In October 2025, the World Health Organisation (WHO) issued a global medical product alert warning against three “substandard” and contaminated cough syrups manufactured in India, linked to the deaths of over 20 children in Madhya Pradesh and Rajasthan. These products, found to contain toxic diethylene glycol (DEG), highlight fatal lapses in pharmaceutical safety standards, exposing vulnerable populations to grave risk. This alarming incident demands an urgent debate on regulatory oversight, healthcare infrastructure, and consumer safety.​

Agenda

This article explores the current crisis through the lens of real incidents, regulatory gaps exposed by the WHO, the role of India’s drug authorities, and pressing public health implications. It advocates for reforms to strengthen quality control, supply chain monitoring, and public trust.

Real-Life Tragedies and the Toxic Syrup Scandal

In October 2025, India witnessed a tragic public health crisis linked to three substandard cough syrups—Coldrif, Respifresh TR, and ReLife—manufactured by Sresan Pharmaceuticals, Rednex Pharmaceuticals, and Shape Pharma, respectively. The World Health Organisation (WHO) issued a global medical product alert cautioning against the use and distribution of these contaminated syrups, found to contain dangerously high levels of diethylene glycol (DEG), a toxic industrial solvent.​

This toxic adulteration led to the deaths of over 20 children, predominantly under the age of five, in the states of Madhya Pradesh and Rajasthan. The children initially exhibited symptoms of common respiratory illnesses but rapidly developed acute kidney failure, resulting in fatalities within days after consuming the contaminated syrups. DEG concentrations in the Coldrif cough syrup were found to exceed permissible limits by nearly 500 times, with samples analysed by health authorities showing approximately 8.6% DEG by weight/volume—far beyond the safe threshold of 0.1%.​

The impact on affected families has been devastating, leaving behind grief and trauma that reverberates through communities. Parents recount the sudden decline of their children, who appeared healthy before falling critically ill after taking what was believed to be harmless medicine. The panic and mistrust generated by this scandal have shaken public confidence in pharmaceutical safety and regulatory oversight. In response, Indian authorities revoked manufacturing licenses, arrested firm owners, and ordered nationwide bans on these products while seeking to identify other potentially affected batches.​

This scandal exposes fatal lapses in drug safety and shines a harsh light on gaps in regulatory enforcement, surveillance, and quality control within the pharmaceutical sector. It underscores the critical need for rigorous oversight and transparent accountability to protect vulnerable populations—especially children—from preventable and avoidable medical tragedies.​

The Regulatory Blind Spots

India’s drug regulatory framework is primarily overseen by the Central Drugs Standard Control Organisation (CDSCO) at the national level, alongside state drug regulatory authorities (SDRAs), which manage local enforcement. CDSCO, functioning under the Directorate General of Health Services and the Ministry of Health and Family Welfare, is tasked with approving new drugs, setting standards, licensing manufacturing facilities, regulating clinical trials, and controlling the quality of imported drugs. Headquartered in New Delhi, CDSCO operates through zonal and sub-zonal offices, drug testing laboratories, and port offices across the country.​

Despite this extensive mandate, recent investigations linked to the contaminated cough syrup scandal have exposed significant regulatory blind spots. The implicated pharmaceutical manufacturers—Sresan Pharmaceuticals, Rednex Pharmaceuticals, and Shape Pharma—were found to have breached Good Manufacturing Practices (GMP), including using toxic diethylene glycol (DEG) as a cheaper solvent substitute. Following the revelations, CDSCO and state authorities ordered temporary shutdowns of the manufacturing units, seized contaminated batches, and initiated large-scale recalls to prevent further distribution.​

The World Health Organisation’s medical product alert further highlighted systemic concerns about informal and unregulated supply chains in India. These channels enable substandard and potentially dangerous pharmaceutical products to evade regular surveillance and quality control, presenting ongoing risks to public health. WHO emphasised the need for improved post-market vigilance and robust coordination between central and state regulators to effectively identify and intercept unsafe medicines before they reach consumers.​

This episode underscores critical gaps in regulatory enforcement, transparency, and inter-agency coordination, raising urgent calls for reform to enhance pharmaceutical quality control in India. Without addressing these blind spots, future tragedies involving substandard or falsified medicines remain a serious threat.​

Wider Public Health Implications

The circulation and widespread use of substandard medicines, such as the contaminated cough syrups recently flagged by the WHO in India, pose grave risks not only to patient safety but also to public trust and overall healthcare outcomes. When medicines fail to meet quality standards, patients face ineffective treatment or severe adverse effects, undermining confidence in healthcare providers and pharmaceutical products. This erosion of trust can prompt patients to avoid formal care or seek unverified alternatives, ultimately worsening health indicators.​

