to occur.