New Delhi: The government-appointed committee investigating claims that four cough syrups produced in India may have contributed to 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 informed the WHO of this on Saturday.
A committee of technical experts has been constituted to examine and analyse the details of the adverse event reports and all related details shared by or to be shared by WHO. Dr Somani had written to the DCGI seeking to know the progress with the investigation of the manufacturer of the four cough syrups.
Somani stated that the four-member committee, led by Dr. Y. K. Gupta, Vice Chairperson, Standing National Committee on Medicines, has evaluated the reports and communications as far received from WHO and has made a number of remarks. Dr. Somani mentioned the observations and stated, ‘The clinical symptoms and the therapy received by the children as disclosed by WHO so far are inadequate to define the aetiology’.
The names and brands of the drug formulations used in the treatment before and after hospitalization, their manufacturers, their expiry and other relevant information in each of the cases, are necessary, he said. The details of initial illness, sign and symptoms, duration of anura in the cases and results of laboratory investigations are also required.
Dr Somani has sought details on the number of stool samples collected and analysed. He also sought the details of the product samples tested (with their compositions, manufacturers) which were reported to be negative for EG and DEG. ‘The manufacturing site has been inspected, test reports of sampled products from the laboratory are awaited,’ he said.
Experts will recommend further course of action to the Drugs Controller General of India (DCGI). A panel of experts will examine the details and adverse event reports received from the WHO on the deaths of 66 children in Gambia being linked potentially to four cough syrups made by the Sonipat unit of Maiden Pharmaceuticals. The World Health Organization has so far shared with CDSCO certificates of analysis of each of the sampled products, their photographs and summary of the adverse events.
Haryana State Drug Controller has stopped all manufacturing activities of Maiden Pharmaceuticals with immediate effect. The Haryana government issued a show cause notice to the company on October 7 for ‘many contraventions’ found during an inspection, or face suspension or cancellation of license. The WHO had informed the Central Drugs Standard Control Organisation (CDSCO) that they were providing technical assistance and advice to Gambia where children have died from contaminated cough syrups may have been used.
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