A Public Interest Litigation (PIL) has been filed before the Supreme Court of India seeking a court-monitored investigation into the deaths of several children reportedly caused by the consumption of toxic cough syrups. The plea, filed by Advocate Vishal Tiwari, calls for immediate accountability, a nationwide recall of contaminated medicines, and comprehensive reforms in India’s drug safety framework.
Background of the PIL
The petition arises from a tragic incident in Madhya Pradesh, where at least 14 children under the age of five allegedly died after consuming Coldrif Cough Syrup, manufactured by Sresan Pharma Pvt. Ltd., a Tamil Nadu–based company. Laboratory analysis by the State Forensic Science Laboratory, Bhopal, confirmed the presence of Diethylene Glycol (DEG) — a highly toxic industrial chemical that is banned for use in pharmaceuticals.
The PIL describes how the children developed acute renal failure shortly after consuming the syrup. Despite confirmation of contamination, the petitioner argues that the Union Ministry of Health and Family Welfare and the Central Drugs Standard Control Organisation (CDSCO) failed to issue a nationwide recall, allowing the toxic product to remain in circulation.
Key Allegations
According to the plea, the tragedy exposes a systemic collapse in India’s drug regulatory mechanism. It asserts that the government’s delayed and inconsistent response represents a gross violation of the right to life under Article 21 of the Constitution, as well as the State’s obligation under Article 47 to protect public health.
The petitioner has alleged the following key failures:
- Regulatory Negligence: Even after laboratory confirmation of contamination, no immediate central-level recall or alert was issued.
- Lack of Coordination: Contradictory statements from government agencies created confusion and delayed emergency response.
- Absence of a Central Recall System: India still lacks a uniform national drug recall mechanism, allowing contaminated batches to remain on sale.
- Weak Pre-Release Testing: There is no mandatory nationwide protocol for toxicological testing of syrups for DEG or Ethylene Glycol (EG) before they are released in the market.
- Poor Oversight of Small-Scale Manufacturers: Many smaller pharmaceutical units lack adequate testing facilities and procure unverified raw materials from unregulated sources, including industrial-grade chemicals.
Constitutional and Legal Basis
The PIL emphasizes that such systemic negligence violates the fundamental right to life (Article 21), which includes the right to safe medicines and a healthy environment. It also invokes Article 47, which directs the State to improve public health and protect citizens from harmful substances.
The petition highlights that the recurring presence of toxic substances in cough syrups—despite prior national and international warnings—constitutes a continuing constitutional breach and a failure of due diligence by regulatory authorities.
It further argues that the absence of a national recall framework contravenes the doctrine of public trust, under which the government holds the responsibility to protect citizens from foreseeable health hazards.
Reliefs Sought in the Petition
Advocate Vishal Tiwari’s petition seeks a set of specific, structured remedies to ensure accountability and long-term reform in drug safety. The key prayers include:
- Constitution of a Judicially Monitored National Expert Committee headed by a retired Supreme Court judge to investigate the manufacturing, regulation, testing, and distribution of the contaminated cough syrup and to recommend systemic reforms.
- Nationwide Recall and Seizure of all batches of Coldrif Cough Syrup and any related formulations found to be contaminated.
- Suspension of Manufacturing Licence of Sresan Pharma Pvt. Ltd., pending investigation into its production processes and quality-control systems.
- CBI Investigation under Judicial Supervision into the deaths of children across states linked to consumption of the toxic syrup.
- Nationwide Testing Mandate for all syrup-based pharmaceutical formulations, particularly pediatric medicines, to detect contamination by DEG or EG before market release.
- Creation of a Central Digital Drug Recall and Pharmacovigilance Portal for real-time tracking of substandard or contaminated medicines and swift dissemination of public alerts.
- Formulation of a National Drug Recall Policy and a Toxicological Safety Protocol that would make DEG/EG testing compulsory before release of any pediatric syrup into the market.
Need for Systemic Reform
The petition underscores that India’s pharmaceutical industry, though globally significant, is hindered by fragmented regulatory mechanisms and weak enforcement. Drug testing infrastructure varies widely between states, and coordination between state drug controllers and the central regulator remains inconsistent.
The absence of a national pharmacovigilance database or uniform recall system means contaminated medicines can remain in the supply chain for weeks before being traced. In this context, the PIL calls for a centralized, technology-enabled system to ensure faster identification, recall, and disposal of harmful drugs.
The petitioner further argues that hundreds of small-scale manufacturers continue to operate without adequate laboratory facilities, while inspection mechanisms are either under-resourced or inactive. The lack of raw material traceability — particularly for excipients used in syrups — increases the risk of contamination with industrial chemicals like diethylene glycol.
Role of the Supreme Court
By seeking a court-monitored investigation, the petitioner places faith in the judiciary to ensure impartiality, transparency, and accountability. The Supreme Court’s intervention, it is argued, is essential to ensure that investigative and regulatory actions are not compromised by bureaucratic inertia or corporate influence.
The PIL urges the apex court to treat the matter as one of national urgency, emphasizing that preventable lapses in drug safety amount to a denial of constitutional rights. It seeks judicial directions that can lay the foundation for long-term reform of India’s pharmaceutical oversight system.
Broader Implications
If admitted and acted upon, this PIL could have far-reaching consequences for India’s health governance. It could:
- Set judicial standards for drug safety and recall protocols.
- Mandate centralized pre-release toxicological testing for sensitive formulations.
- Establish accountability for regulatory negligence at both central and state levels.
- Spur creation of a digital pharmacovigilance framework for real-time monitoring.
Such directions would not only address the immediate tragedy but also help rebuild public trust in India’s pharmaceutical industry and healthcare system.
Conclusion
The Supreme Court petition in Vishal Tiwari v. Union of India represents a decisive moment in the fight for safer medicines and stronger public-health regulation. The deaths of innocent children underscore the urgent need for accountability, reform, and a comprehensive overhaul of India’s drug-safety mechanisms.
Through this PIL, the petitioner has asked the apex court to reaffirm the constitutional guarantee of life and health — ensuring that no family again suffers the loss of a child due to preventable negligence in the manufacture or regulation of medicines.
If the Court issues the requested directions, it could pave the way for India’s first unified national drug-recall framework, stricter toxicology standards, and a new era of regulatory vigilance — protecting millions of lives and strengthening the public’s faith in the justice system.
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