The World Health Organization (WHO) has issued a global warning on three Indian-made cough syrups after they were linked to the deaths of many children in Madhya Pradesh (MP). Researchers determined that the syrups had a lot of diethylene glycol (DEG), which is very poisonous. The WHO said that the contaminated products pose “significant and potentially life-threatening risks” and encouraged governments around the world to stay alert and report any findings. Indian officials have verified that the items were contaminated and that children died as a result, but they also made it clear that the supplies were not sent to other countries.
Information about the syrups that were tainted
The WHO’s advice, which came out after India’s Central Drugs Standard Control Organization (CDSCO) was told about the problem, named certain batches of three oral liquid medications as being affected:
Coldrif (made by Sresan Pharmaceuticals in Tamil Nadu)
Respifresh TR is made by Rednex Pharmaceuticals in Gujarat.
ReLife (Made by Shape Pharma in Gujarat)
The Deadly Contaminant and Concentration Lab testing showed that the syrups had diethylene glycol (DEG), a poisonous industrial solvent that is used in antifreeze and brake fluids. It is deadly when swallowed, especially by kids, because it causes immediate renal failure.
Extreme Contamination: The CDSCO told the WHO that the contaminated batches had levels of the deadly DEG that were almost 500 times higher than the safe limit of 0.1%.
Coldrif Analysis: Specifically, lab tests showed that the infamous Coldrif syrup, which is most closely linked to the deaths in MP, had a dangerously high level of DEG, with reports saying it had 48.6% and almost 49% of the chemical.
Other syrups, such Respifresh TR and ReLife, also had DEG in them, albeit in smaller amounts (1.342% and 0.616%, respectively). However, these amounts were still much higher than the 0.1% restriction.
Enforcement Action and Tragedy in Madhya Pradesh
At least 22 to 24 youngsters in India, mostly from the Chhindwara district of Madhya Pradesh, have died after drinking the tainted syrups. The children who died were all under five years old and had symptoms like fever, vomiting, urinary problems, and acute renal failure after taking the Coldrif syrup.
After the tragedy:
The owner of Sresan Pharmaceuticals (Tamil Nadu), which makes Coldrif, was jailed and the company lost its license to make the drug.
The CDSCO told the factories in question to stop making items right away and started the process of recalling all of the affected products.
The government put out a warning saying that cough syrups should not be given to kids younger than two and are not suggested for kids younger than five.
International Response No Export Confirmed: The CDSCO told the WHO that none of the tainted drugs were sent to other countries, and the US Food and Drug Administration (FDA) also said that the syrups were not sent to the US.
The WHO is nevertheless “deeply concerned” about the products getting to other countries through unregulated distribution channels, which they say is a “potential risk.” They have called on national regulatory authorities (NRAs) to keep an eye on the market.