A Public Interest Litigation (PIL) has been filed in the Supreme Court of India seeking a CBI investigation and sweeping reforms in India Medicine safety regulatory system, following the deaths of several children in Madhya Pradesh and Rajasthan allegedly caused by contaminated cough syrups.
The petition, filed by advocate Vishal Tiwari, requests a court-monitored investigation into the incident and the establishment of a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge to ensure accountability within India pharmaceutical regulatory framework.
The PIL comes amid mounting public concern over reports linking multiple fatalities to toxic or substandard cough syrups, raising questions about the effectiveness of India Medicine quality control and export oversight mechanisms.
According to the plea, the existing investigations conducted by state police and Medicine control authorities have been fragmented and inconsistent, creating scope for regulatory lapses and potential cover-ups. To address this, the petitioner has urged the apex court to transfer all related FIRs and state-level probes to the Central Bureau of Investigation (CBI) for a unified and impartial inquiry.
Advocate Tiwari petition also calls for the creation of a national-level Medicine safety body to conduct a comprehensive review of systemic failures within India pharmaceutical manufacturing and distribution network. The PIL emphasizes the need for a centralized and independent mechanism that can ensure the safety of Medicine being sold domestically and exported abroad.
In addition, the plea demands that the Centre mandate toxicological testing for all suspect medicines and pharmaceutical batches through NABL-accredited laboratories before allowing further sale or export. This, the petitioner argues, would help prevent further loss of life and restore global confidence in India Medicine manufacturing standards.
The petition highlights that India, as one of the world largest producers and exporters of generic medicines, bears a global responsibility for ensuring that its pharmaceutical products meet the highest safety benchmarks.
In recent years, similar concerns have surfaced internationally. Indian-made cough syrups were linked to child deaths in Gambia (2022) and Uzbekistan (2023), prompting international scrutiny of India Central Medicine Standard Control Organisation (CDSCO) and state-level regulatory practices.
The PIL further urges the Supreme Court to direct the Union Health Ministry to strengthen coordination between the CDSCO and state Medicine regulators, and to establish a national pharmacovigilance network capable of rapid response to reports of adverse Medicine reactions or quality failures.
Legal experts suggest that if admitted, the PIL could pave the way for one of India most comprehensive reviews of its Medicine safety ecosystem in decades. The case is expected to test how effectively India judiciary can intervene to improve accountability in a sector critical to both public health and international trade.
As the Supreme Court considers whether to take up the matter, the outcome could have far-reaching implications — not just for India pharmaceutical regulation but for its reputation as a global medicine supplier.
