BHOPAL: Investigations by Tamil Nadu drugs control authorities into the making of the Coldrif cough syrup, which is believed to have caused the deaths of 17 kids so far in Madhya Pradesh’s Chhindwara district, by the Kancheepuram-based Sresan Pharmaceuticals have revealed that non-pharmaceutical grade propylene glycol was used for manufacturing the syrup.
The inspection of the drugs manufacturing unit and perusal of the purchase invoices of the propylene glycol used to make the syrup led to the observations that non-pharmaceutical grade propylene glycol was purchased on two different dates and that too without invoices, mentions the detailed report of the TN director of drugs control.
Not only did the manufacturer use non-pharmaceutical grade propylene glycol, instead of using its pharmaceutical grade, but it didn’t even test the propylene glycol for the presence and concentration of diethylene glycol and ethylene glycol.
This means that non-pharmaceutical grade propylene glycol was used as excipient. In medicines, excipients are inactive ingredients, or non-drug substances, added to a drug formulation to facilitate the delivery, stability, and manufacturing of the active ingredient. They make a medicine safe, stable, and effective, serving various roles such as diluents, binders, disintegrants, flavourings, preservatives and coatings.
Investigations by the TN drugs control department, whose findings ultimately led to the banning of the Coldrif cough syrup in MP, have found that with the alleged batch of the syrup (SR-13) having been manufactured by using non-pharmacopoeial grade propylene glycol as an excipient, it was found adulterated with diethylene glycol (DEG)(48.6%w/v), a poisonous substance, which may render the content injurious to health.
In a related development in Madhya Pradesh, the state's Food and Drug Administration has found increased levels of diethylene glycol (DEG) in two more cough syrups, and has begun the process of banning the medicine. The drug controller has ordered the immediate halting of sales and seizures of the concerned cough syrups. ReLife and Respifresh TR were found to have DEG more than the prescribed standard. While the standard only allows for 0.1 per cent in the medicine, ReLife contained 0.616 per cent and Respifresh TR contained 1.342 per cent.
Meanwhile, the death toll of kids who have suffered acute kidney injury (AKI) following the cough syrup’s adulteration with the poisonous substance, has reportedly risen to 17 with two more deaths at hospitals in Nagpur on Tuesday.
The two kids, Vedansh Pawar (2.5 years) and Jiyusha Yaduvanshi (2), hailed from Chhindwara district. They too had been prescribed the same cough syrup by Parasia-based government paediatrician Dr Pravin Soni at his private clinic.
Dr Soni is in judicial custody following his Saturday night arrest from Parasia town amid rising calls and demands by the doctor fraternity from across the country to release him.
According to the Madhya Pradesh government’s official statement, nine more kids (seven from Chhindwara district and two from Betul district) are currently under treatment at five government and private hospitals in Nagpur. The entire medical treatment of the nine kids will be funded by the MP government.
As per informed sources, while the condition of two to three children has started improving, the other kids continue to be critical.
Meanwhile, the special investigation team (SIT) of Chhindwara district police, probing the case registered against Dr Soni, the Kancheepuram-based drug manufacturing company and others on Saturday, have sent a team led by a deputy police superintendent to Tamil Nadu.
“Our team has already reached Chennai and will soon be in Kancheepuram to speed up investigations,” a senior police officer in Chhindwara district confirmed to TNIE.