New Delhi: Maiden Pharmaceuticals Ltd said on Friday it will seek clearance to re-open its factory after an Indian government laboratory found nothing wrong in samples taken from syrups that the World Health Organisation had suspected of being linked to children’s deaths in Gambia.
“I have full faith in Indian regulatory and judiciary processes. I have not done anything wrong,” Maiden Managing Director Naresh Kumar Goyal told Reuters.
“We will now try to request the authorities to reopen the factory. But I don’t know when that will happen. We are still waiting.”
Indian health authorities halted production at Maiden’s main factory in Sonepat near New Delhi in October after a WHO report said the company’s cough and cold syrups might be connected to the deaths of 69 children in Gambia this year.
But in a letter to the WHO dated Dec. 13, India’s drugs controller general, V.G. Somani, said that tests on samples of Maiden’s products had “been found to be complying with specifications” and no ethylene glycol or diethylene glycol was detected in them.
The WHO did not respond to a request for comment. The U.N. agency said in October that its investigators had found “unacceptable” levels of diethylene glycol and ethylene glycol, which can be toxic and lead to acute kidney injury, in the products manufactured by Maiden.
A spokesperson for India’s health ministry did not respond to a request for comment.
Drugs officer Somani said in his letter to the WHO that the results of the tests had been sent to a panel of experts for further action. The tests were carried out by the state-run Regional Drug Testing Laboratory in the northern city of Chandigarh, the government said earlier.