Pharmaceutical Contamination and Regulatory Action Following Coldrif Tragedy
Seven months have passed since that Coldrif cough syrup tragedy. Twenty-four children died in Madhya Pradesh.
And now the Central Drugs Standard Control Organisation, the CDSCO , has finally pulled the pharmaceutical industry in. They want everyone to look at the continued use of those high-risk solvents in liquid formulations meant for kids.
It’s a big deal.
The Drugs Controller General of India, Dr. Rajeev Singh Raghuvanshi, flagged this in an office memo. He pointed out the concerns about using solvents like propylene glycol and their nasty impurities. That’s the whole class of stuff that has been at the heart of every major cough syrup poisoning India has seen.
The memo itself was issued because of reports. Reports highlighting worries about polyethylene glycol and the associated impurities in syrups and drops given to children.
The whole thing went to the Drugs Consultative Committee, the DCC. They looked at the contamination risks.
They discussed it. Seriously deliberated.
The focus was on these solvents— propylene glycol , and the stuff that comes along with it, diethylene glycol (DEG) and ethylene glycol (EG).
It came out that several liquid formulations are being made using these high-risk solvents. There’s a real risk of contamination. It’s possible they are mixing in DEG and EG.
The committee also looked at alternatives. Feasibility of using other excipients. It was an unambiguous signal. The regulator is now actively checking if those propylene glycol -based pediatric syrups can even be changed or restricted.
So, what happened next?
The body decided to start looking. They said CDSCO should first consult with stakeholders. They need to check the current situation. Collate details on what’s being manufactured with these risky solvents. Before taking any bigger regulatory action.
They set a date. A meeting.
May 21, 2026. New Delhi headquarters. Stakeholders needed to show up. Industry associations were asked to send reps. People who actually know what they are talking about.
The backdrop to all this is the Coldrif incident itself. That meeting wasn't just some academic exercise. It was a direct response.
It followed the September and October outbreak in Chhindwara, Betul, and Pandhurna.
Coldrif syrup. Made by Sresan Pharmaceuticals, based in Tamil Nadu. It was found loaded with 48.6 per cent diethylene glycol. That’s nearly 500 times the limit allowed—the permissible impurity was just 0.1 per cent.
Twenty-four deaths. Most of them, kids under five. Acute kidney failure.
And it wasn't just one spot. There was another cluster in Rajasthan. They claimed at least three more deaths from a dextromethorphan-based syrup from Kayson Pharma.
Meanwhile, the WHO stepped in. On October 13th, they issued a global Medical Product Alert. Flagging Coldrif. Respifresh TR. ReLife.
Sresan Pharma’s license got ripped away. The owner, G. Ranganathan, was arrested. Culpable homicide charges. And ten states banned Coldrif outright.
It’s a mess. A real toxic trail.
Written by Gree News Team — Senior Editorial Board
Gree News Team covers international news and global affairs at Gree News. Our collective of senior editors is dedicated to providing independent, accurate, and responsible journalism for a global audience.
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