India has halted the production of cough syrup at a factory of Maiden Pharmaceuticals after a WHO report that the medicine may be linked to the deaths of dozens of children in the Gambia.
India’s health minister in Haryana state, Anil Vij, said authorities halted production after an inspection of a Maiden factory near the town of Sonipat in the state revealed 12 violations of good practices.
The WHO said last week that laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – had “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury.
India’s health ministry said last week that samples of all four Maiden products that had been exported to the Gambia had been sent for testing to a federal laboratory and the results would “guide the further course of action as well as bring clarity on the inputs received/to be received from WHO.”
Gambian police, in a preliminary investigation report on Tuesday, said that the deaths of 69 children from acute kidney injury were linked to the cough syrups made in India and imported via a U.S.-based company.
It is one of the worst such incidents involving drugs from India.
Also Read: WHO Warned Against India-Made Cough Syrups
News website Moneycontrol earlier quoted the Haryana drugs controller as saying in a report that Maiden did not perform quality testing of propylene glycol, diethylene glycol and ethylene glycol, while certain batches of propylene glycol did not have the manufacturing and expiry dates.
Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups.
Maiden says on its website it has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets at three factories.
It said it sells its products at home and exports to countries in Asia, Africa and Latin America.
The cough syrups had been approved for export only to the Gambia, India says, although the WHO says they may have gone elsewhere through informal markets.
Zainab Sa’id
