MP children deaths: Contaminant found in cough syrup made by TN firm

Contaminant found in Coldrif cough syrup; risk-based investigations started at manufacturing sites of around 19 drugs sampled across 6 states

Amid probe into the deaths of 11 children in Madhya Pradesh’s Chhindwara district, the Union Health Ministry on Saturday announced that one sample of Coldrif cough syrup has been found to contain Diethylene Glycol (DEG), commonly used in making products like brake fluids and paints, beyond permissible limits.

 

This comes after the Tamil Nadu Food and Drug Administration (FDA) tested samples of the cough syrup taken from the manufacturing premises of Kanchipuram-based Sresan Pharma, at the request of the MP government.

 

“The results of testing of these samples were shared with us late evening on October 3. The samples are found to contain DEG beyond the permissible limit,” the health ministry said in a statement.

 

Investigations were ordered after at least 11 children were reported to have died allegedly due to kidney problems caused by the intake of certain cough syrups. 

 

The discovery comes just a day after it was announced that MP State Food and Drug Administration (SFDA) did not find any contaminants in the three samples that it had tested till then.  

 

As part of ongoing investigation, it is further informed that six samples were collected by Central Drug Standard Control Organisation (CDSCO), which were tested and found to be free of DEG or ethylene glycol (EG) contaminants.

 

Despite a contaminated sample being found, the ministry said that a central team comprising central drug regulators and the Indian Council of Medical Research (ICMR) is still analysing the various samples and factors to assess the cause of deaths.

 

DEG and EG are industrial chemicals most commonly used in making products like brake fluids and paints. These are cheap and colourless liquids, which can sometimes be mistakenly or illegally used in medicines as a substitute for propylene glycol (a solvent that helps dissolve drugs into liquid form).

 

While propylene glycol is safe in regulated amounts, even a small intake of DEG or EG is known to cause severe poisoning, which can lead to kidney problems, especially in children.  

 

Since October 3, risk-based inspections have been initiated at the manufacturing premises of all 19 drugs sampled, spread across six states. 

 

“This will help find gaps leading to quality failure of drug samples and suggest process improvement to avoid such incidents in the future,” the statement added.

 

Failure to detect contaminants in such commonly used medications has led to the Centre directing healthcare facilities and clinical establishments to ensure procurement and dispensing of products manufactured under Good Manufacturing Practices (GMP) and formulated with pharmaceutical-grade excipients.   

 

As part of its advisory to all states and union territories (UTs), the Directorate General of Health Services (DGHS) called for sensible use of cough syrups while cautioning against their prescription and dispensation to children below two years of age. 

 

“These (cough syrups) are generally not recommended for ages below five years. And above that, any use should follow careful clinical supervision and adherence to appropriate dosing,” the advisory had stated. 

 

The recent incidents in MP and Rajasthan come on the back of similar crises that have previously tarnished India's pharmaceutical reputation. In 2022, the World Health Organisation (WHO) issued alerts after Indian-made cough syrups were linked to the deaths of children in Uzbekistan and The Gambia, with tests confirming the presence of lethal contaminants.