By PTI
NEW DELHI: The committee set up by the government to examine reports potentially linking the death of 66 children in The Gambia to four made-in-India cough syrups has observed that the clinical information shared by the World Health Organization so far is inadequate to determine the aetiology.
This was conveyed to the WHO by Drugs Controller General of India (DCGI) VG Somani on Saturday.
Rutendo Kuwana from the WHO on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups — the Sonipat-based Maiden Pharmaceuticals.
In an email response, Dr Somani on Saturday said the Union Ministry of Health has constituted a committee of technical experts to examine and analyse the details of the adverse event reports and all related details shared by or to be shared by WHO and to recommend follow up action.
Somani said the four-member committee chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines, in its first meeting has examined the reports and communications so far received from WHO and has made several observations.
Mentioning the observations, Dr Somani said, “The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology.
“The details of initial illness, sign and symptoms, duration of anura in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for diethylene glycol and ethylene glycol on critical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after acute kidney injury was suspected and reasons thereof, names and brands of the drug formulations used in the treatment before and after hospitalization, their manufacturers, their expiry other relevant information in each of the cases, are necessary, he said.
Dr Somani further said in case, verbal autopsy was conducted, a detailed report may be shared by WHO.
Dr Somani has sought details on the number of stool samples collected and analysed and the number of children with a similar clinical presentation to acute kidney injury from whom the biological samples were collected.
He also sought the details of the product samples collected and tested (with their compositions, manufacturers) which were reported to be negative for EG and DEG, the details of cases who received these products.
“You are therefore requested to share the report on causal relations along with above details, as observed by the said Technical Committee at the earliest for further examination and follow up action at our level,” he wrote.
The DCGI further informed that the 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,” he said.
The Union Health Ministry on Wednesday formed the four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of 66 children in Gambia being linked potentially to the four cough syrups made by the Sonipat unit of Maiden Pharmaceuticals.
The committee will recommend further course of action to the Drugs Controller General of India (DCGI) after examining and analysing the adverse event reports, causal relationship and all related details already shared by or to be shared by the World Health Organization.
The causal relation of deaths is yet to be provided by WHO.
The WHO has so far shared with CDSCO, the certificates of analysis of each of the sampled products, their photographs and summary of the adverse events.
WHO has stated that it is in process of further investigation, official sources said.
The CDSCO has already requested WHO to share at the earliest with it, the report on establishment of causal relation to death with the medical products in question and photographs of labels/products etc, they said.
While the Haryana State Drug Controller issued show cause notice to Maiden Pharmaceuticals on October 7 asking it to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license, the Haryana government on October 11 issued an order to stop all the manufacturing activities of the firm with immediate effect.
The WHO had on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to Gambia, where children have died and where a contributing factor was suspected to be the use of four medicines: Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup.
They are manufactured and exported by Maiden Pharmaceuticals Ltd, Sonepat, Haryana, and the WHO had informed they may have been contaminated with Diethylene glycol or Ethylene glycol.
NEW DELHI: The committee set up by the government to examine reports potentially linking the death of 66 children in The Gambia to four made-in-India cough syrups has observed that the clinical information shared by the World Health Organization so far is inadequate to determine the aetiology.
This was conveyed to the WHO by Drugs Controller General of India (DCGI) VG Somani on Saturday.
Rutendo Kuwana from the WHO on October 13 had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups — the Sonipat-based Maiden Pharmaceuticals.
In an email response, Dr Somani on Saturday said the Union Ministry of Health has constituted a committee of technical experts to examine and analyse the details of the adverse event reports and all related details shared by or to be shared by WHO and to recommend follow up action.
Somani said the four-member committee chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines, in its first meeting has examined the reports and communications so far received from WHO and has made several observations.
Mentioning the observations, Dr Somani said, “The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology.
“The details of initial illness, sign and symptoms, duration of anura in the cases, results of laboratory investigations conducted including various markers and parameters, specific investigations for diethylene glycol and ethylene glycol on critical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after acute kidney injury was suspected and reasons thereof, names and brands of the drug formulations used in the treatment before and after hospitalization, their manufacturers, their expiry other relevant information in each of the cases, are necessary, he said.
Dr Somani further said in case, verbal autopsy was conducted, a detailed report may be shared by WHO.
Dr Somani has sought details on the number of stool samples collected and analysed and the number of children with a similar clinical presentation to acute kidney injury from whom the biological samples were collected.
He also sought the details of the product samples collected and tested (with their compositions, manufacturers) which were reported to be negative for EG and DEG, the details of cases who received these products.
“You are therefore requested to share the report on causal relations along with above details, as observed by the said Technical Committee at the earliest for further examination and follow up action at our level,” he wrote.
The DCGI further informed that the 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,” he said.
The Union Health Ministry on Wednesday formed the four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of 66 children in Gambia being linked potentially to the four cough syrups made by the Sonipat unit of Maiden Pharmaceuticals.
The committee will recommend further course of action to the Drugs Controller General of India (DCGI) after examining and analysing the adverse event reports, causal relationship and all related details already shared by or to be shared by the World Health Organization.
The causal relation of deaths is yet to be provided by WHO.
The WHO has so far shared with CDSCO, the certificates of analysis of each of the sampled products, their photographs and summary of the adverse events.
WHO has stated that it is in process of further investigation, official sources said.
The CDSCO has already requested WHO to share at the earliest with it, the report on establishment of causal relation to death with the medical products in question and photographs of labels/products etc, they said.
While the Haryana State Drug Controller issued show cause notice to Maiden Pharmaceuticals on October 7 asking it to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license, the Haryana government on October 11 issued an order to stop all the manufacturing activities of the firm with immediate effect.
The WHO had on September 29 had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to Gambia, where children have died and where a contributing factor was suspected to be the use of four medicines: Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup.
They are manufactured and exported by Maiden Pharmaceuticals Ltd, Sonepat, Haryana, and the WHO had informed they may have been contaminated with Diethylene glycol or Ethylene glycol.
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