MP bans Coldrif cough syrup after nine children die of suspected kidney failure within a month

BHOPAL, OCT 4 : The Madhya Pradesh government banned, on Saturday, cough syrup, Coldrif, which was reportedly administered to 80% of the kids aged below five years in Chhindwara district, who died due to acute kidney injury (AKI) since September 4.

“Deaths of children in Chhindwara due to Coldrif cough syrup is extremely tragic. The sale of this syrup has been banned across Madhya Pradesh. A ban is also being imposed on selling other products from the company that manufactures the concerned syrup,” MP Chief Minister, Dr Mohan Yadav, posted on social media platform X on Saturday.

Yadav added that the factory producing the syrup is located in Kanchipuram, so after the incident in Chhindwara, the state government has asked the Tamil Nadu government to investigate.

“The investigation report was received this morning. Strict action has been taken based on the report. Following the tragic deaths of the children, action was underway at the local level. A team has also been formed at the state level to investigate this matter. The guilty will not be spared at any cost,” Yadav said.

On October 1, the Tamil Nadu Drugs Control Department had received information from the MP Drugs Control Authority to conduct an investigation into the matter, after which a team commenced investigation into the matter the same day.

During the in-depth investigation, several non-compliances with respect to Revised Schedule M(GMP) and Schedule L1 (GLP) of the Drugs Rules,1945 were noticed at the said manufacturing facility in Kanchipuram district.

Further, it was found that the alleged batch was manufactured using non-pharmacopoeial grade Propylene Glycol as an excipient, which might have been contaminated with Diethylene Glycol (DEG) and Ethylene Glycol, known nephrotoxic and poisonous substances.

The stocks of Coldrif Syrup (Batch No. SR-13) were drawn for urgent analysis, while the remaining quantity kept for sale at the said premises was frozen immediately to prevent further distribution.

The samples were sent for urgent analysis forthwith to Government Drugs testing laboratory, Chennai to analyse as per the label claim and also with the special request for the identification and quantification of Diethylene glycol and Ethylene glycol. Rapid testing was undertaken by the Drugs Testing laboratory with top priority in the Public Interest even during the holidays.

Investigation was continued on October 2, where several non-compliances of Schedule M and Schedule L1 of Drugs Rules, 1945 were observed, i.e 39 critical observations and 325 Major Observations were noticed by the team. A statewide alert was issued in Tamil Nadu to prevent the sale and distribution of the alleged drug.

The distribution list of the alleged drug formulation was circulated to all drugs inspectors across Tamil Nadu, and they were instructed to freeze all available stocks at wholesale and retail levels. Communications were also sent to Odisha and Union Territory-Puducherry through email based on the interstate distribution details available at the manufacturing premises.

Within 24 hours, the Government Analyst, Drugs Testing laboratory promptly analysed and reported in Form-13, that Coldrif Syrup, Batch No. SR-13, was declared as not of standard quality and adulterated with Diethylene Glycol (DEG)(48.6%w/v), a poisonous substance, which may render the content injurious to health. The Sample didn’t answer the identification test for Ethylene glycol, informed sources told TNIE.

While the MP CM announced on Saturday, banning Coldrif cough syrup across the state in the wake of Tamil Nadu Drug Control Department’s investigation report which detected major adulteration of the syrup with the nephrotoxic poisonous solvent, the opposition Congress accused the state’s deputy CM and health minister Rajendra Shukla for rendering clean chit to the cough syrup just a few days back, without waiting for the findings of the drug test reports.

“On the one hand MP CM Dr Mohan Yadav has announced on Saturday to ban the cough syrup after the death of nine kids, while on the other hand just two days back, the deputy CM and state’s health minister Rajendra Shukla said the cause of deaths is not cough syrup. Are you (Shukla) a pharmaceutical scientist/inventor that you have a clean chit even before the investigation report was out?” former chairman of MP Congress’s media wing KK Mishra wrote on X, while posting two recent

Notably, at least nine children aged up to five years, who were suffering from mild fever, cough and cold in Chhidwara’s coal mining belt Parasia, were prescribed a combination of medicines last month, by local doctor Dr Ravindra Soni (a government doctor, who also operates a private clinic), reportedly died due to acute kidney injury (AKI) at hospitals in Chhindwara and adjoining Nagpur (Maharashtra) since September 4.

“Analysis of the medical history and medicines prescribed to those kids revealed that in 80% cases, the cold-cough syrup Coldrif had been prescribed to them along with other medicines. The biopsies of kids who died in Nagpur hospitals revealed the possibility of toxin-mediated AKI to have caused the death. Old research has shown possible contamination of some cold-cough syrups during manufacture by the chemical Diethylene Glycol (DEG) or Ethylene Glycol (EG).

“Suspecting the role of the adulteration/contamination of the concerned syrup, the Chhindwara district administration, through an advisory, had restrained the sale, prescription and use of the concerned Coldrif syrup in the district,” Dr Pawan Nandurkar, the paediatrician at the Chhindwara district hospital, had told journalists in Chhindwara on Friday.

At least three to four more critically ailing kids (who were administered a combination of medicines, including Coldrif) are reportedly battling for life at hospitals in Nagpur (Maharashtra) with dialysis and ventilator support, the officials in Chhindwara said.

Most of the children, who have either died or are battling for life at hospitals in Nagpur and Chhindwara, were reportedly prescribed a combination of medicines, including Coldrif syrup, by Dr Ravindra Soni, a government doctor posted at a government health facility in Parasia (Chhindwara), who also runs a private clinic in the coal belt’s main town.

-PTI