NEW DELHI: The World Health Organisation has sought to know from Indian authorities whether the cough syrup linked to child deaths in the country was exported to other nations, sources said on Thursday.
They said the global health agency will take a call on issuing a 'Global Medical Products Alert' on the cough syrup, Coldrif, after receiving an official confirmation from authorities here. The agency issues such alerts for substandard and contaminated medicines.
Five children from Madhya Pradesh are in a critical condition, while 20 have died due to kidney infections caused by the consumption of the "contaminated" cough syrup, containing Diethylene Glycol (DEG) and Ethylene Glycol (EG).
Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state.
"The World Health Organisation (WHO) on Wednesday has asked for a clarification on whether the cough syrup linked to children deaths in the country was exported to other countries as part of the routine process", the sources said.
The WHO received confirmation on Wednesday from the CDSCO that Diethylene Glycol (DEG) had been detected in at least three oral syrup medicines. “These medicines were among those consumed by children in the reported cluster of cases.”
The CDSCO also informed the WHO that they have further identified the contaminated products as Coldrif, manufactured by Sresan Pharmaceuticals, Tamil Nadu. In the batch, 48.6 % of DEG contamination was found.
Another medicine, Respifresh TR, manufactured by Rednex Pharmaceuticals, Gujarat, was also found to contain 1.342% DEG. Similarly, ReLife, manufactured by Shape Pharma Pvt Ltd, Gujarat, was found to have 0.616% of DEG.
The CDSCO also informed the WHO that all the contaminated products have been recalled and that the identified manufacturers have been ordered to stop production of all medical products. CDSCO also stated that none of the products were exported from India.
“WHO has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified,” it said.
Expressing deep sadness at the reported fatalities, WHO extended its “sincere condolences to the affected families and communities.”
The Drugs Controller General of India (DCGI) on Wednesday had urged all state and UT drug controllers to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing in them in the market in the wake of children deaths allegedly due to consumption of contaminated cough syrup in Madhya Pradesh.
In an advisory, the DCGI said during recent inspections at manufacturing facilities and in the investigations of the drugs declared as 'Not of Standard Quality', it was found that several manufacturers are not testing each batch of excipients and active ingredients for compliance with prescribed standards before use.
There have been recent reports of child deaths in Chhindwara in Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to quality of these cough syrups, the advisory stated.
"During the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products," the advisory dated October 7 said.
"All State/UT drug controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc.
Further, it shall also be ensured that the manufacturers have robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only," the advisory said.
The Centre in 2023 had ordered pharma companies to mention warnings on the label and the package insert stating the fixed-dose combination (FDC) of chlorpheniramine maleate IP 2mg and phenylephrine HCl IP 5mg drop/ml "should not be used in children below four years of age".
(With inputs from PTI)
