CDSCO calls for list of all cough syrup manufacturers in India, initiates joint audit

CDSCO calls for list of all cough syrup manufacturers in India, initiates joint audit


File image of a bottle of the Coldrif cough syrup
| Photo Credit: Reuters

Central Drugs Standard Control Organisation (CDSCO) has asked all State governments to submit a list of cough syrup manufacturers while initiating a joint audit of these companies, said a senior Health Ministry official on Thursday (October 9, 2025) following the deaths of over 20 children allegedly due to contaminated cough syrup in the past month. 

CDSCO has also informed the World Health Organisation (WHO) that it has identified three contaminated cough syrups – Coldrif, Respifresh and ReLife —linked to the recent child deaths in India— as containing Diethylene Glycol (DEG). It stated that none of the products were exported from India.

It added that the products have been recalled and identified manufacturers have been ordered to stop production of all medical products.

The WHO had contacted the CDSCO on October 1, seeking clarification regarding potential links to contaminated medicines and whether the products were exported to other countries.

The United Nations health agency noted that the CDSCO had identified the three products as Coldrif from Sresan Pharma (Tamil Nadu) showing 48.6 percent DEG; Respifresh TR from Rednex Pharmaceuticals (Gujarat) that showed 1.342% DEG and ReLife from Shape Pharma (Gujarat) showing 0.616%.

The symptoms described were consistent “with acute renal failure and acute encephalitis syndrome, with suspected links to the use of oral syrup medicines,” it added.

WHO added that it is “ready to support national authorities in investigating and responding to these tragic events,” adding that it hasn’t received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified. 

It also flagged the “regulatory gap in DEG/EG screening for domestically marketed medicines in India”, stressing the need to identify “the source of the contamination and identifying and removing any contaminated pharmaceutical material which may be in circulation.”

Meanwhile a Health Ministry official said that Coldrif from Sresan Pharma (Tamil Nadu) wasn’t in the radar of the Central Government when it was first given license in 2011 and even when this was renewed in 2016. 

“The CDSCO has now recommended cancellation of the manufacturing license for the company. If the raw material and the finished product were tested, we could have avoided the situation,’’ added the official.

He further explained that deaths of children in Rajasthan had no connection with contaminated cough syrup. “Child deaths in Rajasthan have been under scrutiny and have been medically attributed to meningitis, mucositis, and acute respiratory distress syndrome (ARDS),’’ said the official. 



Source link

Leave a Reply

Your email address will not be published. Required fields are marked *