The Union Health Ministry Thursday charged the WHO for a “premature deduction” on linking the deaths of Gambian kids with made-in-India cough syrups by asserting that the UN health body didn’t provide any causality data even after repeated requests while tests conducted by the Indian regulator did not find any toxic contaminants in the syrups and their ingredients.
The Drugs Controller General of India (DCGI) V G Somani on Tuesday wrote to the World Health Organisation reminding them that even after five requests, the world’s apex health body was yet to furnish the cause-and-effect data to India linking the deaths of children in Gambia with four cough syrups manufactured by Haryana-based Maiden Pharmaceuticals.
“All the alerts and communications received from the onset of the unfortunate event in such a manner as to hint that the cough syrup consumption was the primary cause of the mortality. It is clear that perhaps a premature deduction was drawn regarding the cause of death,” he said.
While the company has been asked to stop manufacturing in the public interest, tests carried out by the Indian authorities did not reveal presence of the two toxic contaminants - diethylene glycol and ethylene glycol – in any of the samples of the four cough syrup brands as well as their two key base materials.
“The WHO statement of October was unfortunately amplified by the global media, leading to a narrative being built internationally targeting the quality of Indian pharmaceutical products,” Somani wrote to Rogerio Gasper, director, regulation and prequalification at the WHO headquarters.
“This, in turn, has adversely impacted the image of India’s pharmaceutical products across the globe and caused irreparable damage to the supply chain of pharmaceutical products as well as repute of the national regulatory framework over an assumption that has not yet been substantiated by the WHO or its partners on the ground.”
In the first week of October, the WHO raised a global alert against four India-made cough and cold syrups, claiming that their consumption might have led to the death of more than 60 children in The Gambia, a country in west Africa.
Turning the table on the WHO, Somani said the Central Drug Standards Control Organisation as well as an expert panel set up by the ministry to probe the episode wrote to the WHO seeking the causality data. But no information has been shared by the UN agency.