The World Health Organization drew a premature link between the deaths of children in The Gambia and the cough syrups made by Haryana-based Maiden pharmaceuticals, India’s drug regulator has said.
Authorities in the west African country have linked 66 deaths, most of them due to acute kidney failure, to four medicines – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – manufactured by the drugmaker.
In October, the World Heath Organization had issued a global alert for the four brands of cough syrups. Laboratory analysis of the syrups “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants,” the health body had said. Diethylene glycol and ethylene glycol are common impurities in cough syrups.
In a letter written to Rogerio Gaspar, director (Regulation and Prequalification) at the World Health Organization, Drugs Controller General of India VG Somani on December 13 said that the samples of the syrups were tested in government laboratory and found to be complying with specifications. Test reports also showed that the syrups were not contaminated with diethylene glycol or ethylene glycol.
Somani sought details from Gasper about the causality relationship between drugs manufactured in India and the deaths in The Gambia.
“Every time WHO has maintained that they are in contact with their team handling the case assessment and would get back at the earliest or that their ground partners are working on it,” the letter said. “But no information so far has been exchanged by WHO with CDCSO [Central Drugs Standard Control Organisation].”
The health regulator said The Gambia has informed, according to media, that there has been no direct causal relation established yet between the cough syrup consumption and the deaths, adding that certain children who had died had not consumed the syrups even.
“It is clear that perhaps premature deduction was drawn on September 29th itself regarding the cause of death,” Somani said. “Every subsequent alert or publication from the WHO only seems to be a reaffirmation of this deduction, without waiting for independent verification.”
He added that the global health body’s October statement has adversely impacted the image of the Indian pharmaceutical products.
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