Our drugs can’t be their deaths

When a parent gives their child a spoonful of cough syrup, they do so with faith that the medicine has passed through a strict chain of oversight. That faith has been shaken again by the deaths of at least fourteen children in Madhya Pradesh’s Chhindwara district, after consuming a cough syrup found to be contaminated with diethylene glycol (DEG), a toxic industrial solvent. The children, all under 15, reportedly suffered acute kidney failure before succumbing. Tests confirmed that the syrup—Coldrif, manufactured by Tamil Nadu-based Sresan Pharma Pvt. Ltd.—contained DEG, a chemical long banned for pharmaceutical use.

This tragedy follows a grim pattern India knows too well. Over the past two decades, DEG poisoning has resurfaced repeatedly. From the deaths of 33 children in Jammu in 2020 to the international incidents in Gambia and Uzbekistan in 2022 and 2023, where contaminated syrups linked to Indian manufacturers claimed dozens of lives, the story has been the same: toxic formulations slipping through the regulatory net. Each time, the official reaction is swift but short-lived—temporary bans, licence suspensions, and press conferences that fade before any deep reform takes hold.

The root cause lies in India’s fragmented and weak system of drug regulation. Oversight of pharmaceuticals is shared between the Centre and the states, creating gaps that are easily exploited. The Central Drugs Standard Control Organisation (CDSCO), under the Union Health Ministry, sets national standards, approves new drugs, and coordinates overall policy. Enforcement, however—inspections, sample testing, and prosecution—rests with state drug control departments. In practice, this division has led to inconsistent enforcement, uneven capacity, and confusion over accountability.

The Chhindwara episode exposed these fractures. The contaminated batch was produced in Tamil Nadu, distributed through intermediaries, and sold in Madhya Pradesh. By the time deaths were reported, the syrup had already entered markets elsewhere. A timely nationwide alert could have stopped further sales, but no such real-time coordination mechanism exists between state regulators.

India’s pharmaceutical industry is vast—over 10,000 manufacturers and thousands more distributors and retailers—but regulation is thinly spread. Official reports have repeatedly highlighted the shortage of inspectors, with one inspector often responsible for hundreds of manufacturing units. Several state drug control departments operate with significant vacancies, outdated laboratories, and limited testing capabilities. Small and medium firms, which make up a large portion of India’s domestic drug producers, often lack in-house quality systems or rely on third-party testing. Many operate as contract manufacturers for larger brands, diffusing responsibility and making traceability difficult when contamination occurs.

While India’s pharmaceutical exports are worth over $30 billion annually and its largest companies meet global Good Manufacturing Practice (GMP) standards, small-scale violations can undermine the credibility of the entire sector. Following the WHO’s medical product alerts in 2022 and 2023, several countries imposed additional scrutiny on Indian exports. The reputational damage threatens one of India’s strongest economic sectors and its position as the “pharmacy of the world.”

Within India, enforcement remains ad hoc. The CDSCO has issued guidelines for recalls and rapid alerts, but these are advisory rather than legally binding. There is no national law mandating immediate product recall, nor a central digital database that can track every batch from manufacturer to pharmacy. As a result, once a contaminated product enters the market, withdrawing it from circulation depends on local vigilance and voluntary compliance. In rural areas with weak surveillance, such products may linger on shelves long after official bans.

The human consequences are heartbreaking. In Chhindwara, parents sold their belongings to pay for hospital treatment for their children. Many travelled to Nagpur or Bhopal in desperation. They trusted a medicine that became poison. Their grief underscores a moral and institutional failure: when regulation collapses, the poorest pay the price. Compensation may bring temporary relief, but it cannot restore lost trust or prevent the next disaster.

To fix the drug safety net, India must begin with structural reform. A National Drug Recall Authority with statutory powers should be established to oversee recalls across states. Every manufacturer, distributor, and retailer should be connected to a single digital supply-chain platform that allows batch tracking and real-time alerts. When contamination is detected, a nationwide notification should reach all state regulators, hospitals, and pharmacies simultaneously.

The CDSCO’s mandate must also be strengthened. Instead of acting primarily as a coordinating body, it should have direct authority to conduct surprise inspections, suspend manufacturing licences, and prosecute violations that have interstate implications. Enforcement should not depend on the discretion of state officials when public health is at stake.

Testing infrastructure is another weak link. Many state laboratories lack modern equipment to detect impurities like DEG and ethylene glycol. The Centre should provide funding to upgrade these facilities and establish regional reference laboratories capable of rapid analysis. All syrup-based formulations—particularly those for children—should be subjected to mandatory DEG and EG testing at certified laboratories before being cleared for sale.

Transparency is equally critical. India’s Pharmacovigilance Programme (PvPI) records adverse drug reactions, but its data is not easily accessible to the public or integrated with recall mechanisms. A public-facing pharmacovigilance and recall portal could serve as an early warning system, allowing doctors and consumers to verify the safety status of medicines. This would also help build accountability across the supply chain, as adverse reactions could be tracked back to manufacturers and distributors.

Global best practices offer useful lessons. The U.S. Food and Drug Administration (FDA) operates a structured recall system categorised by severity, publishes weekly public updates, and can enforce mandatory recalls. The European Medicines Agency (EMA) runs a shared digital database across member states linking  manufacturers, regulators, and consumers. Both systems are backed by legal authority and public transparency. India can adapt this within its federal framework by empowering the Centre while preserving the states’ enforcement role.

Ultimately, this is not merely about protecting India’s export image; it is about safeguarding lives at home. Medicines are not ordinary commodities. Every bottle and tablet carries an implied promise from the state that it is safe, effective, and manufactured under watchful regulation. When that promise fails, it is not just a manufacturing defect—it is a breach of the social contract between citizens and the state.