WHO Warns Against Three India-Made Cough Syrups After Child Deaths
The tainted products were found in specific batches of COLDRIF, Respifresh TR and ReLife manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals and Shape Pharma, the WHO said.
The World Health Organization issued a global alert over three contaminated cough syrups made in India, the latest development in a series of quality-control failures linked to the deaths of more than a dozen children.
The tainted products were found in specific batches of COLDRIF, Respifresh TR and ReLife manufactured by Sresan Pharmaceutical, Rednex Pharmaceuticals and Shape Pharma, the WHO said in a notification late Monday. These were used to treat cough, flu and common cold.
At least 22 children have died in the central Indian state of Madhya Pradesh, local media reports say. India’s health regulator, Central Drugs Standard Control Organization, found diethylene glycol in these three cough syrups — a toxic substance that’s also showed up in other some tainted products made in India over the last few years.
While the Indian drug regulator has confirmed that the contaminated medicines have not been exported and there’s no evidence so far of illegal trade, the global health agency urged public health authorities to ramp up scrutiny and report back immediately if these products are detected in their countries.
Gambia Deaths
While India has become the world’s largest supplier of cheap non-patented medicines, it has also struggled to police the manufacturing standards, especially in thousands of smaller drug makers.
More than 60 children in Gambia died in 2022, after consuming cough syrup from India. A year later, more than a dozen cases of blindness in the US were linked to contaminated eye drops.
WHO asked public health authorities on Monday “to consider targeted market surveillance, with particular attention to informal and unregulated supply chains” where three cough medicines may circulate undetected. It also urged them to “carefully evaluate” any oral medicines from these manufacturing sites, especially those produced since December.
Indian authorities have started a criminal investigation into the manufacturer, according to India’s Ministry of Health and Family Welfare.
The state government of Tamil Nadu, where the manufacturer Sresan Pharmaceutical is based, has revoked the license of the manufacturer, the Press Trust of India said in a recent report.
Production Halt
The Indian drug regulator has confirmed that states have ordered an immediate halt to its production and have suspended product authorizations as well as issued a recall of the tainted medicines.
The Indian regulator has also sought stricter testing of ingredients for drugs, it said in a circular last week, and asked all regional bodies to ensure raw materials and finished formulations are tested before those are released to the market.
The WHO continues to work closely with Indian health authorities to monitor the situation, identify the source of the contamination and mitigate any potential public health risks, it said in the alert.
