India committee tells WHO: Information on 'killer' cough syrups 'inadequate'

The government-appointed committee investigating claims that four cough syrups made in India may have ledto the deaths of 66 children in The Gambia has found that the clinical data provided by the WHO so far is insufficient to identify the aetiology.

Drugs Controller General of India (DCGI) V G Somani said that the WHO has been informed about this on Saturday.

On October 13, the WHO's Rutendo Kuwana wrote to the DCGI to inquire about the status of the inquiry into Maiden Pharmaceuticals, the Sonipat-based maker of the four cough syrups.

Add WION as a Preferred Source

In response to an email, DrSomani said on Saturday that the Union ministry of health has established a committee of technical specialists to review and analyse the specifics of the adverse event reports and any relevant information supplied or to be shared by WHO, and to recommend subsequent action.

In its first meeting, the four-member committee, which is led by Dr Y. K. Gupta, Vice Chairperson of the Standing National Committee on Medicines, reviewed the reports and communications that have been so far received from the WHO. The committee also made a number of 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 specifics of the initial illness, signs and symptoms, length of anura in the cases, results of laboratory tests including different markers and parameters, investigations for diethylene glycol and ethylene glycol on critical patient samples, treatment received prior to and following hospitalisation at the tertiary hospital in Gambia, treatment received prior to and following acute kidney injury was suspected, and reasons therefore, names and brands of the drugs,he said.

Dr Somani added that if a verbal autopsy was performed, the WHO might share a complete report.

DrSomani has also enquired about the quantity of biological samples taken from children who had clinical symptoms similar to acute renal injury as well as the quantity of stool samples taken and analysed.

He also wanted information on the circumstances in which these items were used, as well as information on the product samples that were tested and found to be free of EG and DEG (as well as their composition).

"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 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 four-person expert panel was set up by the Union health ministry on Wednesday to look into the specifics and adverse event reports regarding the deaths of 66 children in Gambia that may have been connected to four cough syrups produced by Maiden Pharmaceuticals' Sonipat facility. These reports were received from the WHO.

After reviewing and analysing the reports of adverse events, the causal relationship, and all relevant information that has already been shared by or will be shared by the World Health Organization, the committee will recommend a further course of action to the Drugs Controller General of India (DCGI).

WHO has not yet disclosed the connection between the deaths. To date, the WHO has provided CDSCO with the certificates of analysis, images, and summaries of each product sampled.

According to official sources, the WHO has announced that it is doing more inquiry.

While the Haryana State Drug Controller on October 7 issued Maiden Pharmaceuticals a show cause notice requesting an explanation of the "many contraventions" found during a recent inspection within a week or risk licence suspension or cancellation, the Haryana government on October 11 issued an order to cease all manufacturing operations of the company with immediate effect.

Official sources reported that the WHO has declared that it is doing additional inquiry.

(With inputs from agencies)

WATCH WION LIVE HERE: