Adv. Shraddha Sunil

Few regulatory failures expose the fragility of governance as starkly as contaminated medicines. In India, cough syrups are cheap, widely consumed, and often administered to children without prescriptions and have repeatedly transformed from therapeutic agents into instruments of death. The recent deaths of at least 22 children following the consumption of contaminated cough syrup branded Coldrif mark not merely another pharmaceutical scandal, but a culmination of long-standing neglect in India’s drug regulatory framework.

What distinguishes the Coldrif tragedy is not only the scale of human loss but the convergence of three critical fault lines:

1. The failure of drug manufacturing oversight,

2. The permissive regime governing over-the- counter (OTC) medicines, and

3. The constitutional silence surrounding state accountability when regulatory lapses result in mass fatalities.

As the Union Government simultaneously moves to pull several cough syrups out of the OTC list amid rising misuse and safety concerns, the crisis presents a rare moment of reckoning such as forcing policymakers, courts, and regulators to confront whether India’s pharmaceutical governance can continue to operate without constitutional consequence.

The Coldrif Tragedy: A Regulatory Failure with Fatal Consequences

In October 2025, laboratory analyses revealed that Coldrif, manufactured by Sresan Pharmaceuticals in Tamil Nadu, contained between 45% and 48.6% diethylene glycol (DEG) which is a toxic industrial solvent commonly used in antifreeze and brake fluids. The ingestion of DEG led to acute renal failure, multi-organ damage, and death in young children, many of them were infants.

Subsequent enforcement actions were swift but reactive such as the manufacturing unit was sealed, the company’s license cancelled, and its proprietor arrested. Investigations were launched by the Central Drugs Standard Control Organisation (CDSCO), while the Enforcement Directorate initiated proceedings under the Prevention of Money Laundering Act, probing whether profits from adulterated drugs constituted “proceeds of crime”.

Yet these actions unfolded only after irreversible harm had occurred which resulted in raising the central legal question: where was the regulatory state before the deaths?

A Repeating Pattern: From Global Scandals to Domestic Catastrophe

The Coldrif incident is not an aberration. It fits into a grim pattern that has played out across borders. In 2022, cough syrups manufactured in India were linked to the deaths of children in The Gambia and Uzbekistan, with the World Health Organization confirming contamination with DEG and ethylene glycol. Despite international alerts and diplomatic fallout, domestic regulatory reform remained minimal.

What makes Coldrif particularly alarming is that the tragedy unfolded within India’s domestic market, not in export consignments. This punctures the narrative that unsafe medicines are an “export problem” and exposes the vulnerability of India’s own population especially children to regulatory apathy which in turn is a misconduct.

Repeated scandals point not to isolated corporate misconduct but to systemic regulatory breakdown, where inspections are namesake, laboratories under-resourced, and post-market surveillance virtually non-existent.

OTC Cough Syrups and the Illusion of Safety

Overlaying the manufacturing crisis is the long-ignored problem of over-the-counter cough syrups. India’s OTC regime allows widespread sale of syrups containing opioids, sedatives, and alcohol-based formulations without medical supervision. Paediatricians and public health experts have repeatedly warned that children are especially vulnerable to overdose, misuse, and toxicity.

It is against this backdrop that the Union Government’s move to pull several cough syrups from the OTC list must be understood, not as a policy innovation, but as a delayed acknowledgment of regulatory failure. The ease of access to potent formulations, combined with weak quality control, creates a lethal environment where unsafe drugs can circulate widely before finding.

Crucially, OTC deregulation also diffuses accountability. When medicines are freely available without prescription, tracing responsibility from manufacturer to prescriber to regulator becomes legally and procedurally complex.

India’s Drug Regulatory Architecture: Accountability Gaps

India operates under a dual drug control regime:

1. The CDSCO, responsible for approvals, standards, imports, exports, and new drugs;

2. State Drug Controllers, responsible for licensing, inspections, sampling, and enforcement under the Drugs and Cosmetics Act, 1940.

While federalism is often cited as justification, in practice this structure has produced diffused responsibility and regulatory accountability passing. Parliamentary Standing Committee reports have repeatedly described CDSCO as understaffed and compromised, while state regulators often lack accredited laboratories, trained inspectors, or digital tracking systems.

