Cough syrups linked to deaths: Government panel says WHO info is insufficient for aetiology

Government-appointed committees have examined reports potentially linking four cough syrups made in India to the deaths of 66 children in The Gambia, but have concluded that the clinical information provided by the World Health Organization to date is insufficient to determine the underlying cause.

V G Somani, the Drugs Controller General of India (DCGI), conveyed this information to the WHO on Saturday.

The WHO’s Rutendo Kuwana had written to the DCGI on October 13 seeking information regarding the progress of the investigation into the manufacturer of the four cough syrups, Maiden Pharmaceuticals, based in Sonipat.

The Union Ministry of Health has constituted a committee of technical experts on Saturday to examine and analyze the details of adverse event reports and all related details shared by or to be shared by WHO and to recommend appropriate follow-up actions, according to Dr Somani in an email response on Saturday.

In its first meeting, Somani said, the four-member committee chaired by Dr Y K Gupta, Vice Chairperson, Standing National Committee on Medicines, assessed the reports and communications received from WHO so far.

“The clinical features and treatment received by the children as shared by WHO so far are insufficient to determine the aetiology,” Dr Somani stated.

Initial symptoms, signs, and duration of anura in the cases, laboratory findings including 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 Gambia tertiary hospital. The reasons behind the treatment received before and after acute kidney injury, the names and brands of the drug formulations used in treatment before and after hospitalization, their manufacturers, their expiration dates, and any other relevant information are necessary in each case, he said.

Moreover, Dr Somani said WHO may share a detailed report if a verbal autopsy was conducted.

In order to collect biological samples from children with a similar clinical presentation to acute kidney injury, Dr Somani is seeking details on how many stool samples were collected and analyzed.

Additionally, he requested the details of the product samples that were collected and tested (with their compositions, manufacturers), which were reported to be negative for EG and DEG, as well as the details of the cases that received the products.

As a result, he asked that the report on causal relations, along with the above details, be shared with us as soon as possible for further examination and action at our level.

According to the DCGI, the investigation of the manufacturer in question is ongoing.

According to him, the manufacturer’s manufacturing facility has been inspected, test results for sampled products are awaiting and all manufacturing activities have been halted.

In the wake of the deaths of 66 children in Gambia linked potentially to cough syrups produced by the Sonipat division of Maiden Pharmaceuticals, the Union Health Ministry formed a panel of experts on Wednesday to review the details and adverse event reports received from the WHO.

Upon review and analysis of the adverse event reports, causal relationship and all related details already shared by or to be shared by the World Health Organization, the committee will make recommendations to the Drug Controller General of India (DCGI).

WHO has not yet provided the causal link between deaths and diseases. CDSCO has received from the WHO certificates of analysis for each of the sampled products, photographs of the products, and a summary of the adverse events.

According to official sources, WHO is conducting further investigations.

According to the CDSCO, WHO has already been requested to share with it at the earliest possible date the report on establishing causality between the medical products in question and photographs of the labels/products involved.

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 halting the firm’s manufacturing activities immediately.

Earlier this week, the WHO informed the Central Drugs Standard Control Organization (CDSCO) that they would be providing technical assistance and advice to Gambia, in which children had died as a result of the use of four medicines: Promethazine Oral Solution BP, KOFEXNALIN Baby Cough Syrup, MaKOFF Baby Cough Syrup and MaGrip n Cold Syrup.

The WHO informed that they may have been contaminated with Diethylene glycol or Ethylene glycol, as they are manufactured and exported by Maiden Pharmaceuticals Ltd of Sonepat, Haryana.

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