The US Food and Drug Administration (FDA) has banned imports from Indian generic drug maker Ipca Laboratories’ plant at Ratlam in the central Madhya Pradesh state due to violations of standard production practices.
According to a Reuters report, Ipca had voluntarily halted shipments to the US from the plant in July last year after the FDA outlined half a dozen violations including data integrity issues.
The FDA announced the ban, called import alert, in a notice on its website. It did not elaborate.
Over the past year, large Indian drugmakers such as Ranbaxy Laboratories and Wockhardt have been hit by a spate of regulatory sanctions due to concerns about production processes at their local plants.
EP News Bureau – Mumbai