After 14 Child Deaths Linked to Toxic Syrup: PIL in Supreme Court Seeks CBI Probe, National Drug Recall Policy

The petition, filed under Article 32 of the Constitution, calls for protection of the right to life, health, and safety under Article 21, arguing that the tragedy reflects a systemic regulatory collapse in India’s drug control mechanism.

The PIL states that laboratory tests conducted by the Government of Madhya Pradesh confirmed the presence of Diethylene Glycol (DEG), a toxic industrial solvent; in the Coldrif cough syrup, which is strictly prohibited for use in medicines. The contamination has reportedly led to the deaths of at least 14 children, most of them under the age of five, from Chhindwara in Madhya Pradesh and Nagpur in Maharashtra. The children suffered acute renal failure after consuming the syrup.

Despite the alarming findings, the petition notes that the Union Ministry of Health and the Central Drugs Standard Control Organisation (CDSCO) failed to immediately recall or ban the contaminated product, allowing its continued circulation. The petitioner argues that this “regulatory inaction” has turned a preventable crisis into a national tragedy.

Drawing parallels with the 2022 Gambia and Uzbekistan incidents, where Indian-made syrups were linked to the deaths of over 90 children abroad, the plea asserts that this recurring pattern exposes India’s “broken pharmaceutical surveillance network.” It cites repeated World Health Organization (WHO) alerts on DEG and Ethylene Glycol contamination and India’s failure to implement uniform pre-release testing protocols or a national recall mechanism despite prior warnings.

Quoting the Supreme Court’s own precedent in Consumer Education and Research Centre v. Union of India (1995) 3 SCC 42, the PIL underscores that the right to health and safety forms an integral part of the right to life under Article 21. “This tragedy is not of chance but of negligence, apathy, and regulatory failure,” the plea says, calling it an “institutional rot” that allows adulterated and counterfeit medicines to reach the public unchecked.

The petition seeks several wide-ranging directions, including 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, testing, and distribution of contaminated syrups. It also prays for a Central Bureau of Investigation (CBI) probe into the deaths of children across different States, under the supervision of a former Supreme Court judge.

Further, the petitioner urges the top court to transfer all FIRs related to the tragedy to the CBI for a uniform investigation. It also seeks immediate recall and seizure of all batches of Coldrif syrup and other formulations by Sresan Pharma, pending independent toxicological clearance by NABL-accredited laboratories.

In a push for systemic reform, the PIL requests that the CDSCO be directed to conduct nationwide mandatory DEG/EG testing for all syrup-based pharmaceutical formulations, with results made public to ensure transparency. It also calls for the creation of a Central Digital Drug Recall and Pharmacovigilance Portal to track and report contaminated drugs in real time, integrating data from State Drug Controllers and accredited testing agencies.

Significantly, the petition demands criminal prosecution and cancellation of licenses of pharmaceutical companies found responsible for the production or distribution of toxic medicines, under Sections 18(a)(i) and 27(a) of the Drugs and Cosmetics Act, 1940. Finally, it seeks the formulation of a National Drug Recall Policy and a Toxicological Safety Protocol, mandating pre-release DEG/EG testing for all oral liquid formulations, particularly pediatric syrups.

Describing the matter as a test of the State’s moral and constitutional duty, the plea concludes that the case “is not merely about enforcement of law but about the preservation of governance itself, ensuring that no medicine meant to heal becomes an instrument of death.”

The PIL prays for:-

1.⁠ ⁠Judicial Commission headed by a retired SC judge to probe manufacture, regulation & testing of toxic syrups (DEG/EG).

2. CBI probe under SC monitoring into child deaths across States.

3.⁠ ⁠Transfer of all FIRs on the incident to CBI for uniform investigation.

4.⁠ ⁠Immediate recall & ban on all Coldrif Cough Syrup batches by Sresan Pharma (Tamil Nadu).

5.⁠ ⁠Nationwide DEG/EG testing of all syrup-based medicines, results to be made public.

6.⁠ ⁠Creation of a national Drug Recall & Pharmacovigilance Portal for real-time alerts.

7.⁠ ⁠Criminal prosecution and license cancellation of firms producing contaminated drugs.

8.⁠ ⁠Formulation of a National Drug Recall Policy and Toxicological Safety Protocol for all pediatric syrups.