India is investigating claims made by Uzbekistan’s government that 18 children died after ingesting a cough syrup brand made in the South Asian nation just two months after a similar tragedy was reported in Gambia.
(Bloomberg) — India is investigating claims made by Uzbekistan’s government that 18 children died after ingesting a cough syrup brand made in the South Asian nation just two months after a similar tragedy was reported in Gambia.
The Uzbek health ministry in a statement Tuesday said a preliminary study of the Doc-1 Max syrup manufactured by Marion Biotech Ltd. — a small pharmaceutical maker based in the Delhi satellite town of Noida — found it contained toxic ethylene glycol and was responsible for the fatalities. It has been withdrawn from sale in the country.
Mansukh Mandaviya, India’s health minister, said on Twitter Thursday that “immediately on receipt of the information” a joint inspection by federal and state drug regulators was carried out on Marion’s Noida factory and further action may be taken based on their report. Samples have been taken for testing, Mandaviya said, adding that India has been in “regular contact” with Uzbekistan’s national drug regulator since Tuesday.
Uzbekistan has also launched legal action against Marion Biotech’s local representatives, Arindam Bagchi, a spokesman for India’s Ministry of External Affairs, told reporters at a routine briefing in New Delhi Thursday. Marion didn’t immediately respond to an emailed request for comment.
Multiple Scandals
The children’s deaths are the latest tragedy linked to India’s $42 billion drugmaking industry, which Prime Minister Narendra Modi has repeatedly marketed as the “pharmacy of the world” thanks to the abundance of cheap generic manufacturers that operate in the country. However, multiple medical scandals have originated from Indian plants in recent years and public health campaigners say attempts at reforming the industry have been slow.
In October, the World Health Organization issued a warning after four cold and cough syrups made by another little-known New Delhi-based firm, Maiden Pharmaceuticals Ltd., were potentially linked to acute kidney injuries and dozens of infant deaths in Gambia. They were contaminated with “unacceptable amounts” of diethylene glycol and ethylene glycol, its analysis showed and Gambian lawmakers have called for the drugmaker to be sued.
Prognosis: Gambia Deaths Bring Scrutiny to India’s Drugmakers
India’s main regulator, the Central Drugs Standard Control Organisation, earlier this month rejected the WHO’s findings and said that samples taken from Maiden’s plant didn’t find any toxic substances. The company has denied any wrong-doing. CDSCO Director General V.G. Somani also said the the global health organization’s warning caused “irreparable damage” to the reputation of the Indian pharmaceutical industry.
In its statement this week, Uzbekistan’s health ministry said the dead children were taken into inpatient care and found to have consumed the Indian-made cough syrup without a doctor’s prescription in doses that exceeded the standard measures for infants.
Initial lab studies in the Central Asian country then found that Marion’s Doc-1 Max syrup contained the toxic ethylene glycol, which is mainly used in automotive antifreeze and to make polyester fibers. It can be fatal if consumed and is an illegal adulterant that companies sometimes use as an alternative to non-toxic solvents, such as glycerin, to reduce costs.
“Uzbek authorities have not formally taken up the matter with us,” said Bagchi at India’s foreign ministry. “Nevertheless, our embassy has contacted the Uzbek side and is seeking for the details of their own investigation.”
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