Maiden Pharmaceuticals said on Friday it will seek to reopen its main factory after India’s main drugs officer said test samples of cough syrups that had been linked to deaths in The Gambia showed they had not been contaminated and met with government standards.
The plant was closed after the World Health Organisation 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. It linked the products to the deaths of 69 children.
But India this week told the WHO that tests of samples from the same batches of syrups sent to The Gambia were compliant with government specifications. The results of the tests, carried out by a government-run laboratory, have been sent to a health ministry panel of experts for further action.
The WHO has not responded to a Reuters request for comment.
“I have full faith in Indian regulatory and judiciary processes. I have not done anything wrong,” Maiden MD 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.”
Drugs Controller General of India, V.G. Somani, said in a December 13 letter to the WHO that the U.N. agency’s accusations had “adversely impacted the image of India’s pharmaceutical products across the globe, and caused irreparable damage to the supply chain of pharmaceutical products.”
The country, known as the “pharmacy of the world”, supplies 45% of all generic medicines to Africa. India’s pharmaceutical exports have more than doubled in the last decade to hit $24.5 billion in the last fiscal year.
Union Minister of State for Health and Family Welfare told Parliament on Friday that Maiden’s manufacturing operations remain shut for now due to other violations. The government found in October that the firm had violated rules “across its manufacturing and testing activities”.
