CDSCO Informed the WHO that the Syrups Contained Toxic Diethylene Glycol in Quantities Nearly 500 Times the Permissible Limit
The World Health Organization (WHO) has issued a safety warning against three cough syrups manufactured in India after several child deaths were reported in Madhya Pradesh. The health governing body has identified three such syrups in India, urging authorities to report back to the health agency in case they detect any of them in their countries.
Warning from WHO
India's drug regulator has reportedly identified specific batches of Coldrif from Sresan Pharmaceuticals, Respifresh TR from Rednex Pharmaceuticals, and ReLife from Shape Pharma as affected medicines.
According to news agency Reuters, the WHO has said that the “syrups identified in India pose significant risks and can cause severe, potentially life-threatening illness.”
Central Drugs Standard Control Organization (CDSCO), reportedly informed the WHO that the syrups contained toxic diethylene glycol in quantities nearly 500 times the permissible limit, and were consumed by children, all under the age of five, who recently died in MP.
WHO has asked Indian authorities to submit reports on whether the syrup was exported to other nations. Accordingly, the global health agency would issue a Global Medical Products Alert.
However, the Indian health authority also clarified that none of the contaminated medicines were exported from India, and the US also confirmed that the toxic cough syrups weren't shipped to them.
The Toxic Medicine
The infamous Coldrif syrup faced huge backlash following the children's deaths, allegedly after consumption of its adulterated version. The medicine is produced by Sresan Pharmaceutical, a Tamil Nadu-based firm, whose manufacturing license was recently fully revoked.
Lab tests have found the use of diethylene glycol (DEG), a chemical historically associated with mass poisoning incidents, in the syrup. Consumption of Coldrif is linked to the deaths of at least 22 children in Madhya Pradesh, mostly residents of Parasia village in Chhindwara.
Negligence & Inadequate Testing
Last week, police arrested G Ranganathan, who is the owner of Sresan Pharmaceuticals. Ranganathan, 73, is well-known in national pharmaceutical circles and has been manufacturing medicines for decades.
A Tamil Nadu Drug Control department inspection has found that Sresan Pharmaceuticals violated 364 manufacturing rules - 39 "very serious" and 325 "major."
The state-based drug controller reported “poorly qualified staff”, “substandard water and equipment”, “lack of pest control”, “missing production monitoring procedures”, and “no quality assurance or data collection department” in the manufacturing units.
"Manufactured products are stored in a very unhygienic manner...Sewage was discharged without purification. Water for drug production was stored in an unhygienic manner," the report stated.
Tamil Nadu Health Minister Ma. Subramaniam said that the “firm's manufacturing license is going to be permanently cancelled".
Praveen Soni, the doctor who prescribed the syrup, has also been arrested for negligence.
Indian medical groups have blamed regulators for inadequate testing and oversight.
India-made Cough Syrup & its Dark History
Indian-made cough syrups have come under global scrutiny several times in recent years. In 2023, Indian syrups tainted with diethylene glycol were linked to the deaths of 70 children in Gambia and 18 in Uzbekistan.
Between December 2019 and January 2020, at least 12 children under five died in Jammu in Indian-administered Kashmir, allegedly from cough syrup.
The government issued an advisory to states and union territories urging caution in prescribing cough syrups to children. It stressed that such medications should not be prescribed or dispensed to children below two years of age and are generally not recommended for those under five.