New Delhi: A Public Interest Litigation (PIL) has been filed in the Supreme Court seeking an inquiry and systemic reform in drug safety mechanisms following the deaths of children in Madhya Pradesh and Rajasthan allegedly due to consumption of toxic cough syrups.

The PIL, filed by advocate Vishal Tiwari, requests a court-monitored investigation and the constitution of a National Judicial Commission or Expert Committee, headed by a retired Supreme Court judge, to ensure impartial oversight of the probe.

Calls for CBI investigation

The petition seeks that all pending FIRs and investigations related to child deaths caused by toxic cough syrups across different states be transferred to the CBI, arguing that state-level probes have resulted in fragmented accountability. “Separate state-level investigations have led to repeated lapses, allowing hazardous formulations to reach the market,” the PIL contends.

The petitioner has urged the Supreme Court to direct the Central government to constitute a national-level judicial or expert body to identify failures in the regulatory system that allowed substandard medicines to circulate.

Toxicological testing and regulatory reforms

The PIL also demands that all suspect cough syrup products undergo toxicological testing in NABL-accredited laboratories before they are sold or exported. The objective is to prevent further child fatalities and ensure that unsafe drugs do not enter the market again.

The plea comes in the backdrop of reports from Madhya Pradesh and Rajasthan, where several children reportedly died after consuming a specific type of cough syrup.

Fragmented accountability and systemic gaps

Advocate Tiwari’s petition highlights the lack of uniformity in state-level investigations, which, according to the plea, has led to delays in holding accountable those responsible for negligence in drug manufacturing, distribution, and monitoring. The PIL emphasizes that a centralised judicial oversight mechanism is necessary to prevent repetition of such incidents in the future.

Court-monitored expert panel

The PIL proposes that the National Judicial Commission or Expert Committee should:

  • Be headed by a retired Supreme Court judge
  • Examine regulatory lapses in drug safety
  • Monitor ongoing investigations for fairness and uniformity
  • Recommend policy and regulatory reforms to strengthen drug monitoring

The petition underscores the urgency for robust and uniform mechanisms to safeguard public health, especially children, from unsafe pharmaceuticals.