India halts production of Maiden Pharma
Indian health authorities said on Wednesday they had halted all production at Maiden Pharmaceuticals’ main plant near New Delhi after a WHO report that its cough syrups exported to Gambia may be linked to death dozens of children there.
Known as a “pharmacy of the world”, India supplies 45% of all generic medicines to Africa.
The death of 69 children in The Gambia – one of the worst such incidents involving drugs from India – has dealt a heavy blow to the industry whose exports have more than doubled over the past decade to reach $24.5 billion in the last fiscal year.
Indian authorities inspected the Maiden factory in Haryana state four times this month and on Tuesday suspended all manufacturing activities there “due to deficiencies found during the site inspection”.
Haryana’s health minister said a joint inspection by state and federal government officials revealed 12 “defects”.
“Keeping this in mind, all production of the company has been banned and a notice has also been issued,” Minister Anil Vij said in a statement, referring to Maiden’s main factory in the district of Sonipat.
Maiden executive Naresh Kumar Goyal declined to comment.
A senior Indian health official, who declined to be named, said the government would not tolerate wrongdoing, but it was important to know exactly what happened in The Gambia. He denied claims by some critics that health regulations in India, especially at state level, were lax.
The Federal Ministry of Health has formed a committee of four experts who will advise further action after “review and analysis of adverse event reports, causal relationship and all related details shared by WHO. “.
Indian laws provide for jail sentences and fines for the sale of fake drugs.
But the source said the WHO has yet to share a report directly linking the deaths to the Indian-made drugs.
WHO Assistant Director-General Mariângela Simão told a virtual press conference on Wednesday that the agency was working closely with Indian authorities to investigate Maiden’s cough and cold syrups.
She said the WHO’s conclusion on Maiden’s drug-related deaths was based on analysis of several samples of drugs used by hospitalized children.
Maiden states on its website that it has an annual production capacity of 2.2 million bottles of syrup, 600 million capsules, 18 million injections, 300,000 tubes of ointment and 1.2 billion tablets in its Haryana factories. He says he has two other factories in the state in addition to the suspended one.
The WHO issued a medical products alert last week asking regulators to remove Maiden products from the market.
The United Nations health agency said laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – contained “unacceptable” amounts of diethylene glycol and of ethylene glycol, which can be toxic and lead to acute kidney injury.
Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications, but also as a cheaper alternative in some pharmaceuticals to glycerine, a solvent or thickener in many syrups against cough.
Gambian police, in a preliminary investigation report released on Tuesday, said the deaths of 69 children from acute kidney injury were linked to cough syrups manufactured in India and imported via Atlanta-based Atlantic Pharmaceuticals , which is authorized to export medicines to The Gambia.
Atlantic Pharmaceuticals could not be reached for comment.
The Moneycontrol news website earlier quoted Haryana’s drug controller as saying in a report that Maiden failed to perform quality tests on propylene glycol, diethylene glycol and ethylene glycol, while some lots of propylene glycol did not have manufacture and expiry dates.
The cough syrups had been approved for export only to The Gambia, according to India, although the WHO says they may have gone elsewhere via informal markets.