indica News Bureau-
After a ban of nearly six years, the US Food and Drug Administration (FDA) has partially lifted an import alert on Ipca Laboratories’ two labs in Madhya Pradesh, India, to ensure the supply of chloroquine tablets, considered to be one of the possible treatments for the infections. The US FDA has voluntarily imposed a ban on MP’s Ratlam plant in July 2014.
The medicine is considered one of the possible treatments for the infection, officially called Covid-19, by the US Centre for Disease Control (CDC). For the import of active pharmaceutical ingredients (APIs) of hydroxychloroquine sulphate and chloroquine phosphate produced at the company’s APl manufacturing unit situated at Ratlam in Madhya Pradesh, the US FDA has partially lifted the ban to allow the import in the US.
In 2014, a Mumbai-based IPCA Labs had said that it had stopped the supply of ingredients to the US market from its Madhya Pradesh plant after the US Food and Drug Administration (FDA) issued an import alert against it. During a recent inspection at IPCA’s facility at Ratlam, Madhya Pradesh, manufacturing Active Pharmaceutical Ingredients, the company had received certain inspection observations in Form 483 from the FDA. Form 483 outlined violations, including data integrity issues at the Ratlam plant.
“Consequent to this, the company has voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed,” IPCA had said in a release, in 2014.
However, with the coronavirus infections spreading at an alarming pace in the world’s largest economy, the US regulator has been forced to partially reconsider its ban. Along with the Ratlam plant, the FDA has also allowed import of hydroxychloroquine sulphate tablets produced at the formulations manufacturing units at Indore special economic zone and Pithampur in Madhya Pradesh, and Silvassa, Ipca Laboratories said in an exchange filing.
“US FDA has also informed that their exception will be re-considered if the shortage implications change,” Ipca Laboratories said.
Ipca Laboratories’ plants are under the US regulator’s import alert for more than three years for multiple violations of good manufacturing practices.