Dr Reddy's gets court stay on Maharashtra FDA action

In response to a writ petition filed by Dr. Reddy's on the action taken by the Maharashtra drug controller (FDA) to suspend wholesale licence of the company's clearing and forwarding agent, the Bombay High Court on Thursday, January 8th, granted an interim stay for a period of two weeks on the FDA action.

This was following the Maharashtra FDA's visit of the storage premises of the clearing and forwarding agent of Dr Reddy's at Bhiwandi near Thane.

Clarifying that "the order relates only to the wholesale licence of the clearing and forwarding agent," the company spokesperson said, "In our opinion there has been no violation of any statute or regulation by the company and it has been in compliance. The product being investigated is not a drug and is neither manufactured nor marketed by us."

She also says the company will approach the concerned state minister on Monday the 12th as directed by the court. It apparently is to plea with the minister to stay the FDA action.

Speaking to Business Today, FDA Assistant Commissioner and self licensing authority GK Vakharia said the order to suspend was given as there was a violation of the conditions for licence including things such as proper signatures and maintenance of notes.

The suspension is to be from January 12th to February 10th, 2015. The items in question here are hand sanitisers/hand wash made by a third-party vendor, and were promotional items.