Representative image of cough syrup.
Credit: iStock Photo
The deaths of several children in Madhya Pradesh and Rajasthan due to kidney failure following alleged consumption of contaminated cough syrup made the national headline last week.
As many as 14 child deaths have been reported from Madhya Pradesh's Chhindwara district while three children died in different districts of Rajasthan.
Central drug regulator CDSCO initiated a risk-based inspection of drug manufacturing units in six states, collecting 19 samples including that of cough syrups, antipyretics and antibiotics following which one cough syrup, 'Coldrif', has been banned in several states while a doctor was arrested in MP for alleged negligence.
Here is all you need to know about the incident that has raised several questions on the safety of drug regulation in India.
Initial incidents and reaction
When initial reports of deaths of children allegedly due to consuming "toxic" cough syrup emerged, the Rajasthan Medical Services Corporation (RMSCL) banned the sale and use of 19 batches of a generic cough syrup and the health department issued advisories to parents, doctors, and medical operators to be vigilant.
Meanwhile, the state's health department clarified that the deaths of two children in Bharatpur and Sikar districts were not caused by cough syrup distributed under the state's free medicine scheme.
Public Health Director Ravi Prakash Sharma said inquiry reports confirmed that in both cases, the children were administered the syrup at home without a doctor's advice.
As per protocol, Dextromethorphan (DXM) drug is not prescribed to children, Sharma said in the statement released on Thursday and added that in both incidents, the doctors had not prescribed the drug.
Centre advises against prescribing cough syrups to children below 2 years
As the matter grew big, the Centre issued an advisory to all states and Union Territories, directing that cough and cold medications should not be prescribed to children under the age of two years.
Meanwhile, the Union Health Ministry noted none of the tested syrup samples in Madhya Pradesh contained Diethylene Glycol (DEG) or Ethylene Glycol (EG) -- contaminants that are known to cause serious kidney injury.
The DGHS, which comes under the health ministry, said in the advisory that cough syrups are generally not recommended for children below five years.
Dextromethorphan Hydrobromide Syrup IP not faulty: Rajasthan health minister
Rajasthan Health Minister Gajendra Singh Khimsar has maintained that Dextromethorphan Hydrobromide Syrup IP, the cough syrup that was alleged to have led to the death of three children in the state was safe and not faulty.
"We got the medicine checked twice. First our drug controller tested it and then the RMSCL (Rajasthan Medical Services Corporation Limited) tested it. Both test reports did not find it faulty," the minister claimed at a press conference at the Circuit House in Jodhpur.
Khimsar claimed that the three deceased children were comorbid and that they were administered the cough syrup by the parents on their own, not prescribed to them by doctors.
When asked about the ban on 19 medicines produced by Kaysons Pharma and 40 of its medicines failing the quality test earlier, Khimsar said it was done as a precaution.
'Coldrif' banned in Tamil Nadu, tests samples found to be 'adulterated'
Samples of the Coldrif cough syrup, manufactured by Sresan Pharmaceutical, based in Chennai were found be 'adulterated', following which the state banned the use and sale of the cough syrup.
The Tamil Nadu drug control authorities, in their report of October 2, declared the Coldrif syrup sample (Batch No SR-13; Mfg: May 2025; Exp: April 2027) manufactured by Sresan Pharmaceuticals, Kancheepuram, as adulterated because it contained diethylene glycol (48.6% w/v), a poisonous substance "which may render the contents injurious to health".
States that banned 'Coldrif'
Tamil was the first state to ban the sale and use of 'Coldrif' cough syrup. Kerala and Madhya Pradesh followed suit. The Kerala Health Department on Monday also ordered that no medicines should be given to children under 12 without a doctor’s prescription.
Telangana Drugs Control Administration on Saturday issued a 'public alert - stop use notice' for Coldrif cough syrup.
The Maharashtra FDA on Monday appealed to the people to immediately stop the sale or use of a specific batch of Coldrif.
The Karnataka government directed all enforcement officers to maintain strict vigil over certain cough syrups including Coldrif and Dextromethorphan Hydrobromide Syrup IP, manufactured by Kaysons Pharma, Jaipur.
MP forms SIT to probe death of 14 children
The Madhya Pradesh police have formed a special investigation team (SIT) to probe the death of 14 children in Chhindwara due to suspected renal failure, linked to the consumption of a “toxic” cough syrup, officials said.
Dr Praveen Soni from Chhindwara was arrested for alleged negligence in connection with the child deaths, while a case has been registered against the Coldrif cough syrup manufacturing company, the officials said on Sunday.
(With PTI inputs)