Updated: Sat, 15 Oct 2022 10:58 PM IST
THE committee of experts set uop by the government of India to examine the reports claiming the death of 66 children in Gambia after consuming four made-in-India cough syrups on Saturday observed that the clinical information shared by the World Health Organization so far is inadequate to determine the aetiology.
In a response to WHO, DCGI chief Dr VG Somani said, "Committee in its first meeting has examined the reports or communications so far received from WHO and has made the following observations: The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology."
The response also included details of initial illness, signs and symptoms, duration of anuria in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for DG and EG (diethylene glycol and ethylene glycol) on clinical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after Acute kidney injury (AKI) was suspected and reasons thereof, the names and brands of the drug formulations used in the treatment before & after hospitalization, their manufacturers, their expiry and any other relevant information in each of the cases, are necessary.
Somani mentioned that in respect of the investigations carried out as shared by WHO so far, require more detailed information e.g. the number of stool samples collected and analysed.
"The number of children with a similar clinical presentation to AKI (Acute Kidney Injury) from whom the biological samples were collected, 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 etc. are required to analyse the events to test method adopted for testing of samples," Somani added in the observation.
In the end, DCGI requested WHO to share the report on causal relations along with the above details, as observed by the said Technical Committee at the earliest for further examination and follow-up action at our level.
The first meeting of the four-membered committee to examine the World Health Organisation's report regarding Maiden Pharmaceuticals Ltd was held on Thursday.
Earlier, the manufacture of cough syrups by Maiden Pharmaceuticals was suspended on Wednesday, however, its lab report is awaited.
Somani also mentioned in his reply that 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.
According to the media reports, Atlanta-based Atlantic Pharmaceuticals Company Ltd which has permission to export medicines to West Africa's Gambia had ordered combined cough syrup bottles that were purchased from Maiden Pharmaceuticals Limited.
(With inputs from ANI)