The World Health Organization (WHO) on December 17 said that its contracted laboratories in Ghana and Switzerland had tested the cough syrups supplied by Maiden Pharma in The Gambia, and confirmed that they were contaminated.
The global health body said that it had acted quickly as children had died after a mysterious sickness in The Gambia. However, it didn't reply to queries related to a letter by VG Somani, the Drug Controller General of India (DCGI), regarding the casualties.
"WHO-contracted laboratories in Ghana and Switzerland tested the suspected cough syrups from The Gambia and confirmed excessive levels of ethylene glycol and diethylene glycol. These contaminated syrups are dangerous and should not be in any medicine, ever," a WHO spokesperson told Moneycontrol in an email reply.
The WHO spokesperson said that the lab findings were immediately shared with the Gambia and India, as well as the manufacturer of the products, Maiden Pharmaceuticals.
"WHO’s mandate is to issue global alerts about potential risks. WHO stands by the action taken," the spokesperson said.
In the letter dated December 13, Somani had sought details from the global body on the causality and connection between the drugs manufactured in India and deaths in The Gambia.
The DCGI wrote to Dr Rogerio Gaspar, Director, Regulation & Pre-Qualification (WHO) and sought details of the assessment report on the children's deaths in The Gambia.
The letter, seen by Moneycontrol, cited media reports from The Gambia stating that no direct causality had been established between consumption of the cough syrup and the deaths, and that certain children who had died had not consumed the syrup in question.
The letter also stated that the control samples — samples of the syrup from the same batch exported to Gambia maintained by the company for quality control purposes — did not contain ethylene glycol or di-ethylene glycol.
In his letter, the DCGI accused the WHO of taking a "strange contrary position" on the matter, adding that the WHO statement had led to Indian drugs being targeted internationally.
“This has adversely impacted the image of India’s pharmaceutical products across the globe and caused irreparable damage to the supply chain of pharma items, as well as the reputation of the national regulatory framework," the letter said.
To look into the matter, the Indian government has constituted a four-member committee of experts chaired by Dr YK Gupta, Vice-Chairman, Standing National Committee on Medicines, along with experts from the National Institute of Virology (NIV) and the National Centre for Disease Control (NCDC).
“The technical committee has met several times. Each time the committee has requested specific information from the WHO to establish causality. Communications were sent to WHO on 15, 20, and 29 October. Every time the WHO has maintained that they are in contact with their team handling the case and would get back at the earliest. But no relevant information has so far been shared by WHO with the CDCSO (Central Drugs Standard Control Organisation)," Somani said in his letter.
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