India’s drug regulator CDSCO on Thursday reposnded to 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 has also informed the global health agency that none of the products were exported from India.
WHO seeks reply from India on syrups linked to children deaths
Earlier, 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.
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 told news agency PTI.
WHO expresses concern over children deaths due to syrup
The global health agency has expressed deep concern over the developments and emphasised 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.
Earlier, the Drugs Controller General of India (DCGI) had urged drug controllers of all states and Union territories 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 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.
Child deaths reported on Madhya Pradesh, Rajasthan
There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, and also in Rajasthan 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.
With inputs from PTI
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