New Delhi: The World Health Organization (WHO) has issued an alert against three cough syrups after the reports of deaths of at least 22 children in Madhya Pradesh’s Chhindwara district led to a probe into them. The global health watchdog has urged national regulatory authorities worldwide to immediately notify it if any of these cough syrups are detected in their country.

"Health-care 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. 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," it said.

The syrups include specific batches of Coldrif, Respifresh TR and ReLife, manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals, and Shape Pharma, respectively. 

In a press release, the WHO said it received a notice from India’s Central Drugs Standard Control Organization (CDSCO) on October 8 alerting it to the presence of diethylene glycol (DEG) in at least three oral liquid medicines. The WHO said that this followed the information it first identified on September 30 of “localized clusters of acute illness and child fatalities in India”.

The CDSCO informed WHO that the contaminated products were reportedly consumed by the affected children.

The toxic DEG in these cough syrups was found to be in quantities nearly 500 times the permissible limit.

The CDSCO has already ordered relevant state authorities to immediately halt production at implicated manufacturing sites and has suspended product authorisations. In addition, a recall of the contaminated products has been initiated by relevant state authorities, it told the WHO.

The health watchdog said the contaminated products posed significant risks and can cause severe, potentially life-threatening illness.

The CDSCO has informed the WHO that none of the contaminated medicines have been exported from India and there is currently no evidence of illegal export. 

According to Reuters, the U.S. Food and Drug Administration has confirmed that these toxic cough syrups had not been shipped to the United States.

Meanwhile, a Public Interest Litigation (PIL) has also been filed in the Supreme Court, seeking a Central Bureau of Investigation (CBI) probe into the deaths of children in Madhya Pradesh and Rajasthan due to consumption of the contaminated cough syrup.

The petition also requests the court to direct the Union government to suspend or cancel the manufacturing licenses of pharmaceutical companies found involved in producing or distributing contaminated medicines and to initiate criminal prosecution against those responsible.

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