WHO's Rutendo Kuwana wrote a letter to DCGI on October 13, seeking to know the progress of investigation into Maiden Pharmaceuticals, a Sonepat-based drug maker that makes four cough syrups.
New Delhi :In the wake of reports of 66 deaths in Gambia linked to four Indian-made cough syrups, a government-appointed committee has found clinical information shared by the World Health Organization (WHO) for pathological determination. is insufficient. The Drug Controller General of India (DCGI) VG Somani informed WHO about this on Saturday. WHO's Rutendo Kuwana had written to DCGI on October 13, asking it to apprise it of the progress in the investigation of Sonepat-based Maiden Pharmaceuticals, the manufacturer of four cough syrups.
In an e-mail reply, Dr Somani said on Saturday that the Union Health Ministry has constituted a committee of technical experts to examine the details of adverse event reports and all relevant details shared or to be shared by the WHO. and to analyze and make recommendations accordingly.
Somani said that the four-member committee, headed by Dr YK Gupta, Vice-Chairman of the Standing National Committee on Medicines, in its first meeting, has taken note of the reports and communications received so far from WHO and made several observations. Referring to the observations, Dr Somani said, "The clinic characteristics shared so far by the WHO and the treatment given to children are insufficient to determine the aetiology (the science that studies the causes of diseases)."
Dr Somani said a detailed report could be shared by the WHO if the autopsy was done. Dr Somani has sought details about the number of stool samples collected and analyzed and the number of children with kidney damage from whom biological samples were collected.
They also sought details of product samples collected and tested (with their compositions, manufacturers) which were reported negative for EG and DEG. DCGI further stated that the investigation has progressed in respect of the manufacturer under consideration.
The Union Health Ministry on Wednesday constituted a four-member committee of experts to inquire into the adverse event report received from WHO regarding the deaths of 66 children in The Gambia from four cough syrups manufactured by Maiden Pharmaceuticals' Sonepat unit.
The committee will recommend further action to the Drug Controller General of India (DCGI) after examining and analyzing the adverse event report, causal link and all relevant details already shared or shared by WHO.
The cause of death has not yet been provided by the WHO. WHO has so far shared with CDSCO, certificates of analysis for each of the sampled products, their photographs and a summary of adverse events.
The Haryana State Drug Controller had on October 7 issued a show-cause notice to Maiden Pharmaceuticals asking it to give an explanation within a week in view of the "several violations" detected during the recent inspection. The Haryana government had issued an order on October 11 to stop all manufacturing activities of the company with immediate effect.
The four cough syrups under investigation - Promethazine Oral Solution BP, Cofexanaline Baby Cough Syrup, Macoff Baby Cough Syrup and Magrip N Cold Syrup - were manufactured by Maiden Pharmaceuticals.
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