Central drug regulator CDSCO has informed the World Health Organisation (WHO) that three cough syrups -- Coldrif, RespifreshTR and ReLife -- have been recalled and manufacturers have been ordered to stop their production.
The CDSCO on Wednesday informed the global health agency that none of the products were exported from India, official sources said.
The WHO had sought to know from Indian authorities whether the cough syrup linked to children deaths in the country was exported to other countries, they said.
The WHO stated that it is closely monitoring recent media reports from India regarding clusters of pediatric illnesses and deaths in Madhya Pradesh and Rajasthan.
These reports, which have emerged during the week of September 29, describe symptoms consistent with acute renal failure and acute encephalitis syndrome, with suspected links to the use of oral syrup medicines.
The WHO has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified, sources said.
The global health agency has expressed deep concern over the developments and emphasized the potential risk of contaminated products being exported to other countries, particularly via unregulated channels and the regulatory gap in DEG/EG screening for domestically marketed medicines in India/ It has also stressed on identifying the source of the contamination and identifying and removing any contaminated pharmaceutical material which may be in circulation, the sources said.
The Drugs Controller General of India (DCGI) on Wednesday had urged drug controllers all states and Union territories to ensure testing of raw materials and finished formulations of pharmaceutical products before releasing 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 that 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, 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 the 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 an order issued December 18, 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".
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