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Maharashtra FDA issues 'Stop Use' notice against Coldrif syrup
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Shardul Nautiyal, Mumbai
October 07 , 2025
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In the wake of alarming reports linking the deaths of several children in Madhya Pradesh and Rajasthan to a contaminated batch of Coldrif syrup (Batch No. SR-13), the Maharashtra Food and Drugs Administration (FDA) has issued a 'Stop Use' notice and taken immediate preventive measures to safeguard public health.
In a strong assurance to the public, the Maharashtra FDA has confirmed that this particular batch of Coldrif syrup has not entered the retail supply chain in the state. Authorities clarified that the product was not procured through government tenders and, as such, has not entered public healthcare systems or retail outlets.
The adulterated batch, manufactured by Sresan Pharma of Tamil Nadu, has tested positive for diethylene glycol (DEG) – a highly toxic chemical known to cause fatal poisoning. The contaminated product, Coldrif syrup (phenylephrine hydrochloride and chlorpheniramine maleate), carried the batch number SR-13, with a manufacturing date of May 2025 and expiry in April 2027.
Maharashtra FDA officials said that all measures have been taken on a war footing to prevent entry of toxic batch into public supply chain.
The statement, issued by Dr D R Gahane, Drug Controller, FDA Maharashtra, emphasized that all available data indicates the toxic batch is absent from the state's market. However, as a precautionary measure, the administration is maintaining a high state of alert.
FDA Maharashtra is working closely with the Drugs Control Administration (DCA) of Tamil Nadu to trace the distribution trail of the tainted batch and ensure zero infiltration into Maharashtra’s supply networks.
Additionally, all Drug Inspectors and Assistant Commissioners across the state have been instructed to immediately alert all retailers, wholesalers, and hospitals, freeze any stocks of Batch No. SR-13, if found and conduct thorough inspections and verifications of cold and retail chains.
The Maharashtra FDA has directed all license holders (retailers, wholesalers, hospitals, etc.) to halt the sale, distribution, and use of Coldrif syrup, Batch No. SR-13 without delay. Possession of the said batch should be reported immediately to local drug authorities or through the following channels: Toll-free number: 1800 222 365, Email: jchq.fda-mah@nic.in and Phone: 98928 32289.
Citizens are also encouraged to report any possession or suspicion of the batch directly to the Maharashtra FDA. The state drug regulator has urged the public to remain vigilant and cautious. The presence of diethylene glycol in any medicinal formulation can lead to serious health risks, including acute kidney failure and death, particularly among vulnerable populations like children.
Maharashtra FDA has assured that it is actively monitoring the situation and will continue to take all necessary steps to protect public health and safety.
Samples of 19 medicines consumed by children were collected from treating private practitioners and retail stores. Of the 10 samples analysed so far, nine met quality standards, but cough syrup Coldrif was found to contain DEG above permissible limits.
The Central Drugs Standard Control Organisation (CDSCO) has recommended cancellation of Coldrif maker Sresan Pharmaceuticals' licence for its Kancheepuram unit in Tamil Nadu, based on inspection findings.
The Union health ministry sources have informed that risk-based inspections (RBIs) have begun across 19 manufacturing units in six states to plug systemic gaps and strengthen quality assurance of cough syrups.
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The Food and Drug Administration (FDA), Maharashtra, has issued a public advisory urging citizens to report any misleadi ...
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