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The Bihar state branch of the Indian Pharmaceutical Association (IPA) has released a scathing assessment of the recent tragic deaths of 23 children in Madhya Pradesh, linking the fatalities directly to the consumption of a diethylene glycol (DEG)-contaminated cough syrup.
The IPA's strong opinion, published in its monthly bulletin, ‘Bihar Bhaisajyak Bulletin’, frames the incident not merely as a failure of one manufacturer, but as a crisis fuelled by systemic regulatory lapses in the country's drug safety framework.
The tragedy unfolded across several districts, with children, mostly under the age of five, developing severe symptoms, including vomiting, abdominal pain, and acute kidney injury (AKI). Subsequent laboratory testing confirmed that the implicated medicine, allegedly manufactured by Sreesan Pharmaceuticals in Tamil Nadu, contained dangerously high levels of DEG, an industrial solvent used in antifreeze, with concentrations reportedly hundreds of times above the pharmacopoeial safety limit of 0.1%. DEG is a cheap, toxic substitute for the safe pharmaceutical solvent propylene glycol, and its metabolism leads to the production of deadly compounds that crystallize in the kidneys.
According to R L Bandhopadhyay, secretary of the Bihar IPA, the core of the IPA’s critique focuses on the failure of the regulatory ecosystem to prevent such a predictable crisis. He points to chronic understaffing of state drug inspectorates, a lack of mandatory real-time testing of raw materials like glycerine and propylene glycol before use, and a fragmented regulatory structure that allows manufacturers with a history of violations to continue operations. According to him, these gaps convert state-level negligence into a fatal, recurring oversight problem at the national level.
This systemic failure is acutely demonstrated in Tamil Nadu, where internal assessments by pharmaceutical industry sources revealed to Pharmabiz that the enforcement of drug safety laws has been significantly impaired over the last six months due to insufficient experienced personnel. The lack of senior leadership following the retirement of the department's last director created a substantial lapse in oversight. Compounding this issue, the critical charge of controlling and licensing authorities has reportedly been assigned to a Deputy Drug Controller who lacks prior experience operating within the headquarters' policy-making and regulatory environment.
Experts quoted in the bulletin emphasized that the lethal adulteration often stems from illicit, cost-cutting measures by manufacturers or suppliers. The use of industrial-grade solvents in place of pharmaceutical-grade equivalents saves money but constitutes a massive, criminal breach of Good Manufacturing Practices (GMP). The IPA demanded that punitive action must extend beyond simply sealing factories to include swift convictions and asset forfeiture against company directors and supply chain actors responsible for facilitating this deadly fraud.
In the immediate aftermath, state authorities acted quickly, sealing the manufacturing facility in Tamil Nadu and placing the company’s founder under arrest. The Central Drugs Standard Control Organisation (CDSCO) initiated a joint audit of syrup manufacturers nationwide, and the Union health ministry issued advisories against prescribing certain cough and cold medications to young children. However, regulatory experts warn that these reactive measures are often temporary fixes that fail to address the fundamental structural issues.
Bandhopadhyaya said this disaster in Madhya Pradesh is not an isolated event, it represents the latest in a decades-long pattern of DEG poisoning incidents across India, echoing tragedies in Gurgaon (1998) and Jammu and Kashmir (2020), as well as international scandals in The Gambia and Uzbekistan in recent years linked to Indian-made syrups. This history strengthens the IPA's argument that the crisis is deeply systemic, highlighting a failure to implement necessary structural reforms despite repeated pledges to improve quality control and standards.
The Bihar IPA’s monthly bulletin calls for a complete overhaul of the nation's drug governance, advocating for a unified drug safety authority that centralizes enforcement powers and standardizes testing protocols for both export and domestic markets. The Association asserts that unless India prioritizes rigorous, proactive enforcement and ensures absolute accountability, public trust in the ‘Pharmacy of the World’ will continue to erode, and children will remain vulnerable to medicines intended to heal but which instead bring death.
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