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CDSCO alert on toxic syrup forces Haryana SDC to expand quality vigil
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Peethaambaran Kunnathoor, Chennai
November 12 , 2025
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A critical public health alert has been issued following the detection of a toxic impurity, diethylene glycol (DEG), in a batch of cough syrup, triggering immediate and stringent regulatory action across India, particularly in Haryana.
The alert, originating from the Central Drugs Standard Control Organization (CDSCO), Sub-Zonal Office in Guwahati, identified a batch of Planokuf D Syrup, containing cetirizine hydrochloride, phenylephrine hydrochloride, and dextromethorphan hydrobromide, as ‘Not of Standard Quality’ due to DEG levels significantly exceeding permissible limits.
The CDSCO Guwahati alert was precipitated by tests conducted at the Regional Drugs Testing Laboratory, which found the Planokuf D batch (No. R25053101), manufactured by Shreya Lifesciences Pvt. Ltd in Uttarakhand, to contain 0.35% diethylene glycol, far surpassing the accepted standard limit of Not More Than (NMT) 0.1%. This finding immediately classified the drug as adulterated and unfit for consumption under the Drugs and Cosmetics Act, 1940.
The Guwahati office swiftly notified drug controllers across multiple northeastern states and other zonal offices, calling for immediate vigilance and necessary action on the movement of the tainted batch.
Responding with urgency, the Drugs Control Administration (DCA) in Haryana, under the leadership of State Drugs Controller Lalit Kumar Goel, issued a ‘Most Urgent’ public alert to all the drugs control officers (drug inspectors) within the state. The directive mandated maintaining a strict vigil on the movement of the specific cough syrup batch, drawing immediate samples, and seizing any remaining stock found in possession. The Haryana DCA emphasized the extreme risk posed by DEG, which is a toxic chemical capable of causing serious poisoning, including kidney failure, neurological complications, and potentially death, particularly among vulnerable populations like children.
Beyond the immediate recall and seizure, the Haryana SDC, Lalit Kumar Goel, has been proactive in tackling the root cause of such contaminations. In a major preventative initiative, the SDC had already escalated a toxic impurity alert across the entire state’s drug manufacturing sector. This initial advisory, directed to all allopathic drug manufacturers, mandates stringent testing and security measures for the solvent propylene glycol (PG), a common ingredient whose contamination with DEG and Ethylene Glycol (EG) is often the source of these crises.
Furthermore, the advisory provides a multi-layered safety net for quality assurance. It makes pre-use testing of Propylene Glycol absolutely mandatory, requiring firms to test every batch via Gas Chromatography (GC) to confirm the complete absence of DEG and EG. Manufacturers are strictly forbidden from purchasing PG from unlicensed dealers and must not use any batch without a prior, satisfactory test report.
A significant highlight of Haryana's strategy for complete vigil is the subsequent expansion of this rigorous quality check to include Ayurvedic medicine manufacturers. Recognizing that PG-like solvents are utilized in traditional Indian medicines as well, the SDC officially communicated with the State Licensing Authority under the Directorate of Ayush. The directive requires all Ayurvedic firms using propylene glycol or similar solvents to adopt the same rigorous quality checks, ensuring a ‘zero-tolerance’ approach to contamination in all segments of drug production.
The vigilance does not stop at raw materials, Goel also insists that finished liquid oral drugs must be tested for the absence of EG/DEG to ensure no contamination occurred during the manufacturing process. Moreover, firms are required to regularly check their retained control samples for these toxic impurities, with an instruction for an immediate and mandatory product recall if DEG or EG is detected in the retained control samples, a firm stance that underscores the state's commitment to protecting its citizens.
These coordinated efforts, from the CDSCO Guwahati’s timely detection and alert to the expansive, proactive, and sector-wide regulatory crackdown by the Haryana Drug Controller, Lalit Kumar Goel, reflect a heightened nationwide focus on pharmaceutical supply chain integrity. The tragic and often fatal consequences of DEG contamination demand that all stakeholders maintain unprecedented levels of scrutiny to ensure that medicines distributed in India are safe and meet the highest standards of quality.
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