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At least 24 children, all under five, have died in Madhya Pradesh over the past month after consuming adulterated cough syrup. Most of the victims were from Chhindwara, with some cases reported in the neighbouring districts of Betul and Pandhurna. Three more children remained in critical condition in Nagpur at the time the magazine went to print. The Central Drugs Standard Control Organisation (CDSCO), under the Union Ministry of Health and Family Welfare, has informed the World Health Organization (WHO) that the deaths have been linked to specific batches of three oral liquid medicines, Coldrif, Respifresh TR and ReLife, which were found to contain diethylene glycol (DEG), a toxic industrial solvent. CDSCO said the contaminated syrups had not been exported. However, WHO has issued a global alert, urging countries to monitor for any trace of the three medicines within their borders.
Similar incidents occurred in The Gambia and Uzbekistan in 2022, and in Cameroon the following year, where dozens of children died after consuming cough syrups manufactured in India. The tragic deaths of otherwise healthy children and the discovery of contamination in medicines, point to a deeper systemic failure: India’s weak regulatory oversight of pharmaceuticals.
People in rural and remote areas are particularly vulnerable to medical malpractice and fraud, including the distribution of adulterated allopathic drugs. Most Indians, regardless of education, are also largely unaware of drug regulation regime. Given the wide distribution of such medicines and legally endorsed process of prescription, a single batch of contaminated medicine can thus have devastating consequences.
In Madhya Pradesh, one doctor has been suspended and arrested in connection with the deaths. This is surprising as a physician is unlikely to suspect contamination in an officially approved medicine. Most of the affected children were referred to the Government Medical College and Hospital in Nagpur, where a pattern of symptoms began to emerge, alerting the Madhya Pradesh health department. Doctors were not aware of the unfolding tragedy, until the Nagpur medical authorities wrote to them.
Experts say patients with suspected or confirmed DEG ingestions present a diagnostic and therapeutic challenge, as the mechanisms of DEG toxicity in humans are not fully understood. This hampers swift diagnosis and administration of antidote treatment. Here, the role of doctors is critical. Their ignorance or apathy can prove fatal. Yet the greater responsibility lies with the government, which must urgently strengthen its drug quality control apparatus.
So far, the Union government has taken little visible and preventive action against companies linked to cough syrup deaths in African countries. India is a major exporter of generic medicines, but the DEG contamination scandals in The Gambia, Uzbekistan, and Cameroon have damaged trust.
Despite a growing number of incidents involving the use of DEG and ethylene glycol (EG) in pharmaceutical products, regulatory oversight of manufacturing and supply chains remains weak. Even though India has a medical intelligence agency, the Central Bureau of Health Intelligence (CBHI), tasked with monitoring and responding to public health threats, it does not seem to be working. CBHI must expand its scope of work.
In India’s highly competitive pharmaceutical markets, some companies thus resort to substituting safe ingredients with cheaper, toxic alternatives. Contract manufacturing further leads to serious quality concerns. Contract manufacturers often operate under pressure to cut costs, leading to the use of cheaper excipients, solvents and packaging materials. In some cases, industrial-grade chemicals like DEG have been used in place of pharmaceutical-grade ingredients—contributing to global scandals and undermining trust in Indian exports.
The infrastructure for testing and quality control is underdeveloped, fragile and largely invisible. The lack of adequate testing and quality control, particularly for low-cost medications, is also a serious concern. As per the Union health ministry, India has only 29 federal government drug testing laboratories; another eight are run by state governments. In nationalised and globalised supply chains, tracing sources of contamination is difficult but not impossible.
Centralisation of powers does not help. The three crucial ministries of chemicals and fertilisers, health and family welfare, and environment and forests operate with little coordination, each more focused on liberalising regulatory framework than strengthening them. Widespread vertical and horizontal corruption further weakens enforcement, rendering existing regulatory frameworks largely ineffective.
The Drugs and Cosmetics Act of 1940, the country’s premier pharmaceutical regulation, is ill-equipped to meet modern challenges. Its provisions are outdated, enforcement is fragmented, and penalties remain too weak to deter violations. Crucially, it lacks provisions for pharmacovigilance, digital traceability, and real-time monitoring of drug quality. These gaps have contributed to recurring drug safety scandals.
The Act also does not adequately regulate export quality standards. There is no national system for rapid recall of substandard or counterfeit drugs, which hampers timely responses during public health emergencies. Drug laws therefore need to be amended to ensure the safety and effectiveness of medicines marketed in India.
There is little coordination between CDSCO and state-level drug regulators, resulting in patchy and inconsistent enforcement. In the recent case, CDSCO, as per reports, initially denied the presence of DEG and EG in samples of the contaminated cough syrup. It later revised its findings after Tamil Nadu’s drug authorities confirmed the presence of these toxic substances.
On the other hand, state drug regulators often lack technical capacity, trained personnel and resources to conduct inspections and testing. Penalties for violations are often minimal, making it more cost-effective for companies to risk non-compliance than to follow regulations. Conviction rates are low, prosecutions sluggish, and deterrence weak. Regulatory decisions, inspection reports and test results are rarely made public, limiting transparency and accountability. Lobbying and corruption have been reported, especially in licensing and approvals.
Epidemiology plays a vital role in drug regulation, and its limited presence across India is a serious obstacle to effective pharmaceutical oversight. In the absence of epidemiological data, drug safety becomes reactive rather than preventive. Many cases of DEG poisoning were detected only after multiple fatalities. Similarly, adverse effects from vaccines often go undocumented. There are no early warning systems to detect and flag toxic batches of drugs or vaccines.
The Pharmacovigilance Programme of India (PvPI) remains underfunded and poorly reported. Doctors and pharmacists rarely submit reports of adverse drug reactions, owing to lack of awareness or incentives. Patients are often unaware of how, or to whom, to report complications. Epidemiological data is neither shared in real time nor integrated with drug regulatory databases. All these delays coordinated action between health departments and drug controllers.
Moreover, drug approvals and bans in India often rely heavily on clinical trial data, with little emphasis on post-market surveillance. This overlooks how medicines perform in real world, diverse populations.
Post-mortem investigations and pathology services are critical for identifying adverse reactions to drugs and vaccines. Yet in many parts of India, these systems are woefully inadequate. Suspected cases of drug toxicity or vaccine complications require histopathological and toxicological analysis—tools that can detect harmful substances in tissues. However, most district hospitals lack toxicology laboratories and trained forensic pathologists. In rural areas, chemical analysis of tissues is often delayed or skipped. In many cases, especially involving children, autopsies are not conducted at all. There is no centralised system linking post-mortem findings with pharmacovigilance programmes such as the PvPI. As a result, critical evidence is lost. Without robust forensic and pathology infrastructure, one of the most effective tools for uncovering the causes behind drug-related deaths is simply unavailable.
In cases involving vaccines or government-run health programmes, there is often pressure to downplay or obscure adverse findings. Families typically lack the resources or legal support to demand independent investigations. Education and greater public participation in pharmacovigilance are therefore essential. This can begin with a wide and visible “adverse drug reactions information system” that collects information from victims as well as from socially conscious citizens.
(Narasimha Reddy Donthi is a public policy expert and is associated with public interest campaigns)
This article was originally published in the November 1-15, 2025 print edition of Down To Earth