‘Samples Are Uncontaminated, Meet Standards’: Center Slams WHO for Premature Links to Children’s Deaths

The World Health Organization forged hasty connections between the four cough syrups manufactured in India and the deaths of children in the Gambia, India’s drug regulator DCGI said in a scathing statement criticising the WHO, according to Reuters. Authorities noted in the most recent notification to the WHO that samples obtained from the Indian pharmaceutical business Maiden Pharma, whose products were connected to infant mortality in the Gambia, ‘had been verified to meet with required criteria and were not tainted’.

In a letter to Dr. Rogerio Gaspar, Director (Regulation and Prequalification) at WHO, DCGI’s Dr. V. G. Somani wrote that the WHO’s statement following the deaths in October ‘was unfortunately amplified by the global media, which led to a narrative being built internationally targeting the quality of Indian pharmaceutical products’.

The DCGI also cited media sources and stated that Gambia has maintained that there has not yet been a direct causal link established between the use of cough syrup and mortality and that some infants who had perished had not ingested the syrup in issue, per PTI.

The samples of four cough syrups prepared in India that were evaluated in this government laboratory were determined to be compliant with standards and free of DEG or EG contamination, Somani informed WHO in the letter. After a WHO assessment suggested that the cough and cold medications manufactured by Maiden Pharmaceuticals may have contributed to the deaths of 69 children in the Gambia, health officials in India issued a production halt at the company’s plant in Sonepat in October.

Reuters claims that WHO’s request for comment was not quickly answered. In October, the U.N. agency said that its inspectors had discovered ‘unacceptable’ concentrations of diethylene glycol and ethylene glycol, which can be poisonous and result in acute kidney impairment, in the goods produced by Maiden Pharma. In the letter, Somani also claimed that the WHO’s October statement connecting the fatalities to the Indian-made cough syrup had irreparably damaged the nation’s pharmaceutical supply chain.