New Delhi, Oct 8 (NationPress) In a significant move, the central government has suggested the suspension of the license for Tamil Nadu's Sresan Pharmaceuticals following the tragic deaths of more than 20 children linked to tainted cough syrup. However, the ultimate decision rests with the state drug regulatory authority, per sources from the Health Ministry on Wednesday.

The cough syrup known as Coldrif, produced by Sresan Pharmaceuticals in Kancheepuram, Tamil Nadu, has been associated with the fatalities of over 20 children in Madhya Pradesh and Rajasthan.

On October 2, Tamil Nadu's drug control officials reported that a sample of Coldrif syrup was found to be adulterated. The sample contained diethylene glycol (48.6 per cent w/v), a toxic substance identified as potentially harmful to health, as per the findings.

In light of the alarming reports, several states including Tamil Nadu, Kerala, Madhya Pradesh, Punjab, and Arunachal Pradesh have prohibited the sale of Coldrif cough syrups. Other states, such as Telangana, Karnataka, and Maharashtra, have issued alerts regarding the product.

According to sources from the Health Ministry, the CDSCO has already recommended the revocation of the license for the affected manufacturer, yet the final decision must come from the Tamil Nadu FDA.

“The license for manufacturing common allopathic drugs is issued by state drug controllers and must be revoked by them as well,” the sources clarified.

Furthermore, the “CDSCO has recommended the cancellation of the license for the firm after confirming the presence of DEG in Coldrif,” they added.

Diethylene Glycol (DEG) is a hazardous substance known to cause kidney damage.

Inspections conducted by the CDSCO revealed unreported containers of DEG at Sresan Pharma’s facility. The company had been incorporating 46-48 per cent of DEG into the cough syrup, far exceeding the permissible limit of just 0.1 per cent.

In an advisory directed to all states and Union Territories, Dr. Sunita Sharma, Director General of Health Services (DGHS), encouraged prudent usage of cough syrups among children.

“Cough and cold medications should not be prescribed or given to children under 2 years of age,” she warned.

“The majority of acute cough incidents in children are self-resolving and typically do not require medication,” noted Sharma, stressing that cough and cold medications “are not generally advised for children below 5 years.”

The medications should only be administered “following a careful clinical assessment with close supervision, strict adherence to appropriate dosages, minimal effective duration, and avoidance of multiple drug combinations.”