New Delhi: At least 14 children died of kidney failure in Madhya Pradesh’s Chhindwara district after consuming a contaminated cough syrup, Coldrif.
The syrup, which was manufactured by Sresan Pharmaceuticals in Tamil Nadu, was found to be adulterated with diethylene glycol (DEG), a poisonous industrial solvent commonly used in antifreeze and brake fluid. Laboratory tests revealed that DEG levels, as high as 48.6 per cent, were present in the cough syrup that made the medicine lethal and unfit for consumption.
The deaths of children, most of them under the age of five, exposed regulatory lapses, delayed action, and medical negligence that allowed the toxic syrup to be distributed for weeks, despite early warning signs.
Media reports said that when the samples of Coldrif and Nextra DS were sent to a Bhopal based lab on September 30, the staff, instead of testing the said medicines, were testing other medicines. Then, they also went on leave during the Dusshera period, which ended up delaying the testing.
Tamil Nadu’s Drug Control Department launched an emergency inspection on 1 October. The team led by Deputy Director of Drugs Control, S Gurubharathi, raided the Sresan Pharmaceuticals plant in Kanchipuram district.
Investigators found multiple violations of drug manufacturing and testing norms, including the use of non-pharmacopoeial grade propylene glycol, which is a solvent that may have been contaminated with DEG. A total of 39 critical and 325 major non-compliances under the Drug Rules 1945 were documented.
Samples from the Coldrif batch (SR-13) and four other syrups were taken for immediate testing. Within 24 hours, Coldrif was confirmed “not of standard quality” and “injurious to health.” Other syrup passed the quality checks. On 3 October, the state ordered Sresan Pharma to stop production, and also served a show-cause notice for possible cancellation of the manufacturing license, the Deputy Director of Drugs Control said.
The negligence
After the first child who died on 2 September, the local health department ignored the pattern until at least six deaths had occurred within at least 15 days. Despite a biopsy report from Nagpur confirming that the children’s kidney failure was caused by the same cough syrup. The local health department had waited for at least three more days to ban it. While the ban was issued only on 29 September, it was only applied to Chhindwara district, and the cough syrup was being sold everywhere else, a Dainik Bhaskar report confirmed.
“After taking the prescribed medicine, many children developed urine retention, and medical tests showed elevated levels of serum creatinine and urea, indicating renal failure,” the complaint said, as per a report by The Indian Express.
When citing the biopsy reports, the Chhindwara district collector indicated that kidney tissue analysis of the affected children had suggested contaminated DEG in the cough syrup.
The Central Drugs Standard Control Organisation has also initiated risk-based inspection of drug manufacturing units in at least six states, following the collection of 19 samples, including cough syrups, antipyretics and antibiotics, a report by Hindustan Times said.
According to health ministry sources, which were quoted in a PTI report, the manufacturing units that are under investigation are based in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra.
The Uttar Pradesh government, too, on Sunday banned the Coldrif. The state’s Assistant Commissioner of Drug Administration has issued instructions to all drug inspectors to collect samples of the cough syrup manufactured by Sresan Pharmaceutical Chhindwara from both government and private institutions across Uttar Pradesh, as per an ANI report.
Criminal and political consequences
Madhya Pradesh police arrested a doctor in Chhindwara district, Praveen Soni. He allegedly prescribed Coldrif syrup to children. In his statement, he said that he had been prescribing the cough syrup for 15 years. Another case has been registered against the Tamil Nadu-based drug manufacturer. A report in The Indian Express further claims that Soni “knowingly produced and administered a dangerous adulterated drug to small children, which was capable of causing death.”
The issue led to political uproar within the state. Senior Congress leader Kamal Nath hit out at the government, stating that they must provide Rs 50 lakh as financial assistance to each family in Chhindwara that lost their children.
“My condolences are with the bereaved families. But it must be remembered that this is not merely an accident, but a man-made tragedy,” Kamal Nath wrote on X.
Urging the BJP Government to cover medical expenses of the affected families, he also said that the government needs to pay attention to the kind of medicines sold in the state, to avert any such tragedies.
(Edited by Ratan Priya)