A petition has been filed in the Supreme Court on Tuesday, demanding an investigation by the Crime Bureau of Investigation (CBI) into 14 children's deaths after consumption of contaminated cough syrups in Madhya Pradesh's Chhindwara.
It is filed by Advocate Vishal Tiwari, also seeking a nationwide ban, with a recall of all contaminated cough syrup batches, and mandatory testing of the syrup-based formulations. He also cited similar incidents reported in other states, urging that the investigation be conducted under the supervision of a former Supreme Court judge.
With the petition, he also called for compensation to the affected families, further seeking the creation of a National Pharmacovigilance Portal that does real-time monitoring of drug safety alerts. The petition invoked the right to health and life of children under Article 21 of the Constitution, saying, "This right ensures that no medicine meant to heal becomes an instrument of death."
It referred to the Chhindwara tragedy, where at least 14 children, all of them aged below 15 years, died after consuming Coldrif cough syrup. After the State Government conducted tests of these samples, it found that the syrups manufactured by Tamil Nadu-based Sresan Pharma Pvt Ltd contained Diethylene Glycol (DEG), which is a toxic industrial solvent banned for any pharmaceutical use.
Primary investigation and reports revealed that after consuming the syrup, the children suffered from acute renal failure, with the death toll rising to fourteen within a few days. Similar incidents were later reported in Rajasthan and Maharashtra.
The petition also raises questions about the inaction of the Central Government and the Central Drugs Standard Control Organisation (CDSCO), accusing them of failing to impose a ban or alert even though contamination was confirmed.
The plea stated, "This regulatory failure is reminiscent of previous tragedies, including the 2022 Gambia and Uzbekistan cases, where Indian-made syrups were linked to over 90 child deaths."
Noting that the World Health Organisation (WHO) had warned India about DEG and Ethylene Glycol contamination, urging it to undertake a systematic reform. It alleged, "Neither the Ministry of Health nor the CDSCO implemented pre-release testing protocols or a national ecall mechanism."
The petition further seeks suspension or cancellation of the manufacturing licenses of those companies that are involved in the production or distribution of contaminated drugs, with prosecution under the Drugs and Cosmetics Act, 1940.
Tiwari also urged the Apex Court to direct the Central Government to formulate and notify a National Drug Recall Policy and a Toxicological Safety Protocol, which makes pre-release DEG/EG testing mandatory for all oral liquid formulations, particularly the pediatric ones, followed by strict quality audits before they are released in the market.