Toxic Cough Syrup: Investigation Reveals Shocking Facts: The Formula That Was Banned Two Years Ago Killed Innocent Children

New Delhi. The cough syrup formula that claimed the lives of children in Madhya Pradesh and Rajasthan was banned by the Central Government two years ago. On December 18, 2023, the Central Drugs Standard Control Organization (CDSCO) formally issued an order to all states not to use the Chlorpheniramine Maleate IP-2 mg and Phenylephrine HCl IP-5 mg formulation on children under four years of age.

The Central Government stated that this fixed dose combination (FDC) syrup has more disadvantages than benefits. Therefore, a mandatory warning should be printed on the label, package, and promotional materials, advising against administering this medication to children under four years of age. Yet, at least 20 children in Madhya Pradesh died from Coldrif syrup, a mixture of paracetamol, chlorpheniramine maleate, and phenylephrine HCl. No warnings were found on the product, nor was any publicity material provided by the state to promote awareness in hospitals. A top CDSCO official said, “Now, strict action is being demanded, even though everyone knows that health care in India is under the jurisdiction of the state government. The drug regulatory process is also under the jurisdiction of the states. The drug was manufactured in Tamil Nadu and was also being sold in Madhya Pradesh, Odisha, and Puducherry. The central government, through file number 04-01/2022-DC, banned the use of this formula for children.”

1,400 factories manufacturing medicines without certification
Following the deaths of children in Gambia from cough syrup, the central government mandated WHO-certified GMP certification for pharmaceutical factories in the country. Of the 5,308 pharmaceutical companies, 3,838 have completed the process, but 1,470 companies have not even applied.

Two cough syrups banned in Gujarat
Two cough syrups manufactured in Gujarat, Reciprefresh TR Syrup and Relife Cough Syrup, have been found to contain concentrations of the deadly chemical DEG above the permissible limit. The sale, distribution, or use of these two medicines has been banned in the state. Legal action has also been initiated against Ahmedabad-based Rednex Pharma and Rajkot-based Sher Pharma, which manufacture them. The deadly DEG can cause severe toxicity, kidney failure, neurological complications, and even death.