Another US FDA blow: Ipca imports from Ratlam plant banned

In another blow to India's generic drugs industry, the US Food and Drug Administration (FDA) has banned imports from the Ipca Laboratories Ltd plant at Ratlam in Madhya Pradesh, citing violations of standard production practices.

Ipca had voluntarily halted shipments to the United States 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 an import alert, in a notice on its website late on Thursday. It did not elaborate.

Over the past year, several large Indian drugmakers such as Ranbaxy Laboratories Ltd and Wockhardt Ltd have been hit by a spate of Western regulatory sanctions over concerns about production processes at their Indian plants.

With regards to the IPCA's Form 483 (import alert) on the Ratlam API facility in Madhya Pradesh, the FDA had listed six serious deviations during inspection carried out between 14 and 18 July 2014.

The voluntarily stoppage of API shipments from the Ratlam manufacturing facility will also have an impact on the company's formulations export business to the US market.

The company's formulations manufacturing units situated at Piparia (Silvassa) and SEZ, Indore (Pithampur) use the APls manufactured from the Ratlam facility.

Last financial year, the US market contributed sales of Rs420 crore (12 per centof total sales) for Ipca Labs.