The body said it had shut production in the manufacturing units of the company days.
The Drug Controller General of India, VG Somani, has written to the World Health Organization (WHO) seeking more details as to the causal relationship between the deaths of 66 children in The Gambia with the cough syrups manufactured in India by Maiden Pharmaceuticals.
The body said it had shut production in the manufacturing units of the company days after WHO blamed the deaths on the syrups that were later allegedly found to contain banned substances.
Listing the actions taken by the body, DCGI said the center has constituted a Committee of Technical Experts to examine and analyze the details of the adverse event.
However, DCGI said, "The clinical features and the treatment received by the children as shared by WHO are inadequate to determine the etiology."
He sought details regarding "initial illness, signs and symptoms, results of lab investigations conducted including various markets and parameters, specific investigations for DEG and EG on clinical samples of the patients, treatment received before and after hospitalization at the tertiary hospital in Gambia, treatment received before and after AKL was suspected and reasons thereof, the name and brands of the drug formulations used the treatment before and after hospitalization, their manufacturers, their expiry and any relevant information in each of the cases, are necessary."
DCGI later said it needs a 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.
External Affairs Minister S Jaishankar spoke to his Gambian counterpart on Thursday and expression his condolences over the deaths of children. He assured him of a thorough investigation.
"In a telecon with Gambian FM Dr Mamadou Tangara, conveyed our deepest condolences on the deaths of young children recently. Underlined that matter is being seriously investigated by appropriate authorities. We agreed to remain in touch," the Minister said in a tweet.
The company has plants in Himachal Pradesh and Haryana. It denied any wrongdoing in a statement earlier this week.
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