The World Health Organisation (WHO) has sought clarification from Indian authorities on whether the cough syrup linked to the deaths of at least 22 children in the country was exported to other nations.
The request comes amid growing concerns over the safety and quality of Coldrif, the cough syrup found to contain toxic substances — Diethylene Glycol (DEG) and Ethylene Glycol (EG).
WHO will decide on issuing a Global Medical Products Alert after receiving an official response from Indian authorities. The agency issues such alerts to warn countries about substandard or contaminated medicines.
According to officials, 22 children have died in Madhya Pradesh after consuming the syrup, while five others are in critical condition with kidney infections. At least three additional deaths have been reported from different districts in Rajasthan.
“The World Health Organisation on Wednesday asked for clarification on whether the cough syrup linked to children’s deaths in India was exported to other countries, as part of the routine process,” sources told.
In response, the Drugs Controller General of India (DCGI) on Wednesday directed all state and Union Territory drug controllers to strengthen quality checks on raw materials and finished pharmaceutical products before they are released into the market.
In an advisory dated October 7, the DCGI highlighted serious lapses during recent inspections, noting that many manufacturers were not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.
“During inspections and investigations of drugs declared ‘Not of Standard Quality’, it was observed that manufacturers are not carrying out testing of each batch of excipients and active pharmaceutical ingredients before using them in formulations and finished products,” the advisory said.
Also Read : Owner of Sresan Pharma, Coldrif syrup maker, arrested
State and UT drug controllers have been asked to ensure strict monitoring during inspections, sensitise manufacturers through circulars, and verify that companies maintain robust vendor qualification systems, sourcing raw materials only from reliable, approved vendors.
The deaths in Madhya Pradesh’s Chhindwara district, allegedly linked to contaminated cough syrups, have renewed concerns over pharmaceutical quality control in India.
This is not the first time the country has faced scrutiny over cough syrup safety.
In 2023, the Centre had ordered pharmaceutical companies to include warnings on labels and package inserts stating that the fixed-dose combination of chlorpheniramine maleate IP 2mg and phenylephrine HCl IP 5mg per ml “should not be used in children below four years of age.”
Follow us
