According to a state minister on Wednesday, after a WHO investigation suggested that the medication may have contributed to the deaths of several children in the Gambia, Indian authorities stopped producing cough syrup at a plant owned by Maiden Pharmaceuticals.
Anil Vij, the health minister for the state of Haryana, told Reuters partner ANI that 12 infractions of best standards were discovered during an inspection at a Maiden plant close to the town of Sonipat. Vij reported that the production was ordered to cease.
A laboratory analysis of four Maiden products, including Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, revealed “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and cause acute kidney injury. This information was released last week by the WHO.
According to a preliminary investigation report released by the Gambian police on Tuesday, cough syrups developed in India and imported through a US-based firm were responsible for the acute renal damage fatalities of 69 children.
It is one of the worst cases involving pharmaceuticals coming from India, which is sometimes referred to as the “pharmacy of the world.”
Earlier, the Haryana pharmaceuticals controller was reported by the news website Moneycontrol as claiming that Maiden failed to do quality testing of propylene glycol, diethylene glycol, and ethylene glycol and that some batches of propylene glycol lacked the production and expiration dates.
Diethylene glycol and ethylene glycol are also employed as less expensive substitutes for glycerin, a solvent or thickening ingredient in many cough syrups, in some medicinal goods. They are used in antifreeze, braking fluid, and other industrial purposes.
Naresh Kumar Goyal, an official at Maiden, declined to comment. Last week, he told Reuters that the business was attempting to learn from its buyer what had occurred in the Gambia.
On its website, Maiden claims that its three facilities can produce 1.2 billion pills, 600 million capsules, 18 million injections, 2.2 million syrup bottles, and 300,000 ointment tubes annually.
It claimed that in addition to selling its goods domestically, it also exports them to Latin America, Asia, and Africa.
According to India, the cough syrups were solely permitted for shipment to the Gambia, despite the WHO’s assertion that they may have travelled to other countries via unofficial markets.
Last week, the Indian Ministry of Health announced that samples of all four Maiden products exported to Gambia had been sent to a federal laboratory for testing. The results would “guide the further course of action” and “bring clarity on the inputs received/to be received from WHO,” according to the ministry.
Officials from the WHO and the health ministry did not reply to requests for comment.
