WHO issues alert against substandard oral cough syrups in India

The World Health Organisation WHO has issued an alert against three substandard oral cough syrups identified in India Coldrif Respifresh TR and ReLife and urged national regulatory authorities worldwide to immediately notify it if these are detected in their countryIt has also advised healthcare professionals to report the detection of these substandard products and any incident of adverse effects or lack of expected effects to their national regulatory authorities or National Pharmacovigilance CentreThe alert comes after at least 22 children mostly under the age of five have died due to suspected kidney failure after being administered Coldrif in Madhya Pradesh Besides at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the stateThe WHO has further called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard productsIncreased surveillance of the informalunregulated market is also advised the alert issued on Monday saidThe affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of common cold flu or coughAccording to the alert the Central Drugs Standard Control Organization CDSCO of India reported to WHO the presence of Diethylene Glycol DEG in at least three oral liquid medicines in October 8 This followed information identified by WHO on September 30 of localised clusters of acute illness and child fatalities in IndiaThe CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children and confirmed that relevant state authorities have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorisationsIn addition a recall of the contaminated products has been initiated by relevant state authoritiesThe contaminated oral liquid medicines have been identified to be specific batches of Coldrif Respifresh TR and ReLife manufactured by Sresan Pharmaceutical Rednex Pharmaceuticals and Shape Pharma the alert saidThe alert stated the CDSCO has informed WHO that none of the contaminated medicines have been exported from India and there is currently no evidence of illegal exportNevertheless WHO encourages National Regulatory Authorities NRAs to consider targeted market surveillance with particular attention to informal and unregulated supply chains where products may circulate undetected NRAs are also advised to carefully evaluate risks associated with any oral liquid medicines originating from the same manufacturing sites particularly those produced since December 2024 the alert statedThe products identified in this alert are considered substandard as they fail to meet their quality standards and their specifications These contaminated products pose significant risks to patients and can cause severe and potentially lifethreatening illness the global health agency saidDiethylene glycol is toxic to humans when consumed and can prove fatalThe contaminated oral liquid medicines referenced in this alert are unsafe and their use especially in children may result in serious injury or death Toxic effects can include abdominal pain vomiting diarrhoea inability to pass urine headache altered mental state and acute kidney injury which may lead to deathTo protect patients it is essential to detect and remove these contaminated products from circulation the alert saidHealthcare professionals should report the detection of these substandard products and any incident of adverse effects or lack of expected effects to their National Regulatory Authorities or National Pharmacovigilance Centre The WHO advises increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard products Increased surveillance of the informalunregulated market is also advisedNational regulatory authorities and law enforcement authorities are advised to immediately notify the WHO if these products are detected in their country the alert statedIf you are in possession of any of these products WHO recommends that you do not use them If you or someone you know has or may have used these products or suffered an adverse event or unexpected sideeffect after use seek immediate medical advice from a healthcare professional or contact a poisons control centre it addedThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever