New Delhi: The government laboratory in Bhopal that tested samples of cough syrup reportedly causing multiple children deaths has found 46.28% diethylene glycol, or DEG, in one of the drugs collected for analysis. DEG, an industrial chemical, is injurious to health.
The report seen by ET says that the sample fails to comply in respect of impurities of DEG, which is more than permissible limit. The presence of Ethylene Glycol has not been detected. "The samples found adulterated with Diethylene Glycol 46.28% which is injurious to health," said the report by drug testing laboratory, food and drugs administration, MP, Bhopal. "The sample is not of standard quality as defined in the Drugs and Cosmetics Act 1940 and rules," it further said.
The samples of Coldrif syrup manufactured by Sresan Pharmaceutical bears manufacturing date of May 2025 and expires in April 2027. The samples were received by the laboratory on October 3.
Diethylene glycol (DEG) and ethylene glycol (EG) are industrial chemicals most commonly used in making products like brake fluids, antifreeze, paints, plastics. Both DEG and EG can damage the kidneys, liver, and nervous system.
Following this report, the Tamil Nadu drugs department has explicitly prohibited the purchase, sale, and consumption of the said batch, citing serious health risks.
"Adulteration with diethylene glycol is highly dangerous, as this chemical is toxic and can cause severe poisoning, including kidney failure and death," it said.
Retailers, distributors, hospitals, and pharmacies in Tamil Nadu have been asked to remove the batch from stocks immediately and report if the product was supplied or sold.
Consumers have also been advised to check the batch details and avoid usage. "Anyone who possesses this product should submit it to the authorities for proper disposal," it said.
The healthcare providers have been asked to monitor for symptoms of diethylene glycol poisoning in patients who may have consumed the affected syrup, stating that adverse reactions or suspected cases must be promptly reported to the Drugs Control Department for further investigation.
Meanwhile investigation at the manufacturer's premises have been initiated and stop production orders was issued to the manufacturing company. Surveillance has been heightened across medical shops and hospitals in Tamil Nadu to prevent further distribution.
Taking cognisance of the issue, the union health ministry on Sunday directed states to curb irrational use of cough syrups and step up quality checks after reports of multiple child deaths linked to adulterated formulations in Madhya Pradesh, Rajasthan and Maharashtra.
At a review meeting with health secretaries of all states and union territories, central health secretary Punya Salila Srivastava stressed strict compliance with revised Schedule M norms by all drug manufacturing units and enhanced surveillance to prevent further incidents.
Preliminary findings ruled out common infectious diseases in the affected children, except for one positive case of leptospirosis, the health ministry said in a statement.
The ministry said risk-based inspections (RBIs) have begun across 19 manufacturing units in six states to plug systemic gaps and strengthen quality assurance.
The Madhya Pradesh government has imposed an immediate ban on the sale of Coldrif and Nextro DS syrups along with the ban on the sale of other products manufactured by the company. The results of samples of Nextro DS are still awaited.
Various clinical, environmental, entomological, and drug samples were collected and sent to NIV Pune, Central Drug Laboratory (CDL) Mumbai, NEERI Nagpur for testing.
The report seen by ET says that the sample fails to comply in respect of impurities of DEG, which is more than permissible limit. The presence of Ethylene Glycol has not been detected. "The samples found adulterated with Diethylene Glycol 46.28% which is injurious to health," said the report by drug testing laboratory, food and drugs administration, MP, Bhopal. "The sample is not of standard quality as defined in the Drugs and Cosmetics Act 1940 and rules," it further said.
The samples of Coldrif syrup manufactured by Sresan Pharmaceutical bears manufacturing date of May 2025 and expires in April 2027. The samples were received by the laboratory on October 3.
Diethylene glycol (DEG) and ethylene glycol (EG) are industrial chemicals most commonly used in making products like brake fluids, antifreeze, paints, plastics. Both DEG and EG can damage the kidneys, liver, and nervous system.
Following this report, the Tamil Nadu drugs department has explicitly prohibited the purchase, sale, and consumption of the said batch, citing serious health risks.
"Adulteration with diethylene glycol is highly dangerous, as this chemical is toxic and can cause severe poisoning, including kidney failure and death," it said.
Retailers, distributors, hospitals, and pharmacies in Tamil Nadu have been asked to remove the batch from stocks immediately and report if the product was supplied or sold.
Consumers have also been advised to check the batch details and avoid usage. "Anyone who possesses this product should submit it to the authorities for proper disposal," it said.
The healthcare providers have been asked to monitor for symptoms of diethylene glycol poisoning in patients who may have consumed the affected syrup, stating that adverse reactions or suspected cases must be promptly reported to the Drugs Control Department for further investigation.
Meanwhile investigation at the manufacturer's premises have been initiated and stop production orders was issued to the manufacturing company. Surveillance has been heightened across medical shops and hospitals in Tamil Nadu to prevent further distribution.
Taking cognisance of the issue, the union health ministry on Sunday directed states to curb irrational use of cough syrups and step up quality checks after reports of multiple child deaths linked to adulterated formulations in Madhya Pradesh, Rajasthan and Maharashtra.
At a review meeting with health secretaries of all states and union territories, central health secretary Punya Salila Srivastava stressed strict compliance with revised Schedule M norms by all drug manufacturing units and enhanced surveillance to prevent further incidents.
Preliminary findings ruled out common infectious diseases in the affected children, except for one positive case of leptospirosis, the health ministry said in a statement.
The ministry said risk-based inspections (RBIs) have begun across 19 manufacturing units in six states to plug systemic gaps and strengthen quality assurance.
The Madhya Pradesh government has imposed an immediate ban on the sale of Coldrif and Nextro DS syrups along with the ban on the sale of other products manufactured by the company. The results of samples of Nextro DS are still awaited.
Various clinical, environmental, entomological, and drug samples were collected and sent to NIV Pune, Central Drug Laboratory (CDL) Mumbai, NEERI Nagpur for testing.
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