The Drugs Controller General of India (DCGI) on Saturday told to World Health Organization (WHO) that the recently formed technical committee 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 WHO so far was inadequate to determine the aetiology. Aetiology is the scientific study of the causes of disease.

This was conveyed to the WHO by DCGI VG Somani. “Committee in its first meeting has examined the reports or communications so far received from the WHO and has made the following observations: The clinical features and the treatment received by the children as shared by WHO so far are inadequate to determine the aetiology,” Somani said.

On October 13, Rutendo Kuwana from the WHO had written to the DCGI and sought to know the progress with the investigation of the manufacturer of the four cough syrups – the Sonipat-based Maiden Pharmaceuticals.

In an email response, Somani also said mentioned that 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 DG and EG (diethylene glycol and ethylene glycol) on clinical samples of the patients, treatment received before and after hospitalisation at the tertiary hospital in The Gambia, treatment received before and after Acute kidney injury (AKI) was suspected and reasons thereof, the names and brands of the drug formulations used in the treatment before and after hospitalisation, their manufacturers, their expiry and any other relevant information in each of the cases, are necessary.

Somani added that in respect of the investigations carried out as shared by WHO so far, require more detailed information such as the number of stool samples collected and analysed.

“The number of children with a similar clinical presentation to AKI (Acute Kidney Injury) from whom the biological samples were collected, 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 etc. are required to analyse the events to test method adopted for testing of samples,” Somani added in the observation.

The DCGI also requested the WHO to share the report on causal relations along with the above details, as observed by the said technical committee at the earliest for further examination and follow-up action at its level.

The first meeting of the four-membered committee to examine the World Health Organisation’s report regarding Maiden Pharmaceuticals Ltd was held on Thursday.

Somani said the four-member committee chaired by Dr YK Gupta, vice chairperson, Standing National Committee on Medicines, in its first meeting has examined the reports and communications so far received from the WHO and has made several observations.

All drug production at the Sonepat unit of Maiden Pharmaceuticals has been halted, even as the Centre on Wednesday set up the four-member committee to investigate the incidents.

Authorities in Haryana have issued a show-cause notice to the company to explain within a week “many contraventions” found during a recent joint inspection by central and state drugs regulators, as reported by HT on Wednesday.

(With inputs from ANI, PTI)