Moreover, while Indian authorities have assured that the contaminated cough syrups were not exported, WHO has urged vigilance given past incidents where toxic syrups from India reached other countries—most notably in Uzbekistan and The Gambia. Those earlier events caused multiple deaths, highlighting the danger of substandard medicines crossing borders via informal or unregulated channels. This export risk threatens not only the health of foreign populations but also India’s reputation as a global pharmaceutical supplier.​

A critical factor exacerbating these risks is the lack of robust post-market surveillance and pharmacovigilance systems capable of timely detecting and responding to medicine quality failures. India’s vast pharmaceutical supply chain, combined with insufficient inspections and regulatory manpower, allows unsafe products to remain in circulation undetected for extended periods. This delay amplifies the morbidity and mortality burden from substandard medicines and complicates mitigation efforts.​

To safeguard public health, systemic enhancements are required: strengthening surveillance networks, improving inter-agency coordination, enforcing penalties for violations, and educating healthcare professionals and consumers to identify and report suspect medicines. Only through such multifaceted vigilance can trust in medicine safety be restored, preventing the severe consequences of unchecked substandard pharmaceuticals.​

Opinion—Urgent Need for Strengthened Oversight and Transparency

India’s recent pharmaceutical crises, including the deadly substandard cough syrup scandal, underscore the urgent imperative for enhanced institutional accountability and comprehensive regulatory reform. Strengthening oversight mechanisms must be a national priority to restore and ensure the safety of medicines that millions of citizens rely upon daily.​

Transparent investigations by both government bodies and pharmaceutical companies are critical to rebuilding public trust. Open communication about failings, corrective actions, and preventive measures helps dissolve suspicion and empowers consumers and healthcare professionals to make informed decisions. The Indian government’s recent rollout of digital tracking dashboards and benchmarking indices for state drug regulators reflects promising steps toward greater transparency and efficiency.​

Systemic reforms must include tighter licensing norms, rigorous and more frequent audits of manufacturing facilities, and robust supply chain tracking to prevent the circulation of substandard or counterfeit products. Moreover, stringent penalties for violations, along with swift enforcement, will serve as powerful deterrents against negligence or deliberate malpractice.​

Equally vital is the empowerment of consumers. Awareness campaigns that educate patients about medicine safety, adverse effect reporting, and whistleblower protection mechanisms can create a vigilant public that acts as a first line of defence. Establishing accessible and confidential reporting channels encourages prompt identification and removal of unsafe medicines from the market.

In sum, India stands at a pivotal point where transparent governance, accountable regulation, and informed citizenry can collectively transform the pharmaceutical landscape—preventing tragedies and securing the health of future generations.​

Conclusion

The tragic deaths linked to substandard cough syrups in India reveal deadly cracks in pharmaceutical regulation that demand swift and comprehensive action. Over 20 children under the age of five have lost their lives in Madhya Pradesh and Rajasthan after consuming contaminated syrups containing dangerously high levels of diethylene glycol (DEG), a toxic industrial solvent. These heartbreaking incidents highlight systemic failures in drug safety, inspection, and enforcement, shaking public confidence in the nation’s pharmaceutical oversight.​

Ensuring medicine quality and patient safety is non-negotiable. It requires vigilance and accountability from all stakeholders—regulators, manufacturers, healthcare providers, and consumers alike. Only transparent investigations, stricter regulatory enforcement, and stronger quality controls can prevent such tragedies from recurring. The Indian government’s immediate actions—including license revocations, manufacturing shutdowns, and recalls—are first steps toward restoring trust.​

The larger lesson from this crisis is that safeguarding public health necessitates sustained reforms, robust surveillance, and empowered citizens. Through strengthened systems and transparent accountability, public trust in medicines can be salvaged, and similar crises averted in the future.​

References

• WHO Medical Product Alert N°5/2025: Substandard Oral Liquid Medicines, October 12, 2025.
• BBC News, WHO flags regulatory gaps after India child deaths from cough syrups, October 10, 2025.
• Business Standard, WHO issues alert against 3 cough syrups linked to MP children’s deaths, October 13, 2025. 
• NDTV, Coldrif, Respifresh TR and ReLife: WHO issues global warning, October 13, 2025.

Disclaimer

The article presents data and expert opinions gathered from credible international and Indian health authorities and media reports. All facts reflect information available as of October 2025 and aim to support public awareness and regulatory advocacy. For medical concerns, consultation with healthcare professionals is advised.

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