India has sought more information from the World Health Organization on the deaths in the Gambia linked to contaminated cough syrups made by Maiden Pharma in India.
The clinical features and the treatment received by children as shared by the World Health Organisation so far are inadequate to determine the aetiology, V.G. Somani, Drugs Controller General of India said in his letter to the World Health Organisation on Friday, while addressing the suspected case of contaminated cough and cold syrup medicines from India, manufactured by Maiden Pharmaceutical Limited, which allegedly was the contributing factor in the death of over 60 children in Gambia.
He said that the Health Ministry had constituted a committee of technical experts who had held a meeting. The team has sought 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 ethylene glycol (EG) and diethylene glycol (DEG) on clinical samples of the patients and treatment received before and after hospitalisation at the tertiary hospital in the Gambia.
“The reasons thereof, the names and brands of the drug formulations used in the treatment before and after hospitalization, their manufactures, their expiry and any other relevant information in each of the cases are necessary,” he said in the letter.
He has also noted that in case a verbal autopsy was conducted a detailed report of the same may be shared by the WHO.
The Ministry said that they need more information on the number of stool samples collected and analysed, the number of children with a similar clinical presentation to acute kidney injury from whom the biological samples were collected and details of the test method adopted for testing of samples.
Dr. Somani added that India wants a report on casual relations and details of the product samples collected and tested which were reported to be negative for EG and DEG and the details of the cases who received these products are required to analyse the events.