Gambia Cough Syrup Deaths | Data received is inadequate to determine aetiology: DCGI tells WHO

Maiden Pharmaceuticals

The Drugs Controller General of India (DCGI) on October 15 informed the World Health Organization (WHO) of the observations made by the government-appointed Committee of Technical Experts. It stated that the Indian authorities were awaiting the reports on the causal relation of children's deaths in Gambia as data provided so far was inadequate to determine the aetiology.

"The Expert Committee in its first meeting on WHO's claims over Maiden Pharmaceuticals has found that the clinical features and treatment received by the children as shared by the WHO so far are inadequate to determine the aetiology," said DCGI chief VG Somani in a mail to WHO's Rutendo Kuwana.

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The DCGI has asked for a detailed report (including case and treatment history) of verbal autopsy (if conducted) from the WHO.

"The 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 DEG and EG on clinical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after 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 said in the mail.

The DCGI has also urged the WHO to share more detailed information about the number of stool samples collected and analysed.

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"The details of product samples collected and tested (with their compositions, manufacturers) which were reported to be diethylene glycol (DEG), the details of cases who received these products etc. are required to analyse the events along with the test method adopted for testing of samples," Somani added.

Accordingly, the DCGI once again reiterated the Indian Government's demand of sharing the reports on causal relations of children's deaths in the Gambia as observed by the Technical Committee for further examination and follow-up action.

Somani in his mail further updated the WHO about the investigation on Maiden Pharmaceutical saying the manufacturing activities have been stopped.

"Our investigation of the manufacturer in question has progressed. 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," Somani said.

Also read: Maiden Pharma’s factory wears a deserted look as its fate hangs in the balance

The WHO's representative in the mail to DCGI said that the global body's legal counsel has written to Maiden Pharmaceuticals regarding the use of the WHO logo.

"Following our observation of the product labelling for all 4 products, our Office of the Legal Counsel has written to Maiden Pharmaceuticals Ltd regarding the use of the WHO logo," Rutendo Kuwana in a mail to DCGI said.

The DCGI has told the global body that the test results of samples collected from the manufacturing facility of Maiden pharma were still awaited.