Tuesday, October 14, 2025

WHO issues medical product alert on three contaminated oral liquid medicines in India

A view of the World Health Organisation (WHO) headquarters. WHO has issued medical product alert on three contaminated oral liquid medicines identified in India.

A view of the World Health Organisation (WHO) headquarters. WHO has issued medical product alert on three contaminated oral liquid medicines identified in India.
| Photo Credit: Reuters

World Health Organisation (WHO) has issued medical product alert on three contaminated oral liquid medicines identified in India and reported to WHO on October 8, 2025. 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 U.N. agency said that the Indian National Regulatory Authorities (NRAs) has been advised 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 the risks associated with any oral liquid medicines originating from the same manufacturing sites — particularly those produced since December 2024.

“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,” it said adding that the affected products are oral liquid medicines containing active ingredients commonly used to relieve symptoms of the common cold, flu, or cough.

Giving details about the syrups WHO maintained that the products identified in this alert are considered substandard as they fail to meet their quality standards and their specifications.

WHO in its statement noted that on October 8, 2025 the Central Drugs Standard Control Organization (CDSCO) of India reported presence of Diethylene Glycol (DEG) in at least three oral liquid medicines.

This followed information identified by WHO on September 30, 2025 of localized clusters of acute illness and child fatalities in India. CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children.

CDSCO has confirmed that relevant State authorities have ordered an immediate halt to production at implicated manufacturing sites and have suspended product authorizations. In addition, a recall of the contaminated products has been initiated by relevant state authorities.

“WHO continues to collaborate closely with Indian health authorities to monitor the situation, identify the source of the contamination and mitigate any potential public health risks,” it said.

The agency further said that contaminated products pose significant risks to patients and can cause severe and potentially life-threatening illness.

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.

It has also advised health-care professionals, regulatory authorities and the public 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.

“We 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,” it said adding that all medical products must be obtained from authorized/licensed suppliers and that any information about the manufacture or supply of these products can be shared to WHO via rapidalert@who.int.

Source link

Latest Topics

Related Articles

spot_img