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 country.

It 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 Centre.

The 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 state.

The WHO has further called for increased surveillance and diligence within the supply chains of countries and regions likely to be affected by these substandard products.

"Increased surveillance of the informal/unregulated market is also advised," the alert issued on Monday said.

The affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of common cold, flu, or cough According 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 India.

The 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 authorisations.

In addition, a recall of the contaminated products has been initiated by relevant state authorities.

The 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 said.

The 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 export.

"Nevertheless, 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 stated.

The 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 life-threatening illness, the global health agency said.

Diethylene glycol is toxic to humans when consumed and can prove fatal.The 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 death.

To protect patients, it is essential to detect and remove these contaminated products from circulation, the alert said.

"Healthcare 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 informal/unregulated market is also advised.

National regulatory authorities and law enforcement authorities are advised to immediately notify the WHO if these products are detected in their country," the alert stated.

"If 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 side-effect after use, seek immediate medical advice from a health-care professional or contact a poisons control centre.," it added.