Child-Deaths from Toxic Cough Syrup & Regulatory Gaps in India

Introduction

The deaths of young children in India after ingesting contaminated cough syrups in 2025 revealed a lethal combination of manufacturing failures and regulatory blind spots. The tragedy  centred on a syrup called Coldrif produced by Sresan Pharmaceuticals and linked to multiple fatalities in Madhya Pradesh prompted national recalls, criminal investigations, and urgent regulatory revisions.1 This article examines the factual matrix, identifies legal and regulatory deficiencies, analyses accountability under Indian law, and proposes reforms to prevent repetition of such tragedies.

Factual background In September and October 2025, health authorities in Chhindwara district, Madhya Pradesh, recorded acute kidney failures and deaths among children who had been given an over-the-counter cough syrup. Laboratory analysis identified diethylene glycol (DEG) at extraordinarily high concentrations in Coldrif; one reported test indicated approximately 48% DEG in the implicated batch many orders of magnitude above pharmacopoeial limits.2 Two additional syrups, Respifresh-TR and ReLife, were also found to contain DEG at elevated levels and were declared toxic and recalled.3 The WHO issued alerts and urged member states to look out for similar products in their supply chains.4

Regulatory framework India’ s regulatory oversight of pharmaceuticals is governed principally by the Drugs and Cosmetics Act 1940 (D&C; Act) and the Drugs and Cosmetics Rules 1945. The Central Drugs Standard Control Organisation (CDSCO), led by the Drugs Controller General of India (DCGI), sets national standards while state drug controllers regulate manufacture, licensing and inspections. The Indian Pharmacopoeia (IP) provides official testing standards; the Indian Pharmacopoeia Commission (IPC) is tasked with issuing amendments and test methods.5 Historically India introduced additional testing requirements for exported oral liquids, but finished-product toxin testing was not uniformly mandated for medicines sold on the domestic market a gap the WHO explicitly identified.6

Identified regulatory gaps and failures Several systemic weaknesses converged to allow contaminated products to reach children:

Domestic blind spot in finished-product testing. Export consignments of syrups had been subject to stricter testing regimes, but equivalent mandatory testing for domestically marketed finished oral liquids was absent prior to the 2025 crisis.7 This asymmetry permitted hazardous batches to be released into local markets.

Inspection and enforcement shortfalls. A performance audit by the Comptroller and Auditor General (CAG) highlighted consistent shortfalls in state inspections and sample collection in Tamil Nadu and other jurisdictions, with inspectors conducting well under the target number of checks and collecting fewer samples for laboratory testing.8 Regulatory resources staffing, laboratories and logistics were found wanting.

Manufacturing and GMP breaches. Media and investigative reports found hundreds of deviations from Good Manufacturing Practices (GMP) at the Sresan facility, including inadequate quality controls and record-keeping.9 The persistence of operations despite repeated notices suggests weak licensing enforcement.

Fragmented federal implementation. While the DCGI can set policy and issue guidance, enforcement depends on state drug controllers; variation in capacity and performance across states creates regulatory arbitrage and uneven protection for consumers.

Legal liability and accountability Criminal liability. The D&C; Act criminalises manufacture and sale of adulterated or misbranded drugs.10 Where death results from such offences, prosecutorial authorities have charged individuals under relevant sections of the Indian Penal Code (IPC) ̶ including offences cognate to culpable homicide ̶  and initiated arrests of company officials in the Coldrif case.11 Successful criminal prosecution, however, requires rigorous forensic proof linking the product to the fatalities and demonstration of mens rea or gross negligence where applicable.

Administrative sanctions. The DCGI and state controllers possess powers to suspend or cancel licences, order recalls and impose penalties under the D&C; Act. In the present crisis, targeted recalls and suspension of manufacturing licences were ordered and DCGI issued directives mandating finished-product testing for DEG and EG in oral liquids.

Civil and consumer remedies. Victims’ families may pursue compensation through consumer protection fora or tort claims in civil courts alleging negligence and product liability. The Consumer Protection Act 2019 provides accessible forums for redress, but delays and evidentiary burdens often impede timely relief for grieving families.

Regulatory response and its limits The immediate regulatory response included:

(a) Declaration of the implicated syrups as toxic and their recall

(b) DCGI directives requiring DEG/EG testing of finished oral liquid formulations And

(c) IPC advisories and pharmacopoeial amendments to incorporate DEG/EG detection methods. Additionally, the government has signalled a refusal to extend timelines for manufacturers to upgrade facilities to international standards.14 These steps are necessary but not sufficient.

Policy analysis and critique Mandatory testing must be matched by capacity. Requiring finished-product testing is meaningful only if accredited laboratories both state and central are adequately resourced to process vastly increased sample volumes and provide timely certificates prior to distribution.

Strengthening inspections and risk-based surveillance. Regulatory policy should shift from calendar-based inspections to risk-based approaches that prioritise firms with prior violations, small-scale manufacturers lacking laboratory infrastructure, and products destined for vulnerable consumers (children’ s formulations).

Clarifying corporate and individual liability. Statutory amendments should make clearer the personal liability of senior officials for systemic compliance failures while preserving enterprise liability; proportionate criminal sanctions must be combined with rapid administrative penalties to deter non-compliance.

Supply chain transparency. Mandating batch-level traceability and digital serialization for oral liquids would assist in rapid recalls, detection of diversion and prevention of illicit cross-border distribution through informal channels.

Compensation mechanism for victims. A statutory compensation fund or expedited compensation panel under consumer law could ensure timely and predictable relief for affected families pending criminal or civil adjudication.

Recommendations On the basis of the analysis above, the article proposes the following reforms:

1. Enshrine mandatory finished-product testing for all oral liquid formulations in regulations and ensure pre-market certification for each batch .
2. Invest in expanding and accrediting state drug testing laboratories and consider public‒private partnerships for timely sample processing.
3. Recalibrate inspection regimes to risk-based surveillance, with CAG-style independent audits published annually.
4. Amend the D&C; Act to clarify individual executive liability for safety breaches and establish fast-track administrative penalties.
5. Implement digital batch traceability (serialization) and strengthen customs checks to deter illicit export.
6. Establish a statutory compensation mechanism for victims of pharmaceutical contamination with interim relief provisions.

Conclusion:- The Coldrif tragedy is a painful reminder that the promise of safe and affordable medicines depends on continuous, adequately resourced regulatory vigilance. India’ s legal framework contains the tools to protect public health; the challenge lies in aligning rule-making with enforcement capacity, clarifying accountability, and ensuring victims’ rights to timely redress. Concerted legislative and administrative reform, driven by transparency and science, is essential to restore public trust and prevent further loss of young lives.

Reference(S):

• Reuters, ‘WHO says India has much to do on toxic cough syrup despite some progress’ (Reuters, 21 October 2025) accessed 21 October 2025.
• Reuters, ‘India declares three cough syrups toxic after child deaths’ (Reuters, 8 October 2025) accessed 21 October2025.
• Times of India, ‘4-year-old Chhindwara girl dies of Coldrif toxicity in Nagpur hospital’ (Times of India, 16 October2025) accessed 21 October 2025.
• Reuters, ‘WHO issues alert over contaminated cough syrups’ (Reuters, 13 October 2025) accessed 21 October 2025.
• Indian Pharmacopoeia Commission, ‘IPC issues update on pharmacopoeial & regulatory resources for identifying EG &DEG’ (Pharmabiz, 23 October 2025) accessed 21 October 2025.
• Indian Express, ‘Year before cough syrup deaths, CAG flagged shortfall in Tamil Nadu drug tests’ (Indian Express, 10 October 2025) accessed 21 October 2025.
• Reuters, ‘India to force drugmakers to upgrade plants after fatal cough syrup crisis’ (Reuters, 17 October 2025) accessed 21 October 2025.
• US Food and Drug Administration, ‘FDA actions to protect children from contaminated cough medicine’ (FDA, 10 October 2025) accessed 21 October 2025.
• Indian Express, ‘Exclusive: 350 violations found at Tamil Nadu unit that produced deadly cough syrup’ (Indian Express,8 October 2025) accessed 21 October 2025.
• Drugs and Cosmetics Act 1940 (India).
• Times of India, ‘Coldrif deaths: SIT arrests Sresan Pharma lab manager…’ (Times of India, 15 October 2025) accessed21 October 2025.