India has sought more details from the World Health Organization (WHO) to continue with its probe into the death of 66 children in The Gambia allegedly due to four made-in-India cough syrups.
The committee set up by the government to investigate the matter observed that the clinical information shared by the WHO so far is inadequate to determine the aetiology.
A WHO official, Rutendo Kuwana on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups — the Sonipat-based Maiden Pharmaceuticals.
In an email response, Drugs Controller General of India (DCGI) V G Somani on Saturday said the Union Ministry of Health has constituted a committee of technical experts to examine and analyse the details of the adverse event reports and all related details shared by or to be shared by WHO and to recommend follow up action.
Somani said the four-member committee chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines, in its first meeting has examined the reports and communications so far received from WHO and has made several observations.
Mentioning the observations, Dr Somani said, “The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology.”
He said that the details of initial illness, sign and symptoms, duration of anura in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for diethylene glycol and ethylene glycol on critical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after acute kidney injury was suspected and reasons thereof, names and brands of the drug formulations used in the treatment before and after hospitalization, their manufacturers, their expiry other relevant information in each of the cases, are necessary, news agency PTI reported.
Dr Somani further said in case, verbal autopsy was conducted, a detailed report may be shared by WHO. He has sought details on the number of stool samples collected and analysed and the number of children with a similar clinical presentation to acute kidney injury from whom the biological samples were collected.
He also sought the details of the product samples collected and tested (with their compositions, manufacturers) which were reported to be negative for EG and DEG, the details of cases who received these products.
“You are therefore requested to share the report on causal relations along with above details, as observed by the said Technical Committee at the earliest for further examination and follow up action at our level,” he wrote in the email.
Informing about the probe into the manufacturer, the DCGI said the manufacturing site has been inspected, test reports of sampled products from the laboratory are awaited and all the manufacturing activities of the manufacturer in question have been stopped.
The Union Health Ministry on Wednesday formed the four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of 66 children in Gambia being linked potentially to the four cough syrups made by the Sonipat unit of Maiden Pharmaceuticals.
Following the probe, the committee will recommend further course of action to the Drugs Controller General of India (DCGI).
The causal relation of deaths is yet to be provided by WHO. The WHO has so far shared with CDSCO, the certificates of analysis of each of the sampled products, their photographs and summary of the adverse events. The WHO has stated that it is in process of further investigation, official sources said.
Maiden Pharmaceuticals Limited, the company under investigation for four “substandard” and “contaminated” cough syrups potentially linked to the deaths of 66 children in Gambia, did not perform quality testing of a raw material used in the manufacture of one of the medicines, according to a report. The Haryana government has also stopped the production of the said cough syrups.
“After the Central and Haryana State drug departments conducted a joint inspection, around 12 flaws were found, keeping which in mind, it’s been decided that the total production shall be stopped; notice given,” Haryana Home and Health Minister Anil Vij was quoted as saying by ANI.
(With PTI Inputs)
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