Indian health authorities said on Wednesday they had halted all production at the main factory of Maiden Pharmaceuticals near New Delhi after a WHO report that its cough syrups exported to Gambia may be linked to the deaths of dozens of children there.
Known as a “pharmacy of the world”, India supplies 45% of all generic medicines to Africa.
The deaths of 69 children in Gambia – one of the worst such incidents involving drugs from India – have come as a blow to the industry whose exports more than doubled in the last decade to hit $24.5 billion last fiscal year.
Indian authorities inspected the Maiden factory in the state of Haryana four times this month and suspended all manufacturing activities there on Tuesday “on grounds of deficiencies found in location inspection”.
Haryana’s health minister said an inspection conducted jointly by state and federal officials found 12 “flaws”.
“Keeping this in view, the entire production of the company has been banned and notice has also been issued,” minister Anil Vij said in a statement, referring to Maiden’s main factory in Sonipat district.
Maiden executive Naresh Kumar Goyal declined to comment.
A top Indian health official, who declined to be named, said the government would not tolerate wrongdoing but that it was important to find out what exactly happened in Gambia. He denied allegations by some critics that health regulations in India, especially at the level of states, were lax.
The federal health ministry has formed a committee of four experts that will advise further action after “examining and analysing adverse event reports, causal relationship and all related details shared by the WHO”.
Indian laws allow for imprisonment and fines for selling spurious drugs.
But the source said the WHO had yet to share any report establishing a direct link to the deaths with the Indian-made medicines.
WHO Assistant Director-General Mariângela Simão told a virtual news 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 about the deaths being linked to Maiden’s medicines was based on analysis of several samples of medicines that were used by hospitalized children.
HEALTH ALERT
Maiden says on its website it has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets at its factories in Haryana. It says it has two other factories in the state apart from the suspended one.
The WHO issued a medical product alert last week asking regulators to remove Maiden goods from the market.
The U.N. health agency said that laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – had “unacceptable” amounts of diethylene glycol and 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 pharmaceutical products to glycerine, a solvent or thickening agent in many cough syrups.
Gambian police, in a preliminary investigation report on Tuesday, said that the deaths of 69 children from acute kidney injury was linked to the cough syrups made in India and imported via Atlanta-based Atlantic Pharmaceuticals, which has permission to export medicines to Gambia.
Atlantic Pharmaceuticals could not be reached for comment.
News website Moneycontrol earlier quoted the Haryana drugs controller as saying in a report that Maiden did not perform quality testing of propylene glycol, diethylene glycol and ethylene glycol, while certain batches of propylene glycol did not have the manufacturing and expiry dates.
The cough syrups had been approved for export only to Gambia, India says, although the WHO says they may have gone elsewhere through informal markets.
Reuters is an international news organisation owned by Thomson Reuters
