Drugmakers in India have been told they must bring their manufacturing facilities up to international standards after at least 24 children died in the country from consuming cough syrup with a high level of toxicity.
The deaths have been linked to a batch of Coldrif syrup made by Sresan Pharmaceutical Manufacturer in May.
Tests found the syrup contained almost 49% diethylene glycol (DEG), nearly 500 times the limit set by India and the World Health Organisation (WHO).
India’s Pharmacopoeia Commission (IPC), which sets national drug standards, said in a presentation this week that DEG is sometimes “fraudulently or unintentionally” used in place of more expensive pricier pharmaceutical-grade solvents like glycerine and propylene glycol, according to Reuters.
“Contamination may occur through deliberate adulteration to cut costs or accidental mix-ups and mislabelling, especially in shared processing facilities,” the news agency, which saw the presentation, said.
While IPC did not name specific companies, India’s Central Drugs Standard Control Organisation has said recent inspections revealed some firms failed to test every batch of medicinal ingredients as required by law.
Sresan’s founder, S Ranganathan, has been arrested on suspicion of manslaughter by police investigating the deaths, while the firm’s license has been revoked and its products banned.
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India-made cough syrups have previously been linked to the deaths of more than 140 children in Africa and Central Asia.
In late 2023, Indian pharmaceutical companies were ordered to ensure their plants meet World Health Organization-recommended standards, requiring them to invest in protocols to prevent cross-contamination and enable batch-testing of samples, among other measures.
While major pharmaceutical companies met a June 2024 deadline, smaller firms, told to comply with a government order to meet WHO standards by December, found out on Thursday there would be no extension, according to Reuters.
The revelation that Sresan had not upgraded its facilities was a key factor in convincing government officials to ignore appeals, sources speaking on condition of anonymity told the news agency.
Mayank Suryavanshi, a three-year-old from the Parasia region of Madhya Pradesh state, died of acute kidney failure earlier this month after taking Coldrif for a fever in September.
“We never imagined a simple medicine could turn life-threatening,” his father, Nilesh Suryavanshi, said.
“My child should be the last.”
In rural Parasia, regional drug inspectors have been visiting pharmacies, some of which have been temporarily shut, to collect samples of cough syrups for testing.
Community health workers have been going door-to-door urging people to surrender remaining bottles of Coldrif.
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Praveen Soni, a local doctor who prescribed Coldrif to several of the children who died, has been arrested as part of the manslaughter investigation.
Sushant Kumar Thakre, whose two-year-old daughter Yojitha was one of them, said they “trusted him blindly. The medicine turned into poison and killed my daughter”.
