India has revoked the manufacturing license of a company whose cough syrup was implicated in the deaths of 18 children in Uzbekistan.
The WHO warned in January against the use of two cough syrups made by Marion Biotech, saying they were substandard.
Marion Biotech denies the allegations.
After the deaths were reported in Uzbekistan, the Indian Ministry of Health suspended production at the company.
On Wednesday, authorities in the state of Uttar Pradesh – where Marion Biotech is based – said they are now “permanently” revoking the company’s license. Pharmaceutical inspector Vaibhav Babbar told the Hindustan Times: “The Noida-based company is currently unable to manufacture.
India is the world’s largest exporter of generic drugs, providing a large portion of the medical needs of developing countries.
But in recent months, many Indian companies have come under scrutiny for the quality of their drugs, with experts voicing concerns about the manufacturing practices used to make the drugs.
The latest action against Marion Biotech comes after government lab tests in December found 22 samples of the company’s cough syrup were “fake and tampered with”.
“Counterfeit and counterfeit drugs can cause serious harm to the public and it is suspected that related documents/records may be destroyed,” said Asheesh Kaundal, Inspector of the Central Drug Control Organization of India.
Earlier this month, police in Uttar Pradesh also arrested three company employees for selling adulterated products.
On Wednesday, SK Chaurasia, head of Uttar Pradesh’s drug licensing division, said Marion Biotech had not responded “satisfactorily” to the announcement of the findings.
India has opened an investigation against Marion Biotech after the WHO issued a global health alert, linking the deaths of 18 children in Uzbekistan to the company’s Dok-1 Max and Ambronol cough syrup.
The health agency said an analysis carried out by the quality control laboratories of the Ministry of Health of Uzbekistan found “unacceptable amounts” of diethylene glycol and ethylene glycol in the drug.
The substance is toxic to humans and can be fatal if consumed.
In an emailed response to the BBC in January, Marion Biotech said it “disagrees” with the WHO’s findings and is cooperating with Indian government investigations.
Marion Biotech is not the first Indian pharmaceutical manufacturer to have trouble with cough syrup.
In October, the WHO issued a global alert and linked four cough syrups made by Maiden Pharmaceuticals to the deaths of 66 children from kidney damage in the Gambia.
The Indian government and Maiden Pharmaceuticals have denied the allegations.