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.