Spurious drugs: Data shared not sufficient to reveal cause of illness, India writes to World Health Organisation

Aditi Tandon

New Delhi, October 15

India on Saturday asked the World Health Organisation (WHO) for a range of information on the tragic death of 66 Gambian children 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.

Drug Controller General of India VG Somani, in a letter to WHO’s Rutendo Kuwana today, said India had stopped all production at Maiden Pharmaceuticals 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 high-level committee”, which held its first meeting today.

Somani quoted the committee conclusions and said, “The committee has examined the reports and communications received from the WHO so far and observed the clinical features and treatment received by the children as shared so far are inadequate to determine the aetiology (cause of illness).”

The committee has asked the Ministry of Health to seek from the 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, and specific investigations for the stated contaminants, diethylene glycol and ethylene glycol, on the clinical samples of the patients.

Somani’s letter adds other details the committee has sought are — treatment received by children before and after hospitalisation; treatment received before and after acute kidney injuries (AKIs) were suspected and reasons for such treatment; names and brands of drug formulations used before and after hospitalisation; 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,” the DCGI wrote to Kuwana.

The Indian regulator further urged the WHO for more information in respect of its own investigations in the matter, including the number of stool samples collected and analysed; number of children with similar clinical presentation to AKIs from whom biological samples were collected; and the methods the WHO adopted to test the samples.

“All this information is necessary to analyse the events,” Somani said in his letter, reiterating India’s pending request for a report on causal relations between 66 deaths and Indian products.

Indonesia bans use of DEG, EG in syrups

• Indonesia has banned the use of contaminants the WHO flagged on October 5 in its alert related to four India-made products
• It is said to be investigating the death of 20 children in Jakarta this year, following acute kidney injuries as seen in the case of Gambia
• Indonesian drug regulator said, “To provide protection to the public, all medicinal syrup products for children are not allowed to use diethylene glycol and ethylene glycol.”

Events in Gambia shared by WHO

• In July-end, Gambia got notification of increase in acute kidney injuries among young kids from the main tertiary hospital
• By September 30, 78 cases of AKI had been reported and 66 deaths (fatality rate 85%)
• 72% of cases were reported among kids under 2 years

Explain use of logo: WHO to Maiden Pharma

The WHO has said its legal counsel office has written to Maiden Pharma to explain the use of WHO logo on the product labelling for all four products that the world body flagged as contaminated in its October 5 alert