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The Drugs Control Administration (DCA) of Jharkhand has formally requested the Central Drugs Laboratory (CDL) in Kolkata to issue a formal correction, known as an addendum, to a recent test report for a common cough syrup.
Sumant Kumar Tiwari, joint director of DCA in Jharkhand, has raised concerns that while the laboratory correctly identified the product ‘RespiFresh-TR’ as ‘Not of Standard Quality’ (NSQ) due to low menthol levels, a critical safety finding was buried in the technical data. The department is now insisting that the report explicitly state that no toxic contaminants were found during the analysis.
The controversy centers on RespiFresh-TR (Batch No. R12GL2426), manufactured by Rednex Pharmaceuticals, which was sampled by Ranchi-I drugs inspector Rajeev Ekka in October 2025. Laboratory analysis conducted in December 2025 revealed that the syrup contained only 73.76% of the claimed menthol content, falling below the required legal limits. Consequently, Jharkhand authorities issued a statewide notice on January 1, 2026, to stop the sale and distribution of this specific batch.
However, the Jharkhand DCA contends that the current report is misleading because it omits vital safety clearances from its final conclusion. While the syrup failed the menthol assay, it successfully passed rigorous testing for diethylene glycol (DEG) and ethylene glycol (EG). These two contaminants have been linked to numerous global fatalities and are a top priority for drug regulators. The department argues that although these toxins were ‘Not Detected’, this essential safety information was relegated to the technical tables rather than being highlighted in the ‘Reasons for Not of Standard Quality’ summary.
By demanding an addendum, S K Tiwari aims to rectify what he describes as a grave oversight. The department explains that the drugs inspector had specifically requested DEG and EG verification due to ongoing national health alerts. By failing to highlight the absence of these toxins in the final opinion section, the laboratory report could lead to unwarranted scrutiny and imply a level of toxicity that does not exist, despite the failure of the minor menthol ingredient.
The complaint also serves as a broader critique of regulatory reporting under the Drugs and Cosmetics Act, 1940. Tiwari noted that selective reporting, focusing only on minor failures while ignoring major safety successes, risks undue prosecutions and erodes faith in the official reporting system. The Jharkhand DCA is pushing for a standardized protocol where all critical safety parameters are explicitly listed in the final summary of Form 13, regardless of the overall pass or fail status.
To ensure the matter receives high-level attention, a copy of the complaint has been marked to the Drugs Controller General of India (DCGI) in New Delhi. The department is urging the central authorities to mandate that laboratory reports be as transparent as possible to protect both public health and the reputation of the pharmaceutical supply chain. The outcome of this request could set a new precedent for how safety data is disclosed in government laboratory reports across India.
As of early January 2026, the Jharkhand DCA continues to monitor the recall of the affected batch while awaiting a response from CDL Kolkata. The department maintains that a formal addendum is necessary to provide a complete and fair picture of the medicine's safety profile, ensuring that minor quality issues are not confused with life-threatening contamination.
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