Tribune News Service
Aditi Tandon
New Delhi, October 15
India on Saturday asked the World Health Organisation for a range of information on the tragic deaths of 66 Gambian infants allegedly due to contaminated cough syrups manufactured by a Sonepat firm, and said the clinical data shared so far by the world body was not enough to determine the cause of the disease.
The Drug Controller General of India VG Somani in a letter to WHO’s Rutendo Kuwana today, said India had stopped all production at Maiden Pharma and formed a high level committee to analyse the details of adverse events as reported by the WHO, and demanded information on 18 additional points “as flagged by the national high level committee”, which held its first meeting today.
Somani in his letter to WHO quoted the committee conclusions saying, “The committee in its first meeting has examined the reports and 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 the WHO so far are inadequate to determine the aetiology (cause of illness).”
The high level committee has asked the Ministry of Health to seek from WHO details of initial illness, symptoms, duration of anuria (failure of kidneys to produce urine) in the cases, results of lab investigations conducted including various markers; specific investigations for the stated contaminants diethylene glycol and ethylene glycol on the clinical samples of the patients.
Somani’s letter, accessed by The Tribune, adds other details the committee has sought—treatment received by children before and after hospitalization at the tertiary hospital in Gambia where they were admitted; treatment received before and after acute kidney injuries (AKIs) were suspected and reasons for such treatment; names and brands of the drug formulations used in the treatment before and after hospitalization of infants, and their manufacture and expiry dates.
“In case a verbal autopsy was conducted, a detailed report, including cases and treatment history of the same be shared by the WHO,” DCGI wrote to Kuwana.
The Indian regulator has further urged WHO for more information in respect of its own investigations in the matter including the number of stool samples collected and analysed; the number of children with similar clinical presentation to AKI from whom biological samples were collected, details of the product samples collected and tested (with their compositions and manufacturer details) which were reported to be negative for DEG and EG, details of cases who received these products and the test methods WHO adopted to test the samples.
“All this information is necessary to analyse the events,” DCGI Somani said in his letter to WHO, reiterating India’s pending request for a report on causal relations between 66 infants deaths and the WHO-flagged Indian products.
WHO asks Maiden Pharma to explain use of its logo
WHO in its letter to India on October 13 said its legal counsel office had written to Maiden Pharma to explain the use of WHO logo on the product labelling for all four products that the world body had flagged as contaminated in its October 5 alert.
Course of disease in Gambia shared by WHO
* In July end, Government of the Gambia received a notification of increase in acute kidney injuries (AKI) among young children from the country’s main tertiary hospital Edward Francis Small Teaching Hospital.
* By 30 September, 78 cases of AKI had been reported and 66 deaths (fatality rate 85%).
* 72% cases were under the two years.