In the Coldrif case, early findings point to:

1. prolonged operation without meaningful inspections,
2. failure to test raw materials,
3. continued licensing despite GMP violations, and
4. absence of post-market surveillance mechanisms.
5. Such failures are not incidental; they are structural.

From Public Health Crisis to Constitutional Question

The deaths caused by contaminated medicines directly engage Article 21 of the Constitution, which guarantees the right to life. The Supreme Court has consistently interpreted this right to include access to health, safe medical treatment, and protection from avoidable harm.

In Consumer Education and Research Centre v. Union of India and Paschim Banga Khet Mazdoor Samity v. State of West Bengal, the Court affirmed that the State has a positive obligation to prevent foreseeable health risks. Applied to Coldrif, the issue extends beyond private wrongdoing: did the State fail in its constitutional duty to regulate?

When regulatory neglect allows toxic medicines to reach children, the resulting deaths are not merely regulatory infractions they are constitutional failures.

Children, Vulnerability, and Heightened State Responsibility

The fact that the victims were children demands heightened constitutional scrutiny. Articles 21, 39(f), and 47 collectively impose a non-negotiable duty on the State to safeguard child health.

Children’s physiological vulnerability, lower body weight, immature renal systems make DEG exposure particularly dangerous. International human rights law, including the Convention on the Rights of the Child, obligates States to regulate private actors whose conduct threatens child survival.

The Coldrif tragedy thus implicates not only domestic constitutional law but India’s international obligations, which courts have previously relied upon to interpret fundamental rights (Vishaka v. State of Rajasthan).

Litigation Pathways and the Role of the Supreme Court

The legal response to the crisis is unfolding across multiple fronts:

1. Criminal prosecutions under the Drugs and Cosmetics Act for adulteration and unsafe manufacture;

2. Money laundering investigations probing regulatory corruption;

3. Potential PILs seeking judicial inquiry, compensation, and structural reform.

The Supreme Court’s past interventions in industrial disasters from Oleum Gas Leak to environmental catastrophes demonstrate that judicially mandated reforms often emerge only after sustained constitutional litigation.

Of particular relevance is the doctrine of constitutional torts, recognised in Nilabati Behera v. State of Orissa, which allows compensation for State failures independent of criminal prosecution.

Why Post-Facto Enforcement Is Not Enough

One of the gravest concerns in pharmaceutical regulation is that accountability rarely survives public outrage. Licenses are suspended, arrests made, and inquiries announced only for enforcement to quietly disappear over time.

Procedural weaknesses plague prosecutions: delayed sampling, broken chains of custody, under-equipped and under- funded forensic labs, and the near-absence of personal liability for regulators. Without structural deterrence, tragedies repeat.

As the Supreme Court observed in A.P. Pollution Control Board v. Prof. M.V. Nayudu, reactive governance cannot substitute preventive regulation.

The Way Forward: Structural Reform, Not Symbolic Compliance

If India is to prevent future tragedies, reform must extend beyond bans and recalls:

1. creation of a unified national drug safety authority,

2. mandatory real-time batch tracking,

3. independent GMP audits,

4. transparent public databases of violations,

5. personal liability for egregious regulatory negligence,

6. and a constitutional compensation framework recognising collective harm.

The withdrawal of unsafe cough syrups from OTC lists is only meaningful if accompanied by robust enforcement and constitutional accountability.

Medicines as Public Trust, Not Market Commodities

The Coldrif deaths force an uncomfortable but necessary question: will India continue to treat medicines as ordinary commodities, or as a public trust the State is constitutionally bound to safeguard?

Every contaminated bottle reflects a chain of institutional decisions and indecisions. Justice for the children lost cannot be reduced to prosecutions or policy circulars. It requires constitutional courage where courts, regulators, and governments accept that regulatory failure leading to death is not administrative error, but a violation of the right to life.

Until accountability is embedded into the architecture of drug governance, tragedies like Coldrif will not be the last. The price of delay is paid not in reports or hearings, but in children’s lives.

About the Author:

Shraddha Sunil is a legal researcher and advocate deeply committed to advancing human rights and constitutional justice in India. She holds an LL.M. in Human Rights, where her dissertation examined India’s inconsistency with its treaty obligations under CEDAW, focusing on the non-criminalisation of marital rape and the State’s positive obligations under international law. Her academic and professional work reflects a strong intersectional approach, engaging with issues of gender, surveillance, and digital rights.

• NB.: The author certifies that the work is original. Views expressed are personal